Proceedings of the Australasian Association of Clinical Biochemists’ 50th Annual Scientific Conference

. 2012 Nov;33(4):S1–S53.

Proceedings of the Australasian Association of Clinical Biochemists’ 50^th Annual Scientific Conference

PMCID: PMC3529554

Invited Speakers	Page
S1 THE USE OF THYROGLOBULIN (TG) AND TG AUTOANTIBODY MEASUREMENTS FOR MONITORING PATIENTS WITH DIFFERENTIATED THYROID CANCERS	S11
C Spencer
S2 BEYOND ORDERS, SPECIMENS, AND HANDOFFS: ADVANCING LAB COLLABORATION WITH CLINICIANS TO BETTER RECOGNISE, UNDERSTAND, AND PREVENT DIAGNOSTIC ERRORS IN MEDICINE	S11
G Schiff
S3 HARMONISATION – THE COMPLETE PICTURE	S11
M Plebani
S4 NEW US CARDIOVASCULAR DISEASE GUIDELINES AND BIOMARKERS TO ASSESS DISEASE RISK	S11
GL Myers
S5 HARMONISATION OF HBA_1C	S12
DB Sacks
S6 QUALITY INDICATORS FROM A GLOBAL PERSPECTIVE	S12
M Plebani
S7 KEY INCIDENT MONITORING AND MANAGEMENT SYSTEMS (KIMMS)	S12
P Petinos
S8 LABORATORY QUALITY INDICATORS – COLLECTION AND THEN WHAT? A PRACTICAL PERSPECTIVE	S13
J Michael
S9 QUALITY INDICATORS FROM AN INSTITUTIONAL PERSPECTIVE – THE UK EXPERIENCE	S13
J Glaysher
S10 LAB TESTS ONLINE – PATHOLOGY INFORMATION FOR THE PEOPLE	S13
B Campbell
S11 PATHOLOGY REPORTS IN AUSTRALIA’S PERSONALLY CONTROLLED ELECTRONIC HEALTH RECORD (PCEHR) – BETTER VALUE FOR CONSUMERS	S13
R Hosking
S12 THE AUSTRALIAN PATHOLOGY UNITS AND TERMINOLOGY STANDARDISATION PROJECT (PUTS)	S13
M Legg
S13 TRAINING OF MEDICAL SCIENTISTS – AUSTRALIAN UPDATE	S14
T Badrick
S14 TRAINING OF SCIENTISTS – UK PERSPECTIVE	S14
M Thomas
S15 TRAINING OF MEDICAL SCIENTISTS – USA PERSPECTIVE	S14
G Miller
S16 MEDICAL LABORATORY SCIENCE IN NEW ZEALAND – A CHANGING DYNAMIC IN WORKFORCE EDUCATION	S15
M Legge
S17 REVIEW OF QAP ACTIVITIES	S15
G Jones
S18 LOOKING CLOSELY AT THE END-OF-CYCLE CALCULATIONS	S15
G Jones
S19 CELEBRATING 30 YEARS OF CHEMICAL PATHOLOGY QAP	S15
J Gill
S20 NEW PROGRAMS / ANALYTE ISSUES	S15
A Gesmundo, SDA Koetsier
S21 IS IT A MATRIX EFFECT?	S16
J Gill
S22 THE QAP FROM YOUR PERSPECTIVE	S16
SDA Koetsier
S23 QAP - CLINICAL UPDATE: AN INTERACTIVE DISCUSSION OF CASES FROM THE QAP CASE REPORT COMMENTS PROGRAM	S16
S Vasikaran, Q Lam, H Martin, P Coates, G Ward
S24 CLINICAL IMPLICATIONS OF ADRENAL DIAGNOSTICS	S16
PJ Fuller
S25 CLINICAL TESTING FOR BONE TURNOVER MARKERS	S16
PR Ebeling
S26 STANDARDISATION OF BONE TURNOVER MARKERS	S17
SD Vasikaran
S27 ONLY 590 DAYS TO ARMAGEDDON – ILLEGAL SUPPLY, HOME BREWS, AND THE VALUE OF PATHOLOGY	S17
P Harman
S28 LESSONS LEARNED FROM THE CANTERBURY EARTHQUAKES	S17
C Florkowski
S29 FLOOD PREPAREDNESS (QLD FLOODS)	S17
T Badrick
S30 THE VITAMINS WORKING PARTY: WORKING TOWARDS HARMONISATION	S18
SE Briscoe, RF Greaves, GA Woollard, KE Hoad, TA Walmsley, LA Johnson, TL Harrower, SDA Koetsier, JP Gill
S31 HOW MUCH HARMONY EXISTS BETWEEN LABORATORIES PERFORMING URINE BIOGENIC AMINE ANALYSES?	S18
MJ Whiting, J. Earl, L Johnson and Members of the AACB Biogenic Amines Working Party
S32 AACB TRACE ELEMENTS WORKING PARTY	S18
R McQuilty
S33 KIWIS 1 – AUSSIES 1: COMMON REFERENCE INTERVALS NOW A DRAW	S18
J Ryan and members of the Common Reference Interval Working Party
S34 CLUES FROM ROUTINE BIOCHEMISTRY IN DIAGNOSIS OF INBORN ERRORS OF METABOLISM	S19
K Carpenter
S35 METABOLOMICS: TRANSLATION FROM RESEARCH TO CLINICAL PRACTICE	S19
J Pitt
S36 MITOCHONDRIAL DISORDERS FROM CLINICAL BIOCHEMISTRY TO IMPROVED MOLECULAR DIAGNOSIS	S19
AG Compton, SE Calvo, EJ Tucker, SC Lim,VK Mootha, DR Thorburn
S37 URINE ALBUMIN: PROVIDING A HIGH QUALITY SERVICE	S19
G Miller
S38 HBA_1C FOR THE DIAGNOSIS OF DIABETES	S20
JE Shaw

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Oral Presentations	Page
O1 FALSELY ELEVATED ESTRADIOL LEVELS IN POSTMENOPAUSAL WOMEN WITH METASTATIC ER+ BREAST CANCER	S21
CY Chiang, D Faulkner, J Doery, J Grant, G Raines, J Lewis, R Desai, D Handelsman, R Jennens, P Francis
O2 TIME TO REVIEW SYNACTHEN STIMULATION TESTS: CAUTION ON 550 NMOL/L CUT-OFF!	S21
S Fletcher, EM Lim, R Wardrop, N Hadlow, J Joseph, D Henley
O3 THE STABILITY OF ANTI-MULLERIAN HORMONE IN HUMAN SERUM	S21
M Andrew, G Ward, K Young, L Price
O4 TREATMENT OF ACUTE RENAL FAILURE IN MULTIPLE MYELOMA USING HIGH CUT-OFF DIALYSIS	S21
R Hayhurst
O5 SERUM 25-HYDROXY VITAMIN D – A PREDICTOR OF MICRO- AND MACROVASCULAR COMPLICATIONS IN PATIENTS WITH TYPE 2 DIABETES	S22
M Herrmann, DR Sullivan, T McCorquodale, IR Straub, D Bosnjak, S Chan, V Dy, AS Veillard, AC Keech
O6 HOW HARMONISED ARE THE CURRENT COMMERCIAL 25-HYDROXYVITAMIN D ASSAYS?	S22
ZX Lu, W Louey, H Hassan, Andy Liu, KA Sikaris
O7 ALKALINE PHOSPHATASE REFERENCE INTERVALS IN PREGNANCY	S23
ZX Lu, E Ekinci, KA Sikaris, D Atanasovski, I Bittar, Q Lam, N Crinis, K Cheong, C Houlihan
O8 AACB HARMONISATION OF MANAGING CRITICAL RESULTS	S23
CA Campbell, AR Horvath
O9 MAINTAINING HARMONISATION OF GROWTH HORMONE ASSAYS: AN EVALUATION OF THREE LABORATORY METHODS	S23
MJ Ellis, L Manley, CM Florkowski
O10 THE USE OF DATA LINKAGE AS A TOOL TO EVALUATE LABORATORY WORK PROCESSES AND PATIENT CARE PERFORMANCE INDICATORS	S24
A Georgiou, E Vecellio, A Eigenstetter, G Toouli, L Li, R Wilson, JI Westbrook
O11 EVALUATION OF USING INTERPRETATIVE CUTOFF VALUE AS DECISION LIMIT AMONGST PRACTISING CLINICIANS IN NEPAL	S24
P Gyawali, D Bajracharya, P Bhattarai, R K Shrestha, D Acharya
O12 EFFECT OF REPEAT CALIBRATION ON ASSAY PRECISION PROFILE	S24
GRD Jones
O13 SIMULTANEOUS PROFILING OF TEN BIOGENIC AMINES AND THEIR METABOLITES IN URINE BY POLARITY-SWITCHING LC-MSMS	S24
MJ Whiting, DJ Elliot
O14 APPLICATION OF MASS SPECTROMETRY OF INTACT PROTEIN AND TYPTIC PEPTIDES IN THE ANALYSIS OF DES-LEU ALBUMIN IN PLASMA – A NOVEL MARKER FOR CHRONIC PANCREATITIS	S25
TA Walmsley, SO Brennan, U Lankes, R King, S Connor, PM George
O15 UNDERSTANDING QC AND EQA – AN AUTHENTIC LEARNING MODEL FOR UNDERGRADUATE STUDENTS	S25
F Breen
O16 IMPROVED PREDICTIVE VALUE FOR MULTIPLE SCLEROSIS OF CEREBROSPINAL FLUID OLIGOCLONAL BANDING PATTERNS – A SOUTH AUSTRALIAN EXPERIENCE	S25
SDC Thomas, DJ Chappell
O17 LIPID CHANGES IN PREGNANCY	S26
I Bittar, E Ekinci, Q Lam, Z Lu, K Cheong, N Crinis, K Sikaris, C Houlihan
O18 A BENCHMARK AUDIT OF THE TYPES AND FREQUENCY OF PATHOLOGY ERRORS RECORDED IN CENTRAL SPECIMEN RECEPTION	S26
E Vecellio, A Georgiou, G Toouli, A Eigenstetter, L Li, R Wilson, JI Westbrook

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Poster Presentations	Page
P1 POPULATION BASED OPPORTUNISTIC SCREENING FOR TYPE 2 DIABETES	S27
PE Hickman, JL Kerrigan, AJ Simpson, R Krowka, EK Southcott, JM Potter, JD Wilson, CJ Nolan
P2 COMPARISON OF LIAISON DIRECT RENIN ASSAY TO DIASORIN RIA RENIN ACTIVITY ASSAY AND EVALUATION FOR ROUTINE USE IN A HOSPITAL LABORATORY	S27
R Zakariaee Abkoo, R Scott, N Crinis, Q Lam
P3 SERUM INSULIN AND C-PEPTIDE STABILITY OVER SEVEN DAYS	S27
D Atanasovski, W Louey, ZX Lu, KA Sikaris
P4 STABILITY OF B2-TRANSFERRIN AND B-TRACE PROTEIN	S27
L Boscato
P5 ENDOCRINE WORKING PARTY – REVIEW OF QAP PERFORANCE AT LOW ANALYTE CONCENTRATIONS	S28
L Boscato, S Scott
P6 ENDOCRINE WORKING PARTY – MACROPROLACTIN: WHAT DO YOU DO?	S28
L Boscato, S Scott
P7 ENDOCRINE WORKING PARTY – USE OF COMMERCIAL PROLACTIN ANTIBODIES FOR A MACROPROLACTIN QAP	S28
L Boscato
P8 VARIABILITY OF ANTI-MULLERIAN HORMONE DURING UNSTIMULATED CYCLES OF WOMEN REFERRED FOR FERTILITY MANAGEMENT	S29
S Collier, N Hadlow, K Longhurst, J Natawala, A McClements, P Matson
P9 DOES WEIGHT OR BMI AFFECT SERUM CORTISOL LEVELS?	S29
S Collier, N Hadlow, K Kahapola, L Merton,R Wardrop
P10 VARIATION OF SERUM CORTISOL WITH SEASON AND DAYLIGHT SAVINGS	S29
S Collier, N Hadlow, R Wardrop, D Henley
P11 VARIATION OF SERUM CORTISOL WITH AGE AND GENDER	S29
S Collier, N Hadlow, R Wardrop,D Henley
P12 THE RELATIONSHIP BETWEEN TSH AND FREE T4 IS NOT LOG-LINEAR AND DIFFERS BETWEEN GENDERS AND AGE GROUPS	S30
S Collier, K Rothacker, N Hadlow,R Wardrop,E Lim, J Walsh
P13 WAITING FOR AN ELEVATED FSH – TOO LATE A PREDICTOR OF REDUCED OVARIAN RESERVE?	S30
S Collier, N Hadlow, K Kahapola, R Wardrop, B Stuckey, EM Lim
P14 DISCREPANT PROLONGED FAST RESULTS DUE TO LOW END BIAS OF IMMULITE 2000 INSULIN	S30
JA Grant, M Harrop, M Bisignano, R Czajko, CY Chiang
P15 CRITICAL RESULTS NOTIFICATION AT A TERTIARY PAEDIATRIC HOSPITAL	S30
L Nguyen, C Cross, R Brian, C Ceely, T Yen, J Coakley
P16 HBA_1C AS A DIAGNOSTIC TEST FOR DIABETES – SOME ANALYTICAL CONSIDERATIONS	S31
L Nguyen, C Drew, J Lee, G Jones
P17 ANDROSTENEDIONE: POLYETHYLENE GLYCOL TREATMENT OF PATIENT SAMPLES PRIOR TO IMMUNOASSAY IMPROVES ASSAY AGREEMENT WITH LIQUID CHROMATOGRAPHY TANDEM MASS SPECTROMETRY	S31
B Teis, J Galligan, B McWhinney, M Nelson, G Ward
P18 IMPACT OF NEW INTERNATIONAL ASSOCIATION OF DIABETES AND PREGNANCY STUDY GROUP GUIDELINES ON LABORATORY AND CLINICAL WORKLOAD	S31
NG Wijeratne, ZX Lu, JCG Doery
P19 POINT OF CARE DETECTION OF NEONATAL HYPOGLYCAEMIA: PROBLEMS OF GALACTOSE INTERFERENCE	S31
NG Wijeratne, L Mackay, K Hirimuthugoda, JCG Doery, ZX Lu
P21 EVALUATION OF 1, 25-DIHYDROXY VITAMIN D ASSAY ON THE IDS-ISYS AUTOMATED SYSTEM	S32
RA Bahnisch, AN Fudge, PD O’Loughlin
P22 SEASONALITY OF 25-HYDROXYVITAMIN D3 IN TROPICAL SINGAPORE – IS THERE EVIDENCE IN THE LABORATORY DATA?	S32
TP Loh, SK Sethi
P23 ASSOCIATIONS OF SERUM 25-HYDROXVITAMIN D AND PARATHYROID HORMONE LEVELS IN PEOPLE WITH MILD TO MODERATE CHRONIC KIDNEY DISEASE	S32
ZX Lu, MJ Damasiewickz, KP Polkinghorne, KA Sikaris, PG Kerr
P24 CHANGES IN TOTAL B12 AND HOLOTRANSCOBALAMIN IN PREGNANCY	S33
ZX Lu, E Ekinci, KA Sikaris, D Atanasovski, Q Lam, K Cheong, C Houlihan
P25 PLASMA PTH REFERENCE INTERVAL IN INDIVIDUALS WITH NORMAL KIDNEY FUNCTION AND SUFFICIENT VITAMIN D LEVELS	S33
ZX Lu, KA Sikaris
P26 CLOUDY SKYS OR CLOUDY SAMPLE – NEITHER HELPS YOUR VITAMIN D LEVELS!	S33
C Vasiliadis, R Czajko, M Mohr
P27 PHOSPHOLIPIDS CAUSE SIGNIFICANT MATRIX SUPPRESSION AND LOSS OF ASSAY SENSITIVITY WHEN MEASURING 25 HYDROXYVITAMIN D BY ISOTOPE-DILUTION, LIQUID CHROMATOGRAPHY MASS SPECTROMETRY	S34
CE D’Orazio, BR Cooke, P Glendenning
P28 MEASUREMENT OF 25-HYDROXYVITAMIN D BY HIGH THROUGHPUT LIQUID CHROMATOGRAPHY TANDEM MASS SPECTROSCOPY	S34
AN Fudge, P Galettis, PD O’Loughlin
P29 APPRAISAL OF OPTIMAL VITAMIN D LEVELS FOR BONE HEALTH AS MEASURED BY MASS SPECTROMETRY	S35
CT Chen, RI King, DM Cowley, MG Henman, JV Warner
P30 MEASUREMENT OF CORTICOSTERONE AND 11-DEOXYCORTICOSTERONE BY TANDEM MASS SPECTROMETRY: EXPANDING THE DIAGNOSTIC RANGE OF TESTS FOR ADRENAL ENZYME DEFECTS	S35
JP Galligan, B Sipinkoski, BC McWhinney, JPJ Ungerer
P31 COMPARISON OF COMMERCIAL CALIBRATORS FOR ALPHA-TOCOPHEROL	S35
A Albahrani, V Rotarou, P Roche, R Greaves
P32 A HPLC-UV METHOD FOR DETERMINING THE FREE (UNBOUND) CONCENTRATION OF TEN BETA-LACTAM ANTIBIOTICS IN PLASMA	S35
SE Briscoe, BC McWhinney, JPJ Ungerer
P33 BETA-LACTAM ANTIBIOTIC THERAPEUTIC DRUG MONITORING IN CRITICALLY ILL PATIENTS – SHOULD WE MEASURE UNBOUND CONCENTRATIONS?	S36
S Briscoe, J Roberts, B McWhinney, G Wong, J Jamal, J Lipman, J Ungerer
P34 LC-MSMS PROFILING OF URINARY BIOGENIC AMINES AND THEIR METABOLITES FOR NEUROBLASTOMA SCREENING IN CHILDREN	S36
DJ Elliot, MJ Whiting
P35 REFERENCE CHANGE VALUE (RCV) FOR TROPONIN – LESSONS FROM HEALTHY CHILDREN	S36
G Koerbin, JM Potter, W Abhayaratna, R Telford, PE Hickman
P36 OVER TIME, HOW REPEATABLE ARE TROPONIN RESULTS ABOVE THE 99TH PERCENTILE?	S36
G Koerbin, JM Potter, WP Abhayaratna, RD Telford, T Badrick, FS Apple, AS Jaffe, PE Hickman
P37 CARDIAC TROPONIN AND NON-CARDIAC ILLNESS: A HOSPITAL AND COMMUNITY SURVEY	S37
G Koerbin, J Kerrigan, E Southcott, A Simpson, JM Potter, Hickman PE
P38 AUSTRALIAN REFERENCE INTERVALS IN HEALTHY ADULTS (ARIA) STUDY	S37
G Koerbin, JM Potter,W Abhayaratna, J Cavanaugh, N Glasgow, S Apostoloska, J Canard, NP West, DB Pyne, PL Horn, AW Cripps, SJ Lahtinen, PA Fricker, PE Hickman
P39 CAN LABORATORIES USE A COMMON REFERENCE INTERVAL, WHEN SERUM ALBUMIN CONCENTRATION IS QUANTITATED BY BOTH BCG AND BCP METHODS?	S37
C Millen
P40 LOW LEVEL TROPONIN T SURVEY – TOWARDS HARMONISATION OF THE LOWER LIMIT OF REPORTING	S38
K Pearson, P Coates (Chair), D Penglis, G Brettig, J Mitroussis, F Ku, N Pascoe, B Rumbelow, G White, J Gill, S Koetsier
P41 DEVELOPING CRITERA TO VALIDATE THE USE OF COMMON REFERENCE INTERVALS WITHIN A LABORATORY NETWORK	S38
D Penglis, B Sonza
P44 IS THERE HARMONY IN REPORTING UNITS OF BIOCHEMISTRY AND HAEMATOLOGY IN ACCREDITED LABORATORIES OF SRI LANKA?	S38
ID Siriwardhana, KAC Wickramaratne
P42 REFERENCE INTERVALS FOR BCP AND BCG ALBUMIN IN PREGNANCY	S38
KA Sikaris, E Ekinci, ZX Lu, D Atanasovski, I Bittar, Q Lam, N Crinis, K Cheong, C Houlihan
P43 REFERENCE INTERVALS FOR JAFFE AND ENZYMATIC CREATININE IN PREGNANCY	S38
KA Sikaris, E Ekinci, ZX Lu, I Bittar, D Atanasovski, Q Lam, N Crinis, K Cheong, C Houlihan
P44 IS THERE HARMONY IN REPORTING UNITS OF BIOCHEMISTRY AND HAEMATOLOGY IN ACCREDITED LABORATORIES OF SRI LANKA?	S39
ID Siriwardhana, KAC Wickramaratne
P45 THE AACB WORKSHOP ON HARMONISED REFERENCE LIMITS – RECOMMENDATIONS FOR PAEDIATRIC REFERENCE INTERVALS	S39
T Yen, D Cowley, J Doery, E Haworth, B Lewis, R Mackay, M Metz, B Mottram, J Coakley
P47 VIEWING PATHOLOGY RESULTS – WHAT IS THE REAL TURN-AROUND TIME?	S39
GRD Jones, M-S Ong, F Magrabi, F Coiera
P48 INFLUENCE OF TRIGLYCERIDE CONCENTRATION ON HDL AND LDL CHOLESTEROL MEASUREMENT –A QAP STUDY	S40
GRD Jones, J Gill
P49 THE AACB WORKSHOP ON HARMONISED REFERENCE LIMITS – RECOMMENDATIONS FOR ADULT REFERENCE INTERVALS	S40
J Tate, G Koerbin, J Ryan, G Jones, K Sikaris, D Kanowski, M Reed, J Gill, G Koumantakis, T Yen, A St John, P Graham
P50 CLINICAL COMPARISON OF THE FREELITE AND N LATEX SERUM FREE LIGHT CHAIN (FLC) ASSAYS IN THE DIAGNOSIS AND MONITORING OF AL AMYLOIDOSIS	S40
J Tate, S Bazeley, S Klingberg, CJ Pretorius, P Mollee
P51 ANALYTICAL PERFORMANCE CHARACTERISTICS OF THE DIMENSION EXL LOCI TROPONIN I (CTNI) ASSAY	S41
J Tate, M Huymans, T Hawkins, CJ Pretorius, U Wilgen, J Greenslade, W Parsonage, L Cullen, JP Ungerer
P52 USE (AND MISUSE) OF MEASUREMENT OF SERUM FREE LIGHT CHAINS	S41
J Tate, S Bazeley, S Klingberg, CJ Pretorius, C Hawley, P Mollee
P53 COMPARISON OF THE FREELITE AND N LATEX SERUM FREE LIGHT CHAIN (FLC) ASSAYS IN CHRONIC KIDNEY DISEASE	S41
J Tate, S Bazeley, S Klingberg, CJ Pretorius, C Hawley, P Mollee
P54 CORRELATION OF TNI ASSAYS ON THE ABBOTT ARCHITECT AND THE RADIOMETER AQT90	S41
H Ploeg, S Southby, L Stuart, V Buchan, F Loe, PM George
P55 EVALUATION OF THE BG MEDICINE GALECTIN-3™ ELISA	S42
J Pope, N Jenkins, M Black, H Schneider
P56 COMPARISON OF TWO LACTATE DEHYDROGENASE (LDH) METHODS ON BECKMAN COULTER AU680 ANALYSER	S42
S Pulmones, A Pajarillaga, AT Chong, LZ Ong, S Saw, SK Sethi
P57 ALLOWABLE ERROR FOR ELECTROLYTE TESTING ON BECKMAN COULTER AU680 ANALYSER	S42
S Pulmones, A Pajarillaga, AT Chong, LZ Ong, S Saw, SK Sethi
P58 EVALUATION OF ANALYSERS USED FOR FIRST TRIMESTER SCREENING FOR DOWN SYNDROME	S43
R Sinnadurai, JM Morris,V Tasevski
P59 SHOULD ASSAY EVALUATIONS INCLUDE SAMPLES ABOVE THE ASSAY DYNAMIC RANGE?	S43
K Waller, JV Warner, JA Renouf, JC Palmer
P60 EVALUATION OF THERMO SCIENTIFIC B.R.A.H.M.S KRYPTOR ASSAY FOR CHROMOGRANIN A	S43
G Ward, M Freemantle, B Teis, K Young, L Price
P61 WHICH BILIRUBIN METHOD IS THE TEST OF CHOICE?	S44
J Ryan, G Carter, D Deam
P62 METHOD COMPARISON BETWEEN SIEMENS ADVIA PLASMA LACTATE AND ABBOTT ISTAT (POCT) WHOLE BLOOD LACTATE	S44
N Kalamboyias, M Saleem, G Brettig
P63 AUDIT OF A TWO TIER BIOCHEMICAL PHONE LIST FOR A COMMUNITY LABORATORY	S44
J Barron
P64 WHOLE BLOOD PORPHYRIN CLINICAL EVALUATION – ENHANCING EXTERNAL QUALITY ASSURANCE	S44
V Cronin, T Andersen, K Barancek, CM Florkowski, JA Grant, V Poulos, CW Sies, J Zoanetti
P65 MANAGING QUALITY WITH KIMMS (KEY INCIDENT MONITORING AND MANAGEMENT SYSTEMS): A UK PERSPECTIVE	S45
J Glaysher, A Wootton, ID Watson
P66 CLOSING THE GAP BETWEEN CHEMICAL PATHOLOGY LABS IN A DEVELOPING AND A DEVELOPED COUNTRY	S45
B Dayanath, JCG Doery
P67 EVALUATION OF PRE-ANAYTICAL SAMPLE ALIQUOT EVAPORATION ON THE ROCHE COBAS 8000 USING MODULAR PREANALYTICS	S45
M Botros, J Calleja, KA Sikaris
P68 CORRELATION BETWEEN ANALYTES IN URINE FROM PREGNANT WOMEN	S45
M Botros, E Ekinci, Moore P, KA Sikaris, ZX Lu, Q Lam, K Cheong, C Houlihan
P69 TOURNIQUET APPLICATION TIME DURING PHLEBOTOMY AFFECTS BIOCHEMICAL TESTING	S46
M Gupta, D Yadav, S Mishra, P Sharma
P70 72 HOUR SWEAT CHLORIDE STABILITY	S46
H Robins, C Newman, D Talsma, G Koerbin, P Hickman
P71 CREATININE AND EGFR – STRANGE RELATIONS	S46
P Turner, T Badrick
P72 IN VITRO STABILITY OF HIGH SENSITIVE CARDIAC TROPONIN	S47
A Bima, J Calleja, M Botros, R Greaves, KA Sikaris
P73 SERUM URIC ACID LEVELS AND ITS ASSOCIATION WITH CORONARY ARTERY DISEASE: AN INDIAN COHORT STUDY	S47
S Das, SK Gupta, G MP, PC Ray
P74 PLASMA HOMOCYSTEINE AND THE RISK OF VENOUS THROMBOEMBOLISM: INSIGHTS FROM THE FIELD STUDY	S47
M Herrmann, MJ Whiting, AS Veillard, C Ehnholm, DR Sullivan, AC Keech; for the FIELD Study Investigators
P75 POSSIBLE MACRO-TROPONIN I (TROPONIN I-IGG COMPLEX) INTERFERENCE IN A PATIENT WITH SEVERE AORTIC STENOSIS	S47
X Low, L Ha, B Raill, WW Chiu, DR Boswell
P76 ANALYTICAL EVALUATION OF A NEW 5-FU METHOD ON ADVIA 1200 ANALYSER - A STEP TOWARDS PROVISION OF REAL-TIME PHARMACOKINETICALLY GUIDED DOSE ADJUSTMENT	S48
D Faulkner, M Michael
P77 A HETEROHILE ANTIBODY TO VANCOMYCIN – ACROSS THREE ASSAYS	S48
D Hughes, C Woods, C Newman
P78 THE REACTIVITY OF THE ABBOTT I2000 INSULIN ASSAY WITH THE INSULIN ANALOGUES LEVEMIR AND GLARGINE	S48
D Hughes, S Apostoloska
P79 A QUALITY INITIATIVE FOR ‘BOUTIQUE’ ASSAYS	S49
D Hughes, C Yu, N Jenkins, M Black, RScott
P80 A COMPARISON OF THE NEW ARK METHOTREXATE ASSAY RUN ON THE ABBOTT C16000 WITH THE ABBOTT TDX ASSAY	S49
D Hughes, M Silling
P81 DEMONSTRATION OF COMPETITIVE AND NON-COMPETITIVE BINDING OF AN ENZYME: A MODEL FOR DIGOXIN	S49
EK Southcott, JL Kerrigan, JM Potter,
P82 IS THIS A JOB FOR HIGHLY TRAINED SCIENTISTS?	S49
JM Potter
P83 ASSOCIATION OF HLA-B27, IL-23R AND ERAP1 SINGLE NUCLEOTIDE POLYMORPHISMS IN PATIENTS WITH ANKYLOSING SPONDYLITIS	S50
P Deo, JL Pathak, Hu Lihua, Li Yironng, YP Deo, D Dali, RL Shrestha
P84 DETECTION OF HAEMOGLOBIN E-β THALASSAEMIA, HB E TRAIT AND HB E DISEASE BY HAEMOGLOBIN ELECTROPHORESIS ON AGAROSE GEL: FIVE CASE REPORTS	S50
KP Huang, WY Luo, LC Wu
P85 AUTOMATED CHROMOGRANIN A : IS KRYPTOR THE WAY TO GO?	S50
Z Inman, SAP Chubb
P86 AGE RELATED REFERENCE RANGES FOR SERUM PROCOLLAGEN TYPE I N-TERMINAL PROPEPTIDE (P1NP) AND TYPE I COLLAGEN C- TELOPEPTIDE (CTX) IN THE AUSTRALIAN FEMALE POPULATION
N Jenkins, M Black, HG Schneider, E Paul, J Pasco
P87 UNDERGRADUATE CLINICAL BIOCHEMISTRY: CONTEXTUALISING SCIENTIFIC COMPETENCIES FOR THE MODERN LABORATORY	S51
DA Kunde
P88 DIETARY INTERFERENCE OF THE CLINREP® URINARY METANEPHRINE KITSET BY A COMPONENT IN INDIAN FOOD	S51
G Woollard, H Madhavaram
P89 INDIRECT ISE SODIUM – CAN WE CORRECT FOR THE EFFECT OF PROTEIN?	S51
Malkin B, Jones GRD
P90 MESOTHELIOMA TUMOURS MODULATE DENDRITIC CELL LIPID CONTENT, PHENOTYPE AND FUNCTION	S51
C Mamotte, J Gardner, D Nelson
P92 TESTING FOR HELICOBACTER INFECTION IN CHILDREN USING SEROLOGY AND THE UREA BREATH TEST	S52
K Roumeliotis, QT Lam, AR McNeil
P93 RESISTANCE OF METHICILLIN STAPHYLOCOCCUS AUREUS (MRSA) STRAINS PREVALENCE RATE IN MEDICAL STAFFS AND RAPID IDENTIFICATION METHODS OF MRSA	S52
MD Shi, SS Liau
P94 THE DIAGNOSTIC, PROGNOSTIC, AND CLINICAL UTILITY OF SERUM S100B FOLLOWING TRAUMATIC BRAIN INJURY	S52
DE Tuck, C Skilbeck, J Vickers
P95 DECIDING THE ORDER OF UNLABELLED GLUCOSE TOLERANCE TEST TUBES	S53
N Watson, QT Lam, AR McNeil
P96 HOW MANY BLOOD SPECIMENS ARE REQUIRED FOR A LACTOSE TOLERANCE TEST?	S53
B Wee, QT Lam, AR McNeil

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CBR. 2012 Nov;33(4):S11.

S1 The use of Thyroglobulin (Tg) And Tg Autoantibody Measurements for Monitoring Patients with Differentiated Thyroid Cancers

C Spencer ¹

Abstract

Thyroglobulin (Tg) protein is synthesised uniquely by thyroid tissue and is measured as a post-operative differentiated thyroid cancer (DTC) tumour-marker. Tg autoantibodies (TgAb), present in ∼20 percent of DTC patients, interfere with Tg immunometric assay (IMA) measurements causing falsely low/undetectable serum Tg values. Tg radioimmunoassay (RIA) methodology appears resistant to such interferences but has limited availability, whereas new Tg mass-spectrometry methods have inferior sensitivity and unproven clinical value. When present, TgAb concentrations respond to changes in thyroid tissue mass. Thus, when Tg IMA measurements are compromised by the presence of TgAb the TgAb trend can serve as a surrogate DTC tumour-marker. Unfortunately, both physiologic and technical factors impact the interpretation of Tg and TgAb used as DTC tumour-markers.

Serum Tg Testing

Circulating Tg concentrations change in response to thyroid tissue mass, injury (surgery, biopsy or radioiodine) and the degree of TSH stimulation. Technical factors (Tg assay sensitivity, specificity and interferences) additionally impact the clinical utility of Tg testing. Specifically, new 2^nd generation Tg IMAs (functional sensitivities ≤ 0.1 μg/L) now mostly obviate the need for expensive recombinant human TSH(rhTSH)-stimulated Tg testing. Tg molecular heterogeneity remains responsible for two-fold between-method differences in Tg values that preclude switching methods and TgAb interference remains especially problematic.

Serum TgAb Testing

Reliable TgAb testing is critical for authenticating that Tg IMA measurements are not compromised by interference. Unfortunately, TgAb methodologies vary widely in sensitivity, specificity and the absolute values they report, necessitating that TgAb concentrations be monitored using the same method. Furthermore, adopting the manufacturer’s TgAb cut-off value to define a ‘detectable’ TgAb results in falsely classifying sera as TgAb-negative, because manufacturers’ cut-offs are set to diagnose thyroid autoimmunity and not to detect TgAb interference.

CBR. 2012 Nov;33(4):S13.

S10 Lab Tests Online – Pathology Information for the People

B Campbell ¹

Abstract

Lab Tests Online (LTO) is a website aimed at providing reliable information about pathology testing for the general public. It provides information about pathology tests, clinical conditions, appropriate screening for disease, pathology laboratories and the people who work in them and how specimens are collected and processed.

Case 1: Non-secretory multiple myeloma (NSMM) with trace monoclonal KFLC: Freelite (N Latex) KFLC 6,000 (1,420); post-transplantation KFLC 637 (374) mg/L.
Case 2: MM with serum Beta+IgAK paraprotein of 71 g/L and trace monoclonal KFLC: Freelite KFLC 16 mg/L (RR 3–19). At 12 months: serum Beta+IgAK paraprotein 12 g/L and trace monoclonal KFLC. One month later: serum IgAK paraprotein unchanged, monoclonal KFLC 2 g/L, Freelite KFLC 16,700 mg/L.
Case 3: MM with serum monoclonal LFLC of 8 g/L: Freelite (N Latex) LFLC 900 (2,300) mg/L.
Case 4: IgAK MM with light chain cast nephropathy: Freelite (N Latex) KFLC 56 (2,610) mg/L. Freelite KFLC concentration increased post haemodiafiltration whereas N Latex KFLC concentration decreased.
Case 5: MM with serum Beta+monoclonal KFLC of 26 g/L: Freelite (N Latex) KFLC <1 (59,000) mg/L.

Conclusion

These results demonstrate that the BG Medicine Galectin-3 ELISA assay is a precise, reproducible method for determining galectin-3 concentrations in a routine setting.

CBR. 2012 Nov;33(4):S13.

S11 Pathology Reports in Australia’s Personally Controlled Electronic Health Record (PCEHR) – Better Value For Consumers

R Hosking ¹

Abstract

ALT total requests 99000: 16 >1000 U/L: pregnant n=2600, 26 >45 U/L, range 47–509 U/L.

Amylase total requests 2700: 22 >400 U/L: 6 increment <150 U/L. 16 critical: 4 admitted, 3 chronic pancreatitis, 5 community follow up, 4 no follow up test.

Creatinine total requests 107000: creatinine >400 μmol/L. Not phoned 895 (previously known or creatinine increment <200 μmol/L); phoned 40: 8 previous creatinine <165 μmol/L(eGFR >34), age 32–87 years, creatinine range 414–1342 μmol/L(eGFR 3–10); 13 previous creatinine range 213–949 μmol/L(eGFR 7–14), age 42–80 years, creatinine range 408–1696 μmol/L(eGFR 3–14), incremental creatinine range 186–621 μmol/L(eGFR 3–25); 6 new to IT system but previously known under hospital; 13 did not fulfil requirements (previous creatinine >400 μmol/L with maximum increment 88 μmol/L.

Conclusion

The concept of critical values is different in the community and only life-threatening results should be communicated out of hours. A two tier phone list enhanced identification of critical values. Use of eGFR may further enhance identification. This avoids disturbing requestors out of hours with non-emergency abnormal results and saves staff resources at night.

CBR. 2012 Nov;33(4):S44.

P64 Whole Blood Porphyrin Clinical Evaluation – Enhancing External Quality Assurance

V Cronin ^1,^✉, T Andersen ¹, K Barancek ¹, CM Florkowski ¹, JA Grant ¹, V Poulos ¹, CW Sies ¹, J Zoanetti ¹

Abstract

Introduction

The RCPA QAP Porphyrin program has 49 participants from 14 countries. 20 submit results for whole blood total porphyrin and concordance is generally poor. A large range of methods, analytical conditions and reference intervals (RI) is in use. In 2009 a clinical evaluation component was added to enhance diagnostic feedback. We present 3 years of data to assess the value of this addition.

Methods

Participants classify each sample as normal (within RI), slightly elevated (not clinically significant) or elevated (further investigation required), in addition to reporting a quantitative result. Results from three cycles were examined to assess uptake and to compare clinical evaluation with analytical performance.

Results

Clinical evaluation agreement has generally been good at normal (median <1.5 μmol/L) and highly elevated (median >10.0 μmol/l) levels, with 96 and 98% of results respectively correctly assigned. In comparison, quantitative results varied by 22–55%. Interpretation of slightly to moderately elevated levels varied more widely. Participation in this component has increased from 60–90% over three cycles.

Conclusion

The results indicate good concordance at normal and highly elevated levels. Variability at other levels may reflect analytical performance, RI variation or individual interpretation. Increased uptake suggests participants find this component of value. International RI harmonisation is problematic. This program addition allows participants to compare clinical assessment independently of quantitative results obtained. While standardisation of methodology is ideal, ‘pseudoharmonisation’ relating results to RI provides participants with valuable diagnostic information.

CBR. 2012 Nov;33(4):S45.

P65 Managing Quality with Kimms (Key Incident Monitoring and Management Systems): A UK Perspective

J Glaysher ^1,^✉, A Wootton ¹, ID Watson ¹

Abstract

Introduction

Pre-analytical errors constitute a large proportion of the total faults in the sampling-result pathway, reportedly up to 68%. Whilst the laboratory tightly controls areas of analytical performance, in the UK pre- and post-analytical errors are not formally monitored despite their subsequent impact on patients, the laboratory and the clinical service.

Methods

Our laboratory was the first in the UK to enrol in the Australian Key Incident Monitoring and Management Systems QA scheme (KIMMS). We designed and implemented a quality system aligned to KIMMS criteria to capture error information directly from the LIS. The data are available for return to the scheme and are also grouped by location and type for feedback to service users.

Results

Since September 2011 our laboratory has received an average of 3712 errors/month; potentially 44,533 patients/year need to be re-bled. 93% of the errors were outside laboratory control. In June 2012 the major error was not receiving a required sample type (1002), closely followed by haemolysis (849) and collection errors (430).

Conclusion

Building error data collection into standard laboratory working practice with the LIS has ensured that data quality is of high integrity. Implementation of an Australian scheme in the UK met a number of problems including a difference in the allocation of accession numbers, crossover of some error categories and minor differences in working patterns. These difficulties were overcome to produce a reliable robust system, with training targeted at areas of concern. This work illustrates the need for total quality systems to minimise errors and improve patient safety in both primary and secondary care.

CBR. 2012 Nov;33(4):S13–S14.

S12 The Australian Pathology Units and Terminology Standardisation Project (PUTS)

M Legg ¹

Abstract

Pathology reports have evolved from being department-specific to covering the whole patient episode; but now they are often synthesised from the results and records of multiple sometimes-unrelated organisations. The reports are also now distributed more widely. It is now routine for clinicians to receive reports from multiple practices and for these to be further aggregated into regional health records (and soon national records).

Despite electronic reporting since 1993 and an Australian Standard since 1998, there is still significant variation in the form and content of electronic pathology reports, especially the way that tests are named and coded but also the units used. This variation arises from different laboratories having different policies but also from the same laboratory providing different outputs to different customers. Reports go to widely different healthcare settings including hospitals, community and indigenous health services and homes. Components of reports are frequently used in comparative displays and decision support.

There is a risk of misinterpretation if terminology and units differ, but even when these are the same, there are circumstances where differences in test methods and/or reference intervals make comparison inappropriate. All this has led to serious concerns for clinical safety. Combined with the growing desire to make more use of pathology in other information systems there has been a drive to standardisation of units and terminology.

A national project for the Standardisation of Pathology Units and Terminology (PUTS) was initiated by the RCPA in July 2011 with support from the Department of Health and Ageing (DoHA). Around 80 pathologists, scientists, informaticians and other clinicians have been working in eight working groups to establish guidelines for the use of terminology and standardised units covering each of the pathology disciplines. Constrained sets of the most common terms and their corresponding codes and units were developed for requesting and reporting pathology using consensus-based standards development and good clinical governance. The Project Steering Group decided on the adoption of: SNOMED for requesting; LOINC for the reporting question (HL7v2 OBX-3); and UCUM for the representation of units.

In conclusion, a standard has been written that describes the rules and records knowledge work done by the PUTS project teams. The resulting terminology sets are in the final stages of consultation and endorsement.

CBR. 2012 Nov;33(4):S45.

P66 Closing the Gap Between Chemical Pathology Labs in a Developing and a Developed Country

B Dayanath ^1,^✉, JCG Doery ²

Abstract

Introduction

Pathology services in developing countries are similar to laboratories in developed countries approximately 30 years ago. We have analysed the specific deficiencies and hurdles to addressing them in a teaching hospital in Sri Lanka. We propose a multifaceted approach to fast tracking change in a cost effective manner to minimise the gap and improve services.

Method

After local postgraduate training in Chemical Pathology at the National Hospital of Sri Lanka and foreign training at Monash Medical Centre the first author was appointed as the first Chemical Pathologist in a regional teaching hospital of 1700 beds in Sri Lanka. The range of services, analytical systems, quality systems, staff training and industrial relations issues were reviewed and deficiencies identified. Desirable changes were implemented according to standard change management principles learned during foreign training.

Results

In February 2010 there were only five analytes available and no fully automated instruments. There was no IQC and response to EQA was poor. There was poor local understanding of procedure to acquire new instruments from the Ministry of Health but successful purchases have now been made. Over the ensuing two years a new menu of 35 high demand assays including immunoassays have been prioritised introduced. Preanalytical, analytical and post analytical phases have been reviewed, restructured and monitored aiming future accreditation. The laboratory was selected for National Accreditation. Initial staff resistance to change has been overcome and a spirit of pride and achievement embraced by the medical laboratory technologists as well as entire hospital staff.

Conclusion

There are many challenges to reduce the quality of service gap in pathology in developing countries, but cost effective changes can be implemented relatively quickly by application of modern quality management principles practised in developed countries.

CBR. 2012 Nov;33(4):S45.

P67 Evaluation of Pre-Anaytical Sample Aliquot Evaporation on the Roche Cobas 8000 Using Modular Preanalytics

M Botros ^1,^✉, J Calleja ¹, KA Sikaris ^1,²

Abstract

Introduction

The Roche Modular Pre-Analytics (MPA) takes separate aliquots from a primary tube into small sample cups, to enable parallel chemistry and immunoassay analysis. We evaluated the effect of time from aliquotting to processing, on the quality of the results.

Methods

Five pools were prepared and multiple aliquots (500 μL) of each were analysed in duplicate. (Set-A) stored in the Cobas Line Buffer (CLB) and analysed at 10 min intervals from 0–50 min then at 80 min (to evaluate evaporation effects online); (Set-B) stored in the CLB for 30 min, then para-filmed and stored at room temperature for another 50–140 min before analysis (to simulate instrument breakdown). (Set-C) capped and stored at room temperature until analysis in 140 min (to assess drift).

Tests assessed were electrolytes, urea, creatinine, liver function tests, lipids, glucose, calcium, phosphate, magnesium, creatinine kinase and uric acid. Significant evaporation was assessed as percentage deviation from baseline concentration >2.77CVa (where CVa= analytical CV).

Results

(Set-A) Most analytes were stable in the CLB for ≤80 mins. Sodium, chloride and CK were stable for ≤50 mins. Total protein (TProtein) was stable ≤30mins.
(Set-B) All analytes except TProtein and sodium were stable ≤140 mins. Sodium was stable ≤80 mins.
(Set-C) All analytes were stable during the study excluding albumin and TProtein which showed assay drift.

Conclusion

As a result of this study, we limit the sample processing rate to assure aliquots stay on the CLB for ≤30 mins before analysis. Also, when the line crashes, we remove the racks from the line, para-film them and assure analysis within 90 min. In addition we have implemented the monitoring of patient moving medians to assist with detecting pre-analytical aliquot evaporation as well as analytical error.

CBR. 2012 Nov;33(4):S45–S46.

P68 Correlation between Analytes in Urine from Pregnant Women

M Botros ^1,^✉, E Ekinci ², P Moore ³, KA Sikaris ¹, ZX Lu ¹, Q Lam ⁴, K Cheong ², C Houlihan ²

Abstract

Introduction

Several analytes can be measured in urine during pregnancy and since spot urines are easier to collect, analyte/creatinine ratios are assumed to be an appropriate correction for patient hydration. We measured a number of urinary analytes in pregnancy and used the opportunity to investigate the correlation between analytes including creatinine.

Method

150 spot urine samples in the first trimester (9–13/40) were obtained from healthy women enrolled in a thyroid function reference interval study. Routine chemistry assays (Na, K, Cl, creatinine, calcium, protein, albumin) were measured on a Cobas Integra 800. Seventeen trace elements were measured concurrently on Agilent 7500 CE with octopole reaction cell. The distributions were non-Gaussian so Spearman rank correlation (r) was used.

Results

Creatinine, protein, selenium, copper were highly correlated (r>0.7) with each other. Creatinine was also highly correlated with potassium and calcium. Other high correlations were calcium/strontium, strontium/barium, potassium/chloride, vanadium/manganese and the strongest correlation amongst all analytes was (unsurprisingly) sodium/chloride (r=0.91).

Iodine/creatinine had a correlation of 0.49 which was amongst the highest correlations for iodine. Other high iodine correlations were with calcium (r=0.53), selenium (r=0.52) and cobalt (r=0.50). Albumin had low correlation with most analytes, the best of which were albumin/protein (r=0.53) and albumin/copper (r=0.52) and even albumin/aluminium (r=0.36) was better than the albumin/creatinine correlation (r=0.28). The only poorer correlations with creatinine were for nickel, arsenic, bismuth, vanadium and manganese (all r<0.14).

Conclusion

The assumption that creatinine correction is appropriate for all analytes needs to be considered against the different mechanisms of renal handling. The higher GFR in pregnancy may potentially alter renal handling for some analytes. Where correlations are poor, there is a distinct possibility that analyte ratios may add noise rather than reduce variability.

CBR. 2012 Nov;33(4):S46.

P69 Tourniquet Application Time During Phlebotomy Affects Biochemical Testing

M Gupta ¹, D Yadav ², S Mishra ², P Sharma ²

Abstract

Introduction

Venous blood sampling is usually performed using a tourniquet to help locate and define peripheral veins to achieve successful and safe venepuncture. In developing countries like India, there is lack of understanding about good laboratory practices and inadequate training to phlebotomists, compelling them to make errors during phlebotomy. The improper venous accesses or prolonged venous stasis created by tourniquet application will result in collection of unsuitable blood sample.

Methods

The present study was conducted at one of the tertiary care hospital at State Capital to find out the effect of tourniquet application time on 17 common biochemical analytes in 20 fasting healthy adult volunteers. Sequential venepunctures were performed by a single expert phlebotomist either without venous stasis or following the application of standardized external pressure of 60 mm Hg using a sphygmomanometer for 1, 3 and 6 minutes. Biochemical parameters were analysed on Fully Automated Analyzer Olympus AU 400 by using standard protocol of commercially available kits.

Results

ALT concentration was significantly high in samples collected after application of external pressure for 3 min (P<0.05) and 6 min (P<0.01); Alkaline phosphatase, LDH, creatine kinase, total cholesterol, triglyceride, total protein, albumin and calcium concentrations were significantly high in samples collected after application of external pressure for 6 min (P<0.05) as compared to samples collected without venous stasis. There were no significant alterations in concentrations of the other biochemical analytes (glucose, urea, creatinine, AST, uric acid, phosphorus, sodium, and potassium), even after 6 min venous stasis.

Conclusion

Venous stasis from tourniquet placement during venepuncture should be minimised, as it accounts for spurious and significant variations for several biochemical analytes.

CBR. 2012 Nov;33(4):S46.

P70 72 Hour Sweat Chloride Stability

H Robins ^1,^✉, C Newman ¹, D Talsma ¹, G Koerbin ^1,², P Hickman ^1,³

Abstract

Introduction

The measurement of chloride is of value in the investigation of the common inborn error of metabolism, cystic fibrosis. Results of sweat chloride are considered normal if <30 mmol/L for infants ≤6 months or <40mmol/L for 7 months and older. Manufacturers of sweat collection systems claim sweat may be stored in sealed containers for up to 72 hours at 4°C. This study investigated that claim following the introduction by the manufacturer of a new micro storage tube.

Methods

Six sweat collections were obtained from three adult females. All sweat samples were pooled and then 40 μL aliquots were placed into six micro tubes. One sample was analysed immediately on receipt the others were stored at 4 °C until analysis. Further analysis was at 3, 18, 24, 48 and 72 hours post collection. Sample processing used a dilution recovery method where 30 μL of sweat is placed in 90 μL Biorad Lyphochek Quantitative urine control level 1. Analysis was performed on the Abbott ARCHITECT ci16200. Sweat was stimulated by pilocarpine iontophoresis and collected in the small bore plastic tube of the collector using the Wescor Macroduct Sweat Collection System. Standard collection time was 30 min.

Results

Initial sodium and chloride concentrations were 61 mmol/L and 35 mmol/L respectively. No changes were seen over the 72 hour period for either analyte. Analytical imprecision (CVa) for sodium over that 72 hour period was 1.9% at 26 mmol/L, and 0.9% at 102 mmol/L. The CVa for chloride was 3.2% at 23 mmol/L and 1.7% at 48 mmol/L.

Conclusion

This study confirms claims that sweat samples may be stored in a the new micro sealed container at 4°C for up to 72 hours without altering the concentrations of either sodium or chloride.

CBR. 2012 Nov;33(4):S46.

P71 Creatinine and eGFR – Strange Relations

P Turner ¹, T Badrick ^1,^✉

Abstract

Abstract

Introduction

The lipid-lowering effect of fenofibrate is accompanied by a rise in plasma homocysteine (HCY), a potential risk factor for venous thromboembolism (VTE). This study investigated the relationship between HCY and the risk of VTE in patients treated with fenofibrate.

Methods

The relationship between HCY and deep-vein thrombosis or pulmonary embolism was investigated in 9522 participants of the 5-year Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial. All subjects received fenofibrate during a 6-week active run-in phase before randomization. A Cox proportional-hazards model was used to assess the effect of HCY on risk of VTE events.

Results

During active-drug run-in, HCY rose on average by 6.5 μmol/L, accompanied by a substantial rise in plasma creatinine (+12%). Fenofibrate-induced changes in HCY and creatinine were fully reversible in the placebo group but persisted in the treatment group until reversing at the end of therapy. During follow-up, 1.8% had at least one episode of deep-vein thrombosis or pulmonary embolism: 103 on fenofibrate and 68 on placebo (log-rank P=0.006).

In multivariate analysis, every 5 μmol/L higher baseline HCY was associated with 19% higher risk of VTE. Fenofibrate treatment was associated with 52% higher risk, but the change in HCY with fenofibrate was not significantly associated with VTE after adjustment for baseline HCY.

Conclusion

Hyperhomocysteinemia is prospectively associated with VTE. Fenofibrate may predispose individuals with high pretreatment HCY towards VTE. The fenofibrate-induced increase in HCY did not, however, explain the risk associated with fenofibrate therapy.

CBR. 2012 Nov;33(4):S47–S48.

P75 Possible Macro-Troponin I (Troponin I-IGG Complex) Interference in a Patient with Severe Aortic Stenosis

X Low ^1,^✉, L Ha ², B Raill ¹, WW Chiu ¹, DR Boswell ¹

Abstract

Introduction

A series of laboratory investigations were initiated into possibility of antibody related positive interference in plasma troponin I results (Abbott stat TnI, Abbott Architect Ci8200) from a 90-year-old female with severe aortic stenosis, atrial fibrillation but normal coronary arteries from angiogram. She had multiple admissions for chest pain over a three year period - each presentation was associated with a sharp rise and fall in TnI levels but TnI never went below 290 ng/L (ref limit <40 ng/L) even in her recovery bloods.

Methods

Patient’s admission plasma together with two controls (at similar TnI level) were subjected to: a. Heterophilic Blocking Tube (HBT) incubation (Scantibodies Laboratory) before retest, b. 25% Polyethylene glycol (PEG), then 3000g 10 mins centrifugation before retest, c. Protein G affinity column (GE Healthcare MAbTrap^tm cartridge kit) pre-treatment, and unbound TnI/Albumin to Eluate TnI/IgG ratio calculated.

Results

Patient sample (neat): TnI : 560 ng/L (<40); TnT 12 ng/L (<14) (Roche Modular E170)

	Patient	Control 1	Control 2
Pretreatment TnI (ng/L)	560	662	635
Post HBT incubation(ng/L)	581	628	565
Post PEG: TnI recovery	4%	51%	42%
Protein G column: Ratio	0:61	20:1	14:4
Unbound Troponin I/Albumin to Eluate Troponin I/IgG

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Conclusion

Method

All samples were stored at −80 °C and run in duplicate on the in use Chromogranin A Dako ELISA assay (ELISA) and in singleton on the IFA. Patient’s serum samples were concurrently assayed by both methods over four months; manual dilutions in 4-fold series (1, 1/4, 1/16, 1/64) were performed on eleven selected samples with elevated results. Between run imprecision was assessed on two patients’ stored serum aliquots. Within run imprecision was performed using twenty patient samples, each assayed in duplicate.

Results

Passing and Bablok regression for samples not requiring dilution by the ELISA (CgA <403 U/L) showed IFA(ug/L)=3.60.ELISA(U/L)-13; r=0.84, (n=160). The difference between the least and next least diluted samples yielded a mean percent difference of 1.9% (range −11% – +13%), range 276–30466 μg/L. Between-run imprecision (coefficient of variation) was 5.6% at 44 μg/L (n=12) and 7.7% at 257 μg/L (n=24). Mean within-run imprecision was 1.9%, range 0–4.5% on samples with CgA 30–7289 μg/L.

Conclusion

The automated IFA platform provides expedient, reproducible results and is significantly less labour intensive than the ELISA. The broad measuring range provides clinically useful results for patients with elevated levels. Diluted samples showed acceptable linearity in all cases. We can now provide a reliable monitoring indicator for response to targeted radio-peptide therapy of neuroendocrine tumours.

CBR. 2012 Nov;33(4):S14.

S14 Training of Scientists – UK Perspective

M Thomas ¹

Abstract

Proposals to transform the training and education of healthcare scientists in the UK were first consulted on by the Department of Health in 2008 following a similar initiative that transformed medical training (Modernising Medical Careers). This was an ambitious scheme to encapsulate a common training for the 51 differing disciplines across the NHS with diverse roles in life sciences, physiological sciences and physical sciences and engineering, where training and educational pathways were seen, in many cases, to be inadequate.

The lactose tolerance test can be safely shortened to 60 minutes as the glucose concentration has peaked before then in most normal people. It is important that blood specimens are collected at 15 and 30 minutes because failure to do so will lead to many healthy people being falsely labelled as lactose intolerant.

CBR. 2012 Nov;33(4):S14–S15.

S15 Training of Medical Scientists – USA Perspective

G Miller ¹

Abstract

There are two tracks for training doctoral level medical scientists in the US, one for physicians and another primarily for PhD scientists but also open to physicians. The physician track is by a residency program accredited by the Accreditation Council for Graduate Medical Education (ACGME) which can be a combined four year anatomic and clinical pathology residency program, or a three year program in either anatomic or clinical pathology. Certification of competency is by examination by the American Board of Pathology. Specialist training in Chemical Pathology is by an additional one year fellowship and certification as a specialist by examination.

PhD scientists receive training in clinical chemistry or a related discipline by a two year fellowship program that is accredited by the Commission on Accreditation in Clinical Chemistry (ComACC). Analogous training for doctoral scientists is available in medical microbiology, cytogenetics and other clinical laboratory specialties. Certification is by examination by the American Board of Clinical Chemistry which has separate specialty examinations in clinical chemistry, toxicological chemistry and molecular diagnostics.

Doctoral scientists enter training with a broad range of backgrounds including analytical chemistry, biochemistry, physiology, molecular biology, genetics, pharmacology, etc. but frequently have little experience in medical diagnostics. Physician pathology residency programs are multi-disciplinary and tend to emphasise the components for which a pathologist can bill for services which does not include many clinical laboratory test procedures. Nearly all academic centres that offer PhD training programs also have physician pathology residency programs and the curriculum has many common elements so the trainees with different backgrounds function as tutors for each other. Guidelines for curriculum content are provided by ComACC and by the Academy of Clinical Laboratory Physicians and Scientists, and include analytical, clinical, statistical, administrative and quality management areas.

CBR. 2012 Nov;33(4):S15.

S16 Medical Laboratory Science in New Zealand – A Changing Dynamic in Workforce Education

M Legge ¹

Abstract

Since the development of a full time university degree-based qualification, historic workforce patterns in diagnostic pathology remained relatively unaltered. However, in recent times a consequence of developing a degree-based qualification has been the expectation to undertake post-graduate qualifications, higher career expectations of individuals in the work place and an aging workforce across all disciplines in diagnostic pathology. In addition, the creation of a degree qualification provided well-qualified graduates with skills sought after by other sectors such as research groups and biotechnology industries. In this presentation the overall structure of the New Zealand qualification system will be considered, the requirements for registration, and the changing world of the medical laboratory scientist in relation to qualification routes and new technologies.

S19 Celebrating 30 Years of Chemical Pathology QAP

J Gill ¹

Abstract

This year the Royal College of Pathologists of Australasia (RCPA) Chemical Pathology Quality Assurance Programs (QAP) celebrates its 30^th year. This is an opportunity to reflect on the past and how we came to be a world leading external quality assurance (EQA) provider.

The introduction and development of the QAP represents a progressive collaboration of the Australasian Association of Clinical Biochemists (AACB) and the RCPA. The founding principles of the QAP come from the work of the South Australian Branch of the AACB QC Subcommittee which was formed in 1973 to provide EQA for South Australian laboratories. Through their innovative work were introduced lyophilised samples rather than fresh frozen serum, multiple levels by mixing, two sera per time and allowable limits of performance.

When in the late 1970s the RCPA and AACB decided that Australia needed a national QAP, the South Australian model became the basis with the first General Serum Chemistry Program being offered in 1982. From this small beginning the QAP has continued to grow in programs and participants and has continued the tradition of innovation.

CBR. 2012 Nov;33(4):S11.

S2 Beyond Orders, Specimens, and Handoffs: Advancing Lab Collaboration with Clinicians to Better Recognise, Understand, and Prevent Diagnostic Errors in Medicine

G Schiff ¹

PJ Fuller ¹

The TGA regulations relating to in vitro diagnostic medical devices (IVDs) were introduced on 1 July 2010 with a 4-year period to allow for the transition of existing registered, listed and previously exempt IVDs onto the Australian Register of Therapeutic Goods (ARTG) under the new regulations. In addition, the regulations provide for the notification by laboratories of Class 1, 2 and 3 in-house IVDs to the Therapeutic Goods Administration (TGA) by this date.

There are now only 590 days until the 30^th June 2014. Subsequent to this, commercial supply of an IVD that is not included on the ARTG will breach the Therapeutic Goods Act and the sponsor of an illegal product may be subjected to a A$550,000 fine. Despite this, the uptake of the transition for existing commercial assays by sponsors has been slow. There is considerable concern that sponsors will choose to not transition products due to the small market size in relation to the cost of regulation and this may result in unavailability of many tests presently used in the Australian market.

The understanding of the regulations as they apply to laboratories is also less than adequate. Modification of existing commercial assays creates an in-house assay which must be assessed by the National Association of Testing Authorities (NATA) for validation. Many in-house assays are, however, difficult to validate due to low patient numbers, or because they test unusual specimen types such as cadaveric tissue.

The current state of the transition for both commercial and in-house assays will be reviewed.

Finally, the ‘value’ of the pathology sector to the Australian community will be reviewed, and a program that aims to lift the profile of pathology discussed.

MJ Whiting ^1,^✉, J Earl ¹, L Johnson ¹; Members of the AACB Biogenic Amines Working Party

Abstract

Introduction

Various biogenic amines and their metabolites are measured in urine for the biochemical diagnosis, and the monitoring of treatment, of neuroendocrine tumours. The AACB Biogenic Amines Working Party decided to survey laboratories performing these tests to determine the degree of harmony that exists for analytical factors associated with their performance.

Methods

A questionnaire was circulated to all laboratories enrolled in 2012 for urine biogenic amines in the quality assurance program (QAP) of the RCPA. After follow-up, a response rate of 62% was achieved. Information was obtained on the urine sample collected, analytes measured, the analytical principles of methods, sources of calibrators and quality controls, and reference intervals used to interpret results.

Results

There was consistency between most laboratories in the collection and storage conditions for urine (HCl-acidified, cold), use of commercial calibrators, internal standards and QCs, frequency of analysis (usually 1 run per week) and analytical technique (HPLC with electrochemical detection). The most notable differences were in the range of urine testing performed (free catecholamines and/or total metanephrines and/or acid metabolites), and extraction methods (solvent/ion-exchange/alumina/SPE). In addition, there was up to a 2-fold difference in the upper limit of in-house and literature-sourced reference intervals used to report urine biogenic amines for the biochemical diagnosis of neuroendocrine tumours.

Conclusion

Laboratories performing urine biogenic amine analyses are using similar HPLC analytical methods with the same commercial calibrators, and generally produce results within allowable limits of performance with samples from the RCPA QAP for biogenic amines. Further harmonisation may be achievable by updating reference intervals to align them to the best evidence-based literature sources.

CBR. 2012 Nov;33(4):S18.

S32 AACB Trace Elements Working Party

R McQuilty ¹

Abstract

The RCPA Trace Elements Quality Assurance Program (QAP) commenced in 2011. The program covers 29 elements over 3 matrices (serum, urine and whole blood) with participants from Australia, New Zealand, Hong Kong, Malaysia and Singapore.

The Trace Elements Working Party (TEWP) was established under the auspices of the Scientific and Regulatory Affairs Committee (SRAC). The TEWP comprises members with appropriate expertise in the area of trace elements analysis from NSW, Queensland, Western Australia, New Zealand and a representative from the RCPA QAP. The TEWP meets on a yearly basis to review the QAP, attempt to resolve analytical issues, suggest improvements and to support participants. The areas reviewed include allowable limits of performance, method classification, concentration levels and the suitability of the material. A Participant Satisfaction survey sent out in May 2011 showed overall satisfaction with the program, the material, the analytes and reporting.

Now in its second year, the program is proving to be viable with good reports from participants. New analytes have been added and problems with the material have been identified and resolved. Current projects are looking at stability and reconstitution issues. Future activities include evaluating new analytes, value-added reporting, standardisation of units, interpretive comments and reference intervals.

CBR. 2012 Nov;33(4):S18–S19.

S33 KIWIS 1 – AUSSIES 1: Common Reference Intervals Now A Draw

J Ryan ¹; members of the Common Reference Interval Working Party

Abstract

The rather ‘tongue in cheek’ title of this talk seeks to pay a tribute to the New Zealanders among others, for the monumental amount of work that preceded the Harmonisation weekend on May 4–5 in Sydney earlier this year. By comparing a number of predetermined reference intervals from NZ, Melbourne Pathology, the Alfred Hospital, the UK and also using a bias assessment performed around Australia, real progress towards harmonised reference intervals was made over the weekend.

A number of chemistry reference intervals have been proposed for use throughout Australasia as a direct result of the weekend, and this was due to the consensus reached by the expert participants involved. Common reference intervals or decision limits have been recommended for calcium (and adjusted calcium), phosphate, magnesium, sodium, potassium, chloride, bicarbonate, creatinine, total protein, ALP, AST, ALT and LD (L to P method). Guideline decision limits have been recommended for glucose, fasting lipids and iron studies. Where to from here? Will we be able to publish a score of Kiwis 5 - Aussies 5 by the end of this year?

CBR. 2012 Nov;33(4):S19.

S34 Clues From Routine Biochemistry In Diagnosis Of Inborn Errors Of Metabolism

K Carpenter ¹

Abstract

Inborn errors of metabolism are individually rare but collectively have an incidence of around 1:1500. Although the number of individual conditions is huge and the definitive diagnosis requires specialist testing, inborn errors with an acute presentation can be broadly placed in two groups: conditions with accumulation of a metabolite which acts as a toxin, or conditions resulting in an energy deficiency in one or more tissues. First-line biochemical testing can give important clues to the diagnosis and may allow treatment to be initiated before a final diagnosis is obtained.

Many of the toxic metabolites are organic acids and an increased anion gap and metabolic acidosis is an important finding. Several organic acidaemias and the urea cycle defects will present with an increased ammonia, and a respiratory alkalosis is often the first clue to the presence of hyperammonaemia. Hypoglycaemia is a primary finding in glycogen storage disorders, fatty acid oxidation defects and other mitochondrial disorders. Free fatty acids and 3-hydroxybutyrate levels can be helpful if the samples are taken before giving intravenous glucose. Lactate and pyruvate measurements in plasma and CSF are very important for the mitochondrial respiratory chain disorders.

Other investigations which may be informative include; urate (low in purine disorders and molybdenum cofactor deficiency), creatine kinase (very high in some fatty acid oxidation defects), alkaline phosphatase (low in hypophosphatasia), and creatinine (low in creatine metabolism disorders).

It is important to realise not all inborn errors will present in childhood and the adult clinical chemistry laboratory must be equipped and prepared to initiate further investigations in response to atypical findings.

CBR. 2012 Nov;33(4):S19.

S35 Metabolomics: Translation from Research to Clinical Practice

J Pitt ¹

Abstract

Modern mass spectrometric and nuclear magnetic resonance techniques can detect hundreds of components in biological samples. Combined with powerful statistical software, it is now relatively straightforward to perform comprehensive, non-targeted comparisons of samples from disease vs controls to identify potential biomarkers for disease. Many clinical research studies have identified patterns of abnormal biomarkers in various diseases. However, the translation of these research findings into reliable, routine clinical tests is often difficult. This can be due to relatively poor predictive value, the non-specific nature of the biomarkers in a routine clinical setting and poor analytical robustness. Clinical biochemists are in an important position to assess and validate preliminary research findings from metabolomic studies. This talk focuses on the use of GC-MS and LC-MS in metabolomic studies to initially identify biomarkers and then develop targeted assays with improved sensitivity and imprecision. Some of the techniques of metabolomics will be illustrated with examples of targeted and non-targeted analyses of biomarkers for bacterial intestinal overgrowth.

CBR. 2012 Nov;33(4):S19.

S36 Mitochondrial Disorders from Clinical Biochemistry to Improved Molecular Diagnosis

AG Compton ^1,^✉, SE Calvo ², EJ Tucker ^1,³, SC Lim ^1,³, VK Mootha ², DR Thorburn ^1,^3,⁴

Abstract

The mitochondrial oxidative phosphorylation (OXPHOS) disorders are clinically heterogeneous, cause impaired physical or cognitive development, and frequently death in neonates, infants or children. There is no simple blood or urine test for diagnosis. The diagnostic paradigm is lengthy, expensive, requires invasive biopsies (typically a skeletal muscle biopsy, a liver biopsy or both), and is often inconclusive. Most diagnoses rely on finding a biochemical defect which in some instances can guide subsequent mutation testing. However, in most cases molecular diagnosis is complicated by genetic heterogeneity with over 130 currently known OXPHOS disease genes. Mutations can be inherited through the maternally-inherited mitochondrial DNA (mtDNA) or in nuclear genes, making genetic diagnosis by sequential analysis of candidate genes highly inefficient. These known disease genes account for ∼50% of patients, with many more genes to be identified.

Next Generation Sequencing (NGS) technologies offer great promise for improving diagnosis of genetic diseases. In theory, it is now possible to sequence all of an individual’s genes to determine what genetic conditions they may suffer from or to which they may be pre-disposed. In practice, this is not yet feasible, mostly because we lack the knowledge to interpret the complex data comprehensively. While NGS enables rapid candidate gene detection, it is often difficult to establish a causal role for these genes in most diseases. OXPHOS diseases represent a special class of disorders for which cellular models of disease can be used to rapidly establish pathogenicity. In our recent Mito10k and MitoExome studies, we have exploited this to identify and biologically validate mutations in OXPHOS patients without a previous molecular diagnosis, leading to ∼30 new diagnoses and the identification of at least six now confirmed novel disease genes, underscoring the huge potential for NGS to improve diagnosis of OXPHOS disease and our understanding of its genetic basis.

CBR. 2012 Nov;33(4):S19–S20.

S37 Urine Albumin: Providing a High Quality Service

G Miller ¹

Abstract

Chronic kidney disease (CKD) is defined as abnormalities of kidney structure or function present for ≥3 months. The main markers used to identify patients with CKD are: GFR <60 mL/min/1.73 m², albuminuria >30 mg/day or an albumin creatinine ratio (ACR) >30 mg/g or 3.4 mg/mmol, urine sediment abnormalities, electrolyte and other abnormalities due to tubular disorders, or biopsy or imaging abnormalities. All guidelines for monitoring patients at high risk to develop CKD include a urine albumin (UA) measurement.

Current recommendations for utilising UA suggest that 24 hour collection is not needed; a first morning void is preferred and should be used to confirm an initial positive random UA result, and the ACR should always be reported. In addition, decision values at lower concentrations than commonly used, as well as stratification by gender, race and age, may be appropriate for improved assessment of risk for CKD. Standardisation of sample collection becomes more important to properly utilise more sophisticated decision values.

Assessment of laboratory measurement procedures has identified that the imprecision is not adequate for some procedures, dilution protocols are not adequate for some procedures, and that calibration harmonisation needs improvement. A reference system is in development to enable standardised calibration.

Classification of CKD and assessment of risk for complications and progression should be based on the clinical condition causing the CKD and on information from multiple biomarkers. In addition to UA, creatinine and cystatin C provide complementary information on glomerular function but different assessment of overall kidney disease. Further investigation of decision algorithms based on multiple biomarkers will improve the ability to assess risk.

CBR. 2012 Nov;33(4):S20.

S38 HBA_1C for the Diagnosis of Diabetes

JE Shaw ¹

Abstract

HbA_1c has recently been recommended for use in diagnosing diabetes, but much uncertainty remains over its value in comparison to the traditional blood glucose approach. There are many technical differences in both the strengths and weaknesses of glucose and HbA_1c measurement, including pre-analytical and analytical factors, making it difficult to compare the technical performance of the two different diagnostic tools. This is further confounded by the fact that it is not clear which diagnostic test should be seen as the gold standard. Blood glucose has many limitations in regard to diabetes, not the least of which is that it measures instantaneous glucose levels, but we are trying to measure chronic glycaemia. Data from several large observational studies on nearly 50,000 participants show that the relationships of fasting plasma glucose, 2-hour plasma glucose and HbA_1c with retinopathy are very similar, indicating that any one of them can be used to diagnose diabetes.

There remains some uncertainty over the possibility that the relationship between HbA_1c and the oral glucose tolerance test may differ between sub-groups defined by ethnicity and other factors. Some of these differences may be due to variations in the prevalence of haemoglobin variants, abnormalities of red cell turnover, iron deficiency and other influences on red cells. Another important explanation, not yet fully explored, is differences in day-to-day patterns of glycaemia.

CBR. 2012 Nov;33(4):S21.

O1 Falsely Elevated Estradiol Levels in Postmenopausal Women with Metastatic Er+ Breast Cancer

CY Chiang ^1,^2,³, D Faulkner ², J Doery ⁴, J Grant ¹, G Raines ³, J Lewis ⁵, R Desai ⁶, D Handelsman ⁶, R Jennens ², P Francis ²

Abstract

Introduction

Fulvestrant is an oestrogen antagonist used in postmenopausal women with progressive metastatic breast cancer following anti-oestrogen therapy. We report two post-menopausal women receiving fulvestrant therapy with unexplained elevated serum estradiol (E2) levels.

Methods

Two patients on fulvestrant therapy had frozen serum aliquots sent to four immunoassay platforms for E2 analysis. Fulvestrant obtained from the manufacturer was diluted (final concentration of 50 μg/L) in a male serum pool with a baseline E2 level of <43 pmol/L (immunoassay).

Results

Patients A and B had elevated serum E2 levels on the Siemens Centaur platform. Treatment with scantibodies did not alter the results and serial dilution was linear. Patient samples and a fulvestrant-spiked sample were sent to four immunoassay platforms. Fulvestrant did not interfere with the E2 result on the LC-MSMS.

	Patient A	Patient B	Fulvestrant spiked male serum
Age (yr)	57	51	-
Serum FSH (IU/L)	65.8	39.4	-
Estradiol (pmol/L):
Siemens Centaur	236	283	283
Abbott Architect	56	72	149
Roche Elecsys	21.8	<18	90
Beckman Coulter DxI	<70	<70	<70
LC-MSMS	-	-	34.7

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Conclusion

Methods

The immunoassays examined were DiaSorin (RIA and Liaison XL), Abbott (Architect), Roche (e602), Siemens (Centaur) and IDS (ISYS); all except the DiaSorin-RIA and IDS-ISYS were newly released in 2011. Two LC-MS/MS systems at Pathology Queensland (PQ) and Douglas Hanley Moir Pathology (DHM) were used as reference methods. Serum specimens (n=133) from routine requests were selected and stored in 0.5 mL aliquots at −20 °C until analysis. Each immunoassay was assessed for correlation, concordance (concordance correlation coefficient (CCC) <0.90 as poor concordance) and linearity (p<0.05 by Cusum test as nonlinear) using MedCal (version 12.2.1).

Results

The LC-MS/MS-PQ aligned well with the NIST standards (SRM972) and with the LC-MS/MS-DHM (all r²>0.97). The performance of each immunoassay compared to the mean LC-MS/MS values (n=125) over 10–200 nmol/L are shown in the Table.

Methods	Regression (Passing-Bablok)	Linearity (p) (Cusum test)	Concordance
Methods	Regression (Passing-Bablok)	Linearity (p) (Cusum test)	CCC	Interpretation
DiaSorin-RIA	y=0.96x+4.4	0.64	0.95	substantial
Liaison XL	y=1.03x−1.1	0.93	0.93	moderate
Architect	y=1.16x+1.9	0.02	0.75	poor
Roche	y=1.18x+5.7	0.81	0.76	poor
Centaur	y=0.90x−6.8	<0.01	0.88	poor
IDS-ISYS	y=1.57x−10.4	0.66	0.66	poor

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For specimens with LC-MS/MS values <10 nmol/L (n=7; mean±SD: 6.8±1.5 nmol/L), the lowest values were Diasorin-RIA (10.6±1.9) and Liaison XL (10.2±1.6) while the highest were Architect (20.4±5.9) and Roche (20.0±4.8). For specimens with LC-MS/MS values between 50 and 60 nmol/L (n=12; mean±SD: 55.8±2.7 nmol/L), Centaur gave the lowest results (36.5±6.5 nmol/L) while IDS-ISYS the highest (80.3±26.3 nmol/L).

Conclusion

DiaSorin assays aligned with LC-MS/MS. The Architect assay was non-linear and had positive bias, Roche and especially IDS-ISYS also had a positive bias, while the Centaur assay was non-linear and had significant negative bias. Overall, current assays are not harmonised and can give very different results at clinical decision points.

CBR. 2012 Nov;33(4):S23.

O7 Alkaline Phosphatase Reference Intervals in Pregnancy

ZX Lu ^1,^✉, E Ekinci ^2,^3,⁴, KA Sikaris ¹, D Atanasovski ¹, I Bittar ², Q Lam ², N Crinis ², K Cheong ², C Houlihan ⁵

Abstract

Introduction

Serum alkaline phosphatase (ALP) is predominantly of liver and bone origin. It can also be from placenta. Thus, it is expected that ALP rises during pregnancy. We aimed to define trimester-specific ALP reference intervals.

Methods

Stored sera from 145 pregnant women, originally for a thyroid function reference interval study, were analysed for ALP using Roche c701 and Beckman DxC. After excluding women with GGT >55 U/L (n=2), ALP reference intervals were determined as 95% confidence intervals (mean±2SD) of the log-transformed ALP. This was compared to the non-pregnant range (Roche): 20–105 U/L.

Results

Compared to postpartum levels, ALP in 1^st and 2^nd trimesters were found to be lower (Tukey’s post Hoc p<0.001) and these values were well within the upper limit reported for non-pregnant women. In the 3^rd trimester, a marked rise in ALP was observed compared to earlier pregnancy or postpartum (Tukey’s post Hoc p<0.001). The observed reference intervals were similar for both methods.

	Trimester 1	Trimester 2	Trimester 3	Postpartum
ALP (mmol/L)	9–13/40 (n=144)	(22–26/40) (n=97)	(35–39/40) (n=80)	(8–12/52) (n=84)
Roche	44 (26–75)	52 (32–87)	104 (60–179)	70 (39–125)
Beckman	45 (26–77)	54 (32–89)	113 (64–200)	71 (40–128)

Eight hundred and seventeen clinicians responded to the questionnaire. The study showed 77% of the clinicians interpret values beyond the reference interval as the medical decision limit whereas 56% of the respondents still regard the reference limit and medical decision limit as the same term. The biochemical parameters that were most affected were blood glucose, sodium, ALT, bilirubin, free T4 and TSH.

Conclusion

The study showed that there is no consensus policy with regard to decision limits or critical values practiced by clinicians in Nepal. This therefore necessitates consequent preparation and adoption of effective standard operating procedures in this regard.

CBR. 2012 Nov;33(4):S12.

S5 Harmonisation of HbA1c

DB Sacks ¹

Abstract

CBR. 2012 Nov;33(4):S25.

O16 Improved Predictive Value for Multiple Sclerosis of Cerebrospinal Fluid Oligoclonal Banding Patterns – A South Australian Experience

SDC Thomas ¹, DJ Chappell ¹

Abstract

Introduction

Diagnosis of multiple sclerosis (MS) relies on clinical, radiological and laboratory assessment. Intrathecal synthesis of IgG, identified as oligoclonal bands (OCB) is an important laboratory adjunct in this context. Although OCB are considered to be specific to MS, they have been reported in other inflammatory disorders that induce synthesis of intrathecal IgG. Therefore recognising distinct patterns of OCB was proposed to improve diagnosis of MS. The following study was conducted to ascertain if the proposed pattern correlated with clinical and radiological diagnosis of multiple sclerosis in outpatients presenting to a South Australian public hospital.

Methods

Paired CSF and serum for consecutive patients (Sept 2011 – April 2012) were analysed using isoelectric focusing and immunofixation with anti-IgG. Patients lacking radiological data were excluded. Specimens consistent with intrathecal IgG synthesis were selected (n=53; age 4 to 87 y). For each patient, OCB pattern [delta (prominent, ≥4 bands) or theta (diffuse banding; <4 bands)] was correlated with the radiological findings.

Results

The majority of intrathecal OCB was of delta pattern (72%). Of the patients with a delta pattern, evidence of demyelination was present in 82%. None of the theta group showed any evidence of intracranial demyelination (40% of theta had normal MRI vs 9% of delta). Theta pattern was associated with pathologies other than demyelination. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of delta pattern in the diagnosis of MS with demonstrated cranial demyelination on MRI are 100%, 58%, 71% and 100% respectively.

Conclusions

Delta pattern of OCB has 100% NPV and sensitivity in the diagnosis of CNS demyelination. Recognising and reporting the specific pattern of intrathecal IgG synthesis improves the diagnostic sensitivity for MS.

CBR. 2012 Nov;33(4):S26.

O17 Lipid Changes in Pregnancy

I Bittar ^1,^✉, E Ekinci ², Q Lam ¹, Z Lu ³, K Cheong ², N Crinis ¹, K Sikaris ³, C Houlihan ²

Abstract

Introduction

Pregnancy is often listed as a secondary cause of hyperlipidaemia. Many studies report pregnancy lipid concentrations at a single time-point and compare these to non-pregnancy levels, not recognising that changes in lipid concentrations are continuous throughout gestation. We aimed to characterise lipid concentrations for each trimester in pregnancy using two independent sources of data.

Methods

Total cholesterol and triglyceride results (Roche Modular) from 40,000 pregnant women were extracted from a private pathology database in Australia. HDL-cholesterol (Beckman DxC) and calculated LDL-cholesterol were also obtained from sera in 154 pregnancies originally enrolled in a study for trimester-specific thyroid function reference intervals at the Mercy Hospital for Women, Melbourne.

Results

Results from both study populations showed significant increases in total cholesterol and triglycerides, peaking in the 3^rd trimester. Despite using different assays, the observed reference intervals and medians (2.5^th–97.5^th percentile) for both populations were similar (Table).

		Trimester 1 (9–13 weeks)	Trimester 2 (22–26 weeks)	Trimester 3 (35–39 weeks)
Roche Modular	Total Chol (mmol/L)	4.5 (3.1–5.9)	6.0 (4.1–7.9)	6.8 (4.5–9.1)
Roche Modular	Trigs (mmol/L)	1.0 (0.5–2.0)	1.8 (0.8–3.3)	2.8 (1.5–5.3)
Beckman DxC	Total Chol (mmol/L)	4.7 (3.5–6.9)	6.3 (3.7–8.8)	6.9 (5.0–10.2)
Beckman DxC	Trigs (mmol/L)	1.2 (0.6–2.9)	2.0 (0.9–5.0)	3.0 (1.5–5.8)

Results

A statistically significant decrease of 20.7% in mean insulin concentration from baseline was observed at Day 2 (mean±SD: 15.3±13.7 vs 12.0±11.6 mU/L, respectively, p<0.05). Interestingly, insulin concentration remained unchanged (p=0.92) from Day 2 to 7. For C-peptide, a gradual decrease from 5.4% to 11.8% was observed from Day 2 to 7. The change, however, was not clinically significant until Day 3.

Conclusion

Insulin appears to be unstable after the first 24 h, presumably due to degradation of pro-insulin. Other studies have shown that pro-insulin in serum is unstable and the Roche insulin assay has 32.5% cross reactivity with pro-insulin. Hence serum insulin results would be 20–25% lower for add-on testing up to seven days. Add-ons for serum C-peptide are acceptable for up to three days.

CBR. 2012 Nov;33(4):S12.

S6 Quality Indicators from A Global Perspective

M Plebani ¹

Abstract

Conclusion

FSH is a late indicator of known reducing ovarian reserve and median FSH does not increase significantly over 10 U/L until >45 years. This is approximately 15 years later than the known reduction in fertility that occurs in the early thirties. If fertility is a concern, FSH levels persistently above the median of 5–6 U/L in women <40 years may prompt earlier follow-up with more sensitive tests such as AMH. FSH levels of >9 U/L are outside the 97.5^th centile in women <25 years and should prompt early follow-up.

HbA_1c is being considered as a diagnostic test for diabetes in Australia. As glucose and HbA_1c are likely to be co-requested, we investigated whether fluoride oxalate (FlOx) blood is suitable for HbA_1c measurement. Identification of patients with confounding conditions where HbA_1c may not accurately reflect glycaemic control is also important. Since anaemia is often associated with these conditions, we also investigated the use of information obtained from HPLC measurement of HbA_1c to estimate haemoglobin concentration.

Method

HbA_1c was measured on paired FlOx and EDTA blood using the Biorad Variant II (VII) and Arkray Adams HA-8160 (Adams).
EDTA blood was mixed and manually or automatically sampled for HbA_1c analysis using the VII. The total peak area was compared to a formal haemoglobin measurement.

Results

Using the VII, the mean difference between FlOx and EDTA blood with a HbA_1c of 4.7–7.5% (28–58 mmol/mol) was −0.02% (−0.2 mmol/mol) [range −0.2 to 0.2% (−2 to 2 mmol/mol)]. Using the Adams, the mean difference between FlOx and EDTA blood with a HbA_1c of 5.0–10.3% (31–89 mmol/mol) was 0.02% (0.2 mmol/mol) [range −0.1 to 0.2% (−1 to 2 mmol/mol)]. These differences were within the uncertainty of the measurements.
The total peak area for EDTA blood mixed thoroughly then manually sampled highly correlated with measured haemoglobin (r²= 0.97). Blood that was unmixed or mixed then automatically sampled immediately or up to 1.5 hours later did not correlate as well (r²=0.39 to 0.76).

Conclusion

FlOx blood is suitable for HbA_1c measurement using the VII and Adams analysers. Total peak area may be used to estimate haemoglobin concentration only when samples have been thoroughly mixed and sampled manually. This may not be practical for most labs due to high sample numbers.

CBR. 2012 Nov;33(4):S31.

P17 Androstenedione: Polyethylene Glycol Treatment of Patient Samples Prior to Immunoassay Improves Assay Agreement with Liquid Chromatography Tandem Mass Spectrometry

B Teis ^1,^✉, J Galligan ², B McWhinney ², M Nelson ¹, G Ward ¹

Abstract

Introduction

Since the introduction of the Siemens Immulite 2000 androstenedione assay in our laboratory, an increased proportion of elevated patient results have been observed. This study compares different immunoassay methods to LC-MS/MS. Further, the effect of sample treatment with polyethylene glycol (PEG) prior to Immulite immunoassay is assessed.

Method

Thirty-nine (39) patient samples (age range 14–65) were assayed on Siemens Immulite 2000, Siemens Radioimmunoassay (RIA), Immunotech RIA, Siemens Immulite 2000 after sample pre-treatment with 25% PEG and LC-MS/MS.

Results

Method correlation data (Deming) is provided in the following table.

Method vs. LC-MS/MS	Slope	Intercept	N
Immulite 2000 ^*	2.95	0.07	36
Immulite 2000 post PEG	1.28	0.95	39
Siemens RIA	1.73	2.44	39
Immunotech RIA	1.47	0.83	39

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Note 3 data points were excluded from the untreated Immulite 2000 correlation as the Immulite results were considered outliers with results greater than 15 times that of LCMS.

Discussion

All immunoassays have reasonable correlation with LC-MS/MS but results are ∼47–195% higher than LC-MS/MS. PEG pre-treatment of samples eliminates outliers from the Immulite androstenedione method and improved agreement with LC-MS/MS such that the positive bias was reduced to ∼28%. One inference from the PEG study is that the difference in matrix between serum and standards for immunoassay may be a significant contributor to the observed difference between steroid immunoassays and LC-MS/MS. Matrix effects are likely to be a significant challenge for harmonisation of steroid immunoassays with LCMS.

CBR. 2012 Nov;33(4):S31–S32.

P18 Impact of New International Association of Diabetes and Pregnancy Study Group Guidelines on Laboratory and Clinical Workload

NG Wijeratne ^1,^✉, ZX Lu ^1,², JCG Doery ^1,²

Abstract

Introduction

The new guideline by the International Association of Diabetes and Pregnancy Study Group (IADPSG) has recommended that all pregnant women at 24–28 weeks should have a 75 g oral glucose tolerance test (OGTT) for diagnosis of gestational diabetes (GDM). This omits the traditional screening step using a glucose challenge test (GCT). This will probably be endorsed by the Australian Diabetes in Pregnancy Society (ADIPS) soon. We reviewed our data to examine the potential impact of this change on laboratory and clinical work load.

Method

Data from women who had a 75 g GCT (n=2961) followed by an OGTT when appropriate (glucose ≥8.0 mmol/L following GCT) were reviewed. GDM was classified using both current ADIPS cut-offs (Fasting ≥5.5 and 2h ≥8.0 mmol/L) and new IADPSG cut-offs (fasting glucose ≥ 5.1, 1h ≥ 10.0 and 2h ≥ 8.5 mmol/L)

Results

The GCT positive rate was 24% and 90% (n=638) of them were followed up with a 75 g OGTT in our laboratory. Of these women, 26% was classified as having GDM by current ADIPS criteria while 35% by new IADPSG criteria. This would result in a 33% increase in clinical workload. According to new criteria, the 76% of screened women with negative GCT would have an OGTT substantially increasing current pathology workload.

Conclusion

New guidelines will impact on laboratories significantly by replacing the single sample GCT with a universal OGTT. The cost of clinical management of approximately 33% more cases of GDM will be substantial. The extent to which this improves patient outcome remains to be proven.

CBR. 2012 Nov;33(4):S31–S32.

P19 Point of Care Detection of Neonatal Hypoglycaemia: Problems of Galactose Interference

NG Wijeratne ^1,^✉, L Mackay ¹, K Hirimuthugoda ¹, JCG Doery ^1,², ZX Lu ^1,²

Abstract

Introduction

Some glucose measuring devices can cross react with galactose resulting in falsely high glucose readings. This is hazardous if these devices are used to screen for hypoglycaemia in neonates with galactosaemia.

We evaluated two glucometers (Nova Biomedical Statstrip and Abbott Optium Xceed) and a blood gas analyser (Radiometer ABL800) for galactose cross reactivity. We also determined whether the galactose interference on ABL800 depends on glucose electrode membrane age.

Method

Galactose interference:

Venous heparinised whole blood was spiked with galactose to achieve final galactose concentration of 2.5, 5, 10 and 20 mmol/L. Specimens were prepared with three different glucose concentrations (2.0, 3.4 and 5.3 mmol/L). Results were compared to Beckman DxC analyser.

Glucose electrode membrane aging effect:

A pooled serum with final glucose concentration of 4.1 mmol/L, spiked with galactose to achieve final galactose concentrations of 2.5, 5, 10 and 20 mmol/L were measured for glucose on day 1, 7 and 14 after a glucose electrode membrane change.

Results

Galactose interference:

No significant galactose interference was seen on the two glucometers or the Beckman DxC. The ABL 800 showed bias of +0.3, +0.7, +1.7 and +3.7 mmol/L for galactose concentrations of 2.5, 5, 10 and 20 mmol/L respectively. This is independent of the initial glucose concentration.

Glucose electrode membrane aging effect:

The galactose interference was membrane age dependent. Compared to Beckman DxC, the maximum interference was seen on day 1 with a bias of +6.2 mmol/L at galactose of 20 mmol/L. This decreased to +3.95 mmol/L on day 14.

Conclusion

The Statstrip and Optium Xceed meters do not cross react with galactose. The Radiometer ABL800 analyser is not reliable for the detection of hypoglycaemia in the presence of galactosaemia. The effect is worst immediately following a glucose membrane change.

CBR. 2012 Nov;33(4):S32.

P21 Evaluation of 1, 25-Dihydroxy Vitamin D Assay on The IDS-iSYS Automated System

RA Bahnisch ^1,^✉, AN Fudge ¹, PD O’Loughlin ¹

Abstract

Abstract

Introduction

Low serum total vitamin B12 (TB12) is often observed in pregnant women without complications. Vitamin B12 in blood is bound to haptocorrin (HoloHC) or transcobalamin (HoloTC). HoloTC is the active fraction which gets into most cells (including placental) for metabolic activities. We aimed to examine the changes in TB12 and HoloTC across pregnancy.

Methods

Stored serum from 65 women with bloods available at each trimester and postpartum were analysed for TB12 and HoloTC (both on Abbott Architect) at Melbourne Pathology. These women were originally enrolled in a prospective study for thyroid function reference intervals. After excluding women with HoloTC above the analytical limit at any time point, data from 44 women were used in the analysis.

Results

TB12 levels were significantly lower in pregnancy. The lowest TB12 levels were seen in the 2^nd and 3^rd trimesters and the means were approximately half of that seen postpartum. In contrast, the mean HoloTC was the lowest in the 3^rd trimester and postpartum, and highest in the 1^st trimester. The TB12 and HoloTC concentrations (pmol/L) (Mean±SD) in different trimesters and postpartum were:

	Trimester 1	Trimester 2	Trimester 3
	(9–13/40)	(22–26/40)	(35–39/40)
TB12	302±100^a	237±74^b	223±147^b
HoloTC	58.6±20.3^a	51.0±20.8^ab	44.4±22.0^b

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	Postpartum	p value
	(8–12/52)	(ANOVA)
TB12	415±145^c	<0.001
HoloTC	42.4±13.5^b	0.001

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Tukey’s post Hoc: Means with the same letters were not different.

Conclusion

There is significant decline in both TB12 and HoloTC in pregnancy from the 1^st to the 3^rd trimester. The absolute decline in TB12 (−79 pmol/L) is larger than the decline in HoloTC (−14.2 pmol/L), implying most of the TB12 decline is due to a reduction in HoloHC, the inactive fraction. In conclusion, HoloTC is the best indicator of B12 status during pregnancy.

CBR. 2012 Nov;33(4):S13.

S8 Laboratory Quality Indicators – Collection and Then What? A Practical Perspective

J Michael ¹

Abstract

It is well known that errors in pathology testing occur at a very low rate in the actual testing of the samples. This is largely attributable to the concentration of quality assurance programs (QAP) on the analytical component of the test sample life cycle. The majority of errors in delivering patient results now occur in the pre- and post-analytical phases of the test cycle. Techniques for collection of error statistics range from notes, both electronic and paper, with collation by spread-sheets, through to automated systems utilising structured data inputs into laboratory information management systems and linked or independent quality and incident management systems.

The outcome of internal or external monitoring of quality indicators should be seen in changes that can be implemented to continuously improve laboratory performance and reduce errors that impact upon patient diagnosis and treatment. The effectiveness of this outcome depends on the accuracy of the collected data, its relevance to the environment in which the laboratory operates and the availability of mechanisms to address the errors. It is critical to the effectiveness of programs such as this that clear and unambiguous definitions of errors are utilised so that we can be certain that performance is measured against identical criteria.

To reduce the pre- and post-analytical error rate, we must be sure we are measuring the same parameters in the same context, so that we can determine the true rate of error in the industry and specifically in the segment of the industry in which our facilities operate. Then we can determine the likely effective targets of action to improve overall error rates.

CBR. 2012 Nov;33(4):S33.

P25 Plasma PTH Reference Interval in Individuals with Normal Kidney Function And Sufficient Vitamin D Levels

ZX Lu ^1,^2,^✉, KA Sikaris ^1,³

Abstract

Introduction

Parathyroid hormone (PTH) increases with vitamin D deficiency and impaired kidney functions. However, this information for the population used in PTH reference interval determination are often not provided. We aimed to evaluate PTH reference interval in individuals with normal kidney function and sufficient vitamin D.

Methods

As part of the annual health promotion, staff were offered free blood test including 25-hydroxyvitamin D [25(OH)D], PTH (EDTA plasma), albumin, calcium and creatinine. Serum 25(OH)D was analysed using Diasorin Liaison XL, all others using Roche instruments.

Results

After excluding five with hypercalcaemia, analysis was performed in 487 people (84.4% female) with age (mean±SD) of 45.3±12.1 years. Their 25(OH)D were ranged <10 to 139 nmol/L and PTH ranged 1.7 to 15 pmol/L. The quartile values for 25(OH)D were 43, 57 and 71 nmol/L. Selecting eGFR (by CKD-Epi equation) >90 mL/min/1.73m², PTH in people with different levels of 25(OH)D were :

25(OH)D level	n	Plasma PTH, pmol/L (centiles)

		2.5^th	5^th	50^th
Any	338	2.1	2.3	4.5
<50 nmol/L	139	2.3	2.7	4.8
≥ 50 nmol/L	200	2.0	2.2	4.4

25(OH)D level	n	Plasma PTH, pmol/L (centiles)

		95^th	97.5^th
Any	338	7.9	8.9
<50 nmol/L	139	8.9	10.6
≥ 50 nmol/L	200	7.1	7.5

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Even in people with higher 25OHD (≥75 nmol/L) and an eGFR >90 mL/min/1.73m², PTH was normally distributed, and according to the parametric analysis the lower normal limit (95%CI) for PTH was 1.8 (1.3–2.3) and the upper normal limit was 7.1 (6.6–7.6) pmol/L.

Conclusion

PTH concentrations are vitamin D dependent. In people with 25(OH)D ≥75 nmol/L, the reference interval for plasma PTH obtained in our population is 1.8–7.1 pmol/L. Higher PTH reference intervals could result when including people with insufficient vitamin D levels and impaired kidney function.

CBR. 2012 Nov;33(4):S33–S34.

P26 Cloudy Skys or Cloudy Sample – Neither Helps Your Vitamin D Levels!

C Vasiliadis ¹, R Czajko ¹, M Mohr ¹

Abstract

Introduction

On a day to day basis, 0.5 to 1% of all samples received in our laboratory contain some level of visible lipaemia. This relatively common interferant has adverse effects on many of our analytical systems. Many laboratories resolve this problem by using a lipid clearing agent to remove the interfering lipids. We investigated the effect of lipaemia and use of lipid clearing agents on the measurement of 25 OH vitamin D (25D) on the Liaison as the manufacturer provided limited information on this subject.

Methods

Using ‘Intralipid’ we prepared ten standards, ranging from 1.29 to 81.86 mmol/L of triglyceride. 25D was measured before and after processing these samples with a lipid clearing agent.

Results

We found a significant drop in 25D levels with increasing lipaemia (Table). We verified the use of lipid clearing agents which had no adverse effects on 25D measurement and brought results back to their expected level.

Standard	0	1	2	3	4

Trig mmol/L	1.29	5.25	11.26	14.91	19.35
Baseline 25D nmol/L	73.3	66.9	60.8	58.3	54.14
% Change post Intralipid	0	8.7	17.1	20.5	26.1
25D post lipid clearing	78.7	74.3		73.5
% Change post lipid clearing	−7.4	−1.4		−0.3

Standard	5	6	7	8	9

Trig mmol/L	25.95	29.94	36.94	38.02	81.86
Baseline 25D nmol/L	54.85	49.85	50.1	48.55	35.15
% Change post Intralipid	25.2	32.0	31.7	33.8	52.0
25D post lipid clearing	74.4		71.8		67.8
% Change post lipid clearing	−1.5		2.0		7.5

The concentrations of free catecholamines, metanephrines and acidic metabolites were calculated as mmol/mol creatinine to allow comparison with recently published age-related reference ranges for seven paediatric age groups. 32 patient urines had normal concentrations of all 8 analytes, including 2 patients with neuroblastoma in post-treatment remission and 1 with Wilm’s tumour. Two new cases of neuroblastoma were identified with raised urine excretion of dopamine, 3-MT, HMMA and HVA. In addition, a rare abdominal paraganglioma in a 12-year-old girl was found with raised noradrenaline, normetanephrine, and HMMA. Three patients were observed to have a single raised result of <2x ULN of unknown significance [adrenaline (1), HMMA (2)].

Conclusion

LC-MSMS profiling for a panel of biogenic amines and their metabolites can be usefully applied to spot urine samples collected from children for screening for neuroblastoma and other neuroendocrine tumours.

Albumin levels are well known to be lower in pregnancy. Bromocresol Green (BCG) based albumin measurements are known to be less specific because of globulin cross reactivity. The globulins are also known to be altered in pregnancy, which may further complicate BCG albumin measurements in pregnancy. Therefore, Bromocresol Purple (BCP) albumin measurements may be preferred in pregnancy. We sought to define trimester specific reference intervals for BCP albumin in pregnancy and compare these with BCG albumin values.

Methods

145 healthy women were followed prospectively at each trimester throughout pregnancy. They were originally recruited for a thyroid reference interval study. Albumin measurements were performed using Beckman BCP on a DxC analyser and both Roche BCG and BCP reagents on a c701 analyser. The table below gives the 2.5^th to 97.5^th reference interval.

Results	1st Trimester	2nd Trimester

(all values in g/L)	9–13/40	22–26/40
(all values in g/L)	(n=145)	(n=97)

BCP–Alb (Beckman)	32–44	28–37
BCP–Alb (Roche)	33–45	27–37
BCG–Alb (Roche)	39–49	34–43

Results	3rd Trimester	Postpartum
(all values in g/L)	35–39/40	8–12/52
(all values in g/L)	(n=80)	(n=85)

BCP–Alb (Beckman)	25–35	37–48
BCP–Alb (Roche)	25–35	37–48
BCG–Alb (Roche)	31–41	41–52

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Conclusion

BCP albumin values were similar and consistent between the two BCP albumin methods but were typically 6 g/L lower than Roche BCG albumin estimates. As albumin estimation will impact on globulin calculations, globulin values for pregnancy will vary depending on both the albumin and total protein methods used.

CBR. 2012 Nov;33(4):S38–S39.

P43 Reference Intervals for Jaffe and Enzymatic Creatinine In Pregnancy

KA Sikaris ^1,^✉, E Ekinci ², ZX Lu ¹, I Bittar ³, D Atanasovski ¹, Q Lam ³, N Crinis ³, K Cheong ², C Houlihan ²

Abstract

Introduction

As glomerular filtration is known to increase in pregnancy, creatinine levels are predictably lower. Most laboratories use the Jaffe creatinine method, and while this is calibrated to the reference method it also involves rate blanking and compensation to correct for the known interferences in the Jaffe method from bilirubin and protein, respectively. As protein levels are known to be lower in pregnancy, it is likely that the standard compensation in the modified Jaffe calculation may be incorrect for pregnant women. We sought to define the reference intervals for Jaffe and enzymatic creatinine to investigate these potential errors.

Method

145 healthy women were followed prospectively in pregnancy and postpartum. Serum creatinine were analysed using Beckman Jaffe on a DxC analyser or Roche Jaffe and enzymatic on a c701 analyser. The distributions were Gaussian so parametric 95% reference intervals were calculated.

Results

Results: (all umol/L)	1^st Trimester	2^nd Trimester
	9–13/40	22–26/40
	(n=144)	(n=96)

Modified Jaffe (Beckman)	29–58	27–57
Modified Jaffe (Roche)	35–65	31–61
Enzymatic (Roche)	36–64	34–63

Results: (all umol/L)	3^rd Trimester	Postpartum
	35–39/40	8–12/52
	(n=79)	(n=84)

Modified Jaffe (Beckman)	29–63	39–79
Modified Jaffe (Roche)	32–64	48–82
Enzymatic (Roche)	35–68	47–83

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Conclusion

Enzymatic creatinine values were higher than either of the modified Jaffe creatinine estimates in pregnancy. This suggests an underestimation of creatinine by the Jaffe method in pregnancy due to the inherent overestimation of albumin in pregnancy in the compensated formulae. Large differences were also observed between the two Jaffe reagents suggesting calibration differences may be the more significant confounding variable at the lower creatinine levels observed in pregnancy. Harmonisation for creatinine reference interval in pregnancy may be difficult when using the standard rate blanked modified Jaffe methods. Enzymatic creatinine is recommended for the lower creatinine levels seen in children and this is probably also desirable in pregnancy.

CBR. 2012 Nov;33(4):S39.

P44 Is There Harmony in Reporting Units of Biochemistry and Haematology in Accredited Laboratories of Sri Lanka?

ID Siriwardhana ¹, KAC Wickramaratne ¹

Abstract

Introduction

The Sri Lanka Accreditation Board for Conformity Assessment (SLAB) commenced accreditation of medical laboratories in 2008. The laboratories are assessed for conformity to the ISO 15189:2007. This standard requires the results of examinations to be reported in SI units or units traceable to SI units. A survey was undertaken to assess harmonisation in reporting units for common biochemical and haematological tests in the scopes of accredited laboratories.

Methods

The data were obtained from the scopes of accredited laboratories published in the SLAB website. Tests which were performed by four or more laboratories were included in the survey.

Results

Of the eleven accredited laboratories, nine have biochemistry and haematology tests in their repertoires. Serum bilirubin, urea, creatinine, phosphate, total cholesterol, HDL-cholesterol, triglycerides and plasma glucose are reported using mg/dL or mg/dl. Units for albumin and protein are g/dL, g/dl and g/L. Serum enzymes (ALT, AST, ALP, and GGT) are reported in IU/L, U/L, U/l, and u/l. For electrolytes SI units (mmol/L and mmol/l) are used except one laboratory using mEq/L for chloride. Units for calcium are mg/dL(1), mg/dl(2) and mmol/L(1).

Six different units are used for WBC and platelet counts and five for RBC. Hb is reported in g/dl(5), g/dL(2) and g/L(1). Units for haematocrit and MCHC are percentage and g/dl respectively. MCH is reported using pg(3) and Pg(1). Units for MCV are fl(4), fL(1) and FL(1).

Conclusion

There is harmony in reporting in biochemistry, though conventional units are used with variation in symbols. The diversity in reporting units in haematology and the use of SI units for both disciplines need to be addressed.

PERMALINK

Proceedings of the Australasian Association of Clinical Biochemists’ 50th Annual Scientific Conference

S1 The use of Thyroglobulin (Tg) And Tg Autoantibody Measurements for Monitoring Patients with Differentiated Thyroid Cancers

C Spencer

Abstract

Serum Tg Testing

Serum TgAb Testing

S10 Lab Tests Online – Pathology Information for the People

B Campbell

Abstract

P45 The AACB Workshop on Harmonised Reference Limits – Recommendations for Paediatric Reference Intervals

T Yen

D Cowley

J Doery

E Haworth

B Lewis

R Mackay

M Metz

B Mottram

J Coakley

Abstract

Introduction

Methods

Results

Conclusion

P47 Viewing Pathology Results – What is the Real Turn-Around Time?

GRD Jones

M-S Ong

F Magrabi

F Coiera

Abstract

Background

Methods

Results

Conclusion

P48 Influence of Triglyceride Concentration on HDL and LDL Cholesterol Measurement –A QAP Study

GRD Jones

J Gill

Abstract

Introduction

Methods

Results

Conclusion

P49 The AACB Workshop on Harmonised Reference Limits - Recommendations for Adult Reference Intervals

J Tate

G Koerbin

J Ryan

G Jones

K Sikaris

D Kanowski

M Reed

J Gill

G Koumantakis

T Yen

A St John

P Graham

Abstract

Introduction

Methods

Results

Conclusion

P50 Clinical Comparison of the Freelite and N Latex Serum Free Light Chain (FLC) Assays In The Diagnosis And Monitoring of AL Amyloidosis

J Tate

S Bazeley

S Klingberg

CJ Pretorius

P Mollee

Abstract

Introduction

Methods

Results

Conclusion

P51 Analytical Performance Characteristics of the Dimension EXL LOCI Troponin I (CTNI) Assay

J Tate

M Huymans

T Hawkins

CJ Pretorius

U Wilgen

J Greenslade

W Parsonage

Proceedings of the Australasian Association of Clinical Biochemists’ 50^th Annual Scientific Conference