Table 2.
Biomarkers and their analysers, analytical methods and quality criteria
| Biomarkers in alphabetic order | Analyser model | Manufacturer | Test method | Frequency of quality controls (3 shifts per day.) | Acceptable Root Mean Standard Deviation as defined by Rili-BAEK | Range of interest as defined by Rili-BAEK | Unit |
|---|---|---|---|---|---|---|---|
| Alpha-HBDH | AU 680 | Beckman Coulter Inc., Brea, United States | Kinetic (decreasing) UV-Test at 37 °C | Twice per 8 h-shift plus after every 50 specimen. | not defined by Rili-BAEK | not defined by Rili-BAEK | U/l |
| Antithrombin III | STA-R Evolution | Diagnostica Stago S.A.S., Asnieres sur Seine, France | Colorimetric Assay (ELISA) of Antithrombin III Activity | 4 times per 8 h-shift. | not defined by Rili-BAEK | not defined by Rili-BAEK | U/l |
| aPTT | STA-R Evolution | Diagnostica Stago S.A.S., Asnieres sur Seine, France | Time to clotting after recalcification of plasma in the presence of cephalin (platelet substitute) and a factor XII activator (poly-phenolic component) | 4 times per 8 h-shift. | 10,5% | 20–120 | sec. |
| Calcium (ionized) | ABL 800Flex | Radiometer Medical ApS, Brønshøj, Denmark | Potentiometric method | Once per 8 h-shift. | 14% | 0,2–≤ 1 | mmol/l |
| 7,5% | >1–2,5 | ||||||
| Chloride | ABL 800Flex | Radiometer Medical ApS, Brønshøj, Denmark | Potentiometric method | Once per 8 h-shift. | 4,5% | 70–150 | mmol/l |
| Creatin Kinase (CK) | AU 680 | Beckman Coulter Inc., Brea, United States | International Federation of Clinical Chemistry and Laboratory Medicine Method | Twice per 8 h-shift plus after every 50 specimen. | 11% | 50–1000 | U/l |
| Creatinine | AU 680 | Beckman Coulter Inc., Brea, United States | Kinetic colorimetric Jaffe reaction | Twice per 8 h-shift plus after every 50 specimen. | 11,5% | 0,5–10 | mg/dl |
| Fibrinogen | STA-R Evolution | Diagnostica Stago S.A.S., Asnieres sur Seine, France | Clauss clotting assay | 4 times per 8 h-shift. | not defined by Rili-BAEK | not defined by Rili-BAEK | mg/dl |
| Free Haemoglobin | Cobas Integra 400 | Hoffmann- La Roche AG, Basel, Switzerland | Colorimetric Test | 4 times per 8 h-shift. | 20% | not defined by Rili-BAEK | mg/l |
| Glutamic Oxaloacetic Transaminase (GOT/AST) | AU 680 | Beckman Coulter Inc., Brea, United States | International Federation of Clinical Chemistry and Laboratory Medicine - Method | Twice per 8 h-shift plus after every 50 specimen. | 11,5% | 20–400 | U/l |
| Haemoglobin | XE5000 | Sysmex Corporation KK, Kobe, Japan | SLS (sodium lauryl sulphate) haemoglobin method | Once per 8 h-shift. | 4% | 2–20 | g/dl |
| INR | STA-R Evolution | Diagnostica Stago S.A.S., Asnieres sur Seine, France | Time to clotting after addition of Calcium-rich thromboplastine (Neoplastine CI plus) | 4 times per 8 h-shift. | not defined by Rili-BAEK | not defined by Rili-BAEK | n.n. |
| Leukocytes | XE5000 | Sysmex Corporation KK, Kobe, Japan | Flow cytometry with dynamic focusing | Once per 8 h-shift. | 6,5% | 2–30 | 109/l |
| Myoglobin | AU 5800 | Beckman Coulter Inc., Brea, United States | electrochemiluminescence-immunoassay | Twice per 8-h shift | not defined by Rili-BAEK | not defined by Rili-BAEK | μg/l |
| Potassium | ABL 800Flex | Radiometer Medical ApS, Brønshøj, Denmark | Potentiometric method | Once per 8 h-shift. | 4,5% | 2–8 | mmol/l |
| Sodium | ABL 800Flex | Radiometer Medical ApS, Brønshøj, Denmark | Potentiometric method | Once per 8 h-shift. | 3% | 110–180 | mmol/l |
| Thrombocytes | XE5000 | Sysmex Corporation KK, Kobe, Japan | Flow cytometry with dynamic focusing; traditional impedance technology for very low and very high PLT counts | Once per 8 h-shift. | 13,5% | 40–≤150 | 109/l |
| 8,5% | 150–≤300 | ||||||
| 7,5% | 300–700 | ||||||
| Troponin I | Access 2 | Beckman Coulter Inc., Brea, United States | electrochemiluminescence immunoassay | 4 times per 8 h-shift. | 20% | 0,1–35 | μg/l |
For more detailed information on the laboratory testing of our selected parameters we refer to the technical manuals and reference guidebooks of each analyser as well as the Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations (Rili-BAEK [15])