Lass 2013.
Study characteristics | |||
Patient Sampling |
Inclusion/exclusion criteria Not explicitly reported. Quote: "Formalin fixed paraffin‐embedded (FFPE) tissue of 42 consecutive brain tumor biopsies with previously established 1p/19q status by FISH was available for a comparative analysis of CISH … FISH analysis of 1p/19q was initiated in all cases during diagnostic work‐up and based on morphological features resembling oligodendroglioma". Prior testing Histopathological diagnosis according to WHO 2007 classification. All tumours had previously established 1p/19q status by FISH. |
||
Patient characteristics and setting |
Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 38 Country: Germany Population source and setting: NR Age: mean: 43.2 years, standard deviation: 14.8 years Gender: 52.6% male Karnofsky performance status: NR First diagnosis/recurrent disease: NR |
||
Index tests |
2 tests: CISH and FISH CISH Tumour sample type: FFPE Region(s) analysed: 1p36/1q25, 19q13/19p13 Cut‐off: 50% of cells had to show deletion FISH Tumour sample type: FFPE Region(s) analysed: 1p36/1q25, 19q13/19p13 (ZytoVision) Cut‐off: 50% of cells had to show deletion |
||
Target condition and reference standard(s) | Target condition was absolute 1p/19q deletion. FISH used as reference standard in some of our analyses. | ||
Flow and timing | We presumed that all tests were performed on biopsied tumour material collected on 1 occasion. | ||
Comparative | |||
Notes | |||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Unclear | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Could the selection of patients have introduced bias? | Unclear risk | ||
Are there concerns that the included patients and setting do not match the review question? | Low concern | ||
DOMAIN 2: Index Test (NanoString) | |||
DOMAIN 2: Index Test (aCGH) | |||
DOMAIN 2: Index Test (NGS) | |||
DOMAIN 2: Index Test (G‐banding) | |||
DOMAIN 2: Index Test (FISH (variant 4)) | |||
DOMAIN 2: Index Test (SNP array) | |||
DOMAIN 2: Index Test (PCR (with comparison to normal DNA)) | |||
DOMAIN 2: Index Test (PCR (without comparison to normal DNA)) | |||
DOMAIN 2: Index Test (CISH) | |||
If a threshold was used, was it pre‐specified? | Yes | ||
Were the index test results interpreted without knowledge of the results of the other tests being compared? | Yes | ||
Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 2: Index Test (MS) | |||
DOMAIN 2: Index Test (RFLP) | |||
DOMAIN 2: Index Test (PCR‐based LOH) | |||
DOMAIN 2: Index Test (NGS or aCGH (or both)) | |||
DOMAIN 2: Index Test (Methylation array) | |||
DOMAIN 2: Index Test (FISH) | |||
If a threshold was used, was it pre‐specified? | Yes | ||
Were the index test results interpreted without knowledge of the results of the other tests being compared? | Yes | ||
Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 2: Index Test (FISH (variant 1)) | |||
DOMAIN 2: Index Test (FISH (variant 2)) | |||
DOMAIN 2: Index Test (FISH (variant 3)) | |||
DOMAIN 2: Index Test (Real‐time PCR) | |||
DOMAIN 2: Index Test (MLPA) | |||
DOMAIN 2: Index Test (CGH) | |||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | No | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | High risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Low risk |