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. 2022 Mar 2;2022(3):CD013387. doi: 10.1002/14651858.CD013387.pub2

Jha 2011.

Study characteristics
Patient Sampling Inclusion/exclusion criteria
NR. 40 gliomas including 16 oligodendrogliomas grade‐II (O‐II), 14 oligodendrogliomas grade III (AO‐III) and 10 GBMs were selected for this study.
Prior testing
Histopathological diagnosis according to the WHO 2007 classification.
Patient characteristics and setting Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 40
Country: India
Population source and setting: Neurosurgery Department of All India Institute of Medical Sciences, New Delhi, India. Time period NR
Age: mean: 37.3 years, standard deviation: 10.8 years
Gender: 80% male
Karnofsky performance status: NR
First diagnosis/recurrent disease: NR
Index tests 2 tests: FISH and PCR
FISH
Tumour sample type: FFPE
Region(s) analysed: 1p36/1q25, 19q13/1p36 (using a locus‐specific probe for 1p36 and 19q13) (Vysis, Downers Grove, Illinois, USA).
Cut‐off: an interpretation of deletion or imbalance was made if > 20% of the nuclei showed test to reference ratio of 1/2 or 0/2.
PCR
Tumour sample type: fresh‐frozen
Region(s) analysed: 1p: D1S1184 (1P31.1), D1S1592 (1P36.13), D1S548 (1P36.23), D1S1608 (1P36.32); 19q: D19S431 (19q12), D19S718 (19q13.2), D19S559 (19q13.32), D19S601 (19q13.41)
Cut‐off: a complete loss of band or reduction in intensity of > 50% in the tumour lane in comparison with the corresponding blood lane was scored as LOH.
Target condition and reference standard(s) Target condition was absolute 1p/19q deletion. FISH or PCR‐based LOH 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? Unclear    
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?     High
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)
DOMAIN 2: Index Test (MS)
DOMAIN 2: Index Test (RFLP)
DOMAIN 2: Index Test (PCR‐based LOH)
If a threshold was used, was it pre‐specified? Unclear    
Were the index test results interpreted without knowledge of the results of the other tests being compared? Unclear    
Could the conduct or interpretation of the index test have introduced bias?   Unclear risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
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? Unclear    
Could the conduct or interpretation of the index test have introduced bias?   Unclear 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