Nigro 2001.
| Study characteristics | |||
| Patient Sampling |
Inclusion/exclusion criteria Inclusion criteria: oligodendrogliomas and oligoastrocytomas Prior testing Histopathological diagnosis |
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| Patient characteristics and setting |
Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 22 Country: USA Population source and setting: University of California, San Francisco. Time period NR Age: NR Gender: NR Karnofsky performance status: NR First diagnosis/recurrent disease: NR |
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| Index tests |
2 tests: FISH and real‐time PCR FISH Tumour sample type: FFPE Region(s) analysed: 1p36/1q24, 19p13/19q13.3 Cut‐off: ratio of target to control probes of ≤ 0.85 scored as a loss Real‐time PCR Tumour sample type: FFPE Region(s) analysed: D1S468, D1S214, D1S2736, D1S2783, D1S514, D19S408, D19S596, D19S867, D19S418, D19S926. Not all primers run for all samples. Cut‐off: copy numbers < 1.58 in ≥ 2 sequential loci (requirement for loss at ≥ 2 sequential loci at least for 1p). Additional details: real‐time quantitative PCR, quantitative microsatellite analysis. Utilises a probe designed to bind to CA repeats. |
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| 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? | 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) | |||
| 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) | |||
| 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? | Yes | ||
| 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 (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? | No | ||
| Could the patient flow have introduced bias? | High risk | ||