Goel 2017a.
| Study characteristics | |||
| Patient Sampling | The performance of the SAMBA HIV‐1 Semi‐Q Test for detection of HIV‐1 ribonucleic acid (RNA) at ≥ 1000 copies/mL in HIV‐1 positive patients was evaluated with the SAMBA I platform by testing specimens from consenting adults attending an HIV clinic at St Thomas’ Hospital in London, UK, for routine testing of CD4+ cell count and viral load with the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) v2.0 assay. Leftover frozen plasma specimens from 130 consecutive patients were tested in a blinded manner with 1 lot of reagents for the SAMBA HIV‐1 Semi‐Q Test at the Diagnostics Development Unit, University of Cambridge, Cambridge, United Kingdom. | ||
| Patient characteristics and setting | Samples from HIV‐1 positive adults attending at HIV clinic at London hospital UK for routine testing and viral load monitoring. | ||
| Index tests | SAMBA HIV‐1 Semi‐Q Test at the Diagnostics Development Unit, University of Cambridge, Cambridge, United Kingdom. Frozen samples tested in central laboratory. | ||
| Target condition and reference standard(s) | Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) v2.0 assay. Abbott HIV‐1 RealTime Assay at the Royal Free Hospital (London, United Kingdom). (Discrepant samples, though original and retested samples similar; unlikely to introduce bias). |
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| Flow and timing | Leftover frozen plasma specimens from 130 consecutive patients were tested in a blinded manner with 1 lot of reagents for the SAMBA HIV‐1 Semi‐Q Test at the Diagnostics Development Unit, University of Cambridge, Cambridge, United Kingdom. Testing specimens from consenting adults attending an HIV clinic at St Thomas’ Hospital in London, United Kingdom, for routine testing of CD4+ cell count and viral load with the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) v2.0 assay. | ||
| Comparative | |||
| Notes | 1 discrepant result: Abbott same as Roche. | ||
| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient Selection | |||
| Was a consecutive or random sample of patients enrolled? | Yes | ||
| 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? | Unclear | ||
| DOMAIN 2: Index Test (All tests) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
| If a threshold was used, was it pre‐specified? | 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? | High | ||
| DOMAIN 3: Reference Standard | |||
| Is the reference standards likely to correctly classify the target condition? | Yes | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | Yes | ||
| Could the reference standard, its conduct, or its interpretation have introduced bias? | Low 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? | Unclear | ||
| Did all patients receive the same reference standard? | Yes | ||
| Were all patients included in the analysis? | No | ||
| Could the patient flow have introduced bias? | Unclear risk | ||