Gous 2016.
| Study characteristics | |||
| Patient Sampling | Written informed consent was obtained when patients presented at the phlebotomy room of Themba Lethu HIV Clinic, Helen Joseph Hospital, Johannesburg, for routine viral load monitoring. | ||
| Patient characteristics and setting | Adult ART patients in health facilities in Johannesburg, South Africa. | ||
| Index tests | The Xpert HIV‐1 Viral Load assay (Cepheid) on fresh plasma done in lab; University of the Witwatersrand Diagnostics Research testing laboratory. | ||
| Target condition and reference standard(s) | High HIV viral load > 1000 copies/mL; Roche COBAS TaqMan/COBAS Ampliprep version 2 (TaqMan v2) and Roche COBAS. 6800/8800 (Roche Molecular Diagnostics, Branchburg, US) (fresh plasma samples). |
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| Flow and timing | Following routine blood draw, an additional 4 EDTA.K3 blood tubes were obtained and couriered the same day (approximately 30 minutes) to the University of the Witwatersrand Diagnostics Research testing laboratory. | ||
| 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? | Low concern | ||
| DOMAIN 2: Index Test (All tests) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | Unclear | ||
| If a threshold was used, was it pre‐specified? | 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? | 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? | Unclear | ||
| Could the reference standard, its conduct, or its interpretation have introduced bias? | Unclear 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 | ||
| Did all patients receive the same reference standard? | Unclear | ||
| Were all patients included in the analysis? | Unclear | ||
| Could the patient flow have introduced bias? | Unclear risk | ||