| Study characteristics |
| Patient Sampling |
Study was conducted from June to September 2015 in HIV‐1 positive adults. 314 HIV‐1 seropositive with ART status as follows: (ART naive n = 151, on ART n = 129, suspected ART failure n = 34; individuals were screened to obtain varying viral load ranges) and 20 normal, healthy, HIV seronegative individuals were enrolled at 3 ART centres located in Pune (ART centres: Model Colony; YCM Hospital; Sassoon General Hospital). |
| Patient characteristics and setting |
HIV‐positive adults (ART naive n = 151, on ART n = 129, suspected ART failure n = 34) (51.9% on ART) from ART centres in health centres in India. |
| Index tests |
GeneXpert HIV‐1 Quant assay (a point‐of‐care technology) on frozen plasma samples in the laboratory (stored at −70 °C until tested). Testing seems to be at decentralized sites included in the study. (The national ART programme in India was launched in April 2004 in a limited number of hospitals.) |
| Target condition and reference standard(s) |
HIV viral load at > 5000, > 200, > 40; Abbott HIV‐1 m2000 RealTime PCR |
| Flow and timing |
The whole blood specimens were collected in 10‐millilitre EDTA Vacutainers (Becton Dickinson, USA), transported to National AIDS Research Institute (NARI), centrifuged at 405 g for 10 min, plasma was separated within 6 h, aliquoted, and stored at −70 °C until tested. Samples collected at same time but tested at different times. |
| 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 (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? |
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 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? |
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 |
|
