| Study characteristics |
| Patient Sampling |
In Kenya, the SAMBA HIV‐1 Semi‐Q Test as performed on the SAMBA I system by independent trained technicians at the centralized Kenya Medical Research Institute‐Centers for Disease Control and Prevention (KEMRI‐CDC) HIV research laboratory was evaluated with fresh surplus plasma samples obtained from patients attending rural clinics in 6 counties. 200 leftover plasma samples were selected on the basis of 4 viral load categories. |
| Patient characteristics and setting |
Samples from HIV‐positive patients from rural clinics in Kenya. |
| Index tests |
SAMBA HIV‐1 Semi‐Q Test on SAMBA I platform, done on fresh plasma samples in central laboratory. |
| Target condition and reference standard(s) |
High HIV viral load > 1000 copies/mL; Roche CAP/CTM v2.0 assay and the Abbott HIV‐1 RealTime Assay (for discrepant results). Only original reference results included in analysis. |
| Flow and timing |
All of them tested with same reference standard (main analysis); only a few discrepant results tested with Abbott. Discrepant analysis was performed at an independent laboratory with the Abbott HIV‐1 RealTime Assay. There were 3 discrepant results: Abbott result same as Roche. |
| 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? |
|
|
Unclear |
| 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? |
|
|
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? |
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 |
|
