| Study characteristics |
| Patient Sampling |
Priority criteria were established for patients on clinical suspicion of virological failure, patients receiving second‐line ART, or third‐line ART from 2015, children and adolescents, and patients who had been receiving ART for more than 4 years. |
| Patient characteristics and setting |
Patients on ART for between 6 months and 10 years, rural settings in Malawi. SAMBA I‐equipped sites included Chiradzulu District Hospital, together with 4 out of 10 peripheral health centres. |
| Index tests |
SAMBA I Viral Load (SAMBA I VL) in the field. |
| Target condition and reference standard(s) |
High viral load reflecting ART failure or efficacy > 1000 copies/mL; NUCLISENS bioMérieux (2013 to 2015); Abbott RealTime HIV‐1 (2016 to 2017). |
| Flow and timing |
Same‐day point‐of‐care viral load (POC VL) results, but aliquots of the remaining plasma were prepared onsite, frozen in a dedicated freezer on the same day as blood collection, and sent monthly to a reference laboratory in the same country as collection. |
| 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? |
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? |
|
|
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? |
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? |
No |
|
|
| Were all patients included in the analysis? |
Unclear |
|
|
| Could the patient flow have introduced bias? |
|
Unclear risk |
|
