| Study characteristics |
| Patient Sampling |
A total of 200 samples collected in Chiradzulu, Malawi, from 72 men and 128 women; patients ranged in age from 18 to 61 years. 4 patients were assigned an ID but withdrew from the study with no sample having been collected. |
| Patient characteristics and setting |
HIV‐positive adults (70 patients (19.8%) were ART naive, and 284 patients (80.2%) had been on ART for a period of 1 month to 10 years at the time of testing) in Malawi. |
| Index tests |
SAMBA HIV‐1 Semi‐Q Test on fresh plasma samples in the field setting |
| Target condition and reference standard(s) |
High HIV viral load > 1000 copies/mL; Roche CAP/CTM v2.0 assay and Abbott RealTime; discordant results with Roche were retested with Abbott RealTime |
| Flow and timing |
The 12 discordant samples (from Malawi and Uganda) were retested with Abbott RealTime at 1 of 2 independent laboratories and in a blinded manner with regard to the SAMBA Semi‐Q and Roche TaqMan v2 results. The Abbott RealTime results were concordant with the Roche TaqMan v2 results for 10 of the 12 samples. This is unlikely to have introduced bias in study estimates, as results were similar. |
| 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? |
No |
|
|
| 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? |
No |
|
|
| Were all patients included in the analysis? |
Yes |
|
|
| Could the patient flow have introduced bias? |
|
Unclear risk |
|
