| Study characteristics |
| Patient Sampling |
In Zimbabwe, the performance of the SAMBA HIV‐1 Semi‐Q Test was evaluated by testing plasma specimens from adults attending the Opportunistic Infection Clinic at Harare Hospital. A total of 193 fresh specimens were tested with the SAMBA HIV‐1 Semi‐Q Test as performed on the SAMBA I platform and with the Roche CAP/CTM v2.0 assay at the National Reference Microbiology Laboratory in Harare. |
| Patient characteristics and setting |
Samples from HIV‐positive adults attending an HIV clinic in Harare, Zimbabwe. |
| Index tests |
SAMBA HIV‐1 Semi‐Q Test on SAMBA I platform on fresh plasma samples in a central reference laboratory. |
| Target condition and reference standard(s) |
High HIV viral load > 1000 copies/mL; Roche CAP/CTM v2.0 assay and Abbott HIV‐1 RealTime Assay (discrepant results). 7 discrepant results original Roche testing: 6 discrepant results were concordant with tie‐breaker testing (Abbott = Roche); 1+ Roche and 1‐ SAMBA. Results of the reference test were based on tie‐breaker results but unlikely to introduce bias as it was only one differing result. |
| Flow and timing |
A total of 193 fresh specimens were tested with the SAMBA HIV‐1 Semi‐Q Test as performed on the SAMBA I platform and with the Roche CAP/CTM v2.0 assay at the National Reference Microbiology Laboratory in Harare. There were 7 discrepant results original Roche testing: 6 discrepant results were concordant with tie‐breaker testing (Abbott = Roche); 1+ Roche and 1‐ SAMBA. |
| 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? |
No |
|
|
| Were all patients included in the analysis? |
Yes |
|
|
| Could the patient flow have introduced bias? |
|
Unclear risk |
|
