| Study characteristics |
| Patient Sampling |
The performance of the SAMBA HIV‐1 Semi‐Q Test on the SAMBA II system for detection of HIV‐1 RNA at ≥ 1000 copies/mL in HIV‐1–positive patients was evaluated with surplus samples from adults on ART attending the Kiev Regional AIDS Center, Ukraine, for viral load quantification with the Abbott HIV‐1 RealTime Assay. A total of 150 frozen samples were shipped to Cambridge, United Kingdom, and tested with the SAMBA II assay at the Diagnostics Development Unit in a blinded manner. The Abbott HIV‐1 RealTime Assay was performed at the Kiev Regional AIDS Center. Discrepant samples were tested with the QIAGEN artus test by Public Health England, Cambridge. |
| Patient characteristics and setting |
Surplus samples from HIV‐1 positive adults on ART attending the Kiev Regional AIDS Center, Ukraine; samples tested in laboratory. |
| Index tests |
SAMBA HIV‐1 Semi‐Q Test on the SAMBA II system tested on frozen plasma samples in central research laboratory. |
| Target condition and reference standard(s) |
HIV‐1 RNA/viral load > 1000 copies/mL; Abbott HIV‐1 RealTime Assay and QIAGEN artus test (for discrepant results). Only original reference results included in the analysis. |
| Flow and timing |
A total of 150 frozen samples were shipped to Cambridge, United Kingdom, and tested with the SAMBA II assay at the Diagnostics Development Unit in a blinded manner. The Abbott HIV‐1 RealTime Assay was performed at the Kiev Regional AIDS Center. Discrepant samples were tested with the QIAGEN artus test by Public Health England, Cambridge. In Ukraine, original discordant and retesting with tie breaker yielded similar results. |
| 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? |
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? |
|
|
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? |
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? |
Yes |
|
|
| Could the patient flow have introduced bias? |
|
Unclear risk |
|
