| Study characteristics |
| Patient Sampling |
Routine plasma viral load (VL) and CD4 samples from public sector antiretroviral clinics across the Western Cape Province were used in this evaluation. In order to ensure that most of the VL analytical spectrum was covered, a convenient sampling strategy randomly selected paired CD4/VL EDTA samples where at least 50 samples of plasma VL results were from each of 4 categories: target not detected, < 40 to 1000 copies/mL, 1000 to 10,000 copies/mL, and > 10,000 copies/mL. |
| Patient characteristics and setting |
Unclear; routine plasma VL and CD4 samples from public sector antiretroviral clinics across the Western Cape Province were used in this evaluation; laboratory‐based cross‐sectional study. |
| Index tests |
Alere q (Alere Technologies, Jena, Germany) was performed using a prototype cartridge (prototype assay) at Groote Schuur virology laboratory in Cape Town. |
| Target condition and reference standard(s) |
Abbott RealTime HIV‐1 assay (Abbott Laboratories, Chicago, USA). |
| Flow and timing |
Once plasma VL and CD4 testing were complete, the remainder of the blood sample from CD4 testing was used for whole blood Alere q test and dried blood spots (DBS) within 72 hours of sample receipt to prevent sample degradation. |
| Comparative |
|
| Notes |
Final commercially available version known as the m‐PIMA HIV‐1/2 VL test. |
| 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? |
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? |
Unclear |
|
|
| Could the patient flow have introduced bias? |
|
Unclear risk |
|
