Jani 2016.

Study characteristics
Patient Sampling	Adult HIV‐positive patients at Polana Caniço Health Centre, Maputo, Mozambique, were invited to participate in the study. Only consenting patients were included in the study. In order to include patients with viral loads throughout all ranges (undetectable, detectable to 10,000 copies/mL, and greater than 10,000 copies/mL), patients were targeted for representation in those 3 ranges based on the following clinical information: on ART for longer than 6 months, on ART for between 4 weeks and 6 months, and on for ART less than 4 weeks, respectively. This clinic was selected based on its proximity to the HIV reference laboratory in Maputo and to facilitate study management and sample logistics. Eligibility criteria included age over 18 years, documented HIV infection, and receipt of ART. Exclusion criteria included any serious medical conditions that could disrupt the accuracy of normal laboratory testing and its interpretation; however, no participants met this criterion. There was no exclusion on grounds of gender, socioeconomic status, race, or ethnicity.
Patient characteristics and setting	Adult HIV‐positive patients on ART; peri‐urban health centre in Maputo, Mozambique.
Index tests	Alere Q NAT POC viral load technology (Alere Technologies, Jena, Germany) on fresh whole blood samples (capillary) at point of care.
Target condition and reference standard(s)	HIV viral load total HIV RNA (HIV‐1/2 RNA); > 1000 copies/mL and > 5000 copies/mL; Roche COBAS AmpliPrep/COBAS TaqMan v2.
Flow and timing	Viral load testing was performed within 1 week of sample 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?	Yes
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?	Yes
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	Yes
Could the patient flow have introduced bias?		Low risk