Gueudin 2016.

Study characteristics
Patient Sampling	Clinical performance was evaluated relative to the Abbott RealTime HIV‐1 assay on 285 HIV‐1 seropositive samples selected to cover the assays quantification range (40 copies/mL to 10,000,000 copies/mL), and included RNA undetectable or detected seropositive samples. Samples collected during routine viral load measurements for 285 patients managed at the Charles Nicolle Hospital, Rouen, France.
Patient characteristics and setting	Samples from 285 HIV‐1 seropositive patients (224 patients on ART and 59 untreated patients; no ART information available for 2 patients); lab setting in France.
Index tests	Cepheid Xpert HIV‐1 Viral Load assay done on fresh plasma samples in a hospital laboratory in France.
Target condition and reference standard(s)	High viral load > 40 copies/mL; Abbott RealTime HIV‐1 assay.
Flow and timing	Fresh samples were stored at 2 °C to 8 °C and tested simultaneously by both techniques within 5 days of collection and separation, and frozen samples were tested simultaneously within the same freeze/thaw cycle.
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?	Unclear
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?	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?			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