Domain	Participant selection	*Index test (IT)	Reference standard (RS)	Flow and timing
Description	Methods of participant selection	How IT was conducted and reported	How RS was conducted and reported	Describe participants who did not receive and time interval between IT or RS
Signalling questions (yes, no, unclear)	Consecutive or random sample of participants? Yes: when the authors reported random participant sampling or consecutive enrolment. No: when participants were selected, for example, based on previous (reference or index) test results. Unclear: if there was insufficient information on study sampling.	IT results interpreted without knowledge of the results of RS? Yes: when study reported that results of the ITs were interpreted without knowledge of RS results or when ITs were done before the RS. No: when study reported that results of the ITs were interpreted with knowledge of RS results or in cases when RS were used before the index tests. Unclear: when there was insufficient information on when the IT and RS were interpreted.	RS likely to correctly classify the target condition? Yes: if the RS threshold was clearly reported as > 1000 copies/mL or > 5000 copies/mL. No: if the RS threshold was not reported or if other thresholds used without justification. Unclear: if there was insufficient information to make a judgement.	Appropriate interval between IT and RS? Yes: if samples tested by both the RS and IT were taken at the same time or within 24 hours. No: if samples tested by both the RS and IT were taken at the same time or within 24 hours. Unclear: when there was no or insufficient information on time period.
	Was a case‐control design avoided? Yes: if a case‐control design was not used. No: if a case‐control design was used. Unclear: if there was insufficient information on study design.	Prespecified threshold used? Yes: when the authors reported the use of 1, prespecified, cut‐off value. A prespecified threshold also included statements such as, "the test was scored according to manufacturer’s instructions." No: when multiple cut‐off values were tested and the best 1 chosen afterwards. Unclear: when only a cut‐off value was used, but this was not explicitly stated in the methods section.	RS results interpreted without knowledge of the results of IT? Yes: when study reported that results of the RS were interpreted without knowledge of IT results or in cases when RS were used before the IT. No: when study reported that results of the RS were interpreted with knowledge of the IT results in cases when IT were used before the RS. Unclear: when there was insufficient information on when the IT and RS were interpreted.	Number of participants receiving a RS, and included in the analysis? Yes: when the whole sample or a random selection of the sample or a selection of the sample with consecutive series received verification using a RS. No: when a part of the sample that was non‐randomly or non‐consecutively selected receives verification with the RS. Unclear: when there was no or insufficient information to ascertain if the whole sample or a random selection of the sample received verification with a RS.
	Did the study avoid inappropriate exclusions? Yes: no participants were excluded after inclusion. No: for example, when specific participants were excluded (for example, those with mild disease because they are more difficult to detect). Unclear: if there was insufficient information on inclusion/exclusion criteria.			Number of participants receiving same RS, and included in the analysis? Yes: when study participants were tested with the same reference standard RS regardless of index test result. No: when different RS were used. Unclear: when there was no or insufficient information the different RS used.
				Were all participants included in the analysis? Yes: when the participants who were included in the study, were also included in the analysis. No: when some participants/results were missing. Unclear: when there was no or insufficient information to make a judgement.
Risk of bias (high, low, unclear)	Could the selection of participants have introduced bias?	Could the conduct or interpretation of the IT have introduced bias?	Could the RS, its conduct, or its interpretation has introduced bias?	Could the participant flow have introduced bias?
Applicability concerns (high, low, unclear)	Are there concerns that the included participants do not match the review question? High: if some included participants were not on ART. Low: if all participants were on ART. Unclear: if there was insufficient information to make a judgement.	Are there concerns that the IT, its conduct, or interpretation differs from the review question? High if IT was not a true POC, i.e. required ancillary laboratory equipment or staff or testing done on frozen samples or if IT was not commercially available (a prototype). Low: if IT was a true POC and commercially available. Unclear: if there was insufficient information to make a judgement.	Are there concerns that the target condition as defined by the RS does not match the review question? High if the RS threshold was not reported or if other thresholds used without justification. Low if the RS threshold was clearly reported as > 1000 copies/mL or > 5000 copies/mL. Unclear if there was insufficient information to make a judgement.	—
Scoring risk of bias assessment. If we answer 'yes' to all signalling questions for a domain, then we will score as 'low' risk of bias. If we answer 'no' to any signalling question, this will flag the potential for bias and we will score as high risk of bias. We will assign the 'unclear' category when any other combination of answers are used, for example, all questions are unclear or if ≥ 2 questions were unclear. IT: index test; POC: point of care; RS: reference standard.