Study characteristics |
Patient Sampling |
Prospective study of pregnant or early postpartum women living with HIV (WLHIV) admitted to labour or postdelivery wards and their newborn infants until return of results or discharge, 4 high‐volume tertiary obstetric units (TOUs) in Gauteng, South Africa. All WLHIV admitted to labour or postnatal wards at the 4 TOUs during the study period were offered POC VL or birth polymerase chain reaction (PCR) testing, or both, by routine staff. Specimens were collected by doctors and nurses as part of their routine duties. POC testing was conducted by a POC operator working in a designated POC testing room. |
Patient characteristics and setting |
Pregnant or early postpartum WLHIV admitted to labour or postdelivery wards > 95% on ART from 4 high‐volume TOUs in Gauteng, South Africa. |
Index tests |
Cepheid’s Xpert HIV‐1 quantitative in the field. |
Target condition and reference standard(s) |
High viral load > 1000 copies/mL, central laboratory testing. |
Flow and timing |
For both WLHIV and infants, 2 specimens were collected ‐ 1 for POC and the other for central laboratory testing. |
Comparative |
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Notes |
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Methodological quality |
Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
DOMAIN 1: Patient Selection |
Was a consecutive or random sample of patients enrolled? |
Yes |
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Was a case‐control design avoided? |
Yes |
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Did the study avoid inappropriate exclusions? |
Yes |
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Could the selection of patients have introduced bias? |
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Low risk |
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Are there concerns that the included patients and setting do not match the review question? |
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Unclear |
DOMAIN 2: Index Test (All tests) |
Were the index test results interpreted without knowledge of the results of the reference standard? |
Yes |
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If a threshold was used, was it pre‐specified? |
Yes |
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Could the conduct or interpretation of the index test have introduced bias? |
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Low risk |
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Are there concerns that the index test, its conduct, or interpretation differ from the review question? |
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Low concern |
DOMAIN 3: Reference Standard |
Is the reference standards likely to correctly classify the target condition? |
Yes |
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Were the reference standard results interpreted without knowledge of the results of the index tests? |
Yes |
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Could the reference standard, its conduct, or its interpretation have introduced bias? |
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Low risk |
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Are there concerns that the target condition as defined by the reference standard does not match the question? |
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Low concern |
DOMAIN 4: Flow and Timing |
Was there an appropriate interval between index test and reference standard? |
Yes |
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Did all patients receive the same reference standard? |
Unclear |
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Were all patients included in the analysis? |
No |
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Could the patient flow have introduced bias? |
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Unclear risk |
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