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. 2022 Mar 10;2022(3):CD013208. doi: 10.1002/14651858.CD013208.pub2

Kufa 2020.

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  
Notes  
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
Could the selection of patients have introduced bias?   Low risk  
Are there concerns that the included patients and setting do not match the review question?     Unclear
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? Unclear    
Were all patients included in the analysis? No    
Could the patient flow have introduced bias?   Unclear risk