Fig 1.
STARD diagnostic flow diagram.
Infants receiving an HIV PCR test as per local protocol were tested on the POC device and at the laboratory. Some infants provided multiple specimens and underwent multiple point-of-care tests. This diagram reflects the first point-of-care result for each specimen which is directly compared to the standard of care result from the laboratory. Tests are stratified by field testing site.
Table 1.
Summary study population demographics stratified by health care facility.
Infants received a routine EID test (SOC) at either the obstetric hospital or primary care centre. The specimen used for routine testing was also used for POC testing in parallel within the field setting (SOC: Standard of Care).
Table 2.
Performance of Alere q Detect HIV-1 (first test) against the standard of care Roche CAP/CTM HIV-1 PCR.
Table 3.
Operational features of Alere q Detect HIV-1 performed at the obstetric hospital and primary care centre.
Numbers reflect total tests run, including repeat tests for specimens recording an error message on the first attempt, but exclude samples run on faulty device.