Background:  Accurate and timely rapid HIV testing could allow HIV-infected women with undocumented HIV status, presenting at labor and delivery immediate access to antiretroviral prophylaxis. 

Methods:  The multicenter Mother-Infant Rapid Intervention at Delivery (MIRIAD) study implemented 24-hour counseling and voluntary rapid HIV testing for women presenting at labor and delivery with undocumented HIV status.  The OraQuick Rapid HIV-1 Antibody Test was used on whole blood specimens at 15 hospitals in 6 cities (Atlanta, Georgia; Baton Rouge and New Orleans, Louisiana; Chicago, Illinois; Miami, Florida; and New York, New York). Duplicate specimens were sent for standard HIV screening (EIA and Western blot).  Turn-around times from blood draw to receipt of rapid and standard HIV-1 test results were recorded for each patient.

Results:  From November 2001 until June 2003, 69,094 encounters were recorded on labor and delivery units; 5374 (7.8%) eligible women presented with undocumented HIV status, ranging from 2.5% in Atlanta to 10.3% in Miami.  Of these, 4330 (80.6%) were approached for rapid HIV testing.  Consent was obtained from 3660 (84.5%) women.  Younger age, Hispanic ethnicity, and gestational age <32 weeks were associated with higher test acceptance (p <0.01).  With both OraQuick and EIA/WB, 29 patients tested positive (HIV-1 seroprevalence = 0.8%).  Sensitivity and specificity of the OraQuick assay were 100% and 99.9%, respectively; positive predictive value was 94% compared with 78% for EIA.  Median turn-around time from blood draw until the patient was informed of her rapid test result was 70 minutes while median time for EIA results to become available was 28 hours after blood draw (p <0.0001).  Median rapid test turn-around time was longer at 6 hospitals using laboratory testing (90 minutes; interquartile [IQR] range = 60 - 145 minutes) than at 9 hospitals using point-of-care testing (45 minutes; IQR = 35 - 70 minutes).  In multivariate Cox regression, the adjusted hazard ratio for modeling time to results was 2.4 (95% CI = 2.1 - 2.7; p <0.001) for laboratory-based versus point-of-care rapid testing.

Conclusions:  In laboring women with undocumented HIV status, rapid HIV testing using OraQuick delivered accurate and timely test results. This intervention allowed HIV⁺ women and their infants immediate access to antiretroviral prophylaxis, a proven measure to reduce perinatal transmission.

Keywords: perinatal HIV; rapid testing; antiretroviral prophylaxis