Cohen MH, Olszewski Y, Branson B, et al. AIDS. 2003;17:2121–2124
Purpose of the Study.
The US Food and Drug Administration recently approved the OraQuick rapid human immunodeficiency virus-1 (HIV-1) antibody test (OraSure Technologies, Bethlehem, PA). The test is designed for point-of-care testing for HIV. The test is performed with a tiny amount of blood, and results are available within 20 to 30 minutes. Remarkably, this test is as sensitive and specific as the standard enzyme-linked immunosorbent assay for HIV-specific antibodies. The purpose of this study was to evaluate the differences in turnaround times between hospitals where obstetric staff members performed the rapid test at the point of care and a hospital where testing was performed in the hospital laboratory.
During a 7-month period, 5771 women were evaluated in the labor and delivery areas of the target hospitals, and 514 met the criteria for rapid HIV testing. Of those, a total of 225 women were tested at 3 hospitals that used point-of-care testing and 155 were tested at a hospital that used the laboratory for the same test. Standard enzyme-linked immunosorbent assays confirmed 100% of the rapid test results. Three women were identified as being HIV infected; in those instances, antiretroviral therapy was administered during labor and delivery and/or administered to the neonate. The median turnaround time at the 3 hospitals that used point-of-care testing was 45 minutes (range: 30 minutes to 2.5 hours); the hospital that used the laboratory had a median time of >3.5 hours (range: 94 minutes to >16 hours; P < .0001).
The OraQuick rapid HIV-1 antibody test is a highly accurate measure of HIV risk, for use in a number of clinical settings. With the OraQuick test, hospitals can rapidly identify HIV-infected individuals. This study demonstrates that true point-of-care testing dramatically reduces the time needed for test result availability and allows clinical interventions in a timely manner.
Same-day access to HIV test results could greatly reduce the number of adults who are tested but never return to the test site for their HIV test results. The availability of the OraQuick test also has the potential to reduce the already low incidence of perinatal HIV transmission. It currently takes days to obtain HIV antibody test results for individuals presenting to a hospital or clinic. For women who have received no prenatal care and who present in labor, this time frame precludes the implementation of antiretroviral therapy during labor and delays the administration of antiretroviral agents to the newborn. In many cases, the delay exceeds the 48- to 72-hour period within which transmission might be reduced with treatment of the newborn. Finally, the availability of the OraQuick test might reduce the time that caregivers would need to receive antiretroviral agents after accidental sharps exposures, with the source being quickly shown to be HIV-negative. Anyone who has needed to take an antiretroviral “cocktail” for even 2 or 3 days can understand the potential savings in emotional stress and physical discomfort in such situations.