aThe CORE Center, Cook County Bureau of Health Services, Chicago, IL, USA; and bDivision of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Sponsorship: The MIRIAD Study is funded by the National Center for HIV/STD/TB Prevention, Centers for Disease Control and Prevrevention (CDC), Atlanta, GA, USA.
Received: 11 March 2003; accepted: 28 April 2003.
The Food and Drug Administration recently approved the OraQuick Rapid HIV-1 Antibody Test. Four hospitals rapidly tested 380 women at labor and delivery. A comparison of turnaround times showed that the median turnaround time at point-of-care hospitals was 45 min compared with over 3.5 h at the laboratory hospital (P < 0.0001). Point-of-care testing was feasible and accurate, permitting undiagnosed HIV- infected pregnant women to learn their HIV status quickly, and access intrapartum antiretroviral therapy to reduce vertical transmission.
On 7 November 2002, the US Food and Drug Administration (FDA) approved the OraQuick Rapid HIV-1 Antibody Test (OraSure Technologies, Inc., Bethlehem, PA, USA) . Access to same-day HIV test results can greatly increase the number of individuals who learn their HIV status . In labor and delivery, rapid HIV testing also allows pregnant women who were not previously tested to learn whether they are infected and to begin timely antiretroviral therapy to reduce HIV transmission to their infants [3,4].
Point-of-care rapid HIV testing in the labor and delivery suite may save valuable time compared with sending the specimen to a laboratory. To evaluate the difference in turnaround times, we compared three hospitals where obstetric staff performed rapid tests on whole-blood specimens at point-of-care with a fourth where testing was performed in the hospital laboratory.
Four Chicago hospitals (with the city's highest HIV-1 prevalence among childbearing women) are participating in the Mother Infant Rapid Intervention At Delivery (MIRIAD) Study. MIRIAD is a multisite study funded by the Centers for Disease Control and Prevention: to determine the feasibility of rapid HIV testing in obstetric units among women with undocumented HIV status; to provide timely therapy to reduce perinatal transmission; and to facilitate follow-up care for HIV-infected mothers and infants.
After institutional review board approval, hospital staff were trained to recruit eligible women, obtain informed consent, perform the Oraquick rapid test, and counsel participants about their test results. Eligible women did not have documentation of HIV status in healthcare records, and were expected to deliver during that hospitalization or were more than 34 weeks’ gestational age.
A treatment investigational device exemption from the FDA allowed the MIRIAD Study to use the OraQuick test in advance of its approval. Three of the four hospitals also received approval from their respective point-of-care testing committees to perform the OraQuick test on site in labor and delivery with appropriate quality control; one hospital used their 24 h laboratory to perform the rapid tests. At each hospital, duplicate specimens were sent for standard HIV testing (enzyme-linked immunosorbent assay and, when necessary, Western blot).
Hospital staff performing the test in labor and delivery used timers clipped to their clothing, so they could continue other work during the 20 minutes necessary for the development of test results. In the hospital where testing was performed in the laboratory, nurses brought specimens to the laboratory and reported test results back to the patients once they were received from the laboratory. Staff recorded the time of each step in the testing protocol. Median times were analysed using the Wilcoxon rank-sum test.
From January 2002 to July 2002, 5771 women were evaluated in the four hospitals’ labor and delivery areas, and 514 (9%) were eligible for rapid HIV testing. Of these, 30 women (6%) were not offered participation, 104 women (20%) declined participation, and 380 women (74%) gave informed consent and were enrolled. A total of 225 women were tested at the three hospitals using point-of-care testing and 155 were tested at the hospital using the laboratory for rapid test processing. Standard enzyme immunoassay/Western blot confirmed 100% of the rapid test results. Three women were identified as being HIV infected, and in these instances, antiretroviral therapy was given during labor and delivery and or to the neonate.
Turnaround time was measured as the time that elapsed between drawing the participant's blood and her receipt of a test result. Fig. 1 shows a box plot of turnaround times for testing comparing the three point-of-care hospitals and the one laboratory hospital. The median turnaround time at the three hospitals using point-of-care testing was 45 min, with a narrower interquartile range (30 min to 2.5 h) than at the hospital using their laboratory (median time > 3.5 h, interquartile range 94 min to > 16 h) (P < 0.0001).
Staff at all hospitals attributed delays in reporting results to not wanting to wake the patient, forgetting about the test during a shift change, and being busy with other patients. Staff at the hospital using laboratory testing also said that they forgot about tests sent to the laboratory, and had difficulty obtaining timely results from the laboratory. Nurses, midwives and doctors performing point-of-care testing expressed positive feelings about using a test that allowed the quick delivery of results to their patients, the ability to complete the task themselves, and a sense of personally making a difference for their patients.
As rapid HIV testing becomes more widely available in labor and delivery, its implementation will require training and logistical planning. Point-of-care rapid testing by labor and delivery staff delivered valid HIV test results in a more timely fashion than when the test was sent to the laboratory. The median turnaround time was three times shorter, and staff were especially motivated to complete the test expeditiously in order to give this important information to their patients.
Implementing point-of-care rapid HIV testing poses some challenges. The FDA initially categorized the OraQuick test as of ‘moderate complexity’ under the Clinical Laboratory Improvement Amendments , which required qualified laboratory technicians or medical staff to perform the test, but expanded its use to offices and counseling sites by granting waived categorization on 31 January 2003. Our data support using non-laboratory personnel to perform these rapid tests to obtain rapid test results quickly, but quality control procedures must be implemented to ensure accurate test results. Point-of-care testing requires coordination with the laboratory information system to ensure that test results are documented correctly. Hospitals will need to assess the costs and benefits of implementing point-of-care HIV testing in their institutions .
Nonetheless, for our study hospitals, we found that point-of-care HIV testing was feasible, accurate, and timely. It permitted previously undiagnosed HIV-infected pregnant women to learn their HIV status quickly, allowing for the opportunity to administer intrapartum and neonatal antiretroviral therapy, a measure proven to reduce vertical HIV transmission.
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2. Centers for Disease Control and Prevention. Update: HIV counseling and testing using rapid tests – United States, 1995. MMWR 1998, 47:211–215.
3. Hillyer GV, Febo I, Diaz C. The rapid diagnosis of HIV-1 infection in mothers in Puerto Rico: a crucial testing strategy for maximal reduction of perinatal transmission. Puerto Rico Health Sci J 2002, 21:133–135.
4. USPHS Task Force recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States. MMWR 2002, 51(RR-18):1–38.
5. Humbertson SK. Management of a point-of-care program. Organization, quality assurance, and data management. Clin Lab Med 2001, 21:255–268.#m AcknowledgementsThe authors would like to acknowledge the MIRIAD centers (and principal investigators) at Atlanta (Steven Nesheim), Chicago (Mardge Cohen), Miami (Mary Jo O'Sullivan), New Orleans (Robert Maupin), and New York (Mayris P. Webber). The authors would like to thank Anna Podolanczuk (CORE Center, Chicago) and Jeff Wiener (Centers for Disease Control and Prevention, Atlanta) for assistance with data analysis.
© 2003 Lippincott Williams & Wilkins, Inc.