The Illinois 24/7 Perinatal HIV Hotline and Mother and Child Alliance (MACA) have been informed of a temporary supply shortage of the Abbott Determine HIV-1/2 Ag/Ab Combo Rapid Test. This is a lateral flow test that can detect both HIV-1/2 antibodies and p24 antigen; it is utilized by many hospitals in Illinois for rapid HIV testing of patients in the labor and delivery setting. The manufacturer anticipates supply may resume in the coming weeks, but a firm date is not available. A delay in identifying HIV during labor and delivery can delay time-sensitive care for the birthing parent and newborn. Hospitals are encouraged to review their procedures now and plan for any interruption in their local supply.
The definition of a rapid HIV test has not changed: for purposes of Illinois requirements, a rapid HIV test is one that provides results in under one hour. Illinois law requires rapid opt-out HIV testing to be offered during labor and delivery in specified circumstances. Hospitals should consult their legal and risk-management teams promptly about how to manage testing and compliance during the shortage.
While the Abbott Determine HIV-1/2 Ag/Ab Combo lateral flow test is unavailable, please consider the following steps:
- Pursue alternative rapid test options. Contact your laboratory leadership, suppliers, and relevant hospital departments to determine whether another rapid HIV test—such as an antibody-only test—is available and can be implemented at your facility. Although procurement, funding, contracts, validation, and workflow changes may take time, please assess these options rather than relying solely on a send-out test that may take several days to result. Confirm with your laboratory and legal teams that any proposed test is appropriate for the intended use and meets applicable requirements.
- Arrange expedited testing with your reference laboratory. Send specimens as quickly as possible and request STAT processing. Ask the laboratory to communicate a preliminary screening result to the treating team as soon as available, without waiting for supplemental testing results. Confirm in advance how results will be communicated and who will receive them. A preliminary reactive result is not a confirmed HIV diagnosis; however timely communication of the preliminary result can be critical for obstetrical decision making at labor and delivery.
- Contact your perinatal center. Ask whether it can accept specimens for STAT processing on its instrumented fourth generation (antigen/antibody) HIV assay and promptly communicate the initial screening result to your hospital. Agree in advance on specimen handling, turnaround expectations, and direct result notification.
- Reinforce third-trimester testing. Remind clinicians and prenatal care teams of the importance of documenting HIV testing during the current pregnancy’s third trimester. Earlier testing can help avoid a situation in which a patient arrives at the hospital without a documented result. Illinois guidance recommends repeat testing during the third trimester and rapid testing during labor when the required documentation is absent.
- Call the Illinois 24/7 Perinatal HIV Hotline for clinical support. Contact the hotline at 1-800-439-4079 for help managing a preliminary positive result or other time-sensitive perinatal HIV questions. Preliminary positive rapid HIV test results must be reported to the hotline within 12 hours, and no later than 24 hours, after the result.ILperinatalID.org.
- Communicate contingency plans to labor and delivery, laboratory, neonatal, and on-call teams, and ensure staff know how to expedite specimens and reach the appropriate decision-makers at all hours.
The Illinois 24/7 Perinatal HIV Hotline and MACA will share updates as more information about supply becomes available.