(Last updated: March 1, 2016; last reviewed: March 1, 2016)
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials in children† with clinical outcomes and/or validated endpoints; I* = One or more randomized trials in adults with clinical outcomes and/or validated laboratory endpoints with accompanying data in children† from one or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; II = One or more well-designed, nonrandomized trials or observational cohort studies in children† with long-term outcomes; II* = One or more well-designed, nonrandomized trials or observational studies in adults with long-term clinical outcomes with accompanying data in children† from one or more similar nonrandomized trials or cohort studies with clinical outcome data; III = Expert opinion
† Studies that include children or children/adolescents, but not studies limited to post-pubertal adolescents
HIV Testing in Pregnancy
HIV infection should be identified prior to pregnancy or as early in pregnancy as possible. This provides the best opportunity to prevent infant HIV infection and to identify and start therapy as soon as possible in infants who become infected. Universal voluntary HIV testing is recommended as the standard of care for all pregnant women in the United States by The Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children (the Panel), the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the U.S. Preventive Services Task Force.1-6 All HIV testing should be performed in a manner consistent with state and local laws (http://nccc.ucsf.edu/clinical-resources/hiv-aids-resources/state-hiv-testing-laws/). CDC recommends the “opt-out” approach, which involves notifying pregnant women that HIV testing will be performed as part of routine care unless they choose not to be tested for HIV. The “opt-out” approach during pregnancy is allowed in every jurisdiction. The "opt-in" approach involves obtaining specific consent before testing and has been associated with lower testing rates.7,8 The mandatory newborn HIV testing approach, adopted by several states, involves testing of newborns for perinatal HIV exposure with or without maternal consent, if prenatal or intrapartum maternal testing is not performed.
Knowledge of antenatal maternal HIV infection enables:
Technological improvements have resulted in increased sensitivity for early infection and reduced performance time for laboratory-based assays, allowing completion in less than 1 hour. Accordingly, the Panel now incorporates CDC’s 2014 HIV Laboratory Testing Recommendations.18 The guidelines recommend that HIV testing begin with a fourth-generation immunoassay capable of detecting HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen (called an antigen/antibody combination assay). Individuals with a reactive antigen/antibody combination assay should be tested further with an HIV-1/HIV-2 antibody differentiation assay (supplemental testing). Individuals with a reactive antigen/antibody combination assay and a nonreactive differentiation test should be tested with a Food and Drug Administration-approved HIV nucleic acid test to establish diagnosis of acute HIV infection (http://www.cdc.gov/hiv/pdf/hivtestingalgorithmrecommendation-final.pdf#page=11).
The fourth-generation immunoassay testing for both antigen and antibody is the test of choice and can be done quickly (referred to as expedited), but requires trained laboratory staff and therefore may not be available in some hospitals 24 hours a day. If this test is unavailable, then initial testing should be performed by the most sensitive expedited or rapid test available. Every delivery unit needs to have access to an HIV test that can be done repidly (<1 hour) 24 hours a day. If positive, testing for confirmation of infection should be done as soon as possible (as with all initial positive assays). Because older tests have lower sensitivity in the context of recent infection, testing following the 2014 CDC algorithm should be considered as soon as feasible if HIV risk cannot be ruled out. Results of maternal HIV testing should be documented in the newborn’s medical record and communicated to the newborn’s primary care provider.
Repeat HIV Testing in the Third Trimester
Repeat HIV testing should be considered for all HIV-seronegative pregnant women. A second HIV test during the third trimester, before 36 weeks’ gestation, is recommended4,19 for women who:
Women who decline testing earlier in pregnancy should be offered testing again during the third trimester, using a fourth-generation antigen/antibody combination immunoassay, as these tests have a higher sensitivity in the setting of acute infection, compared to older antibody tests.18,22 When acute retroviral syndrome is a possibility, a plasma RNA test should be used in conjunction with the fourth-generation test to diagnose acute HIV infection.
HIV Testing During Labor in Women with Unknown HIV Status
HIV testing is recommended to screen women in labor whose HIV status is undocumented and identify HIV exposure in their infants. HIV testing during labor has been found to be feasible, accurate, timely, and useful both in ensuring prompt initiation of intrapartum and neonatal ARV prophylaxis and in reducing perinatal transmission of HIV.1-3,5,16
Every hospital offering intrapartum care and every delivery unit must have access to an HIV test that can be performed rapidly (that is, in an expedited fashion with results available within 1 hour) and is available 24 hours a day. Policies and procedures must be in place to ensure that staff are prepared to provide patient education and expedited HIV testing, that appropriate ARV drugs are available whenever needed, and that follow-up procedures are in place for women found to be HIV-infected and their infants.
The test of choice is the fourth-generation antigen/antibody combination immunoassay. Because it can be done quickly it is sometimes referred to as “expedited,” but it requires trained lab staff and may not yet be available in hospitals 24 hours a day. If the fourth-generation antigen/antibody combination immunoassay is not available, initial testing should be performed by the most sensitive expedited or rapid test available.
A positive expedited HIV test result must be followed by a supplemental test.18 However, immediate initiation of ARV drug prophylaxis for prevention of perinatal transmission of HIV is recommended pending the supplemental result after an initial positive expedited HIV test.1-6,16 No further testing is required for specimens that are nonreactive (negative) on the initial immunoassay.18
HIV Testing During the Postnatal Period
Women who have not been tested for HIV before or during labor should be offered expedited testing during the immediate postpartum period or their newborns should undergo expedited HIV testing with maternal consent (unless state law allows testing without consent).1,3,4,16 Testing should be done using the fourth-generation antigen/antibody combination immunoassay to screen for established infection and for acute HIV-1 infection; results should be obtained in less than 1 hour. If acute HIV-1 infection is a possibility, then a plasma HIV RNA test should be sent as well. Use of expedited HIV assays for prompt identification of HIV-exposed infants is essential because neonatal ARV prophylaxis should be initiated as soon as possible after birth—ideally no more than 6 to 12 hours after birth—to be effective for the prevention of perinatal transmission. When an initial HIV test is positive in mother or infant, initiation of infant ARV drug prophylaxis and counseling against initiation of breastfeeding is strongly recommended pending results of supplemental HIV tests to confirm and/or differentiate between HIV-1 and HIV-2 infection.4 If supplemental tests are negative and acute HIV infection is excluded, infant ARV drug prophylaxis can be discontinued. In the absence of ongoing maternal HIV exposure, breastfeeding can be initiated. Mechanisms should be developed to facilitate HIV screening for infants who have been abandoned and are in the custody of the state.
Infant HIV Testing when Maternal HIV Test Results Are Unavailable
When maternal HIV test results are unavailable (e.g., for infants who are in foster care) or their accuracy cannot be evaluated (e.g., for infants adopted from a country where results are not reported in English), HIV antibody testing is indicated to identify HIV exposure in those infants.1 If antibody testing is positive, further testing is needed to diagnose HIV infection, or in the case of infants older than 18 months, to confirm HIV infection (see Diagnosis of HIV Infection in Infants).
Acute Maternal HIV Infection During Pregnancy or BreastfeedingThe risk of perinatal transmission of HIV is increased in infants born to women who have acute HIV infection during pregnancy or lactation.19,23-26 The fourth-generation antigen/antibody combination immunoassay will detect acute infection more readily than other immunoassays. If acute HIV infection is suspected, and the supplemental test is negative, a plasma HIV RNA test should be sent as well. Women with possible acute HIV infection who are breastfeeding should cease breastfeeding immediately until HIV infection is confirmed or excluded.14 Pumping and temporarily discarding breast milk can be recommended and (if HIV infection is excluded), in the absence of ongoing maternal exposure to HIV, breastfeeding can resume. Care of pregnant or breastfeeding women identified with acute or early HIV infection, and their infants, should follow the recommendations in the Perinatal Guidelines.4
Clinicians should be aware of public health surveillance systems and exposed-infant reporting regulations that may exist in their jurisdictions; this is in addition to mandatory reporting of HIV-infected persons, including infants. Reporting cases allows for appropriate public health functions to be accomplished.