ACOG Committee Opinion
Number 418, September 2008
(Reaffirmed 2011, Replaces No. 304, November 2004)


Committee on Obstetric Practice

This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.


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Prenatal and Perinatal Human Immunodeficiency Virus Testing: Expanded Recommendations

ABSTRACT: Early identification and treatment of all pregnant women with human immunodeficiency virus (HIV) is the best way to prevent neonatal disease and improve the woman's health. Human immunodeficiency virus screening is recommended for all pregnant women after they are notified that they will be tested for HIV infection as part of the routine panel of prenatal blood tests unless they decline the test (ie, opt-out screening). Repeat testing in the third trimester, or rapid HIV testing at labor and delivery as indicated or both also are recommended as additional strategies to further reduce the rate of perinatal HIV transmission. The American College of Obstetricians and Gynecologists makes the following recommendations: obstetrician–gynecologists should follow opt-out prenatal HIV screening where legally possible; repeat conventional or rapid HIV testing in the third trimester is recommended for women in areas with high HIV prevalence, women known to be at high risk for acquiring HIV infection, and women who declined testing earlier in pregnancy; rapid HIV testing should be used in labor for women with undocumented HIV status following opt-out screening; and if a rapid HIV test result in labor is positive, immediate initiation of antiretroviral prophylaxis should be recommended without waiting for the results of the confirmatory test.


The Centers for Disease Control and Prevention (CDC) estimates that 40,000 new cases of human immunodeficiency virus (HIV) infection still occur in the United States each year (1). This figure includes approximately 138 infants infected via mother-to-child (vertical) transmission (2). Antiretroviral medications given to women with HIV perinatally and to their newborns in the first weeks of life reduce the vertical transmission rate from 25% to 2% or less (3–6). Even instituting maternal prophylaxis during labor and delivery, or neonatal prophylaxis within 24–48 hours of delivery, or both can substantially decrease rates of infection in infants (4). A retrospective review of HIV-exposed infants in New York State showed a transmission rate of approximately 10% when zidovudine prophylaxis was begun intrapartum or if given to newborns within 48 hours of life. There is no significant reduction of neonatal transmission if therapy is started after 3 days of life (4). Early identification and treatment of pregnant women and prophylactic treatment of newborns in the first hours of life are essential to prevent neonatal disease.

Prenatal Human Immunodeficiency Virus Testing

All pregnant women should be screened for HIV infection as early as possible during each pregnancy after they are notified that HIV screening is recommended for all pregnant patients and that they will receive an HIV test as part of the routine panel of prenatal tests unless they decline (opt-out screening). No woman should be tested without her knowledge; however, no additional process or written documentation of informed consent beyond what is required for other routine prenatal tests is required for HIV testing. Pregnant women should be provided with oral or written information about HIV (1, 7) that includes an explanation of HIV infection, a description of interventions that can reduce HIV transmission from mother to infant, the meanings of positive and negative test results, and the opportunity to ask questions and decline testing (1). If a patient declines HIV testing,

this should be documented in the medical record and should not affect access to care. Women who decline an HIV test because they have had a previous negative test result should be informed of the importance of retesting during each pregnancy (1). The American College of Obstetricians and Gynecologists, the American Academy of Pediatrics (7), and the CDC (1, 8) recommend opt-out HIV screening for pregnant women. Since the release of CDC recommendations in September 2006 (1), some states have changed their state laws and regulations to opt-out screening. Obstetrician–gynecologists should be aware of and comply with their states' legal requirements for perinatal HIV screening. Legal requirements for perinatal HIV testing may be verified by contacting state or local public health departments. The National HIV/AIDS Clinicians' Consultation Center at the University of California–San Francisco maintains an online compendium of state HIV testing laws that can be a useful resource (see Resources). The Centers for Disease Control and Prevention recommend that jurisdictions with barriers to routine prenatal screening using opt-out screening consider addressing them (9)

 Perinatal Human Immunodeficiency Virus Testing

The conventional HIV testing algorithm, which may take up to 2 weeks to complete if a result is positive, begins with a screening test, the enzyme-linked immunosorbent assay (ELISA) that detects antibodies to HIV; if the results are positive, it is followed by a confirmatory test, either a Western blot or an immunofluorescence assay (IFA). A positive ELISA test result is not diagnostic of HIV infection unless confirmed by the Western blot or IFA. The sensitivity and specificity of ELISA with a confirmatory Western blot test are greater than 99%. The false-positive rate for ELISA with a confirmatory Western blot test is 1 in 59,000 tests. If the ELISA test result is positive and the Western blot or IFA test result is negative, the patient is not infected and repeat testing is not indicated.

If the ELISA test result is repeatedly positive and the Western blot result contains some but not all of the viral bands required to make a definitive diagnosis, the test result is labeled indeterminate. Most patients with indeterminate test results are not infected with HIV. However, consultation with a health care provider well versed in HIV infection is recommended. This specialist may suggest viral load testing or repeat testing later in pregnancy to rule out the possibility of recent infection.

If the screening (eg, ELISA) and confirmatory test (eg, Western blot or IFA) results are both positive, the patient should be given her results in person. The implications of HIV infection and vertical transmission should be discussed with the patient. Additional laboratory evaluation, including CD4 count, HIV viral load, resistance testing, hepatitis C virus antibody, hepatitis B surface antigen, complete blood count with platelet count, and baseline chemistries with liver function tests, will be useful before prescribing antiretroviral prophylaxis.

A rapid HIV test is an HIV screening test with results available within hours. Obstetrician–gynecologists may use rapid testing as their standard outpatient test and should also use rapid testing in labor and delivery (see details as follows regarding labor and delivery). A negative rapid test result is definitive. A positive rapid test result is not definitive and must be confirmed with a supplemental test, such as a Western blot or IFA test. Rapid test results usually will be available during the same clinical visit that the specimen (eg blood, or oral swab) is collected. Health care providers who use these tests must be prepared to provide counseling to pregnant women who receive positive rapid test results the same day that the specimen is collected. Pregnant women with positive rapid test results should be counseled regarding the meaning of these preliminary positive test results and the need for confirmatory testing. As with conventional HIV testing, consultation with a health care provider well versed in HIV infection is recommended. To code for rapid testing, the modifier 92 is added to the basic HIV testing Current Procedural Terminology (CPT")* code 86701-86703) (10). If the results of the rapid test and the confirmatory test are discrepant, both tests should be repeated and consultation with an infectious disease specialist is recommended.

Any woman who arrives at a labor and delivery facility with undocumented HIV status should be screened with a rapid HIV test unless she declines (opt-out screening) in order to provide an opportunity to begin prophylaxis of previously undiagnosed infection before delivery (1). Data from several studies indicate that 40–85% of infants infected with HIV are born to women whose HIV infection is unknown to their obstetric provider before delivery (11–14). If a rapid test is used in labor and HIV antibodies are detected, immediate initiation of antiretroviral prophylaxis should be recommended without waiting for the results of the confirmatory test to further reduce possible transmission to the infant. All antiretroviral prophylaxis should be discontinued if the confirmatory test result is negative (11). Recommendations for the use of antiretroviral medications in pregnant women infected with HIV are available at www.aidsinfo.nih.gov and are updated frequently.

The rapid HIV antibody screening tests, which are approved by the U.S. Food and Drug Administration, all have sensitivity and specificity equal to or greater than 99% (15). As with all screening tests, the likelihood of a false-positive result is higher in populations with low HIV prevalence when compared with populations with high HIV prevalence. Additionally, at present it is not known how the false-positive rate for rapid testing will compare with the false-positive rate for conventional testing.

If the rapid HIV test result at labor and delivery is positive, the obstetric provider should take the following steps:

  1. Tell the woman she may have HIV infection and that her neonate also may be exposed
  2. Explain that the rapid test result is preliminary and that false-positive results are possible
  3. Assure the woman that a second test is being done right away to confirm the positive rapid test result
  4. Immediate initiation of antiretroviral prophylaxis should be recommended without waiting for the results of the confirmatory test to reduce the risk of transmission to the infant
  5. Once the woman gives birth, discontinue maternal antiretroviral therapy pending receipt of confirmatory test results
  6. Tell the woman that she should postpone breast-feeding until the confirmatory result is available because she should not breast-feed if she is infected with HIV
  7. Inform pediatric care providers (depending on state requirements) of positive maternal test results so that they may institute the appropriate neonatal prophylaxis

Repeat Human Immunodeficiency Virus Testing in the Third Trimester

Repeat testing in the third trimester should be considered in jurisdictions with elevated HIV or AIDS incidence and in health care facilities in which prenatal screening identifies at least one HIV-infected pregnant woman per 1,000 women screened (1). Additionally, although physicians need to be aware of and follow their states' perinatal HIV screening requirements, repeat testing in the third trimester, preferably before 36 weeks of gestation, is recommended for pregnant women at high risk for acquiring HIV. Criteria for repeat testing can include (1):

  • Have been diagnosed with another sexually transmitted disease in the last year
  • Injection drug use or the exchange of sex for money or drugs
  • A new or more than one sex partner during this pregnancy or a sex partner(s) known to be HIV-positive or at high risk

Women who are candidates for third-trimester testing, including those who declined testing earlier in pregnancy, should be given a conventional or rapid HIV test rather than waiting to receive a rapid test at labor and delivery (as allowed by state laws and regulations).

Recommendations

Given the enormous advances in the prevention of perinatal transmission of HIV, it is clear that early identification and treatment of all pregnant women with HIV is the best way to prevent neonatal disease and also may improve the women's health. Therefore, the American College of Obstetricians and Gynecologists makes the following recommendations:

  • Screen all pregnant women for HIV as early as possible during each pregnancy following opt-out prenatal HIV screening where legally possible
  • Repeat HIV testing in the third trimester is recommended for women in areas with high HIV prevalence, women known to be at high risk for acquiring HIV infection, and women who declined testing earlier in pregnancy
  • Use conventional or rapid HIV testing for women who are candidates for third-trimester testing
  • Use rapid HIV testing in labor for women with un-documented HIV status following opt-out screening
  • If a rapid HIV test result in labor is positive, immediate initiation of antiretroviral prophylaxis should be recommended without waiting for the results of the confirmatory test

Resources

AIDSinfo
PO Box 6303
Rockville, MD 20849-6303
1-800-448-0440
http://www.aidsinfo.nih.gov

The American College of Obstetricians and Gynecologists
409 12th Street SW, PO Box 96920
Washington, DC 20090-6920
800-673-8444 or (202) 638-5577
http://www.acog.org
Perinatal HIV page: http://www.acog.org/goto/HIV ACOG Bookstore: http://www.acog.org/bookstore

Centers for Disease Control and Prevention
1600 Clifton Road NE
Atlanta, GA 30333
(404) 639-3311 or 800-232-4636
http://www.cdc.gov
HIV/AIDS page: http://www.cdc.gov/hiv

National AIDS Hotline: 800-342-AIDS (2437) (English); 800-344-7432 (Spanish); 800-243-7889 (TTY, deaf access)
http://www.cdc.gov/hiv

National HIV/AIDS Clinicians' Consultation Center
UCSF Department of Family and Community Medicine at San Francisco General Hospital
1001 Potrero Ave., Bldg. 20, Ward 22
San Francisco, CA 94110
(415) 206-8700
Perinatal HIV Hotline: 1-888-448-8765
http://www.nccc.ucsf.edu

References

  1. Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep 2006;55(RR-14):1–17; quiz CE1-4.
  2. McKenna MT, Hu X. Recent trends in the incidence and morbidity that are associated with perinatal human immunodeficiency virus infection in the United States. Am J Obstet Gynecol 2007;197(suppl):S10–6.
  3. Recommendations of the U.S. Public Health Service Task Force on the use of zidovudine to reduce perinatal transmission of human immunodeficiency virus. MMWR Recomm Rep 1994;43(RR-11):1–20.
  4. Wade NA, Birkhead GS, Warren BL, Charbonneau TT, French PT, Wang L, et al. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. N Engl J Med 1998;339:1409–14.
  5. Mofenson LM, Lambert JS, Stiehm ER, Bethel J, Meyer WA 3rd, Whitehouse J, et al. Risk factors for perinatal transmission of human immunodeficiency virus type 1 in women treated with zidovudine. Pediatric AIDS Clinical Trials Group Study 185 Team. N Engl J Med 1999;341:385–93.
  6. Garcia PM, Kalish LA, Pitt J, Minkoff H, Quinn TC, Burchett SK, et al. Maternal levels of plasma human immunodeficiency virus type 1 RNA and the risk of perinatal transmission. Women and Infants Transmission Study Group. N Engl J Med 1999;341:394–402.
  7. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Joint statement on human immunodeficiency virus screening. Elk Grove Village (IL): AAP; Washington (DC): ACOG; 1999; Reaffirmed 2006.
  8. Advancing HIV prevention: new strategies for a changing epidemic—United States, 2003. Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep 2003;52:329–32.
  9. Gerberding JL, Jaffe HW. Routine prenatal testing – the opt-out approach. Atlanta (GA): Centers for Disease Control and Prevention; 2003. Available at: http://www.cdc.gov/ hiv/topics/perinatal/resources/other/dear_colleague-2003.htm. Retrieved June 10, 2008.
  10. American Medical Association. Current procedural terminology: CPT® 2008. Standard ed. Chicago (IL): AMA; 2007.
  11. Centers for Disease Control and Prevention. Rapid HIV-1 Antibody Testing during Labor and Delivery for Women of Unknown HIV Status: A Practical Guide and Model Protocol. Atlanta (GA): CDC; 2004. Available at: http://www.cdc.gov/hiv/topics/testing/resources/guidelines/rt-labor&delivery.htm. Retrieved June 10, 2008.
  12. Peters V, Liu KL, Dominguez K, Frederick T, Melville S, Hsu HW, et al. Missed opportunities for perinatal HIV prevention among HIV-exposed infants born 1996-2000, pediatric spectrum of HIV disease cohort. Pediatrics 2003;111: 1186–91.
  13. Gross E, Burr CK. HIV counseling and testing in pregnancy. N J Med 2003;100:21–6; quiz 67–8.
  14. Paul SM, Grimes-Dennis J, Burr CK, DiFerdinando GT. Rapid diagnostic testing for HIV. Clinical implications. N J Med 2002;99:20–4; quiz 24–6.
  15. Centers for Disease Control and Prevention. FDA-approved rapid HIV antibody screening tests. Atlanta (GA): CDC; 2008. Available at: http://www.cdc.gov/hiv/topics/testing/ rapid/rt-comparison.htm. Retrieved June 10, 2008.

Copyright © September 2008 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on the Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.

Prenatal and Perinatal Human Immunodeficiency Virus Testing: Expanded Recommendations. ACOG Committee Opinion No.418. American College of Obstetricians and Gynecologists. Obstet Gynecol 2008;112:739–42.