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ACOG COMMITTEE OPINION

Number 418 September 2008

(Replaces No. 304, November 2004)

Prenatal and Perinatal Human


Immunodeficiency Virus Testing: Expanded
Recommendations
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.

Reaffirmed 2011

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

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 womans 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: obstetriciangynecologists 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 (36). Even instituting maternal prophylaxis during labor and
delivery, or neonatal prophylaxis within
2448 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. Obstetriciangynecologists 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
CaliforniaSan 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 impli-

cations 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. Obstetriciangynecologists 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 4085% of
infants infected with HIV are born to women whose HIV
infection is unknown to their obstetric provider before
delivery (1114). 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
*Current Procedural Terminology (CPT) is copyright 2008 by
American Medical Association. All rights reserved. No fee schedules,
basic units, relative values, or related listings are included in CPT. The
AMA assumes no liability for the data contained herein. CPT is a
trademark of the American Medical Association.

ACOG Committee Opinion No. 418

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).

ACOG Committee Opinion No. 418

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 womens 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 undocumented 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
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
www.acog.org
Perinatal HIV page: www.acog.org/goto/HIV
ACOG Bookstore: www.acog.org/bookstore
Centers for Disease Control and Prevention
1600 Clifton Road NE
Atlanta, GA 30333
(404) 639-3311 or 800-232-4636
www.cdc.gov
HIV/AIDS page: www.cdc.gov/hiv
National AIDS Hotline: 800-342-AIDS (2437) (English);
800-344-7432 (Spanish); 800-243-7889 (TTY, deaf access)
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
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(RR14):117; 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):S106.
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):120.
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;339:140914.
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;341:38593.
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
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Obstetricians and Gynecologists. Joint statement on human
immunodeficiency virus screening. Elk Grove Village (IL):
AAP; Washington (DC): ACOG; 1999; Reaffirmed 2006.
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epidemicUnited States, 2003. Centers for Disease Control
and Prevention (CDC). MMWR Morb Mortal Wkly Rep
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and Prevention; 2003. Available at: http://www.cdc.gov/

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hiv/topics/perinatal/resources/other/dear_colleague2003.htm. Retrieved June 10, 2008.


American Medical Association. Current procedural terminology: CPT 2008. Standard ed. Chicago (IL): AMA; 2007.
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.
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:
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Gross E, Burr CK. HIV counseling and testing in pregnancy. N J Med 2003;100:216; quiz 678.
Paul SM, Grimes-Dennis J, Burr CK, DiFerdinando GT.
Rapid diagnostic testing for HIV. Clinical implications. N J
Med 2002;99:204; quiz 246.
Centers for Disease Control and Prevention. FDA-approved
rapid HIV antibody screening tests. Atlanta (GA): CDC;
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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
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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;112:73942.
ISSN 1074-861X

ACOG Committee Opinion No. 418

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