Reducing Maternal-Fetal HIV Transmission with Rapid HIV Tests

[摘要]

The American Public Health Association,

Knowing that previous APHA policy recognizes the importance of international prevention of perinatal HIV transmission,¹ supports testing under prevailing guidelines for confidentiality and counseling, and is opposed to mandatory HIV testing of pregnant women²; and

Noting that APHA has no formal policy on rapid HIV testing in labor and delivery; and

Realizing that the APHA Task Force on Rapid HIV Testing in Labor and Delivery recently provided to HRSA its recommendations supporting the availability of rapid HIV tests in labor and delivery for women in labor of unknown HIV status whose fetus may be at risk for maternal-fetal HIV transmission³; and

Understanding that those recommendations were based on the availability of the FDA-approved SUDS HIV test, which has since been withdrawn from the US market in October 2000 and returned in April 2001, a test that must be run in a CLIA-certified lab making it logistically difficult to provide timely results in a labor and delivery setting; and

Being aware that other rapid HIV tests that are being manufactured, some that have been approved in other countries, have been evaluated and found by the CDC and others to be more accurate than the SUDS test, roughly equivalent to standard EIA tests, and deliver results in less than 10 minutes without laboratory equipment, potentially at the bedside,^4,5 and are not yet approved by the FDA, effectively leaving no available FDA-approved rapid HIV test delivering timely results in labor and deliver; and

Recognizing that approximately 5% to 10% of the 4 million annual births in the US are to mothers with inadequate or no prenatal care⁶ and that approximately 6000 HIV-infected women give birth in the US every year and an estimated 500,000 infants become infected each year worldwide⁷; and

Realizing that the nation, as well as other countries, needs rapid HIV testing with informed consent in labor and delivery to cost-effectively prevent hundreds, and potentially thousands worldwide, of lethal maternal-fetal HIV transmissions to newborns⁸; and

Understanding that rapid HIV testing during labor and delivery in mothers with unknown HIV status has been very well received, with over 85% consenting⁹; and 

Sensing that, in the United States and Europe, the possibility of preventing almost all new cases of pediatric HIV infection is within reach¹⁰; and

Observing that the CDC¹¹ and others¹² recognize the urgent need for rapid HIV tests and that ‘Fast track’ approval of the HIV rapid tests through the FDA has been encouraged by other groups including the National Alliance of State and Territorial AIDS Directors (NASTAD)¹³; therefore, APHA

1. Supports the development of rapid HIV test kits of appropriately high sensitivity and specificity to properly meet the needs of primary prevention;
2. Encourages the expedited and early FDA approval of rapid HIV test kits; and
3. Strongly urges public funding for distribution of rapid HIV test kits to hospitals and birthing centers in developed and developing countries to prevent maternal-fetal HIV transmission in labor and delivery of women in labor with an unknown HIV status; and
4. Urges the rapid widespread dissemination by government agencies of the APHA Working Group guidelines for ethical and effective use of rapid HIV tests in labor and delivery; and
5. Seeks the rapid universal adoption of this policy by local, state and federal authorities, professional societies and hospital associations.

References

1. APHA Policy Statement 9919: International Prevention of Perinatal HIV Transmission. APHA Policy Statements; 1948—present, cumulative. Washington, D.C.: American Public Health Association; current volume. Available online: http:
2. //www.apha.org/legislative/policy/policysearch/index.cfm? fuseaction=view&id=190
3. APHA Policy Statement 9520: Opposition to Mandatory HIV Testing of Pregnant Women. APHA Policy Statements; 1948—present, cumulative. Washington, D.C.: American Public Health Association; current volume. Available online: http:
4. //www.apha.org/legislative/policy/policysearch/index.cfm?fuseaction=view&id=115
5. American Public Health Association HIV Rapid Test Working Group, “The Use of Rapid HIV Tests During Labor and Delivery: Recommendations for Best Practices”, Nov. 2000. Available online: http://www.apha-hivaids.org/
6. Giles RE, Perry KR, Parry JV. Simple/rapid test devices for anti-HIV screening: do they come up to the mark? J Med Virol. 1999 Sep;59(1):104-9.
7. Webber LM, Swanevelder C, Grabow WO, Fourie PB. Evaluation of a rapid test for HIV antibodies in saliva and blood. S Afr Med J. 2000 Oct;90(10):1004-7.
8. Kogan, MD, JA Martin, et al. The changing pattern of prenatal care utilization in the United States, 1981-1995, using different prenatal care indices. JAMA. 1998;279(20):1623-8.
9. Fowler, MG, RJ Simonds, et al. Update on peri–natal HIV transmission. Pediatr Clin North Am. 2000; 47(1):21-38.
10. Grobman WA, Garcia PM. The cost-effectiveness of voluntary intrapartum rapid human immunodeficiency virus testing for women without adequate prenatal care. Am J Obstet Gynecol. 1999;181:1062-71
11. Rajegowda BK, Das BB, Lala R, Rao S, Mc Neeley DF. Expedited human immunodeficiency virus testing of mothers and newborns with unknown HIV status at time of labor and delivery. J Perinat Med. 2000; 28(6):458-63.
12. Fowler MG. Prevention of perinatal HIV infection. What do we know? Where should future research go? Ann N Y Acad Sci. 2000 Nov;918:45-52.
13. Tao G, Branson BM, Kassler WJ, Cohen RA. Rates of receiving HIV test results: data from the U.S. National Health Interview Survey for 1994 and 1995. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):395-400.
14. Minkoff, H. and M. J. O’Sullivan. The case for rapid HIV testing during labor. JAMA. 1998;279(21): 1743-4.
15. National Alliance of State and Territorial AIDS Directors (NASTAD) Letter to the FDA Urging Expedited Approval of Rapid HIV Tests. May 18, 2000. Available online: http://www.nstad.org/fda_rapidtest. htm.

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[发布日期] 2001-01-02

[学科分类] 医学（综合）