Failure of routine HIV-1 tests in a case involving transmission with preseroconversion blood components, during the infectious window period

JAMA

Volumn 284, Issue 2, 2000, Pages 210-214

  Ling, Ai Ee ^a   Brown, Teresa M ^a   Dunmire, Valerie ^a   Thoe, Su Yun Se ^a   Wong, Sin Yew ^a   Yee Sin, Leo ^a   Diana, Teo ^a   Gallarda, James ^a   Phelps, Bruce ^a   Chamberland, Mary E ^a   Busch, Michael P ^a   Folks, Thomas M ^a   Kalish, Marcia L ^a   Robbins, Kenneth E ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ARTICLE; BLOOD DONOR; CONTROLLED STUDY; DIAGNOSTIC VALUE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HUMAN TISSUE; PRIORITY JOURNAL; RECIPIENT; SCREENING TEST; SEROCONVERSION; VIRUS LOAD;

EID: 0012140441     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.284.2.210     Document Type: Article

References (31)

1. Lackritz EM, Satten GA, Aberle-Grasse J, et al. Estimated risk of transmission of the human immuno-deficiency virus by screened blood in the United States. N Engl J Med. 1995;333:1721-1725.
2. Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The risk of transfusion-transmitted viral infections. N Engl J Med. 1996;334:1685-1690.
3. Busch MP, Lee LL, Satten GA, et al. Time course of detection of viral and serologic markers preceding human immunodeficiency virus type 1 seroconversion. Transfusion. 1995;35:91-97.
4. Recommendations for donor screening with a licensed test for HIV-1 antigen [memorandum]. Rockville, Md: Food and Drug Administration, Center for Biologies Evaluation and Research; August 8, 1995.
5. Clark SJ, Saag MS, Decker WD, et al. High titers of cytopathic virus in plasma of patients with symp tomatic primary HIV-1 infection. N Engl J Med. 1991; 324:954-960.
6. Daar ES, Moudgil T, Meyer RD, Ho DD. Transient high levels of viremia in patients with primary human immunodeficiency virus type 1 infection. N Engl J Med. 1991;324:961-964.
7. US Public Health Service guidelines for testing and counseling blood and plasma donors for human immunodeficiency virus type 1 antigen. MMWR Morb Mortal Wkly Rep. 1996;45(RR-2):1-9.
8. Busch MP, Satten GA, Herman SA, et al. HIV plasma RNA for confirmation of HIV-1 p24 ag/anti-HIV reactivity in seroconverting donors [abstract]. Transfusion. 1996;36(suppl):41S. Abstract S163.
9. Brown AE, Jackson B, Fuller SA, et al. Viral RNA in the resolution of human immunodeficiency virus type 1 diagnostic serology. Transfusion. 1997;37:926-929.
10. FDA holds workshops on blood donor suitability, leukocyte reduction, and NAT. AABB Wkly Rep. December 17, 1999;5:3.
11. Report of the Interorganizational Task Force on Nucleic Acid Amplification Testing of Blood Donors. Nucleic acid amplification testing of blood donors for transfusion-transmitted infectious diseases. Transfusion. 2000;40:143-159.
12. Kleinnnan SH, Busch MP. Risks of transfusion transmitted infection: direct estimation and mathematical modeling. In: Contreras M, ed. Best Practice and Research in Clinical Haematology. London, England: Bailliere Tindall Publishing. In press.
13. Delwart EL, Shpaer EG, Louwagie J, et al. Genetic relationships determined by a DNA heteroduplex mobility assay. Science. 1993;262:1257-1261.
14. HIV-1/HCV TMA Assay, 5000 Test Kit [draft package insert]. Emeryville, Calif: Chiron Procleix; 1998.
15. COBAS AmpliScreen HIV-1 Test, v1.5 [draft package insert]. Pleasanton, Calif: Roche Molecular Systems, Inc; 1999.
16. Schochetman GS, Subbarao S, Kalish ML. Viral Genome Methods. Boca Raton, Fla: CRC Press Inc; 1996:25-41.
17. Ginocchio CC, Tetali S, Washburn D, et al. Comparison of levels of human immunodeficiency virus type 1 RNA in plasma as measured by the NucliSens nucleic acid sequence-based amplification and Quantiplex branched-DNA assays. J Clin Microbiol. 1999;37: 1210-1212.
18. Update: serologic testing for HIV-1 antibody -United States, 1988 and 1989. MMWR Morb Mortal Wkly Rep. 1990;39:380-383.
19. Kleinman S, Busch MP, Hall L, et al. False-positive HIV-1 test results in a low-risk screening setting of voluntary blood donation. JAMA. 1998;280: 1080-1085.
20. McNearney T, Westervelt P, Thielan BJ, et al. Limited sequence heterogeneity among biologically distinct human immunodeficiency virus type 1 isolates from individuals involved in a clustered infectious outbreak. Proc Natl Acad Sci U S A. 1990;87:1917-1921.
21. Wolfs TFW, Zwart G, Bakker M, Goudsmit J. HIV-1 genomic RNA diversification following sexual and parenteral virus transmission. Virology. 1992;189:103-110.
22. Zhu T, Mo H, Wang N, et al. Genotypic and phenotypic characterization of HIV-1 patients with primary infection. Science. 1993;261:1179-1181.
23. Zhang LQ, MacKenzie P, Cleland A, et al. Selection for specific sequences in the external envelope protein of human immunodeficiency virus type 1 upon primary infection. J Virol. 1993;67:3345-3356.
24. Diaz RS, Zhang L, Busch MP, et al. Divergence of HIV-1 quasispecies in an epidemiologic duster. AIDS. 1997;11:415-422.
25. Laperche S, Moreau P, Lair J, Courouce AM. Two successive HIV contaminations from subjects in the window period. AIDS. 1998;12:1397-1398.
26. Busch MP, Stramer SL, Kleinman SH. Evolving applications of nucleic acid amplification assays for prevention of virus transmission by blood components and derivatives. In: Garratty C, ed. Applications of Molecular Biology to Blood Transfusion Medicine. Bethesda, Md: American Association of Blood Banks; 1997:123-176.
27. Cardoso MS, Koerner K, Kubanek B. Mini-pool screening by nudeic acid testing for hepatitis B virus, hepatitis C virus, and HIV. Transfusion. 1998;38:905-907.
28. LeCorfec E, Le Pont F, Tuckwell HC, et al. Direct HIV testing in blood donations. Transfusion. 1999; 39:1141-1144.
29. Yerly S, Pedrocchi M, Perrin L. The use of polymerase chain reaction in plasma pools for the concomitant detection of hepatitis C virus and HIV type 1 RNA. Transfusion. 1998;38:908-914.
30. Blood organizations outline plans for nucleic acid testing at FDA workshop. America's Blood Centers' Newsletter. September 25,1998:9-10.
31. Murthy KK, Henrard DR, Eichberg JW, et al. Redefining the HIV-infectious window period in the chimpanzee model. Transfusion. 1999;39:688-693.