Prevalence of Human Immunodeficiency Virus Type 1 p24 Antigen in U.S. Blood Donors — An Assessment of the Efficacy of Testing in Donor Screening

Alter, Harvey J.; Epstein, Jay S.; Swenson, Sally; VanRaden, Mark; Ward, John W.; Kaslow, Richard A.; Menitove, Jay E.; Klein, Harvey G.; Sandler, S. Gerald; Sayers, Merlin H.; Hewlett, Indira; Chernoff, Amoz I.; Popovsky, Mark; McDonald, Hilda; Herman, Jay H.; Sherwood, W Cullen; Forey, Jan; Rothko, K; Ness, Paul M.; Ellisor, Sandy; Shulman, Gerald I.; Grindon, Alfred J.; Kleinman, Steven; Lenes, Bruce A.; Tomasulo, Peter; Gilcher, Ronald O.; Chandler, Linda; Belcher, Linda; Fortes, Pablo; Fortenberry, D.; Simon, Ely S.; Busch, M. P.; Perkins, Herbert A.; Randell, R; Holland, Paul V.; Leparc, Germán F.; Schmidt, Paul; Rayfield, Mark; Doll, Lynda S.; Peterson, Lyle

doi:10.1056/nejm199011083231905

Cited by 126 publications

(27 citation statements)

References 18 publications

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“…In this respect, the diagnostic value of a p24 antigen assay is restricted to detecting infections in newborns of HIV-positive mothers or individuals who have had very recent high-risk exposure (59). In fact, dedicated p24 antigen tests add very little to safety when used in blood screening (1), especially in view of the advances made with molecular testing (22). For even earlier detection, nucleic acid tests were often found to have a clear advantage in sensitivity over p24 antigen assays (22,51,84) or other immunoassays (66).…”

Section: Mp Biomedicals Asia Pacific Pte Ltd Singapore Science Parkmentioning

confidence: 99%

Frequency, Causes, and New Challenges of Indeterminate Results in Western Blot Confirmatory Testing for Antibodies to Human Immunodeficiency Virus

Guan

2007

Clin Vaccine Immunol

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Section: Mp Biomedicals Asia Pacific Pte Ltd Singapore Science Parkmentioning

confidence: 99%

Frequency, Causes, and New Challenges of Indeterminate Results in Western Blot Confirmatory Testing for Antibodies to Human Immunodeficiency Virus

Guan

2007

Clin Vaccine Immunol

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“…These findings led to a clear need to evaluate the utility of p24 antigen screening of blood donations in a rapid, large-scale manner. Two studies were initiated in the U.S. at that time [5,6]. First, the HIV-Antigen Study Group [5] tested for p24 antigen in 515,494 blood units donated at U.S. blood centers in 1989.…”

Section: Projections Of Yield Prior To Implementationmentioning

confidence: 99%

The Efficiency of HIV p24 Antigen Screening of US Blood Donors: Projections versus Reality

Busch¹,

Stramer²

1998

Transfus Med Hemother

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“…The HIV-1-neutralizing serum 2 (HNS2) (2) was prepared from an HIV-1-infected participant in a cohort study conducted at the National Institutes of Health for use as a reference reagent for laboratories conducting neutralizing antibody tests (1,19). This serum contains antibodies capable of neutralizing a wide variety of primary HIV-1 isolates (10,11).…”

mentioning

confidence: 99%

A Variable Region 3 (V3) Mutation Determines a Global Neutralization Phenotype and CD4-Independent Infectivity of a Human Immunodeficiency Virus Type 1 Envelope Associated with a Broadly Cross-Reactive, Primary Virus-Neutralizing Antibody Response

Zhang¹,

Bouma²,

Park³

et al. 2002

J Virol

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The human serum human immunodeficiency virus type 1 (HIV-1)-neutralizing serum 2 (HNS2) neutralizes many primary isolates of different clades of HIV-1, and virus expressing envelope from the same donor, clone R2, is neutralized cross-reactively by HIV-immune human sera. The basis for this cross-reactivity was investigated. It was found that a rare mutation in the proximal limb of variable region 3 (V3), 313-4 PM, caused virus pseudotyped with the R2 envelope to be highly sensitive to neutralization by monoclonal antibodies (MAbs) directed against conformation-sensitive epitopes at the tip of the V3 loop, such as 19b, and moderately sensitive to MAbs against CD4 binding site (CD4bs) and CD4-induced (CD4i) epitopes, soluble CD4 (sCD4), and HNS2. In addition, introduction of this sequence by mutagenesis caused enhanced sensitivity to neutralization by 19b, anti-CD4i MAb, and HNS2 in three other primary HIV-1 envelopes and by anti-CD4bs MAb and sCD4 in one of the three. The 313-4 PM sequence also conferred increased infectivity for CD4 ؉ CCR5 ؉ cells and the ability to infect CCR5 ؉ cells upon all of these four and two of these four HIV-1 envelopes, respectively. Neutralization of R2 by HNS2 was substantially inhibited by the cyclized R2 V3 35-mer synthetic peptide. Similarly, the peptide also had some lesser efficacy in blocking neutralization of R2 by other sera or of neutralization of other primary viruses by HNS2. Together, these results indicate that the unusual V3 mutation in the R2 clone accounts for its uncommon neutralization sensitivity phenotype and its capacity to mediate CD4-independent infection, both of which could relate to immunogenicity and the neutralizing activity of HNS2. This is also the first primary HIV-1 isolate envelope glycoprotein found to be competent for CD4-independent infection.

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Prevalence of Human Immunodeficiency Virus Type 1 p24 Antigen in U.S. Blood Donors — An Assessment of the Efficacy of Testing in Donor Screening

Abstract: The finding that no donation studied was positive for p24 antigen and negative for HIV-1 antibody suggests that screening donors for p24 antigen with tests of the current level of sensitivity would not add substantially to the safety of the U.S. blood supply.

Cited by 126 publications

References 18 publications

Frequency, Causes, and New Challenges of Indeterminate Results in Western Blot Confirmatory Testing for Antibodies to Human Immunodeficiency Virus

Frequency, Causes, and New Challenges of Indeterminate Results in Western Blot Confirmatory Testing for Antibodies to Human Immunodeficiency Virus

The Efficiency of HIV p24 Antigen Screening of US Blood Donors: Projections versus Reality

A Variable Region 3 (V3) Mutation Determines a Global Neutralization Phenotype and CD4-Independent Infectivity of a Human Immunodeficiency Virus Type 1 Envelope Associated with a Broadly Cross-Reactive, Primary Virus-Neutralizing Antibody Response

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