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M9470105.TXT
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1994-07-02
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Document 0105
DOCN M9470105
TI Evaluation of a p21e-spiked western blot (immunoblot) in confirming
human T-cell lymphotropic virus type I or II infection in volunteer
blood donors. The Retrovirus Epidemiology Donor Study Group.
DT 9409
AU Kleinman SH; Kaplan JE; Khabbaz RF; Calabro MA; Thomson R; Busch M;
Southern California Region American Red Cross Blood Services, Los;
Angeles 90006.
SO J Clin Microbiol. 1994 Mar;32(3):603-7. Unique Identifier : AIDSLINE
MED/94253317
AB Current algorithms for the serologic confirmation of human T-cell
lymphotropic virus type I and II (HTLV-I/II) antibody reactivity are
complicated. We evaluated the performance of an HTLV-I Western blot
(immunoblot) spiked with recombinant p21e protein (p21e WB) as an
alternative to current confirmatory methods. These methods include the
HTLV-I viral lysate Western blot and either a radioimmunoprecipitation
assay or a p21e enzyme-linked immunosorbent assay. Five hundred fifty
nine blood donations obtained from five U.S. blood centers and
classified as HTLV-I/II seropositive (n = 149) or seroindeterminate (n =
410) by routine testing methods were further evaluated by PCR for
proviral DNA and by the p21e WB. On the basis of serologic and PCR
testing, 155 donations were classified as HTLV-I/II infected. The
sensitivity of the p21e WB was 97.4%, slightly exceeding that of routine
confirmatory testing. The specificity of the p21e WB was 97.5%, as
determined by testing of 404 seroindeterminate samples that were
negative in the PCR. The positive predictive value of the p21e WB was
94%. In contrast, the specificity and positive predictive value of
routine confirmatory testing were both 100%. Follow-up sampling of
presumptive p21e WB false-positive donors substantiated the absence of
HTLV-I/II infection. Although the p21e WB used in this study has high
sensitivity and may be useful as a confirmatory assay in epidemiologic
research studies, it may not be ideal as a confirmatory test for the
notification of blood donors.
DE Blood Donors Blotting, Western/*METHODS/STATISTICS & NUMER DATA DNA,
Viral/BLOOD/GENETICS Evaluation Studies Gene Products, env/IMMUNOLOGY
Human HTLV-I/GENETICS HTLV-I Antibodies/BLOOD HTLV-I Antigens HTLV-I
Infections/*DIAGNOSIS/IMMUNOLOGY/MICROBIOLOGY HTLV-II/GENETICS HTLV-II
Antibodies/BLOOD HTLV-II Infections/*DIAGNOSIS/IMMUNOLOGY/MICROBIOLOGY
Retroviridae Proteins, Oncogenic/IMMUNOLOGY Sensitivity and Specificity
Support, U.S. Gov't, P.H.S. JOURNAL ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).