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).