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

J Clin Microbiol. 1994 Mar;32(3):603-7. doi: 10.1128/jcm.32.3.603-607.1994.

Abstract

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.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Blood Donors
  • Blotting, Western / methods*
  • Blotting, Western / statistics & numerical data
  • DNA, Viral / blood
  • DNA, Viral / genetics
  • Evaluation Studies as Topic
  • Gene Products, env / immunology
  • HTLV-I Antibodies / blood
  • HTLV-I Antigens
  • HTLV-I Infections / diagnosis*
  • HTLV-I Infections / immunology
  • HTLV-I Infections / microbiology
  • HTLV-II Antibodies / blood
  • HTLV-II Infections / diagnosis*
  • HTLV-II Infections / immunology
  • HTLV-II Infections / microbiology
  • Human T-lymphotropic virus 1 / genetics
  • Human T-lymphotropic virus 2 / genetics
  • Humans
  • Retroviridae Proteins, Oncogenic / immunology
  • Sensitivity and Specificity
  • env Gene Products, Human Immunodeficiency Virus

Substances

  • DNA, Viral
  • Gene Products, env
  • HTLV-I Antibodies
  • HTLV-I Antigens
  • HTLV-II Antibodies
  • Retroviridae Proteins, Oncogenic
  • env Gene Products, Human Immunodeficiency Virus
  • gp21 protein, Human T-lymphotropic virus 1