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.

Pubmed ID: 8195365

Pubmed Central ID: PMC263093

Journal: Journal of clinical microbiology

Publication Date: March 1, 1994

Affiliation: Southern California Region American Red Cross Blood Services, Los Angeles 90006.

MeSH Terms: Humans, Blood Donors, DNA, Viral, HTLV-I Infections, HTLV-II Infections, HTLV-I Antibodies, HTLV-II Antibodies, Human T-lymphotropic virus 1, Human T-lymphotropic virus 2, Sensitivity and Specificity, Blotting, Western, Evaluation Studies as Topic, Gene Products, env, HTLV-I Antigens, Retroviridae Proteins, Oncogenic, env Gene Products, Human Immunodeficiency Virus

Grants: N0 1 HB 97080

Authors: Kleinman SH, Thomson R, Kaplan JE, Khabbaz RF, Busch M, Calabro MA

Cite As: Kleinman SH, Kaplan JE, Khabbaz RF, Calabro MA, Thomson R, Busch M. 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.

Studies:

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.