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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.JC

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.

Authors+Show Affiliations

Southern California Region American Red Cross Blood Services, Los Angeles 90006.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

8195365

Citation

Kleinman, S H., et al. "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." Journal of Clinical Microbiology, vol. 32, no. 3, 1994, pp. 603-7.
Kleinman SH, Kaplan JE, Khabbaz RF, et al. 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;32(3):603-7.
Kleinman, S. H., Kaplan, J. E., Khabbaz, R. F., Calabro, M. A., Thomson, R., & Busch, M. (1994). 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. Journal of Clinical Microbiology, 32(3), 603-7.
Kleinman SH, et al. 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;32(3):603-7. PubMed PMID: 8195365.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Kleinman,S H, AU - Kaplan,J E, AU - Khabbaz,R F, AU - Calabro,M A, AU - Thomson,R, AU - Busch,M, PY - 1994/3/1/pubmed PY - 1994/3/1/medline PY - 1994/3/1/entrez SP - 603 EP - 7 JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 32 IS - 3 N2 - 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. SN - 0095-1137 UR - https://www.unboundmedicine.com/medline/citation/8195365/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_ L2 - https://journals.asm.org/doi/10.1128/jcm.32.3.603-607.1994?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -