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Estimation of the window period of human T-cell leukemia virus type 1 and 2 tests by a lookback study of seroconverters among Japanese voluntary blood donors.
Transfusion. 2021 02; 61(2):484-493.T

Abstract

BACKGROUND

Japan is endemic for human T-cell leukemia virus type 1 (HTLV-1), and the horizontal transmission of HTLV-1 is often reported. However, the window period (WP) for serologic or molecular screening is unclear.

STUDY DESIGN AND METHODS

Results for anti-HTLV-1 screening and confirmatory tests obtained from 648 591 repeated blood donors in the Kyushu district, one of the most endemic areas of HTLV-1 in the world, were evaluated. A lookback study was conducted for seroconverters.

RESULTS

During 2012 to 2019, 436 seroconverters (155 men, 281women) were identified with use of a screening chemiluminescence enzyme-immunoassay (CLEIA) and multiple confirmatory tests. Because the period between the latest seronegative donation and seroconversion was highly variable (2.1-276.7 months), 19 cases that seroconverted within 6 months were subjected to the analysis. The WP of the particle agglutination assay and CLEIA was estimated to be 2.2 ± 0.6 and 2.6 ± 1.7 months, respectively. The WP of the indirect immunofluorescence assay was 4.8 ± 6.5 months. Although the WP of western blotting was estimated to be 6.3 ± 8.7 months, four cases were still indeterminate through the study period. Chemiluminescence and line immunoassays, the current screening and confirmatory tests used in the Japanese blood program, showed the shortest WP of 2.2 ± 0.6 months. The WP of real-time polymerase chain reaction for HTLV-1 was estimated to be 4.1 ± 7.8 months.

CONCLUSIONS

The WP in commercially available testing systems for HTLV-1/2 was determined for natural infection among repeated blood donors. Considering the HTLV-1 WP will help increase transfusion safety and facilitate the accurate diagnosis of HTLV-1 infection.

Authors+Show Affiliations

Department of Quality, Japanese Red Cross Kyushu Block Blood Center, Chikushino, Japan.Department of Quality, Japanese Red Cross Kyushu Block Blood Center, Chikushino, Japan.Department of Quality, Japanese Red Cross Kyushu Block Blood Center, Chikushino, Japan.Department of Quality, Japanese Red Cross Kyushu Block Blood Center, Chikushino, Japan.Department of Quality, Japanese Red Cross Kyushu Block Blood Center, Chikushino, Japan.Department of Quality, Japanese Red Cross Kyushu Block Blood Center, Chikushino, Japan.CEO of Japanese Red Cross Central Blood Institute, Tokyo, Japan.Department of Quality, Japanese Red Cross Kyushu Block Blood Center, Chikushino, Japan.

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33368334

Citation

Sagara, Yasuko, et al. "Estimation of the Window Period of Human T-cell Leukemia Virus Type 1 and 2 Tests By a Lookback Study of Seroconverters Among Japanese Voluntary Blood Donors." Transfusion, vol. 61, no. 2, 2021, pp. 484-493.
Sagara Y, Nakamura H, Yamamoto M, et al. Estimation of the window period of human T-cell leukemia virus type 1 and 2 tests by a lookback study of seroconverters among Japanese voluntary blood donors. Transfusion. 2021;61(2):484-493.
Sagara, Y., Nakamura, H., Yamamoto, M., Ezaki, T., Koga, T., Shimamura, M., Satake, M., & Irita, K. (2021). Estimation of the window period of human T-cell leukemia virus type 1 and 2 tests by a lookback study of seroconverters among Japanese voluntary blood donors. Transfusion, 61(2), 484-493. https://doi.org/10.1111/trf.16213
Sagara Y, et al. Estimation of the Window Period of Human T-cell Leukemia Virus Type 1 and 2 Tests By a Lookback Study of Seroconverters Among Japanese Voluntary Blood Donors. Transfusion. 2021;61(2):484-493. PubMed PMID: 33368334.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Estimation of the window period of human T-cell leukemia virus type 1 and 2 tests by a lookback study of seroconverters among Japanese voluntary blood donors. AU - Sagara,Yasuko, AU - Nakamura,Hitomi, AU - Yamamoto,Midori, AU - Ezaki,Toshinobu, AU - Koga,Tomohide, AU - Shimamura,Masuhiro, AU - Satake,Masahiro, AU - Irita,Kazuo, Y1 - 2020/12/24/ PY - 2020/08/03/received PY - 2020/10/20/revised PY - 2020/10/21/accepted PY - 2020/12/29/pubmed PY - 2021/7/9/medline PY - 2020/12/28/entrez KW - HTLV-1/2 tests KW - blood donors KW - seroconverter KW - window period SP - 484 EP - 493 JF - Transfusion JO - Transfusion VL - 61 IS - 2 N2 - BACKGROUND: Japan is endemic for human T-cell leukemia virus type 1 (HTLV-1), and the horizontal transmission of HTLV-1 is often reported. However, the window period (WP) for serologic or molecular screening is unclear. STUDY DESIGN AND METHODS: Results for anti-HTLV-1 screening and confirmatory tests obtained from 648 591 repeated blood donors in the Kyushu district, one of the most endemic areas of HTLV-1 in the world, were evaluated. A lookback study was conducted for seroconverters. RESULTS: During 2012 to 2019, 436 seroconverters (155 men, 281women) were identified with use of a screening chemiluminescence enzyme-immunoassay (CLEIA) and multiple confirmatory tests. Because the period between the latest seronegative donation and seroconversion was highly variable (2.1-276.7 months), 19 cases that seroconverted within 6 months were subjected to the analysis. The WP of the particle agglutination assay and CLEIA was estimated to be 2.2 ± 0.6 and 2.6 ± 1.7 months, respectively. The WP of the indirect immunofluorescence assay was 4.8 ± 6.5 months. Although the WP of western blotting was estimated to be 6.3 ± 8.7 months, four cases were still indeterminate through the study period. Chemiluminescence and line immunoassays, the current screening and confirmatory tests used in the Japanese blood program, showed the shortest WP of 2.2 ± 0.6 months. The WP of real-time polymerase chain reaction for HTLV-1 was estimated to be 4.1 ± 7.8 months. CONCLUSIONS: The WP in commercially available testing systems for HTLV-1/2 was determined for natural infection among repeated blood donors. Considering the HTLV-1 WP will help increase transfusion safety and facilitate the accurate diagnosis of HTLV-1 infection. SN - 1537-2995 UR - https://www.unboundmedicine.com/medline/citation/33368334/Estimation_of_the_window_period_of_human_T_cell_leukemia_virus_type_1_and_2_tests_by_a_lookback_study_of_seroconverters_among_Japanese_voluntary_blood_donors_ L2 - https://doi.org/10.1111/trf.16213 DB - PRIME DP - Unbound Medicine ER -