Evaluation of Line Immunoassay to Detect HTLV-1 Infection in an Endemic Area, Southwestern Japan; Comparison with Polymerase Chain Reaction and Western Blot

Umeki, Kazumi; Umekita, Kunihiko; Hashikura, Yuuki; Yamamoto, Ikuo; Kubo, Kazuyoshi; Nagatomo, Yasuhiro; Okayama, Akira

doi:10.7754/clin.lab.2016.160501

Cited by 16 publications

(16 citation statements)

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“…This assay performs well in confirming HTLV-1 seropositivity by exhibiting a low incidence of indeterminate results. Further, the results are in good agreement with PCR results (Sabino et al, 1999;Umeki et al, 2017). It was reported that the number of indeterminate results was reduced by up to 90% when LIA was introduced to replace the WB confirmatory test (Thorstensson et al, 2002).…”

Section: Confirmatory Testsupporting

confidence: 75%

A Nationwide Antenatal Human T-Cell Leukemia Virus Type-1 Antibody Screening in Japan

Itabashi

Miyazawa

Sekizawa³

et al. 2020

Front. Microbiol.

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Section: Confirmatory Testsupporting

confidence: 75%

A Nationwide Antenatal Human T-Cell Leukemia Virus Type-1 Antibody Screening in Japan

Itabashi

Miyazawa

Sekizawa³

et al. 2020

Front. Microbiol.

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“…Recently, the line immunoassay (LIA) [ 21 ], which has been mainly used in Europe and Brazil as an alternative confirmatory test for HTLV-1 antibodies [ 22 – 25 ], has begun to be used in Japan [ 26 ]. Therefore, in this study, we sought to determine the current issues relating to a WB-based HTLV-1 diagnostic assay kit for Japanese samples, and to investigate the usefulness of the LIA as compared to WB for confirmation of sample reactivity.…”

Section: Introductionmentioning

confidence: 99%

Establishment of a novel diagnostic test algorithm for human T-cell leukemia virus type 1 infection with line immunoassay replacement of western blotting: a collaborative study for performance evaluation of diagnostic assays in Japan

et al. 2020

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Background: The reliable diagnosis of human T-cell leukemia virus type 1 (HTLV-1) infection is important, particularly as it can be vertically transmitted by breast feeding mothers to their infants. However, current diagnosis in Japan requires a confirmatory western blot (WB) test after screening/primary testing for HTLV-1 antibodies, but this test often gives indeterminate results. Thus, this collaborative study evaluated the reliability of diagnostic assays for HTLV-1 infection, including a WB-based one, along with line immunoassay (LIA) as an alternative to WB for confirmatory testing. Results: Using peripheral blood samples from blood donors and pregnant women previously serologically screened and subjected to WB analysis, we analyzed the performances of 10 HTLV-1 antibody assay kits commercially available in Japan. No marked differences in the performances of eight of the screening kits were apparent. However, LIA determined most of the WB-indeterminate samples to be conclusively positive or negative (an 88.0% detection rate). When we also compared the sensitivity to HTLV-1 envelope gp21 with that of other antigens by LIA, the sensitivity to gp21 was the strongest. When we also compared the sensitivity to envelope gp46 by LIA with that of WB, LIA showed stronger sensitivity to gp46 than WB did. These findings indicate that LIA is an alternative confirmatory test to WB analysis without gp21. Therefore, we established a novel diagnostic test algorithm for HTLV-1 infection in Japan,

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“…Furthermore, the HTLV-infected donor in this study had several sex partners and underwent acupuncture theory and endoscopy; unprotected sex and traumatic operations may increase the risk of HTLV transmission [24,25]. After two follow-up tests, one indeterminate case from Hebei changed into negative, while no changes were found in the results of the 2 indeterminate cases and one positive case, which may be related to the a low antibody titer of the donor and the sensitivity and speci city of INNO-LIA [26]. Although one sample was con rmed as HTLV-1 positive, 6 donations had the con rmation lines in the INNO-LIA HTLV I/II score.…”

Section: Discussionmentioning

confidence: 96%

HTLV screening of blood donors using chemiluminescence immunoassay in three major provincial blood centers of China

Zhao

Zhao²,

Wang³

et al. 2020

Preprint

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Abstract Background: Human T-cell lymphotropic virus (HTLV) remains a major safety concern for blood supplies. Despite many HTLV positive cases being reported in southeastern China, the detection of HTLV has not been prioritized in routine blood screening. Additionally, data on the prevalence of HTLV infection among blood donors is also limited.Objective: The objective of this study was to investigate the prevalence of HTLV among blood donors in three Chinese provinces through their representative blood centers, to evaluate the feasibility of chemiluminescence immunoassay (CLIA) for blood screening.Methods: From November 2018 to March 2019, blood plasma samples were collected from Hebei, Changsha, and Shenzhen blood centers and were screened for the HTLV-1/2 antibody using a CLIA and enzyme-linked immunosorbent assay (ELISA). This was followed by confirmatory tests using INNO-LIA HTLV I/II.Results: A total of 59,929 blood donations were collected and screened for HTLV-1/2. The reactive rate of CLIA and ELISA among donations in the Shenzhen blood center (0.0943%, 27/28, 621) was higher than Hebei (0.0248%, 4/16,144), and Changsha (0.0198%, 3/15,164) (p < 0.05). After confirmation, 3 samples were confirmed as indeterminate for HTLV antibodies, and only one sample from the Shenzhen blood center was confirmed as HTLV-1. The overall prevalence of HTLV-1/2 was 1.67 per 100 000 (1/59 929). The HTLV-infected blood came from a 32-year-old first-time female donor with a high school degree, who belonged to the SHE ethnic minority and was born in the Fujian province.Conclusion: In summary, the overall prevalence of HTLV-1/2 among blood donors in the three blood centers in China remains relatively low. However, blood donations with positive or indeterminate results for HTLV antibodies reminded us of the importance of HTLV screening among blood donors in China.

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Evaluation of Line Immunoassay to Detect HTLV-1 Infection in an Endemic Area, Southwestern Japan; Comparison with Polymerase Chain Reaction and Western Blot

Cited by 16 publications

References 0 publications

A Nationwide Antenatal Human T-Cell Leukemia Virus Type-1 Antibody Screening in Japan

A Nationwide Antenatal Human T-Cell Leukemia Virus Type-1 Antibody Screening in Japan

Establishment of a novel diagnostic test algorithm for human T-cell leukemia virus type 1 infection with line immunoassay replacement of western blotting: a collaborative study for performance evaluation of diagnostic assays in Japan

HTLV screening of blood donors using chemiluminescence immunoassay in three major provincial blood centers of China

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