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

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. 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. Conclusions: 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.

Evaluation of human T-cell leukemia virus in vitro diagnostics using plasma specimens collected in Japan

“…In the present study, 10 specimens tested positive for relatively low S/CO or COI in multiple IVDs in primary detection test/screening and were HTLV-indeterminate or negative upon INNO-LIA testing. Primary detection test/screening positive and INNO-LIA-indeterminate or negative cases have also been reported [ 7 , 17 – 21 ]. Because these were plasma specimens, proviral testing could not be performed, and these specimens could not be identified as HTLV-positive.…”

Results of a sample-to-cutoff ratio using Abbott Architect rHTLV-I/II assay allow to predict detection of HTLV-1 and HTLV-2 proviral DNA by real-time PCR

“…In the present study, the S/CO ratios of reactive results for anti-HTLV-1/2 antibodies and the detection of proviral DNA in Brazilian blood donors were examined. It has been shown previously in blood donor populations that high reactivity in serological screening tests for transfusion transmissible infections (TTI) is predictive of confirmed-positive results, whereas low reactivity is frequently associated with BFR results 26,27 .…”

Metaanálisis de la validez del inmunodiagnóstico del virus linfotrópico de células T humanas I/II en bancos de sangre, 2000-2018

“…En adición a lo anterior, investigaciones recientes se han ocupado de la morbilidad por htlv mediante el uso de diferentes pruebas; así, en la actualización de Iwanaga se incluyen estudios que emplearon aglutinación de partículas e inmunofluorescencia [26]; en el análisis que hacen de Cardona et al se estimó la ocurrencia de la infección mediante quimioluminiscencia y confirmación con Western blot (bandas rgp 46-i, GD21, p19, p24, p26, p28, p32, p36, p53) [27]; el grupo de Yousefi utilizó elisa [28] y Zhao et al se sirvieron de quimioluminiscencia y elisa [29], demostrando la alta diversidad de metodologías para la detección del virus.…”