Significance of the signal-to-cutoff ratios of anti-hepatitis C virus enzyme immunoassays in screening of Chinese blood donors

Fu Rong Ren, Qiu Shuang Lv, Hui Zhuang, Jing Jing Li, Xiao Yan Gong, Guo Jing Gao, Chang Li Liu, Jing Xing Wang, Fu Zhu Yao, You Rong Zheng, Fa Ming Zhu, Mei Hei Li Tiemuer, Xu Hua Bai, Hua Shan

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The correlation between signal-to-cutoff (S/CO) ratios of a second-generation hepatitis C virus (HCV) enzyme immunoassay (EIA; Abbott) and a third-generation HCV enzyme-linked immunosorbent assay (ELISA; Ortho) and confirmed HCV infection has been reported. The utility of the values for the Chinese anti-HCV EIA kits, however, has not been studied in evaluating test results in Chinese blood donors. STUDY DESIGN AND METHODS: A total of 156 donor samples repeat reactive for anti-HCV at routine screening from five representative regions of China were retested for anti-HCV by the Ortho third-generation HCV ELISA and six Chinese EIA kits and for HCV RNA by a human immunodeficiency virus-1 and HCV assay (Procleix, Chiron Corp.). The HCV RNA-nonreactive samples were further tested for anti-HCV by a third-generation recombinant immunoblot assay RIBA (Chiron Corp.). The positive result by either nucleic acid amplification test or RIBA was interpreted as confirmed HCV infection. RESULTS: The confirmed HCV prevalence rate in donors in five representative regions obtained in this study was 0.20 percent (77/37,900) in 2004. All seven anti-HCV EIA kits had a significant correlation between S/CO ratios and confirmed HCV infection. The threshold S/CO ratios, which predicted more than 95 percent of confirmed HCV infections for the Ortho, SABC, BGI-GBI, InTec, GWK, KHB, and WANTAI kits, were 3.8, 6.0, 7.0, 8.6, 10.0, 10.0, and 14.0, respectively. CONCLUSIONS: Anti-HCV EIA kits commonly used in Chinese donors screening demonstrate good correlation between S/CO ratios and the confirmed infection. For the Ortho third-generation HCV ELISA, the S/CO ratio of 3.8 determined by the US Centers for Disease Control and Prevention is applicable to Chinese blood donors. The Chinese domestic EIA kits evaluated show a diverse range of threshold S/CO ratios.

Original languageEnglish (US)
Pages (from-to)1816-1822
Number of pages7
JournalTransfusion
Volume45
Issue number11
DOIs
StatePublished - Nov 2005
Externally publishedYes

Fingerprint

Blood Donors
Immunoenzyme Techniques
Hepacivirus
Virus Diseases
Enzyme-Linked Immunosorbent Assay
Tissue Donors
Nucleic Acid Amplification Techniques
RNA
Donor Selection
Centers for Disease Control and Prevention (U.S.)

ASJC Scopus subject areas

  • Hematology
  • Immunology

Cite this

Significance of the signal-to-cutoff ratios of anti-hepatitis C virus enzyme immunoassays in screening of Chinese blood donors. / Ren, Fu Rong; Lv, Qiu Shuang; Zhuang, Hui; Li, Jing Jing; Gong, Xiao Yan; Gao, Guo Jing; Liu, Chang Li; Wang, Jing Xing; Yao, Fu Zhu; Zheng, You Rong; Zhu, Fa Ming; Tiemuer, Mei Hei Li; Bai, Xu Hua; Shan, Hua.

In: Transfusion, Vol. 45, No. 11, 11.2005, p. 1816-1822.

Research output: Contribution to journalArticle

Ren, FR, Lv, QS, Zhuang, H, Li, JJ, Gong, XY, Gao, GJ, Liu, CL, Wang, JX, Yao, FZ, Zheng, YR, Zhu, FM, Tiemuer, MHL, Bai, XH & Shan, H 2005, 'Significance of the signal-to-cutoff ratios of anti-hepatitis C virus enzyme immunoassays in screening of Chinese blood donors', Transfusion, vol. 45, no. 11, pp. 1816-1822. https://doi.org/10.1111/j.1537-2995.2005.00611.x
Ren, Fu Rong ; Lv, Qiu Shuang ; Zhuang, Hui ; Li, Jing Jing ; Gong, Xiao Yan ; Gao, Guo Jing ; Liu, Chang Li ; Wang, Jing Xing ; Yao, Fu Zhu ; Zheng, You Rong ; Zhu, Fa Ming ; Tiemuer, Mei Hei Li ; Bai, Xu Hua ; Shan, Hua. / Significance of the signal-to-cutoff ratios of anti-hepatitis C virus enzyme immunoassays in screening of Chinese blood donors. In: Transfusion. 2005 ; Vol. 45, No. 11. pp. 1816-1822.
@article{1df5b1dee0c443159859e8a88c523d47,
title = "Significance of the signal-to-cutoff ratios of anti-hepatitis C virus enzyme immunoassays in screening of Chinese blood donors",
abstract = "BACKGROUND: The correlation between signal-to-cutoff (S/CO) ratios of a second-generation hepatitis C virus (HCV) enzyme immunoassay (EIA; Abbott) and a third-generation HCV enzyme-linked immunosorbent assay (ELISA; Ortho) and confirmed HCV infection has been reported. The utility of the values for the Chinese anti-HCV EIA kits, however, has not been studied in evaluating test results in Chinese blood donors. STUDY DESIGN AND METHODS: A total of 156 donor samples repeat reactive for anti-HCV at routine screening from five representative regions of China were retested for anti-HCV by the Ortho third-generation HCV ELISA and six Chinese EIA kits and for HCV RNA by a human immunodeficiency virus-1 and HCV assay (Procleix, Chiron Corp.). The HCV RNA-nonreactive samples were further tested for anti-HCV by a third-generation recombinant immunoblot assay RIBA (Chiron Corp.). The positive result by either nucleic acid amplification test or RIBA was interpreted as confirmed HCV infection. RESULTS: The confirmed HCV prevalence rate in donors in five representative regions obtained in this study was 0.20 percent (77/37,900) in 2004. All seven anti-HCV EIA kits had a significant correlation between S/CO ratios and confirmed HCV infection. The threshold S/CO ratios, which predicted more than 95 percent of confirmed HCV infections for the Ortho, SABC, BGI-GBI, InTec, GWK, KHB, and WANTAI kits, were 3.8, 6.0, 7.0, 8.6, 10.0, 10.0, and 14.0, respectively. CONCLUSIONS: Anti-HCV EIA kits commonly used in Chinese donors screening demonstrate good correlation between S/CO ratios and the confirmed infection. For the Ortho third-generation HCV ELISA, the S/CO ratio of 3.8 determined by the US Centers for Disease Control and Prevention is applicable to Chinese blood donors. The Chinese domestic EIA kits evaluated show a diverse range of threshold S/CO ratios.",
author = "Ren, {Fu Rong} and Lv, {Qiu Shuang} and Hui Zhuang and Li, {Jing Jing} and Gong, {Xiao Yan} and Gao, {Guo Jing} and Liu, {Chang Li} and Wang, {Jing Xing} and Yao, {Fu Zhu} and Zheng, {You Rong} and Zhu, {Fa Ming} and Tiemuer, {Mei Hei Li} and Bai, {Xu Hua} and Hua Shan",
year = "2005",
month = "11",
doi = "10.1111/j.1537-2995.2005.00611.x",
language = "English (US)",
volume = "45",
pages = "1816--1822",
journal = "Transfusion",
issn = "0041-1132",
publisher = "Wiley-Blackwell",
number = "11",

}

TY - JOUR

T1 - Significance of the signal-to-cutoff ratios of anti-hepatitis C virus enzyme immunoassays in screening of Chinese blood donors

AU - Ren, Fu Rong

AU - Lv, Qiu Shuang

AU - Zhuang, Hui

AU - Li, Jing Jing

AU - Gong, Xiao Yan

AU - Gao, Guo Jing

AU - Liu, Chang Li

AU - Wang, Jing Xing

AU - Yao, Fu Zhu

AU - Zheng, You Rong

AU - Zhu, Fa Ming

AU - Tiemuer, Mei Hei Li

AU - Bai, Xu Hua

AU - Shan, Hua

PY - 2005/11

Y1 - 2005/11

N2 - BACKGROUND: The correlation between signal-to-cutoff (S/CO) ratios of a second-generation hepatitis C virus (HCV) enzyme immunoassay (EIA; Abbott) and a third-generation HCV enzyme-linked immunosorbent assay (ELISA; Ortho) and confirmed HCV infection has been reported. The utility of the values for the Chinese anti-HCV EIA kits, however, has not been studied in evaluating test results in Chinese blood donors. STUDY DESIGN AND METHODS: A total of 156 donor samples repeat reactive for anti-HCV at routine screening from five representative regions of China were retested for anti-HCV by the Ortho third-generation HCV ELISA and six Chinese EIA kits and for HCV RNA by a human immunodeficiency virus-1 and HCV assay (Procleix, Chiron Corp.). The HCV RNA-nonreactive samples were further tested for anti-HCV by a third-generation recombinant immunoblot assay RIBA (Chiron Corp.). The positive result by either nucleic acid amplification test or RIBA was interpreted as confirmed HCV infection. RESULTS: The confirmed HCV prevalence rate in donors in five representative regions obtained in this study was 0.20 percent (77/37,900) in 2004. All seven anti-HCV EIA kits had a significant correlation between S/CO ratios and confirmed HCV infection. The threshold S/CO ratios, which predicted more than 95 percent of confirmed HCV infections for the Ortho, SABC, BGI-GBI, InTec, GWK, KHB, and WANTAI kits, were 3.8, 6.0, 7.0, 8.6, 10.0, 10.0, and 14.0, respectively. CONCLUSIONS: Anti-HCV EIA kits commonly used in Chinese donors screening demonstrate good correlation between S/CO ratios and the confirmed infection. For the Ortho third-generation HCV ELISA, the S/CO ratio of 3.8 determined by the US Centers for Disease Control and Prevention is applicable to Chinese blood donors. The Chinese domestic EIA kits evaluated show a diverse range of threshold S/CO ratios.

AB - BACKGROUND: The correlation between signal-to-cutoff (S/CO) ratios of a second-generation hepatitis C virus (HCV) enzyme immunoassay (EIA; Abbott) and a third-generation HCV enzyme-linked immunosorbent assay (ELISA; Ortho) and confirmed HCV infection has been reported. The utility of the values for the Chinese anti-HCV EIA kits, however, has not been studied in evaluating test results in Chinese blood donors. STUDY DESIGN AND METHODS: A total of 156 donor samples repeat reactive for anti-HCV at routine screening from five representative regions of China were retested for anti-HCV by the Ortho third-generation HCV ELISA and six Chinese EIA kits and for HCV RNA by a human immunodeficiency virus-1 and HCV assay (Procleix, Chiron Corp.). The HCV RNA-nonreactive samples were further tested for anti-HCV by a third-generation recombinant immunoblot assay RIBA (Chiron Corp.). The positive result by either nucleic acid amplification test or RIBA was interpreted as confirmed HCV infection. RESULTS: The confirmed HCV prevalence rate in donors in five representative regions obtained in this study was 0.20 percent (77/37,900) in 2004. All seven anti-HCV EIA kits had a significant correlation between S/CO ratios and confirmed HCV infection. The threshold S/CO ratios, which predicted more than 95 percent of confirmed HCV infections for the Ortho, SABC, BGI-GBI, InTec, GWK, KHB, and WANTAI kits, were 3.8, 6.0, 7.0, 8.6, 10.0, 10.0, and 14.0, respectively. CONCLUSIONS: Anti-HCV EIA kits commonly used in Chinese donors screening demonstrate good correlation between S/CO ratios and the confirmed infection. For the Ortho third-generation HCV ELISA, the S/CO ratio of 3.8 determined by the US Centers for Disease Control and Prevention is applicable to Chinese blood donors. The Chinese domestic EIA kits evaluated show a diverse range of threshold S/CO ratios.

UR - http://www.scopus.com/inward/record.url?scp=33644662991&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33644662991&partnerID=8YFLogxK

U2 - 10.1111/j.1537-2995.2005.00611.x

DO - 10.1111/j.1537-2995.2005.00611.x

M3 - Article

VL - 45

SP - 1816

EP - 1822

JO - Transfusion

JF - Transfusion

SN - 0041-1132

IS - 11

ER -