Correlation between signal/cutoff ratios of anti-HCV enzyme immunoassay (EIA) and their true positivity in blood donors.
- Author:
Fu-Rong REN
1
;
Xiao-Yan GONG
;
Jing-Jing LI
;
Qiu-Shuang LÜ
;
Chang-Li LIU
;
Hui ZHUANG
;
Hua SHAN
;
Jing-Xing WANG
Author Information
- Publication Type:Journal Article
- MeSH: Blood Donors; Hepacivirus; isolation & purification; Humans; Immunoenzyme Techniques; methods; Predictive Value of Tests; Reagent Kits, Diagnostic; Sensitivity and Specificity
- From: Chinese Journal of Hepatology 2005;13(4):255-258
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVESTo evaluate the correlation between signal/cutoff (S/CO) ratios of anti-HCV EIA and their true positivity for determining the predictive value of S/CO ratios.
METHODSOne hundred and fifty-nine samples of blood from donors positive for anti-HCV at the initial screening were collected from Beijing, Guangzhou, Hangzhou, Kunming and Urumchi. All the samples were retested by Ortho and 6 Chinese domestic anti-HCV EIA kits in duplicate, and detected for HCV RNA (NAT) using Chiron Procleix HIV/HCV system (transcription mediated amplification, TMA). The HCV RNA negative samples were further tested for anti-HCV by Chiron RIBA 3.0. Either NAT or RIBA positive samples were interpreted as the true positive.
RESULTSAll 7 anti-HCV EIA kits had a significant correlation between S/CO ratios and true positivity. The S/CO ratio of Ortho > or = 3.8 predicted the true positivity in 96.1% of the samples tested. The S/CO ratios of BGI-GBI, GWK, SABC, KHB, InTec, and Wantai were > or = 7.0, > or = 10.0, > or = 6.0, > or = 10.0, > or = 8.6, > or = 14.0 and predicted 96.1%, 96.1%, 97.3%, 96.0%, 96.1%, 96.0% of the true positivity, respectively.
CONCLUSIONSThe S/CO ratios of anti-HCV EIA kits are associated with the true positivity. S/CO ratios of Ortho, BGI-GBI, GWK, SABC, KHB, InTec and Wantai predicting > or = 95% true positivity are > or = 3.8, > or = 7.0, > or = 10.0, > or = 6.0, > or = 1 0.0, > or = 8.6 and > or = 14.0, respectively.