Evaluation of the Cutoff of Anti-HCV Antibody Enzyme-Linked Immunosorbent Assay in 7 Blood Station Laboratories.
10.7534/j.issn.1009-2137.2019.01.041
- Author:
Zheng-Min LIU
1
;
Rui WANG
1
;
Li-Qin HUANG
1
;
Jing-Hui HU
1
;
Le CHANG
2
;
Wei ZHEN
1
;
Peng WANG
3
;
Fang WANG
4
;
Chao WEI
5
;
Shao-Wen ZHU
6
;
Jin-Feng ZENG
7
;
Yan-Hua SHI
8
;
Wei ZHENG
9
;
Lu-Nan WANG
2
;
Hong-Wei GE
10
Author Information
1. Beijing Red Cross Blood Center, Beijing 100088, China.
2. National Center for Clinial Laboratories, Beijing Hospital, National Center for Gerontology, Beijing 100730, China.
3. Central Blood Station of Tongzhou,, Beijing 101101, China.
4. Blood Center of Liaoning Province, Shenyang 110044, Liaoning Province, China.
5. Cangzhou Center Blood Station, Cangzhou 061000, Hebei Province, China.
6. Blood Center of Jiangsu Province, Nanjing 210000, Jiangsu Province, China.
7. Shenzhen Blood Center, Shenzhen 518000, Guangdong Province, China.
8. Hubei Xiangyang blood Center, Xiangyang 441021, Hubei Province, China.
9. Heilongjiang Province Blood Center, Harbin 150056, Heilongjiang Province, China.
10. Beijing Red Cross Blood Center, Beijing 100088, China.E-mail: hwge88@163.com.
- Publication Type:Journal Article
- MeSH:
Enzyme-Linked Immunosorbent Assay;
Hepatitis C;
Hepatitis C Antibodies;
Humans;
ROC Curve;
Sensitivity and Specificity
- From:
Journal of Experimental Hematology
2019;27(1):253-259
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To evaluate the necessity and suitability of the anti-HCV ELISA teot gray zone setted up by 7 blood station laboratories.
METHODS:7 blood station laboratories were coded as 1, 2, 3, 4, 5, 6 and 7 respectively; 8 kinds of ELISA reagents were coded as A, B, C, D, E, F, G and H respectively. 1 or 2 of 8 ELISA reagents produced by different manufactories were used to detect the anti-HCV in specimens of same group by 7 blood station laboratories; the Westen blot was used to detect the specimens with difference of detected results so as to difine the serological status of specimens. The true positive rate of specimens detected by laboratories and gray zone-comfirined positive rate of specimens were accounted so as to analyze the necessity of setting up the gray zone for anti-HCV ELISA test of 7 blood station laboratories; the optimal cut-off value for anti-HCV ELISA test was determined in 7 blood station laborafories by ROC curve and the changes of sensitivity and specificity of 3 different cut-off value(laboratory work cut-off value, manifactory-recommended cun-off value and optimal cut-off value) were compared so as to analyze the suitability of gray zone for anti-HCV ELISA test in 7 blood station laboratories.
RESULTS:The true positive rate detected by 7 blood station laboratories, out of which coded 1 laboratory used 2 kinds of coded A, B reagents was 95.40%(1A), 99.23% (1B), 94.25% (2C), 96.17% (3D), 98.08% (4E), 96.93% (5F), 97.32%(6G) and 93.10%(7H). Except for 2C(94.25%) and 7H(93.10%), the true positive rate detected by laboratoies which not sutted up gray zone, the gray zone-con-firmed positive rate in 6 blood station laboratories setted up gray zone: was 0.00%, 0.00%, 21.43%, 0.00%, 0.00%, 0.00% and 38.89%. The comparison of 3 different cut-off valuces by ROC curve showed that the anti-HCV cut-off values in 5 laboratories(1B, 2C, 4E, 5F and 6G) were as follows: optimal cut-off value＞manufactory recommeded cut-off value＞laboratory work cut-off value, thus use of manufactory-recommeded cut-off value abreadly has reached the high sensitivity requinements for laboratory screening; however, the optimal cut-off value in laboratories 1A, 3B and 7H, thas the appropriate gray zone should be used. In 6 laboratories setting up gray zone, the gensitivity in 3D, 7H laboratories only a little improved (1.60% and 2.70% raspectively) in Eamparison between laboratory work cut-off value and manufactorg-recommeded cut-off value; moreover, the sensitivity in other laboratories not is changed, but the specificity decreased (0.20%-0.50%).
CONCLUSION:In addition to setting up the appropriate gray zone in laboratories 1A, 3D and 5H, the gray zone in other laboratories may be cancelled. Even in the same laboratory, the setting up the gray zone also should be scientifically assessed, the same scale cannot be blindly used, thus appropniate strategies should be established.
