[Analyses of anti-hCV detected by ELISA and HCV RNA detected by RT-nPCR in chronic hepatitis C virus infectors].
OBJECTIVE
In order to provide the basis for the clinical test and the blood station screening the health donator, the results of anti-HCV tested by ELISA (enzyme-linked-immuno-absorbed assay ) and HCV RNA tested by RT-nPCR (reverse-transcript-nested-polymerase-chain-reaction) were compared in the chronic hepatitis C virus infectors.


METHODS
Venous blood samples of 133 chronic hepatitis C virus infectors, 52 health controls were collected in May 2005. These infectors were infected with HCV nearly in 1990 through plasma donator and diagnosed in 1993 in a rural area of Zhao County in Hebei Province, which remained the same diagnosis as HCV infectors in 2002 Hebei Province. The anti-HCV was tested by ELISA and HCV RNA was tested by RT-nPCR.


RESULTS
(1) In 185 cases, the positive rates of both anti-HCV and HCV RNA were 49.73% (92/185). The rate of anti-HCV negative but HCV RNA positive was 9.73% (18/185). The rate of anti-HCV positive but HCV RNA negative was 11.89% (22/185). The negative rate of both anti-HCV and HCV RNA tested was 28.65% (53/185). The result-agreement rate of ELISA and RT-nPCR methods were 78.38% [(92 + 53)/185]. The disagreement rate between ELISA and RT-nPCR methods was not obviously different (paired chi2 = 0.40, P > 0.05). (2) In the chronic HCV infectors, the sensitivity of anti-HCV tested by ELISA was 82.71%, the specificity was 92.31%, and the omitting rate was 17.29%. The sensitivity of HCV RNA tested by RT-nPCR was 81.20%, the specificity was 96.15%, and the omitting rate was 18.80%. The sensitivity between ELISA and RT-nPCR was not obviously different (chi2 = 0.102, P > 0.05). (3) The sensitivity tested by ELISA combined with RT-nPCR was 96.75%, which was evidently higher than that of single ELISA (82.71%) (chi2 = 9.62, P < 0.01).


CONCLUSIONS
The false negative rate was nearly 17% when anti-HCV was tested with single ELISA in HCV infectors. The positive testing rate of HCV infection was increased remarkably when ELISA and RT-nPCR were tested simultaneously.
Gao
Qiuju
Q
Department of Epidemiology, College of Public Health, Hebei Medical University, Shijiazhuang 050017, China.
Liu
Dianwu
D
Zhang
Shiyong
S
Tong
Lixin
L
D016022:Case-Control Studies; D004797:Enzyme-Linked Immunosorbent Assay; D005188:False Negative Reactions; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D018937:Hepatitis C Antibodies / Q000097:blood*; D019698:Hepatitis C, Chronic / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D012367:RNA, Viral / Q000097:blood*; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods; D012680:Sensitivity and Specificity
D018937:Hepatitis C Antibodies; D012367:RNA, Viral