Usefulness of Anti-HCV ELISA Test and HCV Reverse Transcriptase-PCR for the Diagnosis of Hepatits C Viral Infection.
10.3343/kjlm.2006.26.6.418
- Author:
Myeong Hee KIM
1
;
Hee Joo LEE
;
Su Yon PARK
;
Youn Sik LEE
;
Jin Tae SUH
Author Information
1. Department of Laboratory Medicine, College of Medicine, Kyunghee University, Seoul, Korea. leehejo@khmc.or.kr
- Publication Type:Original Article
- Keywords:
Hepatitis C;
Anti-HCV ELISA;
HCV RT-PCR
- MeSH:
Carcinoma, Hepatocellular;
Delivery of Health Care;
Diagnosis*;
Enzyme-Linked Immunosorbent Assay*;
Follow-Up Studies;
Genotype;
Hepacivirus;
Hepatitis B, Chronic;
Hepatitis C;
Hepatitis C, Chronic;
Humans;
Immunoblotting;
Liver Diseases;
Liver Function Tests;
Polymerase Chain Reaction
- From:The Korean Journal of Laboratory Medicine
2006;26(6):418-423
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND: The diagnosis of hepatitis C virus (HCV) infection is screened by anti-HCV enzymelinked immunosorbant assay (ELISA) and confirmed by recombinant immunoblotting assay (RIBA) or HCV RT-PCR. We attempted to evaluate the results between anti-HCV ELISA and a qualitative HCV RT-PCR. METHODS: Four hundred and twenty patients who were tested with anti-HCV ELISA and HCV RTPCR, simultaneously, from January 2002 to June 2005 were enrolled in this study. Anti-HCV ELISA was performed by AxSYM HCV version 3.0 (Abbott Laboratories, USA). HCV RT-PCR was performed using in-house RT-nested PCR methods from January 2002 to October 2004 and HCV Genotype Amplification Kit (LiPA) (Bayer Healthcare, USA) from November 2004 to June 2005. RESULTS: Of the 420 patients tested, 321 were positive for anti-HCV ELISA, and 204 were positive for RT-PCR. The positive predictability of anti-HCV ELISA was 63.6%. Among anti-HCV positive patients, RT-PCR was positive in 7.3% of the patients with sample/cut-off (S/CO)<6, compared with 82.8% of the patients with S/CO> or =6. Among the 117 patients with positive anti-HCV, but with negative HCV RT-PCR, 64 had liver diseases such as chronic hepatitis C, chronic hepatitis B, or hepatocellular carcinoma. Twelve patients showed positive HCV RT-PCR, but negative anti-HCV results; of these 9 had hepatic dysfunction. CONCLUSIONS: In the patients who were positive for anti-HCV ELISA with a low S/CO, HCV RT-PCR positivity was shown in a low proportion. Therefore, in such cases, the results should be confirmed by RIBA or HCV RT-PCR. The liver function test showed increased levels of hepatic enzymes in patients with positive HCV RT-PCR, but negative anti-HCV. Such findings correlate to an early phase of chronic hepatitis C, suggesting the necessity of continuous follow up.
