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KMID : 0981820060260060418
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Korean Journal of Laboratory Medicine
2006 Volume.26 No. 6 p.418 ~ p.423
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Usefulness of Anti-HCV ELISA Test and HCV Reverse Transcriptase-PCR for the Diagnosis of Hepatits C Viral Infection
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Kim Myeong-Hee
Lee Hee-Joo
Park Su-Yon
Lee Youn-Sik
Suh Jin-Tae
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Abstract
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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 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.
Conclusion: 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. (Korean J Lab Med 2006;26:418-23)
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KEYWORD
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Hepatitis C, Anti-HCV ELISA, HCV RT-PCR
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