Usefulness of Anti-HCV ELISA Test and HCV Reverse Transcriptase-PCR for the Diagnosis of Hepatits C Viral Infection

Myeong Hee Kim; Hee Joo Lee; Su Yon Park; Youn Sik Lee; Jin Tae Suh

doi:10.3343/kjlm.2006.26.6.418

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Kim, Lee, Park, Lee, and Suh: Usefulness of Anti-HCV ELISA Test and HCV Reverse Transcriptase-PCR for the Diagnosis of Hepatits C Viral Infection

Original Article

Korean J Leg Med 2006;26(6):418-423.

Published online: 10 February 2006

DOI: https://doi.org/10.3343/kjlm.2006.26.6.418

Usefulness of Anti-HCV ELISA Test and HCV Reverse Transcriptase-PCR for the Diagnosis of Hepatits C Viral Infection

Myeong Hee Kim, M.D., Hee Joo Lee, M.D., Su Yon Park, M.D., Youn Sik Lee, M.D., Jin Tae Suh, M.D.

Department of Laboratory Medicine, College of Medicine, Kyunghee University, Seoul, Korea

Received 16 February 2006 Revised 23 October 2006 Accepted 31 October 2006

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

The diagnosis of hepatitis C virus (HCV) infection is screened by anti-HCV enzyme-linked 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 RT-PCR, 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.

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.

Keywords: Hepatitis C, Anti-HCV ELISA, HCV RT-PCR

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Table 1.

Comparison of serum anti-HCV and HCV RT-PCR results according to primers

Anti-HCV	S/CO	HCV RT-PCR						Total (%)
		No. (%) positive			No. (%) negative
		In-house PCR	LiPA kit	Total	In-house PCR	LiPA kit	Total
Positive	1–6	3	3	6 (7.3)	64	12	76 (92.7)	82 (100)
	>6	154	44	198 (82.8)	30	11	41 (17.2)	239 (100)
Negative	<1	10	2	12 (12.1)	75	12	87 (87.9)	99 (100)
	Total	167	49	216	169	35	204	420

Abbreviation: S/CO, sample/cut off ratio.

Table 2.

Characteristics of patients with Anti-HCV positive, but HCV RT-PCR negative

Characteristics		No. cases (%)
Sex	Male	78 (66.7)
	Female	39 (33.3)
ALT	<40 U/L	92 (78.6)
	40–80 U/L	13 (11.1)
	>80 U/L	12 (10.3)
AST	<40 U/L	92 (78.6)
	40–80 U/L	12 (10.3)
	>80 U/L	13 (11.1)
GGT	<50 U/L	116 (99.1)
	≥50 U/L	1 (0.9)
S/CO rate of Anti-HCV	<6	77 (65.8)
	≥6	40 (34.2)
Diagnosis	Chronic hepatitis C	17 (14.5)
	Hepatitis B	20 (17.1)
	Hepatic cell carcinoma	2 (1.7)
	Chronic hepatitis	11 (9.4)
	Fatty liver	11 (9.4)
	Alcoholic liver cirrhosis	2 (1.7)
	Autoimmune hepatitis	1 (0.9)
	Others	53 (45.3)
Total		117 (100)

Abbreviations: S/CO ratio, sample/cut off ratio; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, γ-glutamyl transpeptidase.

Table 3.

Distribution of S/CO ratio according to diagnosis in patients with HCV ELISA positive but HCV RT-PCR negative

Diagnosis	S/CO ratio	No. (%)
Chrinic hepatitis C	<6	5 (4.3)
	≥6	12 (10.3)
Hepatitis B	<6	12 (10.3)
	≥6	8 (6.8)
Hepatocellular carcinoma	<6	2 (1.7)
	≥6	0 (0.0)
Chronic hepatitis	<6	0 (0.0)
	≥6	11 (9.4)
Fatty liver	<6	7 (5.9)
	≥6	4 (3.4)
Alcoholic liver cirrhosis	<6	0 (0.0)
	≥6	2 (1.7)
Autoimmune hepatitis	<6	1 (0.9)
	≥6	0 (0.0)
Other	<6	45 (38.5)
	≥6	8 (6.8)
Total		117 (100)

Abbreviation: S/CO ratio, sample/cut off ratio.

Table 4.

Characteristics of patients with Anti-HCV negative, but HCV RT-PCR positive

Characteristics		No. cases (%)
Sex	Male	7 (58.3)
	Female	5 (41.7)
ALT	<40 U/L	3 (25.0)
	40–80 U/L	3 (25.0)
	>80 U/L	6 (50.0)
AST	<40 U/L	4 (33.3)
	40–80 U/L	2 (16.7)
	>80 U/L	6 (50.0)
γGT	< 50 U/L	10 (83.3)
	≥50 U/L	2 (16.7)
Diagnosis	Chronic hepatitis C	4 (33.3)
	Other liver disease	5 (41.7)
	Others	3 (25.0)
Total		12 (100)

Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; γ GT, γ-glutamyl transpeptidase.

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