Simple fluorescent enzyme immunoassay for detection and quantification of hepatitis C viremia

• Published in: Journal of hepatology Vol. 23; no. 6; pp. 742 - 745
• Main Authors: Tanaka, Takeshi, Lau, Johnson Y.N., Mizokami, Masashi, Orito, Etsuro, Tanaka, Eiji, Kiyosawa, Kendo, Yasui, Koichiro, Ohta, Yohsuke, Hasegawa, Akira, Tanaka, Satoshi, Kohara, Michinori
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier B.V 01.12.1995; Elsevier
• Subjects: Biological and medical sciences; Digestive system; DNA, Viral - genetics; Female; Fluorescence; HCV RNA; Hepatitis C - diagnosis; Hepatitis C virus core protein; Humans; Immunoenzyme Techniques; Investigative techniques, diagnostic techniques (general aspects); Male; Medical sciences; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; Polymerase Chain Reaction; Quantification; RNA, Viral - blood; Viral Core Proteins - blood; Viremia; Viremia - diagnosis; HCV RNA; Quantification; Hepatitis C virus core protein; Viremia; Human; Evaluation; Fluorescence; Quantization; Hepatic disease; Infection; Virus; Immunological investigation; Viral disease; Digestive diseases; Serum; Flaviviridae; Detection; Hepatitis C virus; Nuclear protein; Biomedical engineering; Viral hepatitis C
• ISSN: 0168-8278; 1600-0641
• DOI: 10.1016/0168-8278(95)80043-3

Background/Aims: The viral load of hepatitis C virus, as reflected by hepatitis C virus viremia, has been shown to have important clinical implications. In this study the hepatitis C virus core protein level in serum was evaluated for the detection and quantification of hepatitis C virus viremia. Methods: Hepatitis C virus core protein in serum was detected using a simple and sensitive fluorescent enzyme immunoassay. Hepatitis C virus core protein was quantitated in 100 healthy subjects, 258 patients with hepatitis C virus infection and 108 patients with non-hepatitis-C-virus-related chronic liver diseases. HCV-RNA was determined using the branched DNA (bDNA) assay and reverse-transcription polymerase chain reaction. Results: The detection limit of this fluorescent enzyme immunoassay was found between 10 4–10 5 copies/ml HCV-RNA equivalent. There was a good correlation between the core protein and bDNA assay results ( p<0.01). Hepatitis C virus core protein was detected in 81% of patients with hepatitis C virus infection (acute hepatitis 4 5 , chronic hepatitis 85 104 , cirrhosis 64 73 and hepatocellular carcinoma 56 76 ) but in none of the healthy subjects and patients with non-hepatitis C virus chronic liver diseases. The amount of hepatitis C virus core protein in patients with hepatitis-C-virus-related hepatocellular carcinoma was lower compared to chronic hepatitis and cirrhosis ( p<0.05). All 26 patients treated with interferon-α showed parallel changes between HCV-RNA and core protein levels. Conclusions: This fluorescent enzyme immunoassay is simple and quick (assay time<3 h) with sensitivity at least matching the bDNA assay. Similar levels of hepatitis C virus core protein were detected in patients with chronic hepatitis and cirrhosis, but patients with hepatocellular carcinoma tended to have a lower level of hepatitis C virus core protein.