Simple fluorescent enzyme immunoassay for detection and quantification of hepatitis C viremia.
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. 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. 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-alpha showed parallel changes between HCV-RNA and core protein levels. 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.
Tanaka
T
T
Liver Unit, The Tokyo Metropolitan Komagome Hospital, Japan.
Lau
J Y
JY
Mizokami
M
M
Orito
E
E
Tanaka
E
E
Kiyosawa
K
K
Yasui
K
K
Ohta
Y
Y
Hasegawa
A
A
Tanaka
S
S
D004279:DNA, Viral / Q000235:genetics; D005260:Female; D005453:Fluorescence; D006526:Hepatitis C / Q000175:diagnosis*; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000097:blood*; D014758:Viral Core Proteins / Q000097:blood*; D014766:Viremia / Q000175:diagnosis*
D004279:DNA, Viral; D012367:RNA, Viral; D014758:Viral Core Proteins