An automated hepatitis C virus (HCV) antigen (Ag) assay was evaluated with clinical samples. Determination of HCV Ag and RNA levels in 282 subjects using Abbott HCV Ag and Roche Cobas TaqMan assays revealed that these two tests were highly correlated (r ‫؍‬ 0.9464). Thus, the HCV Ag assay could be an alternative test to quantitative reverse transcription-PCR.Hepatitis C virus (HCV) infection usually causes a progressive disease that can result in chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma (12). Diagnosis and monitoring of HCV infection are commonly based on anti-HCV assays, recombinant immunoblotting, and HCV RNA viral load in current clinical practices (13). However, anti-HCV assays have limitations, including a lack of detection sensitivity in the early window periods of 45 to 68 days after infection (5), although second-and third-generation anti-HCV assays have improved. Real-time quantitative reverse transcription-PCR (qRT-PCR) analyses for measuring viral loads also have some drawbacks. These techniques are not completely free from contamination and false-positive results. Furthermore, some PCR assays require technical skills and may also be labor intensive and expensive.HCV core antigen (Ag) tests have been introduced to supplement anti-HCV tests or HCV qRT-PCR analyses over the last decade (1, 16), and these quantitative HCV Ag assays could be used for the monitoring of antiviral therapy as well as for diagnosis of HCV infection (3, 6). Furthermore, the HCV Ag assay could also be useful in monitoring immunocompromised patients and those undergoing hemodialysis (10). However, most of the past studies detecting HCV Ag utilized enzyme-linked immunosorbent assays (ELISAs) or enzyme immunoassays (EIAs) (4,7,14,18), which may need considerable time and skills. Recently, a fully automated chemiluminescent immunoassay (CLIA) with higher sensitivity and throughput was developed to overcome shortcomings of the conventional core Ag assays (11). Thus, we evaluated the newly introduced HCV Ag assay and compared it with a quantitative RNA assay to verify the utility of this automated Ag assay as an alternative to HCV RNA qRT-PCR.A total of 282 serum samples from the 268 patients who visited a university hospital in Korea with suspected HCV infection were collected from January to April 2009. HCV Ag and qRT-PCR assays were performed for all 282 samples, while anti-HCV antibodies and liver enzymes were measured in 279 and 250 subjects, respectively. HCV genotyping was also performed in 127 specimens. Serum HCV Ag was determined by an Abbott Architect i2000SR analyzer (Abbott Laboratories, Abbott Park, IL) with an HCV Ag assay kit (Abbott Japan Co., Ltd., Tokyo, Japan). The Architect HCV Ag assay is a two-step chemiluminescent microparticle immunoassay for the quantitation of HCV core Ag. The sample volume required is about 110 l, and the total assay time is 36 min. The cutoff value is 3.0 fmol/liter; thus, HCV Ag levels below 3.0 fmol/liter were considered nonreactive. HCV RNA viral load was determi...

Background. Microarrays enable high-throughput screening (HTS) of disease-related molecules, including important signaling proteins/peptides and small molecules that are in low abundance. In this study, we developed a multiplex blood bank screening platform, referred to as the Hi3-1 assay, for simultaneous detection of human immunodeficiency virus 1/2 (HIV 1/2) and hepatitis C virus (HCV). Methods. The Hi3-1 assay was tested using four panels (Panel 1, n = 4,581 patient samples; Panel 2, n = 15 seroconversion samples; Panel 3, n = 4 performance samples; and Panel 4, n = 251 purchased positive control samples), and the results were collected by the Department of Laboratory Medicine, Korea University Medical College, Republic of Korea. The present study compares the sensitivity of the multiplex detection platform for both HIV and HCV using a sol-gel based microarray, which was based on a reference test (Architect HIV Ag/Ab Combo and Architect anti-HCV assays), in Korean patients. Results. The sensitivity of the multiplex detection platform for both HIV and HCV was 100%, and the specificity was 99.96% for HIV and 99.76% for HCV, which is equivalent to that of the reference test. Conclusion. We have successfully applied a novel screening technology to multiplex HIV and HCV diagnoses in a blood bank screening test.