Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test
1
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Background: A reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA). Methods: Clinical sensitivity and specificity were evaluated with oral fluids and sera from 137 patients diagnosed with hepatitis C and 300 healthy blood donors in a multi-center collaborative study. The stored sera of 200 proven HCV-infected patients and 200 healthy subjects were also evaluated. Analytical sensitivity was estimated with 4 commercial seroconversion panels and 7 Korean reference panels. The performance of 4 laboratory-based tests (3 chemiluminescence assays and 1 enzyme immunoassay) and 4 rapid test kits was compared. We also assessed the interference due to bilirubin, hemoglobin, lipid,rheumatoid factor, multipara, and several viral infections. Results: The clinical sensitivity and specificity of the OraQuick HCV test using oral fluid were 97.8% (95% confidence interval [CI], 93.2-99.4%) and 100% (95% CI, 98.4-100%),respectively. The clinical sensitivity using serum samples was 100%. Using the 4 seroconversion panels, the OraQuick HCV test showed results comparable to those of the laboratory-based assays; its analytical sensitivity was higher than that of the other rapid test kits. There was no cross-reactivity with common interfering factors. Conclusions: The clinical performance of the OraQuick HCV Test is comparable to that of laboratory-based tests with both serum and oral fluid. This supports the supplementary use of rapid HCV testing using oral fluid in various medical and non-medical settings.
Abstract
Background: A reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA). Methods: Clinical sensitivity and specificity were evaluated with oral fluids and sera from 137 patients diagnosed with hepatitis C and 300 healthy blood donors in a multi-center collaborative study. The stored sera of 200 proven HCV-infected patients and 200 healthy subjects were also evaluated. Analytical sensitivity was estimated with 4 commercial seroconversion panels and 7 Korean reference panels. The performance of 4 laboratory-based tests (3 chemiluminescence assays and 1 enzyme immunoassay) and 4 rapid test kits was compared. We also assessed the interference due to bilirubin, hemoglobin, lipid,rheumatoid factor, multipara, and several viral infections. Results: The clinical sensitivity and specificity of the OraQuick HCV test using oral fluid were 97.8% (95% confidence interval [CI], 93.2-99.4%) and 100% (95% CI, 98.4-100%),respectively. The clinical sensitivity using serum samples was 100%. Using the 4 seroconversion panels, the OraQuick HCV test showed results comparable to those of the laboratory-based assays; its analytical sensitivity was higher than that of the other rapid test kits. There was no cross-reactivity with common interfering factors. Conclusions: The clinical performance of the OraQuick HCV Test is comparable to that of laboratory-based tests with both serum and oral fluid. This supports the supplementary use of rapid HCV testing using oral fluid in various medical and non-medical settings.
참고문헌 (15)
- "Fact sheet No. 164"[URL]
- Shin HR, "Epidemiology of hepatitis C virus in Korea", Intervirology, 49, pp.18~22 (2006)
- Kim SJ, "Viral hepatitis surveillance system and statue of C hepatitis sentinel surveillance in Korea", Public Health Weekly Report, 5, pp.214~219 (2012), KCDC
- Scheiblauer H, "Evaluation of the performance of 44 assays used in countries with limited resources for the detection of antibodies to hepatitis C virus", Transfusion, 46, pp.708~718 (2006)
- Smith BD, "Evaluation of three rapid screening assays for detection of antibodies to hepatitis C virus", J Infect Dis, 204, pp.825~831 (2011)
- Lee SR, "Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid", J Virol Methods, 172, pp.27~31 (2011)
- Smith BD, "Performance of premarket rapid hepatitis C virus antibody assays in 4 national human immunodeficiency virus behavioral surveillance system sites", Clin Infect Dis, 53, pp.780~786 (2011)
- Jewett A, "Field-based performance of three pre-market rapid hepatitis C virus antibody assays in STAHR (Study to Assess Hepatitis C Risk) among young adults who inject drugs in San Diego, CA", J Clin Virol, 54, pp.213~217 (2012)
- O’Connell RJ, "Performance of the OraQuick rapid antibody test for diagnosis of human immunodeficiency virus type 1 infection in patients with various levels of exposure to highly active antiretroviral therapy", J Clin Microbiol, 41, pp.2153~2155 (2003)
- Kee KM, "Decreased anti-hepatitis C virus titer and associated factors in chronic hepatitis C patients after sustained virological response: a prospective study", J Gastroenterol Hepatol, 27, pp.1106~1111 (2012)
- Thompson ND, "Nonhospital health care-associated hepatitis B and C virus transmission: United States, 1998-2008", Ann Intern Med, 150, pp.33~39 (2009)
- Kim JY, "Acute Hepatitis C in Korea: Different Modes of Infection, High Rate of Spontaneous Recovery, and Low Rate of Seroconversion", JOURNAL OF MEDICAL VIROLOGY, 83(7), pp.1195~1202 (2011), WILEY-BLACKWELL
- Smith BD, "Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965", MMWR Recomm Rep, 61, pp.1~32 (2012)
- "Hepatitis C virus transmission at an outpatient hemodialysis unit--New York, 2001-2008", MMWR Morb Mortal Wkly Rep, 58, pp.189~194 (2009)
- Lee SR, "Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection", J Clin Virol, 48, pp.15~17 (2010)