Carmina Pallarés1, Ângela Carvalho-Gomes1, Vanessa Hontangas2, Isabel Conde3, Tomasso Di Maira2, Victoria Aguilera4, Salvador Benlloch4, Marina Berenguer5, F Xavier López-Labrador6. 1. Liver Transplantation and Hepatology Laboratory, Instituto Investigación Sanitaria La Fe, Valencia, Spain; CIBERehd, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain. 2. Liver Transplantation and Hepatology Laboratory, Instituto Investigación Sanitaria La Fe, Valencia, Spain. 3. Liver Transplantation and Hepatology Unit, Hospital Universitari i Politècnic La Fe, Valencia, Spain. 4. Liver Transplantation and Hepatology Laboratory, Instituto Investigación Sanitaria La Fe, Valencia, Spain; CIBERehd, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain; Liver Transplantation and Hepatology Unit, Hospital Universitari i Politècnic La Fe, Valencia, Spain. 5. Liver Transplantation and Hepatology Laboratory, Instituto Investigación Sanitaria La Fe, Valencia, Spain; CIBERehd, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain; Liver Transplantation and Hepatology Unit, Hospital Universitari i Politècnic La Fe, Valencia, Spain; Department of Medicine, Medical School, Universitat de València, Spain. 6. Virology Laboratory, Genomics and Health Area, Center for Public Health Research, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO-Public Health), Generalitat Valenciana, Valencia, Spain; CIBEResp, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública, Instituto de Salud Carlos III, Madrid, Spain. Electronic address: F.Xavier.Lopez@uv.es.
Abstract
BACKGROUND: A reliable population screening strategy for hepatitis C virus (HCV) infection may be based in easy-to-use point-of-care (POC) tests for HCV antibodies, but validation data is needed before their potential widespread use in primary care or outreach practice. Besides, the sensitivity of these POC tests in patients with spontaneous or treatment-induced viral clearance is unknown. OBJECTIVES: To test the performance of a non-invasive POC anti-HCV test (OraQuick HCV rapid test) in oral mucosal transudate (OMT) and fingerstick blood from patients with known anti-HCV serostatus and with or without active viremia (after treatment-induced clearance). STUDY DESIGN: A risk factor questionnaire was collected from 317 consecutive patients (anti-HCV positive/HCV-RNA positive n = 107; anti-HCV positive/HCV-RNA negative after antiviral treatment n = 107; anti-HCV negative with other liver diseases n = 109) before performing the OraQuick HCV rapid test in OMT (n = 317) and fingerstick blood (n = 251). We calculated the sensitivity and specificity of the test by using anti-HCV serostatus as the reference gold-standard. RESULTS: Among all anti-HCV seropositive patients, the clinical sensitivity and specificity of the OraQuick HCV rapid test in OMT was 89.9% and 100%, respectively. In fingerstick blood, the sensitivity improved to 98.8%. The sensitivity was higher in OMT (97.2%) in anti-HCV seropositive patients who were viremic as compared to that in non-viremic individuals (82.2%). In contrast, there were no significant differences in sensitivity between viremic and non-viremic individuals when testing fingerstick blood. Finally, extension of the read time to 40 min enhanced the sensitivity, especially in OMT (up to 94.7%) and in the subgroup of non-viremic, anti-HCV-positive patients (up to 90.1%). CONCLUSIONS: The OraQuick HCV rapid test in OMT has a high sensitivity and specificity for detecting active HCV infection that decreases substantially in anti-HCV positive/HCV-RNA negative patients with treatment-induced viral clearance. For these individuals, extension of read times and testing fingerstick blood showed improved sensitivity.
BACKGROUND: A reliable population screening strategy for hepatitis C virus (HCV) infection may be based in easy-to-use point-of-care (POC) tests for HCV antibodies, but validation data is needed before their potential widespread use in primary care or outreach practice. Besides, the sensitivity of these POC tests in patients with spontaneous or treatment-induced viral clearance is unknown. OBJECTIVES: To test the performance of a non-invasive POC anti-HCV test (OraQuick HCV rapid test) in oral mucosal transudate (OMT) and fingerstick blood from patients with known anti-HCV serostatus and with or without active viremia (after treatment-induced clearance). STUDY DESIGN: A risk factor questionnaire was collected from 317 consecutive patients (anti-HCV positive/HCV-RNA positive n = 107; anti-HCV positive/HCV-RNA negative after antiviral treatment n = 107; anti-HCV negative with other liver diseases n = 109) before performing the OraQuick HCV rapid test in OMT (n = 317) and fingerstick blood (n = 251). We calculated the sensitivity and specificity of the test by using anti-HCV serostatus as the reference gold-standard. RESULTS: Among all anti-HCV seropositive patients, the clinical sensitivity and specificity of the OraQuick HCV rapid test in OMT was 89.9% and 100%, respectively. In fingerstick blood, the sensitivity improved to 98.8%. The sensitivity was higher in OMT (97.2%) in anti-HCV seropositive patients who were viremic as compared to that in non-viremic individuals (82.2%). In contrast, there were no significant differences in sensitivity between viremic and non-viremic individuals when testing fingerstick blood. Finally, extension of the read time to 40 min enhanced the sensitivity, especially in OMT (up to 94.7%) and in the subgroup of non-viremic, anti-HCV-positive patients (up to 90.1%). CONCLUSIONS: The OraQuick HCV rapid test in OMT has a high sensitivity and specificity for detecting active HCV infection that decreases substantially in anti-HCV positive/HCV-RNA negative patients with treatment-induced viral clearance. For these individuals, extension of read times and testing fingerstick blood showed improved sensitivity.
Authors: John Chen Hsiang; Pream Sinnaswami; Mui Yok Lee; Meng Meng Zhang; Kwang Ee Quek; Keng Hwee Tan; Yew Meng Wong; Prem Harichander Thurairajah Journal: Singapore Med J Date: 2020-07-30 Impact factor: 3.331
Authors: Prithivi Chellamuthu; Aaron N Angel; Melanie A MacMullan; Nicholas Denny; Aubree Mades; Marilisa Santacruz; Ronell Lopez; Cedie Bagos; Joseph G Casian; Kylie Trettner; Lauren Lopez; Nina Nirema; Matthew Brobeck; Noah Kojima; Jeffrey D Klausner; Fred Turner; Vladimir Slepnev; Albina Ibrayeva Journal: Front Immunol Date: 2021-12-09 Impact factor: 7.561