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Aim: HCV Ag test as a diagnostic marker and part of the algorithm for the confirmation of anti-HCV reactivity is introduced for patients at risk, haemodialysis patients, organ donors, occupational exposures to blood and body fluids, on request and for anti-HCV reactive samples. The purpose of the study is to evaluate up-to-date patient testing for HCV Ag and its benefit. Materials and Methods: From 2009 to 2017 overall 60.953 patient samples, including first time tested and follow-up patients, were tested for the Abbott Architect HCV Ag test and Architect Anti-HCV. Samples with HCV Ag concentration values ≥ 0.06 to 0.2 pg/mL were retested in duplicate. Follow-up testing included serology and/or HCV RNA by COBAS AmpliPrep/TaqMan HCV quantitative test, v. 2.0. Results: Out of 60.953 samples tested for HCV Ag 59.889 (98.3%) were negative and 1.064/60.953 (1.7%) positive. 1.005/1.064 (94.5%) were anti-HCV reactive and 59/1.064 (5.5%) negative, respectively. 35/59 (59.3%) are considered as false positive due to the following negative HCV testing, and/or HCV RNA. HCV Ag concentration values in those 35 patients were from 0.06 to 4 pg/mL. 4/59 were window-period infections (seroconversions): in 2 haemodialysis patients, 1 bone marrow transplant and 1 unknown. For 20/59 patients are no data. Conclusion: The results of this study indicate that there is benefit of HCV Ag testing especially for rapid confirmation of an active hepatitis C infection (anti-HCV and Ag reactive, with no need for anti-HCV immunoblot confirmation) or for the detection of an early hepatitis C, where anti-HCV is still negative. |
