Istituto di Fisiologia Clinica     
Vassalle C., Mercuri A., Masini S., Antongiovanni S., Pilo A., Cantini F., Zucchelli G. C. External quality assurance program in anti-HCV serological detection: an Italian experience. In: Immuno-analyse & Biologie spécialisée, vol. 19 pp. 235 - 238. Elsevier, 2004.
Here we reported the results collected in the 2002 cycle of the "Serocheck" External Quality Assessment (EQA) scheme for the detection of antibodies against the hepatitis C virus (anti-HCV). This programme, conducted by the Institute of Clinical Physiology, CNR, Pisa in co-operation with Polymed (Firenze, Italy), involved about 80 among microbiology, transfusional and general Italian laboratories. Methods: The reference panel sent to the laboratories consisted of 12 samples. Three series of samples, from a pool of donors, were negative for anti-HCV. The positive panel, obtained by different dilutions of positive pools with the negative one, was constituted by 2 samples with concentration higher than 10xcut-off (A), 2 samples between 4xcut-off and10xcut-off (B), 4 samples between 2xcut-off and 4xcut-off (C) and 1 sample borderline (1.22xcut-off) (D). Results: On the whole number of serum samples the percentage of correct results was 95% (1.2% doubtful and 3.8% incorrect). The positive samples were identified in the 93.3% (1.4% doubtful, 5.3% incorrect), while the negative ones in the 99.5% of the cases (0.5% incorrect). The A series of samples was detected in 97.5% (2.5% incorrect), the B series in 96% (4% incorrect) and the C series in 96.7% (3.3% incorrect) and the D series was detected in 64.5% (13.5% doubtful and 22% incorrect) of the cases. Conclusion: Results of the present study indicate that running quality control study are needed, that allow the comparison of results from different laboratories less difficult and a reliable evaluation of their performance. In addition, the % of incorrect result for D series is disquieting and makes crucial the importance of control quality schemes.
Subject External quality schemes
Hepatitis C

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