An interlaboratory quality control for the immunometric tests of HBsAg and anti-HBs has been initiated in Italy in 1985. Participants (153 laboratories at present) are periodically supplied with sets of unknown serA for each analyte. The assay results are returned as both positive/negative classification and digital response. Limitedly to a 40-laboratory group, from the latter data quantitative estimates are obtained through interpolation on a 'hidden' calibration curve included in the control sets. Periodical reports containing the results of statistical elaboration of data are distributed to participants (both total results and results subgrouped according to the commercial kits). The analysis of qualitative control data collected so far indicates that misclassifications are relatively frequent in the low-positive ranges, i.e. 18% for HBsAg tests (0.25-0.50 U PEI/ml) and 30% for anti-HBs tests (6.5 15 mU WHO/ml). A progressive decrease is observed in the higher-concentrations (0.2% for both HBsAg concentrations ≥ 2 U/ml and anti-HBs concentrations ≥ 60 mU/ml), while ca 2.5% false positives occur in both assays. Some differences emerge as for the classification ability of individual kits. The quantitative evaluation evidences in both cases a moderate variability (10-40% CV, depending on kind and concentration of analyte) and a good between-kit agreement of estimates.

Interlaboratory quality control of immunometric assays of HBsAg and anti-HBs in Italian laboratories: a two-year experience / R. Malvano, G. Pizzocolo, P. Ferroni, E. Tanzi, C. Signorini, A.R. Zanetti, A. Albertini. - In: ANNALI DELL'ISTITUTO SUPERIORE DI SANITÀ. - ISSN 0021-2571. - 24:2(1988), pp. 225-234.

Interlaboratory quality control of immunometric assays of HBsAg and anti-HBs in Italian laboratories: a two-year experience

E. Tanzi;A.R. Zanetti
Penultimo
;
1988

Abstract

An interlaboratory quality control for the immunometric tests of HBsAg and anti-HBs has been initiated in Italy in 1985. Participants (153 laboratories at present) are periodically supplied with sets of unknown serA for each analyte. The assay results are returned as both positive/negative classification and digital response. Limitedly to a 40-laboratory group, from the latter data quantitative estimates are obtained through interpolation on a 'hidden' calibration curve included in the control sets. Periodical reports containing the results of statistical elaboration of data are distributed to participants (both total results and results subgrouped according to the commercial kits). The analysis of qualitative control data collected so far indicates that misclassifications are relatively frequent in the low-positive ranges, i.e. 18% for HBsAg tests (0.25-0.50 U PEI/ml) and 30% for anti-HBs tests (6.5 15 mU WHO/ml). A progressive decrease is observed in the higher-concentrations (0.2% for both HBsAg concentrations ≥ 2 U/ml and anti-HBs concentrations ≥ 60 mU/ml), while ca 2.5% false positives occur in both assays. Some differences emerge as for the classification ability of individual kits. The quantitative evaluation evidences in both cases a moderate variability (10-40% CV, depending on kind and concentration of analyte) and a good between-kit agreement of estimates.
Settore MED/42 - Igiene Generale e Applicata
1988
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/201245
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