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J. Clin. Microbiol. doi:10.1128/JCM.02430-07
Copyright (c) 2008, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

How accurate is measurement of anti-HBs in serum samples? Comparison of nine commercially available anti-HBs assays

Department of Virology, University Medical Center Freiburg, Freiburg, Germany, Institute of Medical Microbiology and Hygiene, University Hospital Regensburg, Regensburg, Germany

^* To whom correspondence should be addressed. Email: daniela.huzly{at}uniklinik-freiburg.de.

	Abstract

Quantitative measurement of Anti-HBs is used to evaluate the response to Hepatitis B vaccination in health care workers and to optimize post exposure management. The different guidelines for Hepatitis B vaccination and booster policy imply, that measuring anti-HBs by different assays is accurate and consistent yielding comparable quantitative results. We measured 200 sera from patients and health care professionals in 9 different anti-HBs assays and compared the quantitative results and the performance characteristics of the different test systems. The assay specificity ranged between 96.8 and 100% defining sera from individuals without vaccination history and with negative anti-HBc status as true negatives. The sensitivity ranged between 83.9 and 100%. A high number of sera showed discrepancies between the values measured by the different systems. The mean coefficient of variation between the different measurements was 47.1% (range 15.0-201.0%), the factors of multiplication ranging between 2.8 and 105. Haemolysis or lipaemia did not seem to have an influence on the measurement, and there was no difference between anti-HBc-positive and –negative individuals. The classical EIAs tend to measure lower values than the automated systems, with higher values by the Abbott AXSYM. The serial dilution of the international standard preparation was measured accurately by most of the assays. In conclusion, the quantitative measurement of anti-HBs is not reliable, although an international standard is used for the calibration of the systems. Some systems showed specific problems that should be addressed by the manufacturer.