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J. Clin. Microbiol. doi:10.1128/JCM.00498-08
Copyright (c) 2008, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Evaluation of a new HBsAg rapid test with improved sensitivity

Diagnostics for the Real World (Europe) Ltd., Cambridge Science Park, UK; Beijing Red Cross Blood Center, Beijing 100088, China; National Blood Transfusion Center, Conakry, Guinea; Division of Transfusion Medicine, Department of Haematology, University of Cambridge, Cambridge CB2 2PT, UK; Diagnostics Development Unit, Department of Haematology, University of Cambridge, Cambridge CB2 2PT, UK

^* To whom correspondence should be addressed. Email: hl207{at}cam.ac.uk.

	Abstract

A new rapid immunochromatographic assay based on the Signal Amplification System (SAS) has been developed by Diagnostics for the Real World Ltd (DRW) for detection of hepatitis B surface antigen (HBsAg) in plasma or serum specimens. The SAS format features enhanced sensitivity as a result of an increased binding valence of the detector molecules. We have now evaluated the performance of the new HBsAg rapid test (DRW-HBsAg) in comparison with a well-established commercial rapid test (Determine HBsAg, previously Abbott Laboratories now Inverness Medical Innovations) and with a CE-marked enzyme immunoassay (EIA) (Hepanostika HBsAg Ultra, BioMérieux) as the gold standard. Testing of serially diluted HBsAg-positive samples, the World Health Organization standard, as well as sensitivity and reference panels yielded an analytical sensitivity for the DRW test of 0.2 to 0.8 IU/ml across HBsAg serotypes. Evaluation with eight commercially available seroconversion panels showed that DRW-HBsAg detected HBsAg an average of 6.1 days (range, 3 to 8) earlier than did the Determine assay (P = 0.0078). Test sensitivity was also examined with two low-titer HBsAg EIA–positive panels in Beijing, China. Whereas 100% of these samples were detected by DRW-HBsAg, only 15.0 and 87.3% were detected with Determine HBsAg (P < OR 0.0001). Test performance of DRW-HBsAg was further evaluated with HBsAg-positive and negative samples determined by EIA in Conakry, Guinea and Beijing, China. No significant difference in sensitivity between the DRW and Determine tests was apparent with the HBsAg EIA–reactive samples from Guinea (96.7% versus 94.4%, respectively) and China (99.46 versus 98.92, respectively). The specificity of Determine HBsAg was slightly higher than that of DRW-HBsAg (100 versus 99.2%, respectively) with samples from EIA-negative blood donors in China. In conclusion, the new DRW HBsAg rapid test is more sensitive than Determine HBsAg and is suitable for diagnostic and blood screening in resource-limited settings.