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Development and Technical and Clinical Validation of a Quantitative Enzyme-Linked Immunosorbent Assay for the Detection of Human Antibodies to Hepatitis B Surface Antigen in Recipients of Recombinant Hepatitis B Virus Vaccine
Clinical and Vaccine Immunology, 08/11/09
Cambron P et al. – The performance characteristics of the in–house assay are acceptable. There is no evidence that use of the new assay would lead to different clinical conclusions from the reference method.
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