Performance evaluation of the re-standardized Abbott Architect anti-HBs assay
| Autor: | Ann H. Wong, Yolanda I.I. Ho, Raymond Lai |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Anti hbs medicine.medical_specialty Hepatitis B virus 030106 microbiology medicine.disease_cause World Health Organization World health 03 medical and health sciences 0302 clinical medicine Virology Internal medicine medicine Humans Serologic Tests 030212 general & internal medicine Upward shift Hepatitis B Antibodies Immune status Reference preparation business.industry Hepatitis B Reference Standards medicine.disease Infectious Diseases Positive bias Reagent Kits Diagnostic business |
| Zdroj: | Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology. 111 |
| ISSN: | 1873-5967 |
| Popis: | Background As defined by World Health Organization (WHO), an antibody level of ≥ 10mIU/mL to hepatitis B virus confers protection. With the launching of Abbott anti-HBs assay re-standardized to the 2nd WHO International Reference Preparation, a positive bias in antibody level would be anticipated. Manufacturer provides limited data for samples around the immune cut-off which has potential implication on vaccine guidance. Objectives To evaluate the performance of the re-standardized Abbott Architect anti-HBs assay and to determine the impact of the upward shift. Study design A total of 52 samples, including 12 external quality assurance programme samples and 40 clinical samples were tested with both the Abbott 1st WHO standardized and the 2nd WHO re-standardized assay and results compared. The 2nd WHO anti-HBs standard and Acometrix anti-HBs control were also included for comparison. Results Verification of the re-standardized assay with the 2nd WHO anti-HBs standard revealed positive bias with mean closer to target value. Overall, the positive bias introduced by the new assay will only affect interpretation of samples with anti-HBs levels > 5.00 to Conclusions Final interpretation of immune status to hepatitis B was not affected by the upward shift following introduction of the new Abbott anti-HBs assay except for previously negative samples with anti-HBs levels between >5.00 to |
| Databáze: | OpenAIRE |
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