ADVIA CENTAUR HCV - registry 10345160632 - Affected lots: 79643226, 79713226, 84770229. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Investigations did not demonstrate statistical difference in agreement between the specificity of listed lots and recent batches of HCV kit. However, differences between the increased rate of observed reactive outcomes vary between laboratories and can be attributed to demographic differences in patient populations. The internal test showed that the estimated specificity agreement for finished batches at 226, 227, 228 and 229 was 99.76% with 95% confidence interval (CI) of 99.43-99.92%. As indicated in the Instructions for Use (UI), the specificity assigned to the ADVIA Centaur HCV assay is 99.90% with 95% confidence interval (CI) of 99.78-99.97%. People whose HCV positive results require more specific additional tests to confirm the presence of virus, viral load and genotype in order to facilitate appropriate therapy. Therapy is not indicated based solely on the immunoreactivity of IgG antibodies to HCV. Therefore, the health risk is absent. As indicated in the Instructions for Use, for samples considered to be reactive to HCV IgG antibodies, it is recommended that the sample be duplicated in duplicate; and if 2 of 3 results are greater than or equal to the Reference Value, the sample is considered reactive and supplemental testing is recommended. There are no health risks, according to the Good Laboratory Practices, positive results should be sent to confirmation before being released to patients, whose tests must be repeated in reference methodology. People whose results were positive for HCV require more specific additional tests to confirm the presence of virus, viral load and genotype in order to facilitate appropriate therapy. Therefore, the therapy is not indicated based solely on the immunoreactivity of IgG antibodies to HCV. Anvisa follows this action.