The fill patient identifier is (b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access sars-cov-2 igg reagent was not returned for evaluation.No error messages or issues with other assays were reported.Sars-cov-2 is an enveloped non-segmented positive-sense rna virus.It has several structural proteins including spike (s), envelope (e), membrane (m) and nucleocapsid (n).The spike protein (s) contains a receptor binding domain (rbd) which is responsible for recognizing the cell surface receptor, angiotensin converting enzyme-2 (ace2).It is found that the rbd of the sars-cov-2 s protein strongly interacts with the human ace2 receptor leading to endocytosis into the host cells and viral replication.The access assay detect antibodies directed against the spike protein, which are more likely to neutralize the virus.No manufacturer guarantees both a specificity and sensitivity of 100%.The concentration of sars-cov-2 igg in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, diversity of antibodies and reagent specificity.Differences in each individual assay are expected.The access assays is not labelled for vaccine response detection.The performance of our serology assays has not been established in individuals that have received a covid-19 vaccine.Depending upon the vaccine administered, the antibodies generated may be different and therefore the test result may differ depending upon the specific antibody being detected by the assay in use in the laboratory.Different vaccines do not elicit the same immune response and each patient response is different therefore differences in patient responses are expected after vaccination.Per fda safety communication on 19may2021 ¿results from currently authorized sars-cov-2 antibody tests should not be used to evaluate a person¿s level of immunity or protection from covid-19 at any time, and especially after the person received a covid-19 vaccination.While a positive antibody test result can be used to help identify people who may have had a prior sars-cov-2 infection, more research is needed in people who have received a covid-19 vaccination.¿ in conclusion, the cause of this event cannot be determined with the available information.Values obtained with different assay methods should not be used interchangeably and differences between methods are expected.The access assay is not labelled for vaccine response detection.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.
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