Azure Technology has obtained FDA emergency-use approval for a lateral-flow immunoassay test that can detect IgM and IgG antibody against COVID-19.  The test kit is manufactured by Azure Technology Hangzhou Company of Zhejiang, China. 

The test sample of blood is obtained from a simple finger prick and the result can be read within 15 minutes.  Tests will be administered in Kroger pharmacies by licensed pharmacists and pharmacy assistants.  In addition tests will be administered in Little Clinic locations in 35 states before the end of the year. 

The Azure Tech test is qualitative and has relatively high sensitivity.  The test will detect the presence of IgM and IgG if present.  False positives will occur as a result of reaction with antibodies to other diseases to which the patient was previously exposed or from the presence of drugs that may interfere with the reaction.

Interpretation is the critical feature with all rapid tests that are subject to false positives and negatives.  It is also considered necessary for facilities administering tests to report results to a regulatory authority so that epidemiologic data can be assembled in a database to understand the epidemiology of diseases transmitted within communities. All laboratories administering the Covid antibody tests will conform to the FDA Clinical Laboratory Improvements Amendments of 1988.