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Aytu BioScience Announces Positive Results from an Independently Conducted Clinical Study of the Company's Licensed COVID-19 IgG/IgM Point-of-Care Rapid Test
Independent clinical study demonstrates test accuracy of 98.0% and 94.1% for IgG and IgM, respectively, when using PCR-positive cases as true
About this update from Aytu Biopharma, Inc.
[{"type":"text","content":"Independent clinical study demonstrates test accuracy of 98.0% and 94.1% for IgG and IgM, respectively, when using PCR-positive cases as true positivesENGLEWOOD, CO / ACCESSWIRE / April 16, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), (the \"Company\"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that results from an independent clinical study using the Company's licensed Coronavirus Disease 2019 (\"COVID-19\") IgG/IgM Rapid Test were published in the journal Infection Ecology & Epidemiology, further validating the accuracy, specificity and performance of the antibody rapid test.In this recently published clinical study which included 29 COVID-19 positive cases confirmed by PCR and 124 healthy donors, the rapid test showed an overall specificity of 100% and 99.2% for IgM and IgG, respectively. The authors note, \"The high negative predictive value indicates that the rapid test will be useful for detecting past infections and possible immunity, which may be crucial for restoring social functions after lockdown.\"Capillary blood samples or serum from PCR-confirmed COVID-19 patients were analyzed with results from the COVID-19 IgG/IgM Rapid Test. Sixty-nine percent of samples from PCR-confirmed COVID-19 patients tested IgM positive, and 93.1% tested IgG positive. These results are well in line with the previously reported specificity of 91.9% for IgG and IgM. The authors note that variability in samples obtained during COVID-19 disease or convalescence period means that in the PCR-confirmed cases, antibodies may not yet have had time to develop. If this were the case, sensitivities of the test could actually be higher.Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented \"This independently conducted study, which was peer-reviewed and published earlier this week, demonstrates the clinical performance of this COVID-19 IgG/IgM rapid test and establishes the test's utility in understanding a patient's past exposure to COVID-19 and its potential to assess patient immunity as we move past this pandemic and get our society back to work. We are happy to see a leading clinical institution further establish the clinical utility of this important serological test.\"The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay ...