Aytu Bio’s COVID-19 rapid test shows 100% sensitivity in study

Aytu BioScience (AYTU -1.6%) announces that results from an independent clinical study using its licensed 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.

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.”

Serum from PCR-confirmed COVID-19 patients were analyzed with results from the rapid test. Sixty-nine percent of samples 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 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.

This point-of-care test has now been validated in multiple independent trials and is CE Mark’d.

https://seekingalpha.com/news/3561305-aytu-bios-covidminus-19-rapid-test-shows-100-sensitivity-in-study