As per an announcement made by a global healthcare company on 26, Aug, 2020, its’ COVID-19 Ag Card antigen test for the detection of COVID-19 disease infection has been granted an Emergency Use Authorization (EUA) by the FDA. It is inexpensive (test cost $5) and provides rapid results in just 15 minutes.

This test is used for the qualitative finding of nucleocapsid protein antigen from severe coronavirus infection in the nasal cavity. It has been approved for use in patients suspected of COVID-19 in 7 days of beginning of the symptom and can be used by a healthcare provider.

The sample from the patient’s nose via a swab along with a testing reagent is revolved to reveal the results. The results (1 line for negative result and 2 lines for positive result) can be read directly from the testing card within 15 minutes.

Amongst 102 nasal swabs collected from symptomatic patients, alleged of COVID-19 for the clinical study, the COVID-19 Ag Card recognized 34 out of 35 positive samples (97.1% positive agreement) and 66 out of 67 negative samples (98.5% negative agreement).

As expected, this company is likely to make available almost 50 million tests in a month by October, 2020. A corresponding mobile app for iPhone and Android gadgets is also underway to enable patients with a negative test result to have a temporary digital health pass with the day of the test result.

Prior to making the treatment decisions, the negative results may need to be checked with a molecular test. The clinical remarks, history of the patient and epidemiological information needs to be taken into account when assessing the negative result, FDA mentioned in the FDA news release.