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CMAAO Coronavirus Facts and Myth Buster: 15 minutes rapid antigen test

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Dr KK Aggarwal    30 August 2020

With input from Dr Monica Vasudev

1071:  Abbotts 15-minute, point of care COVID-19 nasal swab antigen test gets FDA emergency use authorization

Mobile App Displays Test Results

Abbott announced US FDA Emergency Use Authorization (EUA) for its COVID-19 Ag Card rapid test for detection of COVID-19 infection.

The company is set to sell this test for $5. It is about the size of a credit card, affordable and yields results in 15 minutes.

The test uses the company’s lateral flow technology, which makes it a reliable and familiar format for frequent mass testing. There is no equipment required. This small device can serve as a key tool to manage risk by prompt identification of infectious people so that they dont spread the infection.

Abbott is set to launch a complementary first-of-its-kind mobile app for iPhone and Android devices. This app will be available at no charge and will enable people testing negative to display a temporary digital health pass which will be renewed every time a person is tested through their healthcare provider along with the date of the test result. Organizations can view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, increased cleaning and mask-wearing.

This COVID-19 Ag Card has shown a sensitivity of 97.1% and specificity of 98.5% in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

It can be used as a first line of defence to identify people who are currently infected and must isolate themselves in order to prevent the spread of the disease.

It is designed for qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from people suspected of COVID-19. Patient samples must be tested immediately and should not be diluted in viral transport media.

This COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having active infection. No equipment is required to process the samples and minimal chemical reagents are required, thus reducing exposure to biohazardous materials and improving the safety for those administering the test.

[Source: https://www.prnewswire.com/news-releases/abbotts-fast-5-15-minute-easy-to-use-covid-19-antigen-test-receives-fda-emergency-use-authorization-mobile-app-displays-test-results-to-help-our-return-to-daily-life-ramping-production-to-50-million-tests-a-month-301119289.html]

 

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA

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