Abbott's $5 Rapid COVID-19 Antigen Test Receives FDA Emergency Use Authorization

Leiphone.com(WeChat Official Account: Leiphone)News: On August 26 local time, according to Cailianshe, Abbott Laboratories announced that its portable reagent for SARS-CoV-2 antigen testing has received Emergency Use Authorization from the U.S. FDA. The SARS-CoV-2 test card is only the size of a credit card, with results readable directly from the card, similar to home pregnancy tests.

Abbott stated that its COVID-19 test card, leveraging established lateral flow technology, delivers results in just 15 minutes without the need for instrumentation, at a price of only $5. Clinical studies have demonstrated a sensitivity of 97.1% and a specificity of 98.5%, making it a portable and cost-effective tool for large-scale COVID-19 testing.

Leifeng.com learned that the key to Abbott’s receipt of Emergency Use Authorization this time lies in “lateral flow technology.”

In the past, nucleic acid testing for the novel coronavirus primarily employed the polymerase chain reaction (PCR) method.This method requires first collecting a pharyngeal swab sample and then sending it to the Laboratory Medicine Center.

Subsequently, medical staff at the Laboratory Medicine Center sequentially accepted patient samples in the reagent preparation area; extracted nucleic acids from the samples in the sample preparation area; amplified and replicated the nucleic acid samples in the amplification area; and finally, analyzed whether the nucleic acids in the samples could pair with standard samples in the amplification product analysis area, determining via instrument detection whether the results were positive.

The entire process takes more than 24 hours, which means that patients face a higher risk of infection or being infected while waiting for the results.

A survey by global data and insights company Dynata found that nearly 40% of Americans had to wait more than three days to receive their COVID-19 test results.

Dr. Ashish Jha, a professor of health policy at Harvard University, stated that if test results take more than 48 hours, contact tracing for close contacts of the tested individual becomes ineffective; if the turnaround time exceeds 72 hours, testing is virtually useless.

Lateral flow technology can be used to detect COVID-19.ToxinTestingtime reduced to 15 minutes.

Lateral flow technology uses microporous filter membranes as a carrier, immobilizing specific antigens or antibodies on the membrane. The test sample undergoes colorimetric reactions during lateral movement and filtration, achieving automatic separation and identification, thereby presenting results on-site. Most pregnancy tests utilize this technology, offering advantages of speed, cost-effectiveness, and efficiency.

Abbott also announced on the same day that it would simultaneously launch a mobile application to address the issue of unquantifiable results from visual observation of colorimetric reactions in lateral flow assays. The app can issue a “Digital Health Pass” to healthy individuals who test negative for the virus, displaying it directly on their mobile devices.

Following this approval, Abbott will deliver tens of millions of test cards in September and plans to increase production capacity to 50 million units per month starting in October.

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