Abbott receives emergency authorization for rapid COVID-19 antigen test for $ 5

• Abbott has received FDA emergency approval for the COVID-19 antigen for $ 5 that provides results in 15 minutes.

• Other companies, including BD and Quidel, are already selling antigen tests, but Abbott’s scale has led some analysts to identify market entry as a potential breakthrough. Abbott plans to release 50 million kits per month starting in October to make mass testing more practical.

• The EEA, which Abbott revealed Wednesday, covers an immunoassay that, like a pregnancy test, shows colored lines on the test paper to show whether a sample contains SARS-CoV-2.

Due to the relatively low cost of antigen testing and the ability to produce results in 15 minutes, the technology is best suited for recommended mass testing over multiple quarters to help reopen jobs, schools, and universities. Because of these characteristics, HHS worked with BD and Quidel to obtain tests for 14,000 nursing homes and convinced 10 states to order at least 5 million antigen tests from the same companies.

However, capacity, precision, and cost are potential barriers to the continued use of antigen testing. EEA Abbott can lower these barriers. BD plans to test 8 million tests per month in March. In theory, Quidel could produce 7 million texts a month. In contrast, Abbott plans to publish “billions” of articles on BinaxNOW COVID-19 testing over the next month and hit a current monthly rate of 50 million in October.

Abbott outperforms the price competition. HHS pays between $ 20 and $ 25 for instrumented antigen tests for BD and Quidel. That’s especially lower than the price of PCR testing, which HHS says costs $ 120 each for nursing homes, but repeatedly charges up to $ 5 from Abbott for its antigen kit. The Abbott test does not require a separate instrument to obtain a result.

Available data suggest that Abbott is also competitive in terms of precision. Abbott examined 102 nasal swab samples collected from a human within seven days of the onset of COVID-19 symptoms to compare the results of its antigen test and the results of the PCR method. The results were the same several times and gave an antigen test specificity of 98.5% and a sensitivity of 97.1%.

The Abbott results are similar to the results used by LumiraDx and Quidel to confirm the US antigen test BD failed to jump in terms of sensitivity, reaching 84%, but was better in terms of specificity.

The Abbott data comes from a study conducted at seven locations in the United States. Used by operators with no laboratory experience and no training in the use of the test. When using the test, drops of Extraction Reagent are added to a well before inserting and dipping a swab. The test card is then closed and sealed. After 15 minutes, the operator looks for pink or purple lines that indicate a positive result.

Scott Gottlieb, a former FDA commissioner, said the EEA is a good time to test for COVID-19 in a Twitter post.“This valuable contribution could help provide a more democratic test and provide more testing for those in a difficult situation where not all traps are in the doctor’s office, including schools,” Gottlieb wrote.

The text is approved by the EEA for use by “hospital care facilities operating under a Certificate of Exemption, Certificate of Conformity or Certificate of Accreditation from CLIA” and adds that it is intended to be used by “healthcare professionals or operators competent people working in cross-flow companies are trained, the proof is provided. 

Following the Abbott study, the FDA restricted the use of the antigen test to guide nasal swabs. This can lead to resource limitations. Quidel recently changed its EEA to support the use of nasopharyngeal tampons and nasal tampons. The campaign aimed to “alleviate some of the constraints in the supply chain around nasal devices.”