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HHS Purchasing Quidel Rapid Antigen Tests, Systems for COVID-19 Detection in Nursing Homes

NEW YORK – Quidel said on Friday that the US Department of Health and Human Services intends to purchase 2,000 Sofia and Sofia 2 instruments and 750,000 Sofia SARS Antigen FIA tests to help detect SARS-CoV-2 in nursing homes.

HHS will make its purchases over the "next few months," Quidel said, to expand COVID-19 testing in nursing homes throughout the country.

HHS announced its plans to buy tests and testing platforms from the San Diego-based firm and from Becton Dickinson last week to improve COVID-19 testing in nursing homes. BD said separately last week that HHS would buy 2,000 BD Veritor Plus systems and 750,000 SARS-CoV-2 viral antigen tests.

During the coronavirus pandemic, nursing homes have been hit particularly hard, and labs serving the market have struggled both with the demand for SARS-CoV-2 testing and the financial challenges posed by the pandemic.

Quidel and BD are the only two firms with rapid antigen tests for detecting SARS-CoV-2 so far that have received Emergency Use Authorization from the US Food and Drug Administration. Quidel also said on Friday that the Sofia SARS Antigen FIA has received the CE mark for use with the Sofia and Sofia 2 platforms.

In addition, Quidel said that it has updated the performance data for the Sofia SARS Antigen FIA test on its package insert to 96.7 percent using direct nasal swab specimens versus PCR as a result of additional studies included in its amended EUA submitted to the FDA.