COVID-19 Diagnostics Roundup: News from Thermo Fisher, Quidel, Rutgers

The latest developments on diagnostics and testing for COVID-19 featuring news from Thermo Fisher, Quidel, and Rutgers University.

FDA Provides First Emergency Use OK for COVID-19 Antigen Test
Last week (May 9, 2020), the US Food and Drug Administration issued its first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs.

The EUA was issued to Quidel Corporation for the Sofia 2 SARS Antigen FIA. This test is authorized for use in high and moderate complexity laboratories certified by Clinical Laboratory Improvement Amendments (CLIA), as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.

Source: US Food and Drug Administration

FDA OKs Emergency Use of Rutgers’ Home-Based Saliva COVID-19 Test
Last week (May 8, 2020), the US Food and Drug Administration (FDA) authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing.

Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which had been previously added to the high complexity molecular-based LDT “umbrella” EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. Th approval announcement builds on EUA granted by the FDA last month (April 2020) for the first diagnostic test with a home-collection option, which uses a sample collected from the patient’s nose with a nasal swab and saline.

The Rutgers Clinical Genomics Laboratory test is currently (as of May 8, 2020) the only authorized COVID-19 diagnostic test that uses saliva samples to test for SARS-CoV-2, the strain of coronavirus that causes COVID-19. The test remains prescription only.

The authorization is limited to testing performed at the Rutgers Clinical Genomics Laboratory using its molecular LDT COVID-19 authorized test for saliva specimens collected using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. The EUA is not a general authorization for at-home collection of patient samples using other collection methods, saliva- collection devices, or tests, or for tests fully conducted at home.

Source: US Food and Drug Administration

Thermo Fisher Partners for COVID-19 Antibody Test
Thermo Fisher Scientific reports that it will develop a total antibodies test in collaboration with WuXi Diagnostics and the Mayo Clinic for the novel coronavirus (COVID-19). The new test is the result of ongoing collaboration between all three organizations, including clinical evaluation and support from the Mayo Clinic. Thermo Fisher will seek Emergency Use Authorization (EUA) from the US Food and Drug Administration and international regulatory authorizations for the test over the next few weeks (as reported on May 13, 2020).

Once approved for use, the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test will detect Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to help clinicians determine if a patient has been exposed to SARS-CoV-2, the virus that causes COVID-19. The test is designed to run on an open instrument platform, and the determination of antibody status will aid in the diagnosis of the disease during the acute and recovery stages of infection.

Thermo Fisher says it will begin manufacturing the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test at its sites in the US and Europe in the next few weeks (as reported on May 13, 2020) as it prepares to submit for EUA.

Source: Thermo Fisher Scientific

Thermo Fisher Gets Expanded EUA for SARS‑CoV‑2 PCR Test
The US Food and Drug Administration (FDA) has further expanded emergency use authorization (EUA) for Thermo Fisher Scientific’s multiplex real-time PCR test intended for the qualitative detection of nucleic acid from SARS‑CoV‑2, the virus that causes COVID-19.

Thermo Fisher’s Applied Biosystems TaqPath COVID-19 Combo Kit, initially granted EUA on March 13, 2020 and subsequently expanded on April 20, 2020, is designed to deliver test results within four hours of a sample being received. This third expansion increases the number of high-throughput PCR instruments that labs can use to run tests and also provides new options for reagents and consumables used in sample preparation and extraction.

In addition to the previously approved Applied Biosystems 7500 Real-time PCR series and a version of the Applied Biosystems QuantStudio 5, labs can now run tests on specific configurations of QuantStudio 7 Flex and QuantStudio 5 Real‑time PCR instruments, contributing to the number of instruments available for testing.

This expanded EUA also increases the availability of RNA extraction reagents by adding the company’s MagMAX viral/pathogen II nucleic isolation kit as an alternative. Additionally, the sample purification step has been updated to allow a variety of microplate options.

Source: Thermo Fisher Scientific

FDA Provides Update on COVID-19 Testing
As of May 13, 2020, the US Food and Drug Administration (FDA) reports that it has worked with more than 390 test developers that have already submitted or said they will be submitting emergency-use authorization (EUA) requests to the FDA for tests that detect the novel coronavirus or antibodies to the virus. To date (as of May 13, 2020), the FDA has authorized 95 tests under EUAs, which include 82 molecular tests, 12 antibody tests,, and 1 antigen test.

Source: US Food and Drug Administration

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