Saturday, 04 April, 2020

Coronavirus outbreak: FDA approves new COVID-19 test kit

A close up shot of Coronavirus 2019-nCoV an infectious flu virus which causes respiratory illness. Human blood samples in a medical lab. 3d illustration concept Diagnostic Testing Company Says It Can Produce 50K Coronavirus Tests per Day 3file Getty Images Amy Furr17 Mar 2020
Sandy Nunez | 20 March, 2020, 15:21

But, as recently as last week, the United States had only 23 test kits per million people, according to Dr. Paul Biddinger, MD, FACEP, of Boston's Massachusetts General Hospital (MGH), speaking in a webinar broadcast March 13. The first authorization was issued to Roche Molecular Systems, Inc., for its cobas SARS-CoV-2 Test, and the second issued the following day to Thermo Fisher Scientific, Inc., for its TaqPath COVID-19 Combo Kit.

However, authorities are moving quickly to close that gap and ramp up testing capacity. Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process.

By Feb. 24, state and local labs were begging the Food and Drug Administration to loosen rules preventing non-CDC labs from using their own tests.

As opposed to the earlier rule allowing only high-complexity testing consistent with requirements under the Clinical Laboratory Improvement Amendments to carry out testing, the FDA now said it does not object to commercial manufacturers distributing and labs using new commercially developed tests prior to the agency granting emergency use authorization, or EUA, under certain circumstances.

It is the third EUA granted by the U.S. regulator during the current outbreak of the COVID-19 virus.

Tulsi Gabbard suspends presidential campaign
Gabbard said that, despite their political differences, Biden is the best choice to unite the country. Throughout her candidacy, Gabbard experienced low polling numbers, most often in the single digits.

The Co-Diagnostics boss said that with no known treatment or approved vaccine for the highly infectious COVID-19, the need for "accurate and rapid diagnoses" has never been greater.

Salt Lake City-based Co-Diagnostics is the first USA company to receive a CE-mark from the European Union (EU) for its proprietary Logix Smart COVID-19 diagnostic test. The FDA said the change extends to other states the authority the FDA gave last week to the New York State Department of Public Health to approve diagnostic tests within the state.

He also said that these test kits were polymerase chain reaction-based reagent kits used in laboratories and not point-of-care or do-it-yourself kits.

In a third change, the FDA provided guidance to developers of serological tests, which test the blood for signs of coronavirus infection.

RT-PCR-based tests for COVID-19 seem to be the most common available from developers and while very sensitive, they do have some issues that could affect accuracy. Finally, FDA recommends including a general statement in the test report that FDA review is pending, whenever that is the case.