Roche Diagnostics began shipping 400,000 to 500,000 Coronavirus test kits from the company’s manufacturing facilities in New Jersey on Friday via “the fastest means available” to laboratories around the country.
A spokesman for the company, an American subsidiary of Switzerland-based Roche, told Breitbart News on Friday that the SARS-CoV-2 test kits that detect the virus that causes Coronavirus (COVID-19), approved by the Food and Drug Administration on Thursday, are being sent to 32 laboratory sites around the country where the company’s cobas 6800 and cobas 8800 molecular testing machines are currently used to run a variety of other medical tests.
The spokesman told Breitbart News that 32 out of the 110 laboratory sites in the United States that currently use the cobas 6800/cobas 8800 testing machines were selected as recipients of the first batch of SARS-CoV-2 test kits because they are national reference laboratories or hospitals near areas that have been identified as hot zones of Coronavirus outbreaks.
“We want to make tests available to patients where they are needed most. So we worked with the CDC to develop a strategy that prioritizes labs with the broadest geographic reach and highest patient impact. These labs also have the ability to implement high-volume testing immediately,” Roche Diagnostics said in fact sheet emailed to Breitbart News on Friday.
The SARS-CoV-2 test is an additional test these laboratories will now be capable of running as early as Monday. Given the current Coronavirus health threats, it is anticipated that many of these laboratories will focus their cobas 6800/cobas 8800 usage on running the SARS-CoV-2 tests.
According to the fact sheet emailed to Breitbart News by the company on Friday:
The test detects the genetic signature (RNA) of the SARS-CoV-2 virus in a simple test performed by a healthcare provider using swab samples from the back of the patient’s throat or nose. . .
Healthcare providers can send patient samples to hospital and reference laboratories across the U.S. to run the test. . .
After the lab starts the test, results are available in about 3.5 hours. The instruments can process up to 384 results (cobas 6800 System) and 960 results (cobas 8800 System) in an 8-hour shift.
Test kits will be shipped throughout the weekend, and all 32 laboratory sites are expected to be ready to run the SARS-CoV-2 tests by Tuesday.
The Roche Diagnostics spokesperson told Breitbart News that after the first batch of 400,000 to 500,000 test kits are shipped out this weekend, the company anticipates that it will be able to produce and ship out an additional 400,000 to 500,000 Coronavirus test kits each subsequent week, with an expected monthly test kit production capacity of about 1.5 million.
Friday afternoon, President Trump declared a national emergency to deal with the Coronavirus pandemic in the United States.
At the press conference announcing the national emergency, “Trump said he expected the U.S. to have 1.4 million coronavirus test kits available within a week, and a total of five million kits within the next month,” CNBC reported.
Roche Diagnostics CEO Matt Sause was among several business executives who joined the president at the press conference, as Business Insider reported:
CEOs of laboratory, research, and medical device companies also joined Trump, who said that he has called on the labs to expedite efforts to increase the availability of tests for COVID-19.
Companies like Roche Diagnostics, whose CEO Matt Sause attended the press conference, recently gained expedited approval for coronavirus testing.
The Trump administration has come under criticism for the slow pace at which Coronavirus test kits have been made available in the country.
As of earlier this week, only an estimated 5,000 Coronavirus tests had been completed in the United States, a marked contrast to the estimated 320,000 that have been conducted in Guandong Province, China and the 189,000 that have been conducted in South Korea.
With weekly shipments of 400,000 to 500,000 SARS-CoV-2 test kits to 32 laboratories, each capable of running Coronavirus tests on a minimum of 384 to a maximum of 2,880 patient samples per day, these laboratories as a group have the capacity to complete anywhere from 12,000 to 92,000 tests per day.
Over the next month, that means effective Monday, the United States is expected to have the capacity to complete between 360,000 to 2.7 million Coronavirus tests using the Roche Diagnostics SARS-CoV-2 test kits alone. The constraint then becomes Roche Diagnostics’current monthly production capacity of 1.5 million SARS-CoV-2 test kits.
Politico reported on Tuesday that one of the problems with getting Coronavirus test kits distributed in the United States has been a shortage of key materials, specifically, reagents.
According to Ann Marie Helminstine, Ph.D. in Biomedical Sciences:
A reagent is a compound or mixture added to a system to cause a chemical reaction or test if a reaction occurs. A reagent may be used to find out whether or not a specific chemical substance is present by causing a reaction to occur with it. Reagents may be compounds or mixtures. In organic chemistry, most are small organic molecules or inorganic compounds.
A shortage of reagents has apparently not been a problem for Roche Diagnostics as it begins production of SARS-CoV-2 test kits, nor does the company expect it to be a problem in the near future.
“Everything necessary to carry out the test is in the kit,” the Roche Diagnostics spokesman told Breitbart News.