MELBOURNE, Fla., March 31, 2020 /PRNewswire/ -- S7 LLC, a developer and manufacturer of diagnostic tests, has announced patent-pending status for its new 2019-nCoV IgG/IgM Rapid Test Cassette, or novel Coronavirus test.
The test, which is expected to be available in the United States in mid-April, uses a small finger-stick sample of blood and delivers important results in 10 minutes:
- IgG: This result shows the presence of antibodies, allowing providers to know if the patient has been infected in the past with COVID-19 and has manufactured this specific antibody to fight the virus.
- IgM: The test also shows if the patient has an active infection and is contagious, and thus a danger in terms of spreading COVID-19 to others.
"Emergency rooms are flooded with people who think they may have been exposed, or believe they have COVID-19," says William Miller, president of S7. "This test lets healthcare providers know in only 10 minutes whether that individual is currently ill, so they can be quarantined and treated, or if they have already been exposed.
What that means, he adds, is that "then those medical professionals can quickly separate out and triage the cases of everyone who is coming into their facilities appropriately."
The tests are being manufactured in S7's ISO-certified laboratory and production facility in South Africa and are due to arrive in the United States in mid-April. This is the same site that produces S7's Schistosomiasis test, which was FDA approved and has been in wide use since late 2019. And it was the ramp-up for that test's production that allowed for the rapid deployment of the COVID test, Miller says.
"We have experience in producing rapid cassette testing, and so we were able to quickly get moving on this problem," he says. "We were able to spool our factory up to produce this test and are really happy about getting it out to the dedicated healthcare professionals who are on the front lines of this pandemic. We believe it is going to help them reduce risk, save lives and overall make their jobs a little easier."
This test is for hospital and authorized medical center use only. It is NOT for home use and is sold only to qualified Medical Centers, Hospitals, Clinics or Dr. Offices.
S7's mission is to bring answers to people suffering from unexplained health issues when conventional tests fail to produce the answer.
Rapid Whole Blood COVID-19 test
The 2019-nCov IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies of 2019-nCoV in human whole blood, serum or plasma.
SOURCE S7 LLC