The United State Food and Drug Administration (FDA) is granting special ’emergency use authorization’ the equipment and test that may possibly help increase testing for the COVID_19 in the U.S.
This type of testing that has just been approved for use could help expand the availability of frontline testing mostly in hospitals and at clinics where patients are taking care without needing to rush to a dedicated diagnostics lab.
Cepheid’s COVID-19 test, which was approved this week also has the ability of running either with or without use of a nasal swab, and that is the most important factor because supplies of nasal swabs are taxed globally and is not easy to come by.
The test is also a molecular, PCR-based, with high rates of accuracy, not different from the lab-based testing that’s already available across hospitals and clinics in the U.S. It uses the company’s GeneXpert machine which is a diagnostics kit the size of an inkjet printer cartridge lab in a box about the size of an inkjet printer, to produce results.
Cepheid revealed that about 23,000 of its GeneXpert micro-labs are already in use globally with about 5,000 of that number located in the U.S. The company’s hardware has been in use for testing for the flu for many years and it recorded high reliability rate.
The new coronavirus testing system will begin it shipment by the Sunnyvale-based molecular diagnostics company starting from next week.
COVID_19 testing in the U.S. has increased over the past week. Gratitudes are owed in large part to widespread efforts to expand availability especially in hard-hit regions like New York State.
However, there is still need for more tests as the limits of availability mean that only the most severe cases, most times such that require confirmed contact tracing or proof of elevated risk, are being tested.
Having the new tests like Cepheid’s, and other confirmed alternative test methods than can be done mainly at home, like Scanwell’s forthcoming test that looks for antibodies in a person’s blood, are most needed if the statements to control the spread of the virus are as serious as they seem.