Melville-based Henry Schein is gearing up to ship COVID-19 tests to physicians, hospitals, and other healthcare providers that can give results within 15 minutes from blood taken with a pinprick.
The Standard Q COVID-19 IgM/IgG Rapid Test, made by South Korea-based SD Biosensor is intended to be administered at the point of care. Henry Schein anticipates having at least several hundred thousand tests available by March 30 and “significantly increased availability” as of April and intends to add tests from VelocityDX and other suppliers.
“This pandemic is an unprecedented situation and making rapid diagnostic tools available to healthcare professionals is critical for detecting and mitigating the spread of the coronavirus,” Henry Schein CEO Stanley Bergman said in a written statement.
Hauppauge-based Chembio Diagnostics recently announced it reached a deal to provide its rapid tests in Brazil, but at that time hadn’t begun to make them available in the United States.
Rapid diagnostic tests are seen as an important element in detecting the disease, including people with symptoms, those who have contracted the virus and overcome it and those who are asymptomatic.
SD Biosensor’s rapid test, as well as some others being developed, detects antibodies associated with the 2019 novel coronavirus (SARS-CoV-2) in blood drawn with a pinprick.
Henry Schein said the tests can help assess “the likelihood of past as well as present infection” and diagnose the mid- to later stages of the viral infection and ” along with the presence of symptoms, help determine if someone has recovered from the virus.”
Henry Schein, however, said “follow-up testing with a molecular diagnostic should be considered to confirm or rule out infection.”
“Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV2 infection to to inform infection status,” SD Biosensor says on its website.
SD Biosensor developed four diagnostic kits to detect novel coronavirus, or COVID-19. Its Standard M nCOV Real-Time Detection kit was approved in South Korea n February.
SD Biosensor said the test “is already playing an important role as a confirmation method for COVID-19 in the Korean domestic market.”
“There is urgent need for rapid testing to quickly identify large numbers of previously infected patients, including asymptomatic carriers,” Henry Schein added. “This is important to reduce and prevent virus transmission, assure timely treatment of patients, and help return our citizens to the workforce.”
Henry Schein said these tests are not required to go through FDA’s typical clearance or approval processes and do not require an Emergency Use Authorization.
The U.S. Food and Drug Administration on March 16 established a policy of “not objecting to the development and distribution by commercial manufacturers of serology tests that identify antibodies to SARS-CoV-2,” even if they don’t have an Emergency Use Authorization.
The FDA said it initiated this policy because “serology tests are less complex than molecular tests and are solely used to identify antibodies to the virus.”
Companies can attest to the accuracy of their own tests without bringing in the FDA or a third party to validate them.
“Because of the public health emergency, FDA has issued guidance where it has effectively waived its opportunity to conduct an independent review,” Henry Schein said.
Risks include possible incorrect test results. Negative results do not rule out SARS-CoV-2 (COVID-19) infection and molecular tests should be considered to rule out infection, according to both companies.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E, or past or present infection with SARS virus (no. 6), Henry Schein added.
“Our initial focus is on the U.S. market and we will address the potential to distribute the tests to other geographies at a later date,” Henry Schein said.