Chembio Diagnostics and Molecule Holdings announced the launch of their separate COVID-19 serological point-of-care tests for detecting antibodies associated with coronavirus.
Chembio’s fingerstick-style test using its MicroReader 1 and MicroReader 2 analyzers is designed to detect IgM and IgG antibodies and offer results within 15 minutes, according to a news release.
Chembio (Medford, N.Y.) said its dual path platform (DPP) platform offers numerical results to help clinicians determine current or past exposure to COVID-19 even among patients who exhibit mild to no symptoms. IgM antibodies can determine if a patient may still be infectious and transmit the virus, while IgG antibodies demonstrate prior infection later on in the progression. The platform can also help clinicians monitor infection progression while avoiding human interpretation errors that can accompany visual readings, the company said.
Chembio expects to begin shipping the product sometime this month and is working with its partner LumiraDx to provide DPP COVID-19 tests with the ability to scale upon market demand. The tests received emergency authorization from the FDA, according to the news release.
“The results and data from our DPP COVID-19 test can help improve clinical outcomes through the management of individual patients by enabling clinicians to understand the likelihood of past and present infection and to manage populations as a whole as a surveillance test,” Chembio CEO Richard Eberly said in the news release. “Our measured approach has positioned us to offer a viable and sustainable long-term solution for clinicians.”
Molecule Holdings said its COVID Care Rapid Test received FDA emergency authorization as well and that the company is sending kits to medical professionals, first responders and law enforcement. The test, also for detecting IgG and IgM antibodies, has a 91% clinical sensitivity rating and a 99% clinical specificity rating while delivering results in as fast as five minutes, according to a news release.
Molecule Holdings’s tests come from Pinnacle BioLabs, an FDA-registered laboratory in Tennessee, the company said in a news release. They are manufactured in an ISO-13485 certified facility.
