Staffers help firm win rights to virus test
— Local staff helped a California-based company land rights to distribute a new diagnostic med- ical device intended for used in the fight against COVID-19.
Accounting and customer service workers at Hardy Diagnostics facilities on Pioneer Boulevard in Springboro provided pieces of the pack- age needed for FDA approval for the company to begin distribution of a Chinese device through the Food and Drug Administration’s Emergency Use Authorization program, Joel Tefft, marketing man- ager for for employee-owned Hardy, said Wednesday.
“It’s a com p any-wide effort,” Teft said from Santa Maria, Calif. “We all work collaboratively.”
In addition, Hardy expects by next week to begin shipping a product it has resumed production of for use in transport of tests for the coronavirus.
In three working days, Teftt said Hardy “leveraged our capabilities,” enabling FDA approval of distribution of the rapid test for patients suspected of having COVID19 infections.
Samples of a patient’s finger-prick blood, serum or plasma specimen can yield test results in “only 15 minutes,” according to the release.
The deal involves a “strate- gic partnership” with Auto- bio Diagnostics Co., based in Zhengzhou, China, to become a U.S. supplier of the new “one-step lateral flow assay” that detects two types of antibodies from the virus, according to a news release .
“IgM antibodies are gener- ated initially by the body as a result of infection at about the time symptoms appear. They will dissipate within approx- imately one month. IgG antibodies are generated by the body about one week after symptoms appear and last for an extended amount of time,” according to the release.
Testing is limited to “certi- fied laboratories able to perform highly complex tests at point-of-care or in the labo- ratory,” Hardy added.
The product is “intended for use by clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.”
Negative results do not rule out infection, “particularly in those who have been in recent contact with the virus, due to the lag time between exposure and the patient’s antibody response.”
Positive results could be due to past or present infec- tions with other strains of the virus.
The test “will be useful in identifying asymptom- atic and mildly symptom- atic carriers,” according to the release. “It will also be helpful in identifying per- sons who were infected by the virus previously, but may not have been properly diag- nosed.”
Hardy and Autobio “have begun to open supply chains to deliver this rapid test to the United States,” according to the release.
According to FDA, the emergency program allows the agency “to help strengthen the nation’s public health protections” by “facilitating” approvals “during public health emer- gencies.”