“It’s a company-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.
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In three working days, Teftt said Hardy “leveraged our capabilities,” enabling FDA approval of distribution of the rapid test for patients suspected of COVID-19 infection.
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 “strategic partnership” with Autobio 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 press release .
“IgM antibodies are generated initially by the body as a result of infection at about the time symptoms appear. They will dissipate within approximately 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 “certified laboratories able to perform highly complex tests at point-of-care or in the laboratory,” Hardy added.
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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 infections with other strains of the virus.
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The test “will be useful in identifying asymptomatic and mildly symptomatic carriers,” according to the release. “It will also be helpful in identifying persons who were infected by the virus previously, but may not have been properly diagnosed.”
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 emergencies.”
Hardy explained the approval “allows for simultaneous commercialization while the Anti-SARS-CoV-2 Rapid Test is under review, which enables Hardy Diagnostics to supply product during this critical time.”
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Also Wednesday, Hardy indicated it was still ramping up production of the company’s Viral Transport Medium, used to collect and transport COVID-19 tests.
The medium is to be produced at Hardy facilities in Springboro and California.
On Wednesday, Tefft said Hardy expected to begin shipping this product “next week.” He said the company was still pursuing federal funding to help pay for the resumption and ramping up of this production.
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