Philosys Healthcare said that its Gmate COVID-19, a diagnostic kit for the coronavirus, has achieved 100 percent accuracy.
The company had previously been selling previous versions of Gmate COVID-19, which had 91 percent sensitivity, 97 percent specificity, and 93 percent accuracy, respectively.
It recently improved the accuracy of its kit by collaborating with BBB, a local diagnostic firm, and conducted additional clinical evaluations at EOne laboratories, a local medical foundation, to verify the improved products. The company's trial consisted of 72 specimens -- 36 positive and 36 negative samples.
The sample number was the same as that of specimens set by the U.S. Food and Drug Administration's approval protocol.
"The comparative reference equipment for the clinical trial was Abbott's RealTime SARS-CoV-2, which is one of the standard Covid-19 diagnostic equipment used in the U.S.," the company said in a press release. "As a result, Gmate COVID-19 showed surprising performance of 100 percent for all areas, including sensitivity, specificity, and accuracy."
"The test results exceeded the company's initial goal of increasing the accuracy from 93 to 96 percent," a company official said.
Although a large-scale clinical trial is being postponed due to protests in the United States, the company plans to apply for FDA approval based on this test result, the official added.