Did you even bother to read the announcement?
"Clinical validation studies have been completed by the manufacturer according to Administrative Measures for Registration of In-vitro Diagnostic Reagents by the NMPA making use of 596 clinical samples and have shown specificity of 99.57% and a sensitivity of 86.43% on day 3 and 95% on day 5 of infection. Cross comparison of gold standard PCR based testing with the device showed a 94.93% coincidence, proving that the device is positioned as an excellent rapid screening tool. Technical validation studies have shown no cross reactivity with major respiratory pathogens, no interference from common biological confounders and a kit to kit and intrasample precision of 100%."
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- Ann: Cellmid Signs COVID-19 Rapid Diagnostic Supply Agreement
Ann: Cellmid Signs COVID-19 Rapid Diagnostic Supply Agreement, page-48
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