Cellmid Ltd (ASX: CDY, “Cellmid”) have announced that it has entered into a supply agreement for a COVID-19 rapid diagnostic test with an authorized distributor of the manufacturer, Guangzhou Wondfo Biotech Co Ltd., supplying Australia.
What are the key highlights?
- The COVID-19 rapid diagnostic test was approved as a POCT (point of care test) by the TGA on 25 March 2020, by the NMPA in China on 24 February 2020 and the test received CE mark on 5 March 2020.
- The rapid diagnostic test is already used in several countries including the UK, Belgium, Spain and Germany. It is produced in a TGA approved facility in China and it is available immediately.
- The COVID-19 rapid test is a small disposable kit that uses a lateral flow colloidal goldbased detection method against viral specific IgG/IgM, delivering results in no more than 15 minutes, and requiring only the most basic of laboratory equipment.
- 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.