What's happened?
Cellmid Limited (ASX:CDY) has announced that a validation study has been completed for the Wondfo SARS-COV-2 test, which Cellmid had previously signed a supply agreement for (supply agreement was announced on the 27th March 2020).
What are the key highlights?
- Wondfo’s SARS-VoC-2 diagnostic was tested by The National Institute of Virology of the Indian Council of Medical Research.
- Wondfo’s test detected antibodies as early as day 3 from COVID-19 symptoms.
- 100% of samples (14) from day 6 of disease onset tested positive for antibodies.
- There was no cross reactivity (false positives) detected.
- Results are consistent with Wondfo’s study of 596 COVID-19 patient samples.
- The validation study was conducted on 24 individual samples of COVID-19 patients from day 2 to day 13 from the onset of symptoms, following confirmation of viral load using nucleotide testing.
- The Cellmid sponsored Wondfo SARS-CoV-2kit is manufactured to the highest standards in a facility certified by the Australian Therapeutic Goods Administration (TGA), the US Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA) under the Medical Device Single Audit Program (MDSAP).