17th February 2020 Author: Paul Carton
CDC Covid-19 Diagnostic Kits Can't be Validated say Public Health Labs
Laboratories have been unable to validate the diagnostic kits that were developed by the Centre for Disease Control and Prevention (CDC) due to inconclusive results. The CDC 2019-nCoV Real-Time Reverse Transcriptase PCR diagnostic kit was shipped out on the 5th of February, to 115 laboratories in the US and approximately 191 laboratories internationally. On the 12th of February, the CDC stated that some of the public health laboratories had notified the CDC that they were unable to validate the test due to one of the assays giving inconclusive results.
Even though the kits had not obtained FDA approval, they had been granted Emergency Use Authorisation (EUA) before been dispatched to the qualified laboratories. Each kit could test 800 specimens and promised to give a turnaround time of 4 hours from the initial sample to result. On the 14th of February, Dr Nancy Messonnier of CDC confirmed they had begun to reformulate the reagents that were not working, however, a specific date on when those new reagents would be distributed out again was not given.
Date Published: 17th February 2020
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