The COVID-19 testing supply chain had been under pressure almost a year now from swab, UTM, extraction reagent, pipette tip, analyzer, biosafety hood to COVID reagents. But the biggest shortage that remains unsolved is waived point of care (POC) molecular testing. Currently, all analyzers and test kits that’s capable of waived point of care COVID molecular testing are on backorder; there are labs with analyzers but unable to secure test kits and supplies isn’t guaranteed.
Antigen testing is emerging as an alternative as the supply problem with POC molecular testing challenge isn’t expected to be resolved anytime soon. Then comes the FDA warning letter in November alerting clinical labs and providers of false positive antigen tests. In the FDA letter the problems outlined included:
Michael Yu, MS, MBA, MLS(ASCP)
Michael is the founder and owner of CLIA Lab Consultant where he provides consultation to laboratories and companies world-wide for startup and lab regulations, reimbursement, and testing strategies.