Is rapid COVID antigen testing the solution

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:

• Test components not properly stored 
  
• The test kit being store opened prior to use
  
• Failure to follow the manufacturer’s instruction of use
  
• Reading the test before or after the specified time
  
• Cross-contamination during testing due to insufficient cleaning of the work space, insufficient disinfection of the instrument and failure to change gloves between patient’s testing
  

As most worked in the laboratory field knows those errors are not new, they have been existent in point of care testing, when testing is not being performed by trained laboratory professionals, it’s not specific to COVID testing. Another challenge unique to COVID is normally POC testing is done in low volume and individually. For example, a medical assistant in a typical physician office would be testing one patient at a time, but with COVID healthcare professionals might find themselves performing multiple samples at the same time which lead to increased errors. CLIA/Medical directors need to realize performing waived COVID testing in mass screening is new to many healthcare professionals, it’s critical procedures and training be developed to migrate operator error. In the waived labs that we set up for COVID, we went above and beyond just the package insert but had created customized training checklist, quick reference guide, quiz and competency to ensure testing personnel are prepared to perform mass screening and produce accurate results.