Some experts believe home testing will be the key to end the pandemic, but there has been a lot of confusion on home testing due to differences in home collection vs actual testing.
Home collection kit - The LabCorp’s Pixel COVID-19 Test Home Collection Kit allows individuals to self-collect a nasal swab, then send it to LabCorp for testing without a doctor’s order. There are also other self collection kits for nasal and saliva that require a doctor’s order. The advantage of home collection kit is patients can avoid the long line at the drive thru collection site, the test will be performed by CLIA high complexity labs and using PCR which is more sensitive than antigen testing. One of the major disadvantages of home collection kits is turnaround time the patient must wait days for the lab to run the test.
Home testing kit - currently there are both FDA EUA molecular and antigen test kits available, the patient will collect and test the sample at their own home. With at home testing, the result is available in minutes to the individual. The Ellume antigen test is the only home test that doesn’t require a doctor’s order, both the Abbott BinaxNOW antigen test and Lucira Health molecular test required a doctor’s order. The sensitivity and detection limit is lower than lab performed PCR test.
Home testing supply is currently extremely limited and production is unlikely to ramp up until Spring of next year. Laboratory-based testing would still be a key to control the pandemic in the near future.
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.