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.
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:
On 11/17/20 the FDA issued EUA to Lucira Health All-In-One Test Kit, this is the first test kit allowing anyone over 14 years old to perform self-testing at home. This is definitely a game-changer and many entrepreneurs planning to startup and mobile/pop up lab owners are trying to understand the impact this will have on their business model moving forward. While the technology and the FDA approval are a game changer, but the impact of Lucira approval will be likely minimal in the near future and shouldn’t discourage anyone from starting up a lab. There is still a lot of barriers to break through before the test can make an impact:
At home testing isn’t the end of the mobile/pop up COVID lab, there are still opportunities to open up your own mobile and pop up COVID lab.
There are an increasing number of entrepreneurs wanting to start up new business ventures around COVID testing but without operating a lab. Some of the areas included:
I have worked with clients where the only reason they start looking for a lab consultant is because they received a cease-and-desist letter from CMS or a notice from FDA their company website contains misleading information.
Hiring a lab consultant early on during the business planning process, not only can help entrepreneurs avoid legal actions by CMS, FDA, and State regulators. But an experienced lab consultant can provide valuable insight into the laboratory industry and help make connections.
At CLIA Lab Consultant, we provide startup consultation for $1,000 covering 2 hours of work, for the following topics: CLIA, CMS, State regulations (if applicable), FDA, EUA, Mobile/Temporary Site testing, OSHA, safety regulations, insurance, billing, ICD-10, CPT code and reimbursement.
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.