Mainstream media is abuzz with the handy dandy new home COVID-19 tests approved today. The FDA rushed this test by Lucira to the market faster than you can say “Coronavirus.” The test is performed entirely by the user with a specialized tube; there are no labs involved, and results are available within thirty minutes.
Conveniently, the FDA waived the following standard requirement: “Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of your product, but excluding Subpart H (Acceptance Activities, 21 CFR 820.80 and 21 CFR 820.86), Subpart I (Nonconforming Product, 21 CFR 820.90), and Subpart O (Statistical Techniques, 21 CFR 820.250).”
Along with the waiver of good manufacturing practice requirements (who needs those, anyways…), the FDA mandatd several guidelines for Lucira that must be met within prescribed amounts of time. The mainstream media is not reporting those guidelines.
Among the most interesting guidelines:
H. [Lucira] “must notify FDA of any authorized distributor(s) of your product, including the name, address, and phone number of any authorized distributor(s).”
O. [Lucira] “must evaluate the analytical limit of detection and assess traceability7 of your product with any FDA-recommended reference material(s). After submission to and concurrence with the data by FDA, you will update your labeling to reflect the additional testing. Such labeling updates will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.”
P. [Lucira] “must develop a mobile phone application or website to further facilitate results reporting by both the healthcare provider and the individual using your product, and submit to FDA such application or website within 4 months of the date of this letter (unless otherwise agreed to with DMD/OHT7-OIR/OPEQ/CDRH). After submission of the mobile phone application or website to, and review of and concurrence with the developed mobile phone application or website by FDA, you must update the authorized labeling. Such labeling updates will be made in consultation with, and require concurrence of, FDA.”
Q. [Lucira] “must submit to FDA a summary report within 60 calendar days of authorization summarizing the results of any testing performed using your product during that timeframe, including how many products were distributed, the positivity rate for specimens tested with your product, and how many individuals reported results to their healthcare provider as encouraged by the Quick Reference Instructions.”
S. “All prescribing healthcare providers must report all test results they receive from individuals who use your product to relevant public health authorities in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS- CoV-2 Tests provided by the Centers for Disease Control (available at: https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html). Healthcare providers will also report to Lucira Health, Inc., when requested by Lucira, how many individuals reported test results compared to how many tests they prescribed.”
The FDA letter states the test was approved quickly due to a pandemic emergency. Therefore, extensive efficacy testing and quality control measures aren’t necessary. In fact, the FDA isn’t concerned with quality control as much as the agency is interested in user data.
For the tests to be approved by the FDA, Lucira must agree to make all data traceable, develop an app or website within four months to facilitate users’ reporting of their health data and relevant healthcare agencies tracking and reporting data, and ensure that no testing goes unreported to health departments.
Got it? The home tests will be traceable and the data tracked. Seems legit.