Our experience with the GenBody RAD kit from South Korea has been exceptional and to date we have zero false positives and no reported false negatives.
The probable reason for the exceptional accuracy is in who we are testing. We are strict in using this test for healthy groups and ensure we are not using Rapid Antigen Tests to detect potential infection in people that are likely to have a weak or lagging immuno-response to infection.
That means we don’t use it to test people with comorbidities, chronic illness, the elderly, and anyone on an immuno-suppressant such a Remicade or Humira.
Using the right test for the population being served yields the best results.
When a company reports test data as to the FDA upon entry to the market there is a lot of nuance. One key factor in determining whether a test is say 95% as opposed to 80% is variance in the groups sampled during trial use.
Because all companies are required to test an array of people (young and old, frail and healthy) the accuracy number assigned that test represents how it will perform among the general population.
By using a test that we know to be less accurate in higher risk groups for healthier populations only, there is potential for the value of the test to improve.
Our testing practices, being stringent and fairly conservative, is a key contributor to the success we’ve had in deploying this very useful rapid result tool.
The groups we serve stand to benefit from rapid results in a manner not possible with PCR testing and we are proud to be in a position to keep people safe, businesses open, schools operating, players playing and production houses at work.
We have been notified of counterfeit Flowflex Covid-19 Antigen Home Tests being imported and distributed in the US. ACON Laboratories, the manufacturer of Flowflex tests, states that counterfeit white retail boxes are missing the Lot Number / Expiration Date /2-D datamatrix label. The counterfeit tests are missing the Spanish language instructions for use. The counterfeit pouches inside the box that contain the test cassette have Lot # COV2015122 and are labeled as “SARS-COV-2 ANTIGEN RAPID TEST (SELF-TESTING),” whereas the authentic Flowflex test cassette pouches are labeled “COVID-19 ANTIGEN HOME TEST.” The plastic test cassette may have a 2D barcode which differs from the one printed on authentic Flowflex tests. The counterfeit tests may have a QR code containing square shapes within a square box on 3 corners of the code, as shown below. The authentic Flowflex tests have a 2D-datamatrix without those three boxes. DO NOT USE any Flowflex tests that have one or more of these issues, as results may be erroneous (false positive or false negative). Please contact us at hello@hummingbirdrx.com with questions. You may also contact the FDA at 1-800-FDA-1088.