INSIGHT FROM EVERY ANGLE
INSIGHT FROM EVERY ANGLE
Please reach us at info@vantagepointsinc.com if you cannot find an answer to your question.
How accurate are the diagnostic results?
Most tests are U.S. FDA cleared to be 99.9% accurate, as well as CLIA waived and approved for home use, certifying that they are sufficiently simple to operate and interpret. Any test we make that may be considered a niche test, for which the FDA has not yet established guidelines, is held to this same standard and will be cleared after protocols are established by the FDA
Negative results may be seen in as little as one minute. Positive results may be read in as little as 15 minutes. Results should not be read after 60 minutes.
Some tests do not distinguish between therapeutic use of a drug and abuse of the same drug. A test may yield preliminary positive results when prescription tricyclic antidepressants, barbiturates, benzodiazepines, methadone, buprenorphine or opiates are ingested, even at therapeutic doses. There are no uniformly recognized drug levels for these prescription drugs in urine.
Store at home test kits at room temperature or 35-86 degrees Fahrenheit is recommended.
A red or pink line next to the “T1” or “T2” (drug test line) under the drug name indicates a negative result for that drug, even if the line is very faint. In the case of a positive result, there will be NO line at all. ANY line, no matter how faint, indicates a negative result.
Most COVID-19 Home Tests have received expiration extensions from the FDA. To see if your COVID-19 test has an expiration extension, see the List of Authorized At-Home OTC COVID-19 Diagnostic Tests. For additional COVID-19 Home Test information, visit the FDA At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions.
Yes. Once the test manufacturer has more stability testing results, such as 12 or 18 months, the test manufacturer can contact the FDA to request that the FDA authorize a longer shelf-life. When a longer shelf-life is authorized, the expiration dates will be extended. Expiration dates are extended by the FDA only after extensive studies prove the tests still perform accurately.
The iHealth COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.
You can contact Vantage Points Inc. by phone at (720) 679-9771 or by email at info@vantagepointsinc.com
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