and patient management decisions. Patient management should follow current CDC guidelines.
Negative Result
A negative test result for this test means that antigens from SARS-CoV-2 were not present in the
specimen above the limit of detection. However, a negative result does not rule out COVID-19 and
should not be used as the sole basis for treatment or patient management decisions, including
infection control decisions. The amount of antigen in a sample may decrease as the duration of
illness increases. Negative results should be treated as presumptive and confirmed with a
molecular assay, if necessary, for patient management.
For serial testing programs, additional confirmatory testing with a molecular test for negative
results may be necessary, if there is a high likelihood of COVID-19, such as, an individual with a
close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with
high prevalence of infection. Additional confirmatory testing with a molecular test for positive
results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals
without known exposures to COVID-19 or residing in communities with low prevalence of
infection.
LIMITATIONS
• This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2. Test
performance depends on the amount of virus (antigen) in the sample and may or may not
correlate with viral culture results performed on the same sample.
• A negative test result may occur if the level of antigen in a sample is below the detection limit
of the test.
• The performance of the BinaxNOW COVID-19 Antigen Self Test was evaluated using the
procedures provided in this product insert only. Modifications to these procedures may alter
the performance of the test.
• False negative results may occur if a specimen is improperly collected or handled.
• False negative results may occur if inadequate extraction buffer is used (e.g., <6 drops).
• False negative results may occur if specimen swabs are not twirled within the test card.
• False negative results may occur if swabs are stored in their paper sheath after specimen
collection.
• Positive test results do not rule out co-infections with other pathogens.
• False negative results are more likely after eight days or more of symptoms.
• Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
• Negative test results are not intended to rule in other non-SARS viral or bacterial infections.
• The presence of mupirocin may interfere with the BinaxNOW COVID-19 Antigen Self Test
and may cause false negative results.
• Negative results are presumptive, do not rule out COVID-19 infection and it may be necessary
to obtain additional testing with a molecular assay, if needed for patient management.
• Performance of nasal swabs collected from patients without symptoms or other
epidemiological reasons to suspect COVID-19 infection or for serial screening, when tested
twice over three days with at least 36 hours between tests has not been determined, a study to
support use will be completed.
• If the differentiation of specific SARS viruses and strains is needed, additional testing, in