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BinaxNOWrM COVID-19 Antigen SelfTEST
Health re Provider Instruction s for Use
For Use Under an Emergency Use Authorization (EVA) Only
For use with anterior nasal swab
For in vitro Diagnostic Use Only
INTENDED USE
The COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the
qualitative detection of nucleocapsid protein antigen from SARS - COV-2.
This test is authorized for non-prescription home use with a self-collected anterior nasal (nares)
swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first
seven days of symptom onset. This test is also authorized for non-prescription home use with
adult collected anterior nasal (nares) swab samples from individuals aged two years or older with
symptoms within the first seven days of symptom onset.
This test is also authorized for non-prescription home use with self-collected anterior nasal
(nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal
(nares) swab samples from individuals aged two years or older, with or without symptoms or other
epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24
hours (and no more than 48 hours) between tests.
The BinaxNOW COVID-19 Antigen Self Test does not differentiate between SARS-CoV and
coVQ.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. An antigen is
generally detectable in anterior nasal (nares) swabs during the acute phase of infection. Positive
results indicate the presence of viral antigens, but clinical correlation with a past medical history
and other diagnostic information is necessary to determine infection status. Positive results do
not rule out bacterial infection or co-infection with other viruses. The agent detected may not
the definite cause of the disease. Individuals who test positive with the BinaxNOW M
Antigen Self Test should self-iM)late and seek follow-up care with their physician or healthcare
provider as additional testing may be necessary.
Negative results should be treated as presumptive and confirmation with a molecular assay, if
necessary for patient management, may be performed. Negative results do not rule out SARS-
CoV-2 infection and should not be used as the sole basis for treatment or patient management
decisions, including infection control decisions. Negative results should considered in the
context of an individual's recent exposures, history and the presence of clinical signs and
symptoms consistent with COVID-19.
For serial testing programs, additional confirmatory testing with a molecular test for negative
results may necessary if there is a high likelihood of corvid-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
results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals