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000779049 L020 ENVIAR A MIS RESULTADOS
VIROLOGY
SARS-CoV-2 ANTIGEN NEGATIVE NEGATIVE
METHOD: RAPID DETECTION SARS-CoV-2 BD VERITOR
INTENDED USE:
The product is an chromatographic digital immunoassay that is used with the
BD Veritor Plus Analiser Instrument intended for the direct and qualitative
detection of SARS-CoV-2 nucleocapsid antigen in nasal swabs from individual
who are suspected of COVID-19 by their healthcare provider within the first
five days of the onset of symptoms.
RESULT INTERPRETATION FOR COVID-19 ANTIGEN
POSITIVE: Result indicate presence of SARS-CoV-2 nucleocapsid protein ag
is generally detectable in upper respiratory samples during the
acute phase of the infection. Positive results do not rule out
bacterial infection or co-infection with other viruses.
NEGATIVE: Negative results are presumptive, Negative test results do not
preclude infection and should not be used as the sole basis for
treatment or other patient management decisions,particularly
in the presence of clinical signs and symptoms consistent
with COVID-19, or in those who have been in contact
with the virus. It is recomended that these results be confirmed.
--This test has been authorized by FDA under a EUA for use by authorized
laboratories certified under CLIA.
--This test has not been FDA cleared or approved.
--This test is only authorized for the duration of the emergency.
L:7407-ORG 6/02/2021 11:55AM
TEST VALIDATED BY: L:7407-ORG 6/02/2021 11:55AM
Sample ID: 001992421 Collected: 6/02/2021 11:32AM *Lab Received: 6/02/2021 11:32AM