| SARS-CoV-2 RNA (Rapid) |
This result should be interpreted in combination with the
clinical observations patient history and epidemiological
information. Testing for SARS-CoV-2
(Severe acute respiratory syndrome coronavirus 2 formerly known as
2019 novel coronavirus or 2019-nCoV) to aid in the diagnosis of
COVID-19 is performed using the BD
MAX BioGX Sars CoV-2 reagents for the BD
MAX as authorized by the FDA issuedEmergency Use Authorization (EUA). This BD MAX BioGX
Sars CoV-2 EUA assay is intended for
In-vitro Diagnostic (IVD) use with
respiratory specimens such as nasopharyngeal swabs collected from
individuals meeting the CDC criteria for
testing. The BD MAX EUA assay is performed based on the instructions for
use provided by Becton Dickinson. Testing is performed in the
Microbiology Laboratory at Cheshire Medical Center certified under
the Clinical Laboratory Improvement Amendments of 1988
(CLIA) 42 U.S.C. section 263a to perform
high complexity tests. Assay performance has been verified
according to clinical laboratory regulatory requirements. Test
results are provided above. A result of “Not Detected”
indicates that the viral RNA target is
not present but does not preclude SARS-CoV-2 infection. False negative results may
occur if a specimen is improperly collected transported or handled;
if amplification inhibitors are present; or if inadequate numbers
of viral particles are present in the specimen. A result of
“Detected” suggests a current or recent infection and
the patient is presumed to be infected. As required or requested by
public health authorities positive specimens may be sent for
additional testing. Positive and negative predictive values for
this test are highly dependent on disease prevalence. A result of
“Indeterminate” is used when the inconclusive results
are obtained due to the detection of only one of the viral genome
regions targeted by this assay. Recollection or referral of testing
to the CDC or state public health
laboratory may be considered for specimens with indeterminate
results. A result of “Invalid” indicates that neither
the viral RNA targets nor the internal
control target was detected. An invalid result suggests the
presence of inhibitors or inadequate collection. Recollection is
recommended in the case of an invalid result. CDC COVID-19 criteria for
testing on human specimens and clinical management guidance
information are available at the CDC
Coronavirus Disease 2019 (COVID-19)
webpage under “Information for Healthcare
Professionals”
(https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html)
Additional information about this and other EUA tests can be found in provider and patient fact
sheets at the following FDA website:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas |
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