DxTerity SARS-CoV-2 RT-PCR CE Test EUA Summary – Updated February 11, 2021
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EMERGENCY USE AUTHORIZATION (EUA) SUMMARY
DxTerity SARS-CoV-2 RT-PCR CE Test
(DxTerity Diagnostics, Inc.)
For in vitro Diagnostic Use
Rx Only
For Use Under Emergency Use Authorization (EUA) Only
(The DxTerity SARS-CoV-2 RT-PCR CE Test will be performed at the DxTerity
Diagnostics Clinical Laboratory, located at 19500 S. Rancho Way, Suite 116 Rancho
Dominguez, CA 90220, which is certified under Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a and meets requirements to perform high-
complexity tests, as described in the Laboratory Standard Operating Procedure that was
reviewed by the FDA under this EUA.)
INTENDED USE
The DxTerity SARS-CoV-2 RT-PCR CE Test is an end point reverse transcription polymerase
chain reaction (RT-PCR) test followed by detection with capillary electrophoresis (CE) test
intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in saliva specimens
collected from any individuals determined to be appropriate for COVID-19 testing by their
healthcare provider (HCP), including from individuals without symptoms of COVID-19.
Testing is limited to DxTerity Diagnostics, Inc. located at 19500 S. Rancho Way, Suite 116,
Rancho Dominguez, CA 90220, which is certified which is certified under Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to
perform high complexity tests.
DxTerity SARS-CoV-2 RT-PCR CE Test is for use with saliva specimens that are self-collected
at home using the DxTerity COVID-19 Test Collection Kit when determined to be appropriate
by a HCP.
Results are for the detection and identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is
generally detectable in respiratory specimens during the acute phase of infection. Positive results
are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and
other diagnostic information is necessary to determine patient infection status. Positive results do
not rule out bacterial infection or co-infection with other viruses. The agent detected may not be
the definite cause of disease. Laboratories within the United States and its territories are required
to report all results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis
for patient management decisions. Negative results must be combined with clinical observations,
patient history, and epidemiological information. Negative results obtained from saliva
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