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DxTerity SARS-CoV-2 RT-PCR CE Test EUA Summary – Updated February 11, 2021
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specimens from individuals without symptoms should be considered as presumptive and
confirmed with a preferred specimen type or different molecular assay validated for testing
saliva, if necessary for patient management.
The DxTerity SARS-CoV-2 RT-PCR CE assay is intended for use by qualified clinical
laboratory personnel specifically instructed and trained in the techniques of PCR assays,
capillary electrophoresis and in vitro diagnostic procedures. The DxTerity SARS-CoV-2 RT-
PCR CE assay is only for use under the Food and Drug Administration’s Emergency Use
Authorization.
DEVICE DESCRIPTION AND TESTPRINCIPLE
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). The
SARS-CoV-2 primers are designed to detect RNA from SARS-CoV-2 in saliva specimens from
individuals 18 years old or older as recommended for testing by public health authority
guidelines. Children under the age of 18 may use this test, under adult supervision to assist, as
needed, with the steps beyond spitting into the collection tube.
Saliva specimens must be self-collected using the DxTerity COVID-19 Test Collection Kit
which contains the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.
DxTerity Ordering Process:
The saliva collection kit will be shipped under a standing ordering prescription from a physician
licensed in all 50 states and Washington DC to any individual for COVID-19 testing as
determined to be appropriate by the healthcare provider, including individuals without symptoms
of COVID-19. The individual first receives the saliva collection kit. When they wish to collect
the saliva sample in order to be tested, the individual will login to a secure online portal to
complete a required health questionnaire. As determined by the standing ordering prescription,
individuals exhibiting severe COVID warning symptoms are not allowed to proceed with kit
registration and instead are directed to seek emergency medical care. Individuals deemed to be
appropriate for testing are authorized to proceed with collection kit registration and the
unsupervised saliva collection process. The collection kit is then returned to DxTerity laboratory
for testing; results are returned to the individual via a secure online portal. A statement to the
report for positive and invalid results is added instructing the patient to contact their HCP if they
have concerns regarding the results. In addition, a link to the fact sheets for both HCP and patient
for the test is included in the test report that goes back to the patient via the portal.
The DxTerity COVID-19 Test Collection Kit contains the Spectrum Solutions LLC SDNA-1000
Saliva Collection Device, biohazard specimen bag with absorbent material, pre-labeled return
shipping box along with Instructions for Use for shipping the samples on the same day of
collection for next day delivery to the laboratory. Saliva specimens must be transported and
stored at ambient temperature and tested within 72 hours of collection. Specimens are received
at the clinical laboratory for testing with the DxTerity SARS-CoV-2 RT-PCR CE Test.
The test uses primers to detect specific nucleic acid sequences from the genome of the SARS-
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