Loading ...
Loading ...
Loading ...
DxTerity SARS-CoV-2 RT-PCR CE Test EUA Summary – Updated February 11, 2021
4
Capillary
electrophoresis
Instrument
ThermoFisher
ABI 3500xL
Dx Genetic Analyzer
(K191030) Catalog
#4404688 (IVD
instrument)
Data Collection
Software Version 3.2
COLLECTION KITS USED WITH THE TEST
This test must be used with the Spectrum Solutions LLC SDNA-1000 Saliva Collection
Device to self-collect saliva specimens at home when determined to be appropriate by an
HCP.
REAGENTS AND MATERIALS
Table 2. Reagents and Materials for Use with the DxTerity SARS-CoV-2 RT-PCR CE Test
Reagent
Manufacturer
Catalogue #
DxPure Bead Mix DxTerity
Diagnostics
N/A not
commercially
available
DxBind II
DxTerity
Diagnostics
N/A not
commercially
available
DxPure Wash Buffer
DxTerity
Diagnostics
N/A not
commercially
available
96 well deep well plates
PerkinElmer
43001-0120
TaqPath™ 1-Step Multiplex Master Mix (No ROX)
ThermoFisher
A28523
DxT SARS-CoV-2 Mix 1 – FAM
DxTerity
Diagnostics
N/A not
commercially
available/Proprietary
DxT SARS-CoV-2 Mix 2 – VIC
DxTerity
Diagnostics
N/A not
commercially
available/ Proprietary
DxT SARS-CoV-2 Mix 3 – NED
DxTerity
Diagnostics
N/A not
commercially/
Proprietary available
DxT SARS-CoV-2 Mix 4 – PET equivalent Atto-565
DxTerity
Diagnostics
N/A not
commercially
available/ Proprietary
Twist Synthetic SARS-CoV-2 RNA Control
Twist Biosciences
102024
SARS-Related Coronavirus 2, Isolate USA-
WA1/2020, Gamma-Irradiated
BEI
NR
-52287
Positive Control Dilution Buffer
DxTerity
Diagnostics
N/A not commercially
available
Amplicon Dilution Buffer
DxTerity
Diagnostics
N/A not commercially
available
Loading ...
Loading ...
Loading ...