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DxTerity SARS-CoV-2 RT-PCR CE Test EUA Summary – Updated February 11, 2021
13
Primer
ID
Primer
Length
(bp)
Number of
Mismatches
Mismatch Location
No. of
GenBank
Strains with
Mismatch
GenBank
Accession
Numbers
Exact
Tm
(°C)
*
1
Mismatch
Tm (°C)
2
C-A,
G-A
Middle 1 MW321407 65.5
60.2/
62.3
1 G-C/T 5’ 1 MW321318 65.5
61.3/
61.8
E_F 24
1
G-C
5'
1
MT632491
62.7
60.1
1 G-A Middle 1 MT598173 62.7 58.4
1
C-T
Middle
1
MT628097
62.7
58.3
1 G-T Middle 1 MT731733 62.7 59.7
1 G-K 5' 7
MT451436,
MT451386,
MT451358,
MT451279,
MT451276,
MT451269,
MT451259
62.7 62.7/57.2
E_R 26
1
C-A
3’
1
MW369373
63.9
58.8
1
G-A
5’
1
MW321325
60.3
1
G-T
Middle
1
MW321427
61.4
* Mismatch Tm lower than annealing temperature highlighted in yellow
1
Mismatch Tm calculated using the Oligo Analyzer tool available through Integrated DNA Technologies
(https://www.idtdna.com/calc/Analyzer/Home/Instructions)
3) Cross-reactivity (Analytical Specificity)
The analytical specificity of the DxTerity SARS-CoV-2 RT-PCR CE Assay was
demonstrated in silico and the analysis included evaluation of the primer homology with
the 43 organisms and viruses listed in Table 8.
The in silico analysis demonstrated that the assay does not cross react with any
organisms/strains except some closely related SARS coronavirus and bat coronavirus
RaTG13 (Table 9). However, since the prevalence of these strains is very low, and
contamination of saliva with bat coronavirus is not expected, the risk of cross-reacting
(false positive) is very low.
The analysis also demonstrated a homology of the RNase P gene forward primer with
Candida albicans, Haemophilus influenzae, and Moraxella catarrhalis. However, these
species are not expected to produce a detectable PCR product as there is no homology
between the RNase P reverse primer and these organisms. There is no risk of reporting
SARS-CoV-2 false positive results because of this homology.
Table 8. Organisms and viruses evaluated for potential cross-reaction and/or
interference with the DxTerity SARS-CoV-2 RT-PCR CE Assay
Viruses
Bacteria
Adenovirus
Bacillus anthracis
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