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DxTerity SARS-CoV-2 RT-PCR CE Test EUA Summary – Updated February 11, 2021
25
Sample
Group
Test Point
Number
Tested
Overall
Percent
Positive (%)
# Detected / # Tested by Target Genes
N Gene ORF1ab
E Gene
RNase P
Winter
10
100 (10/10)
10/10
10/10
10/10
10/10
N/A: Not Applicable
1
Testing performed at the conclusion of the thermal excursions described in Table 14D
2
Testing performed at the conclusion of the thermal excursions described in Table 14E
Summary of Results (Table 14F):
• For the SARS-CoV-2 negative specimens, 10 /10 (100%) and 10/10 (100%) were
reported as Negative after summer and winter temperature excursions, respectively.
• For the SARS-CoV-2 High Positive saliva samples 10/10 (100%) and 10 /10 (100%)
were reported as positive after the summer and winter temperature excursions
respectively.
• From 20 Low Positive saliva samples exposed to winter shipping profile, 20/20
(100%) were reported positive. From 20 Low Positive saliva samples exposed to the
summer shipping profile, 20/20 (100%) were reported positive.
These results demonstrate that SARS-CoV-2 positive saliva specimens are stable in the
SDNA-1000 Saliva Collection Device when exposed to a broad range of temperature
conditions. These data support the use of the SDNA-1000 Saliva Collection Device
for transport and storage of specimens for 72 hours following home collection of
saliva.
8) Saliva Sample Volume Tolerance Study:
A study was conducted to evaluate the effect of over or under filling of the Spectrum
Solutions LLC SDNA-1000 Saliva Collection Device by the user. The over fill and
under fill of 25, 50 and 75% were evaluated and compared to intended (standard - STD)
saliva collection volume of 2.0 mL.
The effect of over or under filling the Spectrum Solutions LLC SDNA-1000 Saliva
Collection Device was evaluated using a total of 4 contrived positive and 2 negative
specimens. Presumptive negative saliva collected into the Spectrum Solutions LLC
SDNA-1000 Saliva Collection Device were pooled and spiked with SARS-CoV-2
genomic RNA (BEI Resources) at 2x LoD and 200x LoD to create low and high
positive samples. Negative clinical samples without spiked-in viral genomic RNA were
used as negative samples.
A summary of the results is provided in Table 15.
Table 15. Summary of results from Saliva Sample Volume Tolerance Study by
Primer Mix, stratified by condition and measurand
Primer Mix 1 FAM
Sample
Filling
Condition
Replicates
Tested
Overall Percent
Agreement
# Detected / #Tested by Target Gene
N Gene ORF1ab
E Gene RNase P
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