Product Manual

Solana SARS-CoV-2 Assay Page 8 of 13
Pre-LoD Results
SARS-CoV-2 Concentration (cp/mL)
# Positive/Triplicate Test
% Positive
1.16 x 10
4
3/3
100%
8.72 x 10
3
3/3
100%
3.48 x 10
3
1/3
33%
1.16 x 10
3
1/3
33%
8.72 x 10
2
1/3
33%
Study 3 –LoD Confirmation testing
Based on the Pre-LoD data, the dilution demonstrating ≥95% detection was used in the LoD confirmation study. A 1x LoD
dilution was made in negative nasal matrix. This dilution was tested with twenty replicates with the Solana SARS-CoV-2
Assay.
LoD Confirmation
SARS-CoV-2 Concentration (cp/mL)
# Positive/Triplicate Test
% Positive
8.72 x 10
3
16/20
80%
Based on this data, the next highest LoD dilution was made in negative nasal matrix (1.16 x 10
4
). This dilution was tested
with twenty replicates with the Solana SARS-CoV-2 Assay.
LoD Confirmation
SARS-CoV-2 Concentration (cp/mL)
# Positive/Triplicate Test
% Positive
1.16 x 10
4
20/20
100%
The limit of detection (LoD) of the Solana SARS-CoV-2 Assay using limiting dilutions of heat-inactivated SARS-CoV-2 is 1.16
× 10
4
cp/mL. This LoD was confirmed by testing 20 replicates each of negative nasal matrix collected into the CDC Viral
Transport Media spiked with heat-inactivated SARS-CoV-2 at 1.16 × 10
4
cp/mL.
ANALYTICAL REACTIVITY/INCLUSIVITY
Specific nucleic acid sequences used in the Solana SARS-CoV-2 Assay target the highly conserved regions of the SARS-CoV-
2 virus non-structural Polyprotein (pp1ab).
The inclusivity of the Solana SARS-CoV-2 Assay was established through an in-silico analysis of available SARS-CoV-2
sequences. As of October 30, 2020, a total of 197,133 SARS-CoV-2 sequences were available from the GISAID and NCBI
databases. Of these, 194,584 (98.71%) include the amplicon region (<5 Ns in any oligonucleotide region) and are 92.31-
100% conserved to the Solana SARS-CoV-2 oligonucleotides.
CROSS-REACTIVITY (ANALYTICAL SPECIFICITY):
The Analytical Specificity of the assay was established by both direct testing of organisms in the assay (“wet” testing) and
in-silico analysis.
The potential microbial interference or cross-reactivity of Solana SARS-CoV-2 Assay was evaluated by testing various
microorganisms (13), viruses (16) that may potentially interfere or cross-react based on the reasonable likelihood that
they may be present in upper respiratory tract specimens. Each organism and virus was tested in negative nasal clinical
matrix at target concentrations in the absence (negative) and presence (positive) SARS-CoV-2. Each condition (negative or
positive) was tested with three replicates per substance. The final concentrations of the organisms and viruses are
documented in the table below:
Cross-Reactivity/Microbial Interference Results
Virus/Bacteria/Parasite* Strain
Source/
Sample type
Concentration
Cross-Reactivity
Results*
Interference
Results*
Adenovirus
Type 1
Isolate
1 x 10
7.53
U/mL
No Cross-Reactivity
No Interference
Coronavirus
229e
Isolate
1 x 10
6.10
U/mL
No Cross-Reactivity
No Interference