Product Manual

Solana SARS-CoV-2 Assay Page 7 of 13
 All operators using the Solana SARS-CoV-2 Assay must be appropriately trained in performing and interpreting the
results of the Solana SARS-CoV-2 Assay, use appropriate personal protective equipment when handling this kit, and
use your product in accordance with the authorized labeling.
 Quidel Corporation, authorized distributors, and authorized laboratories using the Solana SARS-CoV-2 Assay will
ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will
be made available to FDA for inspection upon request.
1
For ease of reference, the letter of authorization refers to “authorized laboratories” as follows: laboratories certified
under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to
perform high or moderate complexity tests.
CLINICAL PERFORMANCE
A study was performed comparing the Solana SARS-CoV-2 Assay to an authorized EUA RT-PCR assay. Two hundred forty
(240) nasal swab samples and fifty-one (51) nasopharyngeal swabs in viral transport media were tested with both devices
according to the respective package inserts. Two hundred four (204) samples were tested with the Solana assay after
storage of the viral transport media at -70°C. Eighty-seven (87) were tested with the Solana assay after storage of the
viral transport media at 2°C to 8°C.
Comparison of Solana SARS-CoV-2 Assay and an authorized EUA comparator assay
Specimen Type
Number
Tested
True
Positive
False
Positive
True
Negative
False
Negative
PPA% NPA% PPA 95% CI NPA 95% CI
Nasal Swabs 240 69 0 169 2 97.2 100
90.3% -
99.2%
97.8% -
100%
Nasopharyngeal
Swabs
51 19 1 31 0 100 96.9
83.2% -
100%
84.3% -
99.5%
Combined
Swabs
291 88 1 200 2 97.8 99.5
92.3% -
99.4%
97.2% -
99.9%
ANALYTICAL PERFORMANCE
LIMIT OF DETECTION
The Limit of detection (LoD) was established with BEI NR-52286, SARS-Related Coronavirus 2, Isolate USA-WA1/2020,
Heat Inactivated in three (3) separate studies using dilutions in negative nasal matrix collected into UTM.
Study 1 – LoD Screen
Ten-fold dilutions of the heat-inactivated SARS-CoV-2 were made in negative nasal matrix. Each dilution was tested in
triplicate with the Solana SARS-CoV-2 Assay. The last dilution with detectable RNA was used for the Pre-LoD testing.
LoD Screen Results
SARS-CoV-2 Concentration (cp/mL)
# Positive/Triplicate Test
% Positive
1.16 x 10
7
3/3
100%
1.16 x 10
6
3/3
100%
1.16 x 10
5
3/3
100%
1.16 x 10
4
3/3
100%
1.16 x 10
3
3/3
100%
1.16 x 10
2
0/3
0%
Study 2 – Pre-LoD testing
Based on the LoD screen data, the following dilutions of the SARS-CoV-2 were made in negative nasal matrix: 0.75X LoD,
1X LoD, 3X LoD, 5X LoD and 10X LoD. Each dilution was tested in triplicate with the Solana SARS-CoV-2 Assay.