Product Manual

ManualsBrandsQuidel ManualsRapid TestsSolana SARS-CoV-2 Assay

Solana SARS-CoV-2 Assay Page 1 of 13

For use under the Emergency Use Authorization (EUA) only

For in vitro diagnostic use

A symbols glossary can be found at quidel.com/glossary.

CONTENTS

CONTENTS ....................................................................................................................................................................... 1

INTENDED USE ..................................................................................................................................................... 1

SUMMARY AND EXPLANATION ....................................................................................................................................... 2

PRINCIPLE OF THE TEST ................................................................................................................................................... 2

MATERIALS PROVIDED .................................................................................................................................................... 3

MATERIALS REQUIRED BUT NOT PROVIDED ................................................................................................................... 3

WARNINGS AND PRECAUTIONS ...................................................................................................................................... 3

STORAGE AND HANDLING OF KIT REAGENTS ................................................................................................................. 4

SPECIMEN COLLECTION, STORAGE AND HANDLING ....................................................................................................... 4

TEST PROCEDURE ............................................................................................................................................................ 4

INTERPRETATION OF RESULTS ........................................................................................................................................ 5

QUALITY CONTROL .......................................................................................................................................................... 5

LIMITATIONS ................................................................................................................................................................... 6

CONDITIONS OF AUTHORIZATION FOR THE LABORATORY AND PATIENT CARE SETTINGS ............................................ 6

CLINICAL PERFORMANCE ................................................................................................................................................ 7

ANALYTICAL PERFORMANCE ........................................................................................................................................... 7

CUSTOMER AND TECHNICAL SUPPORT ......................................................................................................................... 11

INTELLECTUAL PROPERTY .............................................................................................................................................. 11

REFERENCES .................................................................................................................................................................. 11

GLOSSARY ...................................................................................................................................................................... 13

INTENDED USE

The Solana SARS-CoV-2 Assay is an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay

intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab

specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified

under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high or moderate

complexity tests.

FOR USE WITH SOLANA

For the qualitative detection of SARS-CoV-2 viral RNA in nasal and nasopharyngeal swabs in viral

transport medium from individuals suspected of COVID-19 by their healthcare provider.

Summary of content (13 pages)

PAGE 1
For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use FOR USE WITH SOLANA For the qualitative detection of SARS-CoV-2 viral RNA in nasal and nasopharyngeal swabs in viral transport medium from individuals suspected of COVID-19 by their healthcare provider. A symbols glossary can be found at quidel.com/glossary. CONTENTS CONTENTS ...................................................................................................................................................
PAGE 2
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 is generally detectable upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
PAGE 3
MATERIALS PROVIDED Cat. #M313 96 Tests per Kit Component Quantity Storage Process Buffer 96 tubes/kit 0.75 mL 2°C to 8°C Empty Reaction Tubes 96 tubes/kit 2°C to 30°C Negative Control 1 tube/kit 2.0 mL 2°C to 8°C Positive Control 1 tube each/kit 1.0 mL 2°C to 8°C 8 tubes/kit 0.
PAGE 4
                Never pool reagents from different tubes even if they are from the same lot. Do not use the reagents after their expiration date. Do not interchange caps among reagents as contamination may occur and compromise test results. Only open the tubes when adding aliquots into tubes or removing aliquots from tubes. Keep the tubes closed at any other time to avoid contamination. For accurate results, pipette carefully using only calibrated equipment.
PAGE 5
9. Add 25 µL of Master Mix to each empty reaction tube. 10. Add 25 µL of each heat lysed Process Buffer specimen to the corresponding Reaction Tube directly into the liquid Master Mix and mix by vigorously pipetting up and down 5 times. Firmly close the Reaction Tubes. 11. Using the Solana Transfer Rack to hold Reaction Tubes at eye-level, visually inspect each Reaction Tube to ensure there are no air bubbles present at the bottom of the tube and liquid levels are equivalent.
PAGE 6
 The external negative control may be treated as a patient specimen. The control should be sampled and tested as if it were a patient specimen and processed as described above in the Assay Procedure. The external negative control is used to detect reagent or environmental contamination (or carry-over) by SARS-CoV-2 RNA or amplicon. It is recommended that the reactivity of each new lot and each new shipment of the Solana SARS-CoV-2 Assay be verified on receipt and before use.
PAGE 7
 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.
PAGE 8
Pre-LoD Results SARS-CoV-2 Concentration (cp/mL) # Positive/Triplicate Test 1.16 x 104 3/3 8.72 x 103 3/3 3.48 x 103 1/3 3 1.16 x 10 1/3 8.72 x 102 1/3 % Positive 100% 100% 33% 33% 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.
PAGE 9
Cross-Reactivity/Microbial Interference Results Virus/Bacteria/Parasite* Strain Source/ Sample type Coronavirus OC43 Isolate Coronavirus Isolate Influenza B Parainfluenza Parainfluenza NL63 Florida/USA2_Saudi Arabia_2014 M129 Z018 Brisbane/10/07 New Caledonia/20/99 Brisbane/33/08 Type 1 Type 2 Parainfluenza Type 3 Isolate Parainfluenza Enterovirus Human Metapneumovirus Type 4b Type 68 A1 (IA10-s003) Type A (3/2015 Isolate #3) MERS-CoV (heat-inactivated) Mycoplasma pneumoniae Streptococcus pyo
PAGE 10
Homology Results of Solana® SARS-COV-2 Primers Against Cross-Reactants Organism # Sequences ≥80% Conserved to both Primers Influenza B Virus 0 Influenza C Virus 0 Human Metapneumovirus 0 Human Parainfluenza Virus 1-4 0 Human Parechovirus 0 Human Respiratory Syncytial Virus 0 Rhinovirus 0 SARS-1 227 Bacillus anthracis 0 Candida albicans 0 Chlamydia pneumoniae 0 Chlamydia psittaci 0 Corynebacterium diphtheriae 0 Coxiella burnetii 0 Haemophilus influenzae 0 Legionella 0 Leptos
PAGE 11
Cross-Reactivity/Interference Results Cross-Reactivity Interfering Substance Active Ingredient Concentration Results* Phenylephrine Neo-Synephrine 5% No Cross-Reactivity hydrochloride Oseltamivir Oseltamivir 2.2 µg/mL No Cross-Reactivity Purified mucin protein Mucin protein 2.5 mg/mL No Cross-Reactivity Budesonide Rhinocort 5% No Cross-Reactivity (Glucocorticoid) Saline nasal spray Saline 15% No Cross-Reactivity Tobramycin Tobramycin 1.25 mg/mL No Cross-Reactivity Zanamivir Zanamivir 282.
PAGE 12
Solana SARS-CoV-2 Assay Page 12 of 13
PAGE 13
GLOSSARY Catalog number Batch code Use by Manufacturer Temperature limitation Intended use Prescription use only Consult e-labeling instructions for use 96 For In Vitro diagnostic use Contains sufficient for 96 determinations Contents/Contains Solana SARS-CoV-2 Assay Page 13 of 13