Product Manual
Table Of Contents
- Contents
- INTENDED USE
- INTENDED USE
- INTENDED USE
- SUMMARY AND EXPLANATION
- PRINCIPLE OF THE TEST
- MATERIALS REQUIRED BUT NOT PROVIDED
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING OF KIT REAGENTS
- SPECIMEN COLLECTION, STORAGE AND HANDLING
- TEST PROCEDURE
- INTERPRETATION OF RESULTS
- QUALITY CONTROL
- LIMITATIONS
- Conditions of Authorization for the Laboratory and patient care settings
- CLINICAL PERFORMANCE
- ANALYTICAL PERFORMANCE
- Customer and Technical Support
- Intellectual Property
- REFERENCES
- GLOSSARY
Solana SARS-CoV-2 Assay Page 11 of 13
Cross-Reactivity/Interference Results
Interfering Substance Active Ingredient Concentration
Cross-Reactivity
Results*
Interference
Results*
Neo-Synephrine
Phenylephrine
hydrochloride
5% No Cross-Reactivity No Interference
Oseltamivir
Oseltamivir
2.2 µg/mL
No Cross-Reactivity
No Interference
Purified mucin protein
Mucin protein
2.5 mg/mL
No Cross-Reactivity
No Interference
Rhinocort
Budesonide
(Glucocorticoid)
5% No Cross-Reactivity No Interference
Saline nasal spray
Saline
15%
No Cross-Reactivity
No Interference
Tobramycin
Tobramycin
1.25 mg/mL
No Cross-Reactivity
No Interference
Zanamivir
Zanamivir
282.0 ng/mL
No Cross-Reactivity
No Interference
Zicam Cold Remedy
Galphimia glauca, Luffa
operculata, Sabadilla
5% No Cross-Reactivity No Interference
* Testing was performed in triplicate.
CUSTOMER AND TECHNICAL SUPPORT
To place an order or for technical support, please contact a Quidel Representative at 800.874.1517 (toll-free in the U.S.)
or 858.552.1100 (outside of U.S.), Monday through Friday, between 8:00 a.m. and 5:00 p.m., Eastern Time. Orders may
also be placed by fax at 740.592.9820. For e-mail support contact: customerservice@quidel.com or
technicalsupport@quidel.com. For services outside the U.S., please contact your local distributor. Additional information
about Quidel, our products, and our distributors can be found on our website quidel.com. Test system problems may also
be reported to the FDA through the MedWatch medical products reporting program (phone: 800.FDA.1088; fax:
800.FDA.0178; http://www.fda.gov/medwatch).
INTELLECTUAL PROPERTY
Dye compounds in this product are sold under license from Biosearch Technologies, Inc. and are protected by U.S. and
worldwide patents either issued or under application.
REFERENCES
1. https://www.who.int/publications/m/item/weekly-epidemiological-update---15-december-2020
2. Lauer, S.A., et. al. The incubation period of Coronavirus disease 2019 (COVID-19) from publicly reported confirmed
cases: estimation and application, Ann Intern Med. 2020
3. www.cdc.gov/coronavirus/2019-ncov/about/symptoms.html
4. Clinical and Laboratory Standards Institute. Viral Culture; Approved Guidelines. CLSI document M41-A [ISBN
1562386239] Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898, USA 2006.
M313 – Solana Assay – 96-Test Kit
Quidel Corporation
2005 East State Street, Suite 100
Athens, OH 45701 USA
quidel.com
PIM313000EN00 (120)