QuickVue SARS Antigen Test

Intended Use

The QuickVue SARS Antigen Test is a lateral flow immunoassay for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens. It is intended for individuals suspected of COVID-19 by their healthcare provider within the first five days of symptom onset. Testing is limited to laboratories certified under CLIA that meet requirements for moderate, high, or waived complexity tests. It is authorized for use at the Point of Care (POC) in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable during the acute phase of infection. Positive results indicate viral antigens but require clinical correlation. Negative results should be treated as presumptive and may require confirmation with a molecular assay. The test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings, and is authorized under the FDA's Emergency Use Authorization.

Summary and Explanation

SARS-CoV-2, the virus causing COVID-19, was first identified in Wuhan, China, in December 2019. It is thought to have originated in bats, possibly with an intermediary host. COVID-19 was declared a pandemic on March 11, 2020, leading to global spread. Symptoms are similar to other viral respiratory diseases and include fever, cough, and shortness of breath. The median incubation time is approximately 5.1 days, with symptoms appearing within 12 days.

Principle of the Procedure

The QuickVue SARS Antigen test utilizes lateral flow immunoassay technology for rapid detection of nucleocapsid protein from SARS-CoV and SARS-CoV-2 (without differentiation). A lyophilized reagent is rehydrated in a Reagent Tube. The swab specimen is added, and the reagent facilitates antigen exposure to antibodies. A Test Strip is then added. A pink-to-red Test Line and a blue procedural Control Line indicate a positive result. Only a blue Control Line indicates a negative result.

Reagents and Materials Supplied (25-Test Kit)

• Individually Packaged Test Strips (25): Monoclonal anti-SARS antibodies
• Reagent Tubes (25): Lyophilized buffer with detergents and reducing agents
• Reagent Solution (25): Vials with 340 µL salt solution
• Sterile Nasal Swabs (Kit #20387) (25)
• SARS Positive Control Swab (1): Swab coated with non-infectious recombinant SARS antigens
• Negative Control Swab (1): Swab coated with heat-inactivated, non-infectious Streptococcus C antigen
• Package Insert (1)
• Procedure Card (1)

Materials Not Supplied

• Timer or watch
• QuickVue SARS Antigen Control Swab Set for additional QC (20389)
• Dry transport tube (SKU # 20385) (25)

Warnings and Precautions

• For in vitro diagnostic use
• For prescription use only
• Product authorized by FDA under EUA for CLIA-certified laboratories (moderate, high, or waived complexity) and for Point of Care (POC) use.
• Authorized only for the detection of SARS-CoV-2 proteins.
• Authorization is for the duration of the COVID-19 emergency declaration.
• Do not use kit contents beyond the expiration date.
• Wear suitable protective clothing, gloves (nitrile or latex), and eye/face protection.
• Reagent Solution is saline; flush with water if it contacts skin or eyes.
• Do not reuse used Test Strips, Reagent Tubes, solutions, or Control Swabs.
• Test Strips must remain sealed in foil pouches until use. Opening for extended periods may cause invalid results.
• Use only provided buffer and reagent solution.
• Proper specimen collection, storage, and transport are critical. Seek training if inexperienced.
• Inadequate collection/transport may yield false negative results.
• Follow Package Insert instructions for accurate results.
• Individuals with color-impaired vision may have difficulty interpreting results.
• Testing should be performed in an area with adequate ventilation.
• Dispose of containers and unused contents according to regulatory requirements.
• Wash hands thoroughly after handling.
• Refer to Safety Data Sheet (SDS) at quidel.com for additional information.

Kit Storage and Stability

Store the kit at room temperature, 59°F to 86°F (15°C to 30°C), out of direct sunlight. Kit contents are stable until the expiration date printed on the outer box. Do not freeze.

Specimen Collection and Handling

Proper specimen collection and handling are critical.

Nasal Swab Sample:

Use the nasal swab supplied in the kit. Instruct the patient to blow their nose before collection. Insert the absorbent tip of the swab (½ to ¼ inch or 1 to 1.5 cm) into the nostril. Firmly sample the nasal wall by rotating the swab in a circular path against the nasal wall at least 4 times for approximately 15 seconds. Collect any nasal drainage present. Sample both nostrils with the same swab.

Sample Transport and Storage:

Test samples as soon as possible after collection. Nasal swabs are stable for up to 120 hours at room temperature or 2° to 8°C in a clean, dry transport tube.

Quality Control

Two types of Quality Control (QC) are available: built-in procedural controls and external controls.

Built-in Control Features:

The test has built-in procedural controls. Daily control involves documenting these for the first sample tested each day. A blue procedural Control Line indicates sufficient flow and test strip integrity (positive control). If the blue Control Line does not appear within 10 minutes, the result is invalid. A built-in negative control is indicated by the clearing of red background color. The result area should be white to light pink within 10 minutes for clear interpretation. Persistent background color invalidates the result. If invalid, repeat with a new sample and test strip.

External Quality Control:

External controls demonstrate reagent and assay procedure performance. Quidel recommends running positive and negative controls once per untrained operator, once per new kit shipment (testing each lot), and as needed per internal procedures and regulations. Test procedures for external controls are in the Package Insert. If controls fail, repeat the test or contact Quidel Technical Support.

Additional Control Swabs can be obtained from Quidel's Customer Support Services at (800) 874.1517 or (858) 552.1100.

Test Procedure

Test materials and clinical specimens must be at room temperature before assay. Check expiration dates.

1. Dispense Reagent Solution into the Reagent Tube and swirl to dissolve contents. Keep the Reagent Tube in the holder.
2. Place the patient swab sample into the Reagent Tube. Roll the swab at least 3 times against the bottom and side of the tube. Keep swab in the tube for 1 minute.
3. Express liquid from the swab head by rolling it at least 3 times as it's removed. Discard the swab according to biohazard waste disposal protocols.
4. Place the Test Strip into the Reagent Tube with arrows pointing down. Do not handle or move until ready for reading.
5. At 10 minutes, remove the Test Strip and read the result within 5 minutes. Test strips should be read between 10-15 minutes after placement. Reading beyond this time may cause invalid results.

Interpretation of Results

Positive Result:

At 10 minutes, the appearance of ANY shade of a pink-to-red Test Line AND a blue procedural Control Line indicates a positive result for SARS antigen. Results are stable for 5 minutes after the read time. Do not read after 15 minutes. A faint pink Test Line with a blue Control Line is still a positive result.

C = Control Line, T = Test Line

Negative Result:

At 10 minutes, the appearance of ONLY the blue procedural Control Line indicates SARS antigen was not detected. Results are stable for 5 minutes after the read time. Do not read after 15 minutes. A negative result does not exclude SARS-CoV-2 infection and should be treated as presumptive, potentially requiring molecular assay confirmation.

Invalid Result:

If the blue procedural Control Line does not appear at 10 minutes (even with a Test Line), the result is invalid. If background color does not clear and interferes with reading at 10 minutes, the result is also invalid. If invalid, perform a new test with a new patient sample and Test Strip.

Limitations

• Test is intended for direct swab specimens only. Viral Transport Media (VTM) may cause false results.
• Kit contents are for qualitative detection of SARS antigens from anterior nares nasal swab specimens only.
• A negative result may occur if antigen levels are below the detection limit or if the sample was collected improperly.
• The test detects both viable and non-viable SARS-CoV and SARS-CoV-2. Performance depends on antigen amount and may not correlate with viral culture.
• Failure to follow procedures may adversely affect performance or invalidate results.
• Test results must be evaluated with other clinical data.
• Negative results do not rule out other non-SARS viral or bacterial infections.
• Positive results do not rule out co-infections.
• Negative results should be treated as presumptive and may require molecular assay confirmation.
• Differentiation of specific SARS viruses/strains requires additional testing in consultation with public health authorities.

Conditions of Authorization for Laboratory and Patient Care Settings

The QuickVue SARS Antigen Test Letter of Authorization, Fact Sheets for Healthcare Providers and Patients, and authorized labeling are available on the FDA website: FDA EUA Website.

Authorized laboratories must:

• Include all authorized Fact Sheets with test result reports.
• Use the product as outlined in authorized labeling; deviations are not permitted.
• Notify relevant public health authorities of their intent to test prior to initiating.
• Have a process for reporting test results to healthcare providers and public health authorities.
• Report product performance information, suspected false positive/negative results, and significant deviations to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov) and Quidel (via email: QDL.COV2.test.event.report@quidel.com or phone: 800.874.1517 / 858.552.1100).

Operators must be appropriately trained, use personal protective equipment, and follow authorized labeling.

Quidel Corporation, distributors, and authorized laboratories must maintain records associated with this EUA until notified otherwise by FDA and make them available for inspection.

Clinical Performance

The QuickVue SARS Antigen Test was compared to a Reference Extracted EUA SARS-CoV-2 RT-PCR Assay using frozen and fresh matched anterior nares swab specimens. 156 specimens were obtained from patients suspected of COVID-19 within five days of symptom onset. Testing was performed on frozen (56) and fresh (100) swabs. An additional 38 specimens from a prospective clinical study at POC sites were also tested.

Comparison Summary:

Analytical Performance

Limit of Detection (LoD)

The LoD was determined using limiting dilutions of heat-inactivated SARS-CoV-2 (ZeptoMetrix 0810587CFHI). The material was supplied at a concentration of 1.15 x10⁷ TCID₅₀/mL.

The LoD determination involved three steps: LoD Screening, LoD Range Finding, and LoD Confirmation. The confirmed LoD was 7.57 x10³ TCID₅₀/mL.

Analytical Reactivity/Inclusivity

The analytical reactivity of monoclonal antibodies targeting SARS-CoV-2 was evaluated with a SAR-CoV-2 strain (USA-WA1/2020) at a concentration of 1.15 x10⁷ TCID₅₀/mL.

Cross-Reactivity:

Cross-reactivity and interference were evaluated by testing various microorganisms and viruses. The QuickVue SARS Antigen Test showed no cross-reactivity or interference with the tested substances, including Adenovirus, Coronaviruses (OC43, 229e, NL63), MERS-CoV, Mycoplasma pneumoniae, Streptococcus pyogenes, various Influenza strains, Parainfluenza strains, Enterovirus, Human Metapneumovirus, Respiratory Syncytial Virus, Human Rhinovirus, Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Streptococcus pneumoniae, Bordetella pertussis, Pneumocystis jirovecii, Mycobacterium tuberculosis, Staphylococcus epidermidis, and Staphylococcus aureus.

Coronavirus HKU1 was not tested due to availability, but 19 specimens containing it tested negative.

*Testing was performed in triplicate.

**CCU/mL is Color Changing Units.

***Stock is inactivated virus with no quantitation.

****IFU/mL is infectious units per milliliter.

Hook Effect:

No Hook effect was detected when testing the highest concentration of heat-inactivated SARS-CoV-2 stock.

Endogenous Interference Substances Studies:

A study demonstrated that 20 potentially interfering substances found in the upper respiratory tract do not cross-react or interfere with SARS-CoV-2 detection. Substances tested included nasal sprays (Afrin, Rhinocort, Saline, Zicam), homeopathic remedies, blood, throat sprays (Chloraseptic, Cepacol), Flonase, Halls, Mupirocin ointment, Nasocort, NasalCrom, NeilMed products, Neo-Synephrine, and Oseltamivir. All showed no cross-reactivity or interference.

Assistance

For questions, contact Quidel's Technical Support at 800.874.1517 (U.S.) or 858.552.1100 (Monday-Friday, 7:00 a.m. - 5:00 p.m. Pacific Time). For international inquiries, contact your local distributor or technicalsupport@quidel.com. Test system problems can be reported to the FDA MedWatch program (phone: 800.FDA.1088; fax: 800.FDA.0178; FDA MedWatch).

References

1. Baker, S., Frias, L., and Bendix, A. Coronavirus live updates: More than 92,000 people have been infected and at least 3,100 have died. The US has reported 6 deaths. Here's everything we know. Business Insider. March 03, 2020.
2. WHO COVID-19 Events as They Happen
3. Clinical and Laboratory Standards Institute. Viral Culture; Approved Guidelines. CLSI document M41-A [ISBN 1562386239].
4. 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.
5. Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. U.S. Department of Health and Human Services, CDC, NIH, Washington, DC (2007).
6. Henretig F.M. MD, King C. MD. Textbook of Pediatric Procedures, Chapter 123 – Obtaining Biologic Specimens. Williams and Williams (April 1997).
7. The Clinical Virology Laboratory, Department of Laboratory Medicine at Yale: Yale Virology Booklet.
8. Australian Management Plan for Pandemic Influenza – Section 5 Annex 5: Laboratory Guidelines.

Product Information

Product Name: QuickVue SARS Antigen 25 Test Kit (Nasal Swab)

Catalogue Number (REF): 20387

Manufacturer:

• Quidel Corporation, 2005 East State Street, Suite 100, Athens, OH 45701 USA. quidel.com
• MDSS GmBH, Schiffgraben 41, 30175 Hannover, Germany (EC REP)

Regulatory Markings: IVD, CE

Version/Date: XXXXXXXEN00 (12/20)

Glossary

REF: Catalogue number

CE: CE mark of conformity

EC REP: Authorized Representative in the European Community

LOT: Batch code

?️ Use by: Temperature limitation

? Manufacturer

℞ ONLY: Prescription use only

? Intended use

ℹ️ Consult instructions for use

IVD: For In Vitro diagnostic use

Σ25: Contains sufficient for 25 determinations

CONT: Contents/Contains

CONTROL +: Positive control

CONTROL -: Negative control