QuickVue COVID-19 Test

K231795 · Quidel Corporation · QYT · Mar 22, 2024 · Microbiology

Device Facts

• Record ID: K231795
• Device Name: QuickVue COVID-19 Test
• Applicant: Quidel Corporation
• Product Code: QYT · Microbiology
• Decision Date: Mar 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3984
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The QuickVue COVID-19 Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 5 days from symptom onset. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2. All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider. The performance characteristics for SARS-CoV-2 were established from January 2021 to February 2024 when COVID-19 variants Alpha, Delta, and Omicron were dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

Device Story

QuickVue COVID-19 Test is a lateral flow immunoassay for qualitative detection of SARS-CoV-2 nucleocapsid protein antigens. Input: anterior nasal swab specimen. Operation: lysis reagent disrupts virus particles; viral antigens react with antibodies on test strip. Output: visual pink-to-red test line (positive) and blue procedural control line. Used in home setting by lay users (self-test or adult-assisted). QVue mobile application provides electronic labeling and digital guidance for test execution. Results interpreted visually by user; negative results are presumptive and require re-testing. Clinical decision-making involves seeking healthcare provider follow-up for negative results with persistent symptoms or if new variants are suspected. Benefits include rapid, accessible COVID-19 screening.

Clinical Evidence

Prospective clinical study (n=878) compared QuickVue to EUA-authorized RT-PCR. In symptomatic individuals (within 5 days of onset), PPA was 82.0% (95% CI: 76.1% - 86.7%) and NPA was 99.1% (95% CI: 98.0% - 99.6%).

Technological Characteristics

Lateral flow immunoassay; visual read. Components: test strips, reagent tubes, nasal swabs. Storage: 15°C - 30°C. Development time: 10 minutes. Analyte: SARS-CoV-2 nucleocapsid protein antigen.

Indications for Use

Indicated for symptomatic individuals (within 5 days of symptom onset) for rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in anterior nasal swab specimens. For non-prescription home use by individuals aged 14+ (self-test) or adults testing individuals aged 2+.

Regulatory Classification

Identification

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

Predicate Devices

• Flowflex COVID-19 Antigen Home Test (K230828)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Quidel Corporation Suzanne Thomas Sr. Regulatory Affairs Manager 10165 McKellar Court San Diego, California 92121

March 22, 2024

Re: K231795

Trade/Device Name: QuickVue COVID-19 Test Regulation Number: 21 CFR 866.3984 Regulation Name: Over-The-Counter Test To Detect SARS-CoV-2 From Clinical Specimens Regulatory Class: Class II Product Code: QYT Dated: June 16, 2023 Received: June 20, 2023

Dear Suzanne Thomas:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Uwe Scherf -S

Uwe Scherf, M.S., Ph.D. Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K231795

Device Name QuickVue COVID-19 Test

### Indications for Use (Describe)

The QuickVue COVID-19 Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 5 days from symptom onset. This test is for nonprescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.

All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as for treatment. Positive results do not rule out co-infection with other respiratory pathogens.

This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

The performance characteristics for SARS-CoV-2 were established from January 2021 to February 2024 when COVID-19 variants Alpha, Delta and Omicron were dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with rounded corners, divided into four quadrants. The top-left quadrant is a gradient of colors, including red, orange, yellow, and green. The top-right quadrant is light blue, and the bottom-left quadrant is dark blue. The bottom-right quadrant is purple. Below the square is the word "QUIDEL" in a sans-serif font.

# 510(K) SUMMARY

#### I. Submitter

Quidel Corporation 10165 McKellar Court San Diego, CA 92121 Telephone: [phone]

# Submission Contact

Suzanne Thomas Sr. Regulatory Affairs Manager 678-727-8786 [e-mail]

# Date Prepared

March 22, 2024

# Proprietary and Established Names

QuickVue COVID-19 Test

### Common Name

Coronavirus Antigen Detection Test

### II. Device Classification

| Product | Product<br>Code | Classification | Regulatory<br>Section | Description |
|---------|-----------------|----------------|-----------------------|----------------------------------------------|
| Assay | QYT | II | 21 CFR 866.3984 | Over-the-Counter<br>COVID-19<br>antigen test |

### Panel

Microbiology

### Predicate Device

ACON Flowflex COVID-19 Antigen Home Test (K230828; cleared 11/09/2023)

### III. Device Description

The QuickVue COVID-19 Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.

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Image /page/5/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square shape with rounded corners, filled with a gradient of colors resembling a rainbow spectrum. Below the square is the word "QUIDEL" in a simple, sans-serif font. The overall design is clean and modern, suggesting a company involved in technology or healthcare.

To begin the test, a self-collected anterior nasal swab sample (in individuals aged 14 and older or individuals between the age of 2 to 14 a swab collected by a parent or guardian), or a healthcare collected anterior nasal swab sample is inserted into the pre-filled reagent tube. The reagent disrupts the virus particles in the specimen, exposing internal viral nucleocapsid antigens. The test strip is then placed in the reagent tube where the viral nucleocapsid antigens in the specimen will react with the reagents in the test strip.

If the extracted specimen contains SARS-CoV-2 viral nucleocapsid antigens, a pink-to-red test line along with a blue procedural control line will appear on the test strip indicating a positive result. If SARS-CoV-2 viral nucleocapsid antigens are not present, or are present at very low levels, only the blue procedural control line will appear.

| Component | 2-Test | 4-Test | 25-Test |
|-------------------------------------------|------------------------------------------------------------------------|--------|---------|
| Individually Packaged Test strips | 2 | 4 | 25 |
| Reagent Tubes containing Reagent Solution | 2 | 4 | 25 |
| Nasal Swabs | 2 | 4 | 25 |
| User Instructions | 1 | 1 | 1 |
| Strip Placement Card | 2 | 2 | 2 |
| QVue Mobile Application (Optional) | Available for download using the QR<br>code located on the Unit Carton | | |

# Assay Components

# IV. Intended Use

The QuickVue COVID-19 Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 5 days from symptom onset. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.

All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens.

This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

The performance characteristics for SARS-CoV-2 were established from January 2021 to February 2024 when COVID-19 variants Alpha, Delta, and Omicron were dominant. Test accuracy may change as new

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Image /page/6/Picture/0 description: The image contains the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, filled with a gradient of colors resembling a rainbow. The bottom right corner of the square is a solid blue color. Below the square is the word "QUIDEL" in a simple sans-serif font.

SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

| Features | Proposed Device<br>QuickVue COVID-19 Test | Predicate Device<br>Flowflex COVID-19 Antigen Home Test<br>K230828 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The QuickVue COVID-19 Test is a visually<br>read lateral flow immunoassay device intended<br>for the rapid, qualitative detection of SARS-<br>CoV-2 nucleocapsid protein antigens directly<br>in anterior nasal (nares) swab specimens from<br>individuals with signs and symptoms of<br>COVID-19 within the first 5 days from<br>symptom onset. This test is for non-<br>prescription home use by individuals aged 14<br>years or older testing themselves, or adults<br>testing individuals aged 2 years or older.<br>The QuickVue COVID-19 Test does not<br>differentiate between SARS-CoV and SARS-<br>CoV-2.<br>All negative results are presumptive.<br>Symptomatic individuals with an initial<br>negative test result must be re-tested once<br>between 48 and 72 hours after the first test<br>using either an antigen test or a molecular test<br>for SARS-CoV-2. Negative results do not<br>preclude SARS-CoV-2 infections or other<br>pathogens and should not be used as the sole<br>basis for treatment. Positive results do not rule<br>out co-infection with other respiratory<br>pathogens.<br>This test is not a substitute for visits to a<br>healthcare provider or appropriate follow-up<br>and should not be used to determine any<br>treatments without provider supervision.<br>Individuals who test negative and experience<br>continued or worsening COVID-19 like<br>symptoms, such as fever, cough and/or<br>shortness of breath, should seek follow up care<br>from their healthcare provider.<br>The performance characteristics for SARS-<br>CoV-2 were established from January 2021 to<br>February 2024 when COVID-19 variants<br>Alpha, Delta, and Omicron were dominant.<br>Test accuracy may change as new SARS-CoV- | The Flowflex COVID-19 Antigen Home<br>Test is a visually read lateral flow<br>immunoassay device intended for the<br>rapid, qualitative detection of SARS-CoV-<br>2 virus nucleocapsid protein antigen<br>directly in anterior nasal swab specimens<br>from individuals with signs and symptoms<br>of COVID19 within the first 6 days of<br>symptom onset. This test is for non-<br>prescription home use by individuals aged<br>14 years or older testing themselves, or<br>adults testing individuals aged 2 years or<br>older. The Flowflex COVID-19 Antigen<br>Home Test does not differentiate between<br>SARS-CoV and SARS-CoV-2. All<br>negative results are presumptive.<br>Symptomatic individuals with an initial<br>negative test result must be re-tested once<br>between 48 and 72 hours after the first test<br>using either an antigen test or a molecular<br>test for SARS-CoV-2. Negative results do<br>not preclude SARS-CoV-2 infections or<br>other pathogens and should not be used as<br>the sole basis for treatment. Positive<br>results do not rule out co-infection with<br>other respiratory pathogens. This test is<br>not a substitute for visits to a healthcare<br>provider or appropriate follow-up and<br>should not be used to determine any<br>treatments without provider supervision.<br>Individuals who test negative and<br>experience continued or worsening<br>COVID-19 like symptoms, such as fever,<br>cough and/or shortness of breath, should<br>seek follow up care from their healthcare<br>provider. The performance characteristics<br>for SARS-CoV-2 were established from<br>December 2022 to March 2023 when<br>SARS-CoV-2 Omicron was dominant.<br>Test accuracy may change as new SARS-<br>CoV-2 viruses emerge. Additional testing<br>with a lab-based molecular test (e.g., PCR) |
| | 2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected. | should be considered in situations where a new virus or variant is suspected. |
| Qualitative | Yes | Same |
| Analyte | SARS-CoV-2 nucleocapsid protein antigen | Same |
| Intended Use Population | Individuals with symptoms of COVID-19 | Same |
| Specimen Type | Direct anterior nasal swab specimens | Same |
| Test Principle | Lateral flow immunoassay | Same |
| Format | Test strip | Test cassette |
| Development Time | 10 min | 15-30 min |
| Storage | Room Temperature (15°C - 30°C) | Same |
| Use Setting (OTC or Rx) | OTC | OTC |
| Rapid test | Yes | Same |
| Result Interpretation | Visual read | Same |
| Utilizes App to display results | Optional | Optional |

#### V. Comparison with Predicate Device

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Image /page/7/Figure/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square divided into four quadrants, with the top left quadrant displaying a spectrum of colors from yellow to red. The bottom right quadrant is filled with shades of blue and purple. Below the square is the word "QUIDEL" in a simple, sans-serif font.

# VI. Performance Data

Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to the predicate device. The performances studies included:

### Limit of Detection

The Limit of Detection (LoD) of the QuickVue COVID-19 Test was determined by evaluating different dilutions of heat-inactivated SARS-CoV-2. isolate USA-WA1/2020, and dilutions of SARS CoV-2, isolate Omicron BA.5, in negative nasal matrix (NNM). The LoD was determined as the lowest virus concentration that was detected ≥ 95% of the time (i.e., concentration at which at least 19 out of 20 replicates tested positive). The limit of detection for the QuickVue COVID-19 Test using SARS-CoV-2 strain WA1/2020 was confirmed to be 3.03E+04 TCIDsy/mL. The limit of detection for the QuickVue COVID-19 Test with SARS-CoV-2 strain Omicron BA.5 was confirmed to be 2.48E+04 TCID50/mL.

| Analyte Strain | LoD Concentration<br>(TCID50/mL) | LoD Concentration<br>(TCID50/Swab) |
|-----------------|----------------------------------|------------------------------------|
| WA1/2020/ Alpha | 3.03E+04 | 1.52E+03 |
| Omicron / BA.5 | 2.48E+04 | 1.24E+03 |

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Image /page/8/Picture/0 description: The image features the logo for Quidel. The logo consists of a square shape with rounded corners, divided into four quadrants. The top and left quadrants are filled with a gradient of colors, including red, orange, yellow, green, blue, and purple. The bottom right quadrant is filled with a solid blue color. Below the square shape, the word "QUIDEL" is written in a sans-serif font.

# Inclusivity (Analytical Reactivity)

Analytical reactivity for OuickYue COVID-19 Test was demonstrated using 2 additional strains/isolates of SARS CoV-2 virus. Heat-inactivated SARS-CoV-2 isolates Omicron BA.1 and Delta stocks were each diluted into NNM at different concentrations. Each concentration was tested with 5 replicates until two consecutive dilutions produced one or more negative replicates out of 5.

The QuickVue COVID-19 Test detected the viral strains/isolates SARS-CoV-2, Omicron BA.1 and SARS-CoV-2, Delta. The minimum detectable concentration of SARS-CoV-2, Omicron BA.1 was 7.08E+04 TCID50/mL. The minimum detectable concentration of SARS-CoV-2, Delta was 3.00E+04 TCID50mL.

### Cross Reactivity/Microbial Interference

The cross-reactivity and potential interference were evaluated by testing various microorganisms (21), viruses (39), and negative matrix (1) with the QuickVue COVID-19 Test. Each organism and virus were tested in five (5) replicates in the absence or presence of 6.06E+04 TCID30mL of heat-inactivated SARS-CoV-2 (isolate USA-WA1/2020). None of the organisms and viruses below in Table 1 showed crossreactivity and interference in the assay at the concentrations listed except for SARS-Coronavirus. Crossreactivity was observed on SARS-Coronavirus sample as expected.

| Virus/Bacteria/Parasite | Strain/ID | Concentration | Units | Cross-<br>Reactivity<br>(Yes/No) | Interference<br>(Yes/No) |
|-------------------------------------------------------------------------------------------------------|-----------------------|---------------|-----------|----------------------------------|--------------------------|
| Adenovirus | Type 1 | 1.41E+05 | TCID50/mL | No | No |
| Adenovirus | Type 2 | 1.04E+05 | TCID50/mL | No | No |
| Adenovirus | Type 3 | 1.05E+05 | TCID50/mL | No | No |
| Adenovirus | Type 4 | 1.78E+05 | TCID50/mL | No | No |
| Adenovirus | Type 5 | 1.58E+05 | TCID50/mL | No | No |
| Adenovirus | Type 7 | 1.90E+05 | TCID50/mL | No | No |
| Adenovirus | Type 11 | 1.47E+05 | TCID50/mL | No | No |
| Adenovirus | Type 14 | 1.06E+05 | TCID50/mL | No | No |
| Adenovirus | Type 22 | 2.50E+06 | TCID50/mL | No | No |
| Adenovirus | Type 31 | 1.06E+05 | TCID50/mL | No | No |
| Adenovirus | Type 35 | 4.00E+05 | TCID50/mL | No | No |
| Coronavirus | 229e | 1.26E+05 | TCID50/mL | No | No |
| Coronavirus | NL63 | 1.06E+05 | TCID50/mL | No | No |
| Virus/Bacteria/Parasite | Strain/ID | Concentration | Units | Cross-<br>Reactivity<br>(Yes/No) | Interference<br>(Yes/No) |
| Coronavirus | 0C43 | 1.28E+05 | TCID50/mL | No | No |
| MERS-CoV | None<br>Specified | 1.04E+05 | TCID50/mL | No | No |
| SARS-Coronavirus | None<br>Specified | 1.05E+05 | TCID50/mL | Yes | No |
| Cytomegalovirus | None<br>Specified | 1.13E+05 | TCID50/mL | No | No |
| Enterovirus | Coxsackie | 1.04E+05 | TCID50/mL | No | No |
| Enterovirus | Echovirus | 1.41E+05 | TCID50/mL | No | No |
| Enterovirus | EV68 | 1.28E+05 | TCID50/mL | No | No |
| Epstein Barr Virus | None<br>Specified | 1.96E+05 | TCID50/mL | No | No |
| Influenza A…