(276 days)
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.
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.
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.
This document describes the performance of the QuickVue COVID-19 Test, a visually read lateral flow immunoassay device. The acceptance criteria and supporting study details are outlined below.
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria for performance are generally implied by the reported results. For a rapid diagnostic test like this, the key performance metrics are Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). While explicit numerical acceptance criteria for PPA and NPA are not stated as "acceptance criteria," the study aimed to demonstrate substantial equivalence to a predicate device, which implies similar or better performance. The performance must also be sufficient for its intended use as an over-the-counter home test.
| Performance Metric | Acceptance Criteria (Implied by context/standard for OTC COVID tests) | Reported Device Performance (QuickVue COVID-19 Test) |
|---|---|---|
| PPA (Positive Percent Agreement) | Sufficiently high to detect positive cases (e.g., >80%) | 82.0% (95% CI: 76.1% - 86.7%) |
| NPA (Negative Percent Agreement) | Sufficiently high to correctly identify negative cases (e.g., >98%) | 99.1% (95% CI: 98.0% - 99.6%) |
| Limit of Detection (LoD) - WA1/2020 | Lowest detectable concentration | 3.03E+04 TCID50/mL |
| LoD - Omicron BA.5 | Lowest detectable concentration | 2.48E+04 TCID50/mL |
| Cross-Reactivity/Interference | No cross-reactivity/interference with common respiratory pathogens/substances (except SARS-CoV) | Not observed for listed organisms/substances (except SARS-Coronavirus) |
| Hook Effect | No hook effect at high concentrations | No Hook (Prozone) Effect from 1.09E+06 to 9.09E+04 TCID50/mL (40X to 3X LoD) |
| Flex Studies | No significant risk of erroneous results under various use-related errors | Assay does not present significant risk of erroneous result |
| Precision | High agreement (e.g., >95% for negatives and low positives) | Negative: 100% agreement; Low Positive (1XLoD): 99.2% agreement; Moderate Positive (4XLoD): 100% agreement |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: A total of 780 symptomatic individuals were included in the prospective clinical study that compared the QuickVue COVID-19 Test performance to an EUA extracted SARS-CoV-2 RT-PCR assay.
- 200 individuals were positive by the comparator assay.
- 580 individuals were negative by the comparator assay.
- Data Provenance: The study was a prospective clinical study conducted at eight clinical sites. The country of origin is not explicitly stated, but given the FDA review, it is highly likely to be the United States. Samples were collected by lay users (self-collected) or collected for a household member.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts or their qualifications for establishing the ground truth. The ground truth was established by an EUA extracted SARS-CoV-2 RT-PCR assay, which is considered the gold standard for SARS-CoV-2 detection. Therefore, human expert judgment for result interpretation of the ground truth assay itself is less relevant than with image-based AI studies.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by a laboratory-based RT-PCR assay, not through human reader interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a visually-read lateral flow immunoassay intended for direct diagnosis, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI outputs. The comparison was to a molecular (RT-PCR) test, not a comparative effectiveness study involving human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The QuickVue COVID-19 Test is a visually read lateral flow immunoassay. It does not involve an algorithm for automated interpretation in its primary intended use. While it has an optional "QVue Mobile Application," the primary interpretation is visual by the user. Therefore, a "standalone algorithm performance" study as seen in AI/software medical devices is not directly applicable in the same way. The performance data presented (PPA, NPA) directly reflects the visually-read results.
7. Type of Ground Truth Used
The type of ground truth used was a lab-based molecular test (RT-PCR). Specifically, an "EUA extracted SARS-CoV-2 RT-PCR assay" was used as the comparator. This is widely considered the gold standard for detecting SARS-CoV-2 viruses.
8. Sample Size for the Training Set
The document describes the performance of a lateral flow immunoassay, not an AI/machine learning model that typically requires a large training set. Therefore, there is no "training set" in the context of an AI model. The development of an immunoassay involves analytical studies and in-house testing to optimize the reagent formulations and visual interpretation, but not a distinct "training set" like in deep learning.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI model, this question is not applicable. The development of the immunoassay itself relies on established laboratory practices, analytical sensitivity (LoD), inclusivity, and specificity studies, using characterized viral isolates and clinical samples, to ensure the test consistently produces accurate results across various conditions.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: (800) 874-1517
Submission Contact
Suzanne Thomas Sr. Regulatory Affairs Manager 678-727-8786 Sue.thomas@quidelortho.com
Date Prepared
March 22, 2024
Proprietary and Established Names
QuickVue COVID-19 Test
Common Name
Coronavirus Antigen Detection Test
II. Device Classification
| Product | ProductCode | Classification | RegulatorySection | Description |
|---|---|---|---|---|
| Assay | QYT | II | 21 CFR 866.3984 | Over-the-CounterCOVID-19antigen 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 QRcode 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 DeviceQuickVue COVID-19 Test | Predicate DeviceFlowflex COVID-19 Antigen Home TestK230828 |
|---|---|---|
| Intended Use | The QuickVue COVID-19 Test is a visuallyread lateral flow immunoassay device intendedfor the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directlyin anterior nasal (nares) swab specimens fromindividuals with signs and symptoms ofCOVID-19 within the first 5 days fromsymptom onset. This test is for non-prescription home use by individuals aged 14years or older testing themselves, or adultstesting individuals aged 2 years or older.The QuickVue COVID-19 Test does notdifferentiate between SARS-CoV and SARS-CoV-2.All negative results are presumptive.Symptomatic individuals with an initialnegative test result must be re-tested oncebetween 48 and 72 hours after the first testusing either an antigen test or a molecular testfor SARS-CoV-2. Negative results do notpreclude SARS-CoV-2 infections or otherpathogens and should not be used as the solebasis for treatment. Positive results do not ruleout co-infection with other respiratorypathogens.This test is not a substitute for visits to ahealthcare provider or appropriate follow-upand should not be used to determine anytreatments without provider supervision.Individuals who test negative and experiencecontinued or worsening COVID-19 likesymptoms, such as fever, cough and/orshortness of breath, should seek follow up carefrom their healthcare provider.The performance characteristics for SARS-CoV-2 were established from January 2021 toFebruary 2024 when COVID-19 variantsAlpha, Delta, and Omicron were dominant.Test accuracy may change as new SARS-CoV- | The Flowflex COVID-19 Antigen HomeTest is a visually read lateral flowimmunoassay device intended for therapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigendirectly in anterior nasal swab specimensfrom individuals with signs and symptomsof COVID19 within the first 6 days ofsymptom onset. This test is for non-prescription home use by individuals aged14 years or older testing themselves, oradults testing individuals aged 2 years orolder. The Flowflex COVID-19 AntigenHome Test does not differentiate betweenSARS-CoV and SARS-CoV-2. Allnegative results are presumptive.Symptomatic individuals with an initialnegative test result must be re-tested oncebetween 48 and 72 hours after the first testusing either an antigen test or a moleculartest for SARS-CoV-2. Negative results donot preclude SARS-CoV-2 infections orother pathogens and should not be used asthe sole basis for treatment. Positiveresults do not rule out co-infection withother respiratory pathogens. This test isnot a substitute for visits to a healthcareprovider or appropriate follow-up andshould not be used to determine anytreatments without provider supervision.Individuals who test negative andexperience continued or worseningCOVID-19 like symptoms, such as fever,cough and/or shortness of breath, shouldseek follow up care from their healthcareprovider. The performance characteristicsfor SARS-CoV-2 were established fromDecember 2022 to March 2023 whenSARS-CoV-2 Omicron was dominant.Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testingwith 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(TCID50/mL) | LoD Concentration(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-Reactivity(Yes/No) | Interference(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-Reactivity(Yes/No) | Interference(Yes/No) |
| Coronavirus | 0C43 | 1.28E+05 | TCID50/mL | No | No |
| MERS-CoV | NoneSpecified | 1.04E+05 | TCID50/mL | No | No |
| SARS-Coronavirus | NoneSpecified | 1.05E+05 | TCID50/mL | Yes | No |
| Cytomegalovirus | NoneSpecified | 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 | NoneSpecified | 1.96E+05 | TCID50/mL | No | No |
| Influenza A | HINI | 1.04E+05 | TCID50/mL | No | No |
| Influenza A | pH1N1 | 1.21E+05 | TCID50/mL | No | No |
| Influenza A | H3N2 | 1.05E+05 | TCID50/mL | No | No |
| Influenza B | Victoria | 1.51E+05 | TCID50/mL | No | No |
| Influenza B | Yamagata | 1.06E+05 | TCID50/mL | No | No |
| Measles | NoneSpecified | 1.04E+05 | TCID50/mL | No | No |
| Human Metapneumovirus | Al | 1.19E+05 | TCID50/mL | No | No |
| Mumps virus | NoneSpecified | 1.19E+05 | TCID50/mL | No | No |
| Parainfluenza | Type 1 | 1.27E+05 | TCID50/mL | No | No |
| Parainfluenza | Type 2 | 1.26E+05 | TCID50/mL | No | No |
| Parainfluenza | Type 3 | 1.15E+05 | TCID50/mL | No | No |
| Parainfluenza | Type 4 | 1.19E+05 | TCID50/mL | No | No |
| Respiratory Syncytial Virus | Type A | 1.26E+05 | TCID50/mL | No | No |
| Respiratory Syncytial Virus | Type B | 1.14E+05 | TCID50/mL | No | No |
| Human Rhinovirus | Type A | 1.06E+05 | TCID50/mL | No | No |
| Human Rhinovirus | Type B | 1.55E+05 | TCID50/mL | No | No |
| Herpes Simplex Virus | Type 1 | 1.58E+05 | TCID50/mL | No | No |
| Virus/Bacteria/Parasite | Strain/ID | Concentration | Units | Cross-Reactivity(Yes/No) | Interference(Yes/No) |
| Varicella-zoster virus | NoneSpecified | 1.21E+05 | TCID50/mL | No | No |
| Bordetella pertussis | A639 | 1.00E+06 | CFU/mL | No | No |
| Candida albicans | NoneSpecified | 1.83E+06 | CFU/mL | No | No |
| Chlamydia pneumoniae | NoneSpecified | 1.45E+06 | IFU/mL | No | No |
| Corynebacterium sp. | NoneSpecified | 1.00E+06 | CFU/mL | No | No |
| Escherichia coli | NoneSpecified | 1.72E+06 | CFU/mL | No | No |
| Haemophilus influenzae | NoneSpecified | 1.52E+06 | CFU/mL | No | No |
| Lactobacillus sp. | NoneSpecified | 1.58E+06 | CFU/mL | No | No |
| Legionella pneumophila | NoneSpecified | 1.00E+06 | CFU/mL | No | No |
| Moraxella catarrhalis | NoneSpecified | 1.04E+06 | CFU/mL | No | No |
| Mycoplasma pneumoniae | NoneSpecified | 1.35E+06 | CCU/mL | No | No |
| Neisseria meningitides | NoneSpecified | 1.68E+06 | CFU/mL | No | No |
| Neisseria sp. | NoneSpecified | 1.23E+06 | CFU/mL | No | No |
| Pseudomonas aeruginosa | NoneSpecified | 1.16E+06 | CFU/mL | No | No |
| Pooled human nasal wash -representative of normalrespiratory microbial flora(Wet-testing) | NoneSpecified | N/A | N/A | No | No |
| Staphylococcus aureus | Type NotSpecified | 1.67E+06 | CFU/mL | No | No |
| Staphylococcus epidermidis | NoneSpecified | 1.53E+06 | CFU/mL | No | No |
| Streptococcus pneumoniae | NoneSpecified | 1.06E+06 | CFU/mL | No | No |
| Streptococcus pyogenes | NoneSpecified | 1.07E+06 | CFU/mL | No | No |
| Streptococcus salivarius | NoneSpecified | 1.05E+06 | CFU/mL | No | No |
| Mycobacterium tuberculosisavirulent | NoneSpecified | 1.16E+06 | CFU/mL | No | No |
| Virus/Bacteria/Parasite | Strain/ID | Concentration | Units | Cross-Reactivity(Yes/No) | Interference(Yes/No) |
| Methicillin-resistantStaphylococcus aureus(MRSA) | NoneSpecified | 3.30E+06 | CFU/mL | No | No |
| Methicillin-susceptibleStaphylococcus aureus(MSSA) | NoneSpecified | 3.67E+06 | CFU/mL | No | No |
Table 1. Cross-Reactivity/Microbial Interference Study Results
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Image /page/9/Figure/0 description: The image contains the logo for Quidel. The logo features a square with rounded corners, divided into sections of different colors, including red, orange, yellow, green, blue, and purple. Below the square is the word "QUIDEL" in a sans-serif font.
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Image /page/10/Figure/0 description: The image shows the logo for Quidel. The logo consists of a square that is divided into four quadrants, each with a different color. The colors are red, yellow, green, and blue. The word "QUIDEL" is written in a sans-serif font below the square.
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Image /page/11/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square divided into smaller triangles of various colors, including red, orange, yellow, green, blue, and purple. The word "QUIDEL" is written in a stylized font below the square, with the "L" extending into a curved line.
- Nineteen (19) specimens containing Coronavirus HKU1 were tested with an EUA version of this test (EUA203086) and all resulted as negative.
Interfering Substances
Twenty-four (24) potentially interfering substances were evaluated with the QuickVue COVID-19 Test to verify if endogenous and exogenous substances that may be present in respiratory specimens interfere with the detection of SARS-CoV-2 in the QuickVue COVID-19 Test. Each substance was tested in five (5) replicates in the absence of 6.06E+04 TCIDsylmL of heat-inactivated SARS-CoV-2 (isolate USA-WA1/2020). None of the substances listed in Table 2 interfered with the assay at the levels tested.
| Substances | Active Ingredient | Concentration |
|---|---|---|
| Throat lozenges, oral anesthetic andanalgesic | Menthol | 700 mg/mL |
| Sore throat spray | Phenol | 15% w/v |
| Mucinbovine submaxillary gland, type I-Sor pooled mucous | Purified mucin protein | 2.5mg/mL |
| Whole Blood (human) | Whole blood | 4% v/v |
| Leukocytes | Leukocytes | 5.00E+06 cells/mL |
| Zinc (common ingredient in manynasal sprays) | Zinc | 15% v/v |
| Nasal sprays or drops | Cromolyn, Oxymetazoline | 15% v/v |
| Nasal corticosteroids | Fluticasone | 15% v/v |
| Nasal gel | Luffa opperculata, sulfur,Sodium Hyaluronate | 5% w/v |
| Homeopathic allergy relief, or nasalwash | Alkalol | 15% v/v |
| Anti-viral drugs | Molnupiravir (broad-spectrum antiviral) | 2.5 mg/mL |
| Anti-viral drugs | Oseltamivir Phosphate(TamiFlu) | 2.5 mg/mL |
| Anti-viral drugs | Ribavirin | 2.5 mg/mL |
| Antibiotic, nasal ointment | Mupirocin | 10mg/mL |
| Hand sanitizer | Isopropyl alcohol | 15% v/v |
| Lotion | Not specified | 15% w/v |
Table 2. Interfering Substances Study Results
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Image /page/12/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, divided into four quadrants. The top-left quadrant displays a gradient of colors, including yellow, orange, red, and green. The bottom-right quadrant is blue. Below the square is the word "QUIDEL" in a sans-serif font.
| Substances | Active Ingredient | Concentration |
|---|---|---|
| Hand Soap | Not specified | 15% v/v |
| Rheumatoid Factor | Rheumatoid Factor | 1.12 IU/mL |
| Homeopathic Alkalol | Thymol; Eucalyptol;Manitol; Camphor;Benzoin; Potassium Alum;Potassium Chlorate;Sodium Bicarbonate;Sodium Chloride; Oils of:Sweet Birch; Spearmint;Pine; Cinnamon | 1:10 dilution |
| Cough syrup (e.g., Robitussin) | Dextromethorphan | 5% v/v |
| Nicotine or Tobacco | Nicotine | 0.03 mg/mL |
| Analgesic ointment (Vicks®VapoRub®) | Camphor, eucalyptus oil,menthol | 1% w/v |
| Petroleum Jelly (Vaseline®) | White petroleum | 1% w/v |
| Systemic antibiotic | Tobramycin | 4 µg/mL |
Hook Effect
To ensure that a high concentration of SARS antigen does not interfere with a positive reaction in the QuickVue COVID-19 Test, a series of five (5) different concentrations of heat-inactivated SARS-CoV2 (isolate WA1/2020) were prepared in NNM and tested in five (5) replicates on the QuickVue COVID-19 Test. The results demonstrated that the QuickVue COVID-19 Test did not display a Hook (Prozone) Effect for any of the levels evaluated from very high to moderate positive inactivated virus concentrations, when tested from 1.09E+06 to 9.09E+04 TCIDsomL (40X to 3X LoD). All spiked samples were 100% positive at all tested concentrations.
Flex Studies
A series of flex studies were performed by testing SARS-CoV-2 negative sample and SARS-CoV-2 positive sample (2XLoD) at various conditions per Table 3 when use-related errors occur. The results demonstrate that the assay does not present a significant risk of an erroneous result when performed by the lay user.
| Flex Study | Conditions |
|---|---|
| Operating Environment Flex | Operating temperature from 5°C to 45°C and relative humidity from10% to 95% |
| Extraction Time Flex | Sample swab is placed in reagent tube for time duration from ten (10)seconds to one (1) hour. |
| Impact of Different Light Sources Flex | Different light sources including fluorescent, incandescent, and LEDlight. |
| Disturbance During Analysis | Strip is removed from the reagent tube for 30 seconds at 5 minutes ofdevelopment time and placed back in tube.Knock over the reagent tube with strip inside immediately, 1 minute,and 5 minutes after adding strip in the tube, then immediately placeupright. |
Table 3. Flex Studies Conditions
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Image /page/13/Figure/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square divided into two sections. The top section is a gradient of colors, including red, orange, yellow, green, and blue. The bottom section is a solid blue color. Below the square is the word "QUIDEL" in a sans-serif font.
| Flex Study | Conditions |
|---|---|
| Open Pouch Flex | Strip is exposed to ambient air from 1 hour to 2.5 hours. |
| Development Time Flex | Strip is placed in reagent tube from 5 minutes to 30 minutes.After 10 minutes development time, strip is removed from the reagenttube and placed on bench top for 5 minutes before result reading. |
| Running Steps Out of Order Flex | After sample extraction, leave swab in reagent tube upon insertion ofthe test strip into the tube for 30 seconds and 10 minutes. |
| Swab Agitation Flex | Place the test swab into the liquid inside the reagent tube, and ensureit is touching the bottom. Do not stir, stir 10 times and stircontinuously for 1 minute.Place the test swab into the liquid inside the reagent tube, do nottouch the bottom or stir.Place the test swab into the liquid inside the reagent tube, and ensureit is touching the bottom. Stir 3-4 times. Do not apply pressure to theswab head. |
| Extraction Reagent Disturbance Flex | Shake the closed reagent tube 10 times, 30 seconds vigorously, and60 seconds vigorously before testing.Drop the reagent tube 3 times from bench top height before testing. |
| Sample Temperature Flex | Cold sample is removed from refrigerated condition at 2-8°C andtested immediately. |
| Sample Stability | Nasal swab samples were stored at ambient temperature (20-25°C)and refrigerated (2-8°C) over different lengths of time from 24 hoursto 196 hours to evaluate specimen stability. |
Precision
The lot-to-lot precision of the QuickVue COVID-19 Test was evaluated by using three (3) product lots. A series of coded, contrived samples were prepared as negative (1XLoD), and moderate positive (4XLoD) using heat inactivated SARS-CoV-2 (isolate USA-WA1/2020). Each sample was tested in duplicate in two (2) events per day over twenty (20) days with two (2) operators. The negative sample produced results with a lower 95% confidence interval limit ≥95% negative agreement. The low positive sample at 1XLoD produced results with a lower 95% confidence interval limit ≥95% positive agreement.
| Table 4. Summary of Precision Qualitative Results | |
|---|---|
| Lot | Negative* | Low Positive**(1XLoD) | Moderate Positive**(4XLoD) | |||
|---|---|---|---|---|---|---|
| Reader 1 | Reader 2 | Reader 1 | Reader 2 | Reader 1 | Reader 2 | |
| 1 | 80/80 | 80/80 | 78/80 | 78/80 | 80/80 | 80/80 |
| 2 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 |
| 3 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 |
| Total | 240/240 | 240/240 | 238/240 | 238/240 | 240/240 | 240/240 |
| %Agreement(95%CI) | 100%[98.4% -100.0%] | 100%[98.4% -100.0%] | 99.2%[97.0% -99.8%] | 99.2%[97.0% -99.8%] | 100%[98.4% -100.0%] | 100%[98.4% -100.0%] |
Method Comparison
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Image /page/14/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, divided into colorful sections resembling a color wheel. Below the square is the word "QUIDEL" in a simple, sans-serif font.
The performance of the QuickVue COVID-19 Test was compared to a SARS-CoV-2 RT-PCR assay in a prospective clinical study. Eight (8) clinical sites participated in the study. Samples were collected by lay users from themselves or collected for a household member. A total of 878 subjects were enrolled in this study, 39.6% male and 60.4% female. In symptomatic individuals tested within 5 days post symptom onset, the QuickVue COVID-19 Test detected SARS-CoV-2 with Positive Percent Agreement (PPA) of 82.0% and Negative Percent Agreement (NPA) of 99.1% in symptomatic individuals when compared to the result from an EUA extracted SARS-CoV-2 RT-PCR assay. Results are provided in Table 5 and Table 6.
| SARS-CoV-2 RT-PCR Assay Result | |||||
|---|---|---|---|---|---|
| Pos | Neg | Total | PPA = 82.0% (164/200)95% CI: 76.1% - 86.7% | ||
| QuickVue Pos | 164 | રે | 169 | NPA = 99.1% (575/580)95% CI: 98.0% - 99.6% | |
| QuickVue Neg | 36 | ર્ રજ | 611 | Positivity Rate by 21.7% (169/780) | QuickVue Assay = 95% CI: 18.9% - 24.7% |
| Total | 200 | 580 | 780 | Positivity Rate by 25.6% (200/780) | Comparator Assay = 95% CI: 22.7% - 28.8% |
| Table 5. QuickVue COVID-19 Test Performance Compared to SARS-CoV-2 RT-PCR Assav | |||
|---|---|---|---|
PPA= Positive Percentage Agreement; NPA= Negative Percentage Agreement
| Days SinceSymptom Onset | # SpecimensTested | # Positiveby QuickVue | # Positiveby RT-PCR | PPA |
|---|---|---|---|---|
| 0 | 61 | 14 | 16 | 87.5% |
| 1 | 203 | 45 | 53 | 81.1% |
| 2 | 248 | 52 | 63 | 79.4% |
| 3 | 148 | 27 | 28 | 92.9% |
| 4 | 74 | 21 | 28 | 75.0% |
| 5 | 46 | 10 | 12 | 83.3% |
Table 6. PPA results by DPSO
Conclusion
These studies demonstrated equivalent performance of the QuickVue COVID-19 Test to the predicate product ACON Flowflex COVID-19 Antigen Home Test (K230828).
N/A