(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.
N/A