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The QuickFinder™ COVID-19Flu Antigen Self Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. 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.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not subsition for a visit to a healthcare provider or appropriate follow-up.

QuickFinder™ COVID-19/Flu Antigen Pro Test

The QuickFinder™ COVID-19/Flu Antigen Pro Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not subsition for a visit to a healthcare provider or appropriate follow-up.

The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test is a rapid lateral flow test for the qualitative detection of the SARS-CoV-2, Influenza A and Influenza B using anterior nares nasal swab samples from those who are suspected of COVID-19, Influenza A, and Influenza B. The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test is validated for testing direct samples without transport media.

The lateral flow test is for:

• . Self-collected anterior nasal (nares) swab specimens from individuals aged 14 years and older with symptoms of COVID-19 within the first 4 days of symptom onset.
• Adult-collected anterior nasal (nares) swab specimens from individuals aged 2 years ● and older with symptoms of COVID-19 within the first 4 days of symptom onset.

The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test is a lateral flow test. The cassette contains membranes which are pre-coated with anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies, anti-influenza A nucleoprotein monoclonal antibodies and anti-influenza B nucleoprotein monoclonal antibodies on the test lines. Another anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies, anti-influenza A nucleoprotein monoclonal antibodies and anti-influenza B nucleoprotein monoclonal antibodies are each bound to the beads. When the sample is put into the sample well, the antibodies bound to the beads and the antigen in the sample bind to form complexes and migrate to the membrane. The complexes will be captured by coated antibodies on the membrane, and then the line will form a visible line. The presence of SARS-CoV-2, influenza A and influenza B antigens are indicated by lines visible in the Smarked position, A-marked position, and B-marked position in the results window, respectively. If no colored line appears on the control line (C), it implies that the test has not worked as intended.

Here's a detailed description of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test

The acceptance criteria for the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test are primarily demonstrated through its clinical performance, comparing its results against a highly sensitive, FDA 510(k) cleared molecular assay. Additional analytical performance studies confirm the device's technical capabilities.

1. Table of Acceptance Criteria and Reported Device Performance

Clinical Performance Acceptance Criteria (Implicit from reported results):
While explicit acceptance criteria are not stated as numerical cutoffs in the document, these are the reported performance values that demonstrate the device's efficacy. From context, the reported PPAs and NPAs are likely what the FDA evaluated for establishing substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Clinical Evaluation):

• Sample Size: A total of 788 evaluable subjects were enrolled.
• Data Provenance: The clinical study was conducted at six (6) sites in the United States from October 2023 to June 2024. The study was prospective, with samples collected by lay users from themselves or for a household member. Subjects were symptomatic individuals experiencing symptoms associated with COVID-19 or Influenza, within 4 days of symptom onset.

Test Set (Usability/Human Factors Assessment):

• Sample Size: 50 subjects participated (25 self-collecting and 25 lay-users collecting from another).
• Data Provenance: Conducted as part of the clinical study from October 2023 to November 2023, likely in the United States. Prospective, as subjects performed tasks in a simulated home environment.

Test Set (Lay User Readability Assessment):

• Sample Size: All 50 subjects who participated in the human factors assessment also interpreted mock devices.
• Data Provenance: Same as the Usability Assessment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for the clinical test set was established by a highly sensitive molecular FDA 510(k) cleared SARS-CoV-2 assay and highly sensitive molecular FDA 510(k) cleared Influenza A and B assays. The document does not specify the number of experts or their qualifications within the context of establishing this ground truth (e.g., for interpreting the molecular assay results). The molecular assays themselves serve as the expert-level reference standard, implying specialized laboratory personnel and validated methods.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for conflicting results between the QuickFinder™ test and the reference molecular assays. The performance metrics (PPA, NPA) are calculated directly from the comparison. For the usability study, "study personnel or a healthcare provider" evaluated the subjects' performance, implying assessment by trained individuals, but a formal adjudication process (like 2+1) isn't detailed for disagreements, as it focuses on task performance rather than a diagnostic outcome.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating how much human readers improve with AI vs. without AI assistance. This device is a lateral flow immunochromatographic assay, a rapid visual test, and does not incorporate AI for result interpretation by human readers. The usability and readability studies assess the lay user's ability to interpret the test results, which is a form of human "reading," but not a comparative effectiveness study with AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The QuickFinder™ devices are standalone rapid visual tests that require human interpretation of the lines on the cassette. They are explicitly stated to "require no instrumentation or mobile applications." Therefore, the clinical performance data, while comparing to a molecular assay, represents the "standalone" performance of the test as interpreted by lay users (for the Self Test) or users (for the Pro Test) without an additional algorithm for interpretation.

7. The Type of Ground Truth Used

The primary ground truth used for evaluating the clinical performance of the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test was a highly sensitive molecular FDA 510(k) cleared SARS-CoV-2 assay and highly sensitive molecular FDA 510(k) cleared Influenza A and B assays. This is considered the gold standard for detecting the presence of viral RNA/antigens.

For the analytical studies (LoD, Co-spiked LoD, Inclusivity, Interference, Hook Effect), the ground truth was established using known concentrations of specific viral strains (UV inactivated SARS-CoV-2 and live Influenza A and B) spiked into pooled human negative swab matrix (PNSM).

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. As this device is a rapid antigen test (lateral flow immunoassay) and likely relies on pre-calibrated reagents and visual signal detection rather than a machine-learning algorithm that requires a "training set" in the computational sense, such information would not typically be applicable or relevant in the same way it would be for AI/ML-based devices. The development of such assays involves extensive analytical validation using contrived and clinical samples, but these are generally referred to as validation sets rather than machine learning "training sets."

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" and its associated ground truth establishment methods (e.g., expert consensus, pathology labels, outcome data) are generally not applicable to a lateral flow immunoassay in the same way they would be for an AI/ML device. The analytical performance studies (LoD, inclusivity, interference) use precisely characterized viral material and reference standards to establish the "truth" for those controlled experiments. For the clinical validation, the ground truth was the results from the FDA-cleared molecular assays.

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