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The QuickVue Influenza A+B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. Negative results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

Nasal swabs, nasopharyngeal swabs, nasal wash and/or nasal aspirates serve as specimens for this test. The patient specimen is placed in a tube containing Extraction Reagent, during which time the virus particles in the specimen are disrupted, exposing internal viral antigens. After extraction, the Test Strip is placed in the Extraction Tube for 10 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip. If the extracted specimen contains influenza Type A and/or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the test Strip. If influenza Type A and B viral antigens are not present, or present at very low levels, only a blue procedural Control Line will appear. If no blue procedural Control Line develops, the result is considered invalid.

The provided text describes the QuickVue Influenza A+B test, a lateral-flow immunoassay for the rapid, qualitative detection of influenza type A and B antigens. However, the document does NOT contain information about specific acceptance criteria or an overarching study proving the device meets those criteria in terms of clinical performance (sensitivity, specificity) with real patient samples. The summary focuses on comparing the proposed device to a predicate device and an analytical study rather than a clinical one.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity or specificity targets) or report clinical performance metrics against such criteria. The "Summary of Performance Data" section describes an analytical study, not a clinical one, and its conclusion refers to the minimum detectable level of cultured viruses.

The document clearly states: "Although this test has been shown to detect the 2009 H1N1 virus cultured from a positive human respiratory specimen, the performance characteristics of this device with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established." This indicates a lack of clinical study data at the time of this filing.

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

The only described study is an analytical study using "cultured viruses."

• Sample Size for Test Set: Not specified, as it's an analytical study with cultured viruses rather than a clinical test set. The study uses "cultured viruses" of specific H1N1 strains.
• Data Provenance: The study uses "cultured viruses" (seasonal H1N1 (New Caledonia/20/1999) and 2009 H1N1 (California/04/2009)). This is laboratory-derived data, not human patient data.

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

Not applicable, as the study described is an analytical sensitivity study using cultured viral strains, not a clinical study requiring expert ground truth establishment from patient samples.

4. Adjudication Method for the Test Set

Not applicable, as the study described is an analytical sensitivity study using cultured viral strains, not a clinical study requiring adjudication of patient results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states that the performance characteristics with clinical specimens have not been established. The study mentioned is an analytical sensitivity study with cultured viruses, not involving human readers or comparative effectiveness.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the described "analytical study" involving cultured viruses to determine the "minimum detectable level" of the QuickVue Influenza A+B test is a standalone performance assessment of the device's ability to detect viral antigens in a controlled laboratory setting. This is a characteristic of a standalone test, as it's measuring the device's intrinsic detection capability.

7. The Type of Ground Truth Used

The ground truth for the analytical study was the presence and concentration (TCID50/ml) of specific cultured viral strains (seasonal H1N1 and 2009 H1N1).

8. The Sample Size for the Training Set

Not applicable. This device is a lateral-flow immunoassay, not a machine learning or AI-based device that typically requires a training set. The "study" described is an analytical validation.

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

Not applicable, as there is no training set for this type of diagnostic device.

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The QuickVue Influenza A + B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal wash and/or nasal aspirate specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. Negative test results should be confirmed by cell culture. The test is intended for professional and laboratory use.

The QuickVue Influenza A + B test, has two Test Line indicators - one for type A and one for type B. The two Test Line indicators allow for the separate identification of type A and type B viral antigens from the same specimen. If either Test Line turns pink-to-red, the test is positive for influenza. Nasal swabs, nasopharyngeal swabs, nasal wash and/or nasal aspirates serve as specimens for this test. The patient specimen is placed in a tube containing Extraction Reagent, during which time the virus particles in the specimen are disrupted, exposing internal viral antigens. After extraction, the Test Strip is placed in the Extraction Tube for 10 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip. If the extracted specimen contains influenza Type A and/or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip. If influenza Type A and B viral antigens are not present, or present at very low levels, only a blue procedural Control Line will appear. If no blue procedural Control Line develops, the result is considered invalid.

Acceptance Criteria and Study for QuickVue® Influenza A + B Test

The QuickVue® Influenza A + B test is a rapid, qualitative lateral-flow immunoassay designed for the detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal wash, and/or nasal aspirate specimens.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., "sensitivity must be > X%, specificity must be > Y%"). However, the summary of performance data implies that "excellent sensitivity and specificity" were the desired outcomes when compared to a reference standard.

Note: The document uses descriptive terms like "excellent sensitivity and specificity" rather than specific numerical thresholds.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document states that a "multi-center field clinical study" was conducted, but it does not specify the exact sample size used for the test set.
• Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a submission to the FDA, it's highly likely that a significant portion, if not all, of the clinical data was collected in the United States. The study was a "field clinical study," implying prospective data collection.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication Method

The document states that results were compared to "viral culture and discrepant results resolved by RT-PCR." This implies an adjudication method where:

• Initial Comparison: QuickVue results were compared against viral culture (the primary reference standard).
• Discrepancy Resolution: For any results where the QuickVue test and viral culture disagreed, RT-PCR was used as a tie-breaker or definitive secondary reference. This can be interpreted as a form of discrepancy resolution or "2-test" rule where viral culture is one and RT-PCR is the second for discrepant cases. It is not a typical 2+1 or 3+1 consensus method among experts on interpretations of the device results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. This device is a rapid diagnostic test, not an AI-powered diagnostic imaging tool, so such a study would not be relevant.

6. Standalone (Algorithm Only) Performance

The primary performance study described is essentially a standalone performance study of the device. The QuickVue® Influenza A + B test is a lateral-flow immunoassay, a diagnostic device itself, and its performance (sensitivity, specificity, accuracy) was evaluated without human interpretation being the primary variable. The results of the test strip are visually interpreted but the "algorithm" is inherent to the chemical reactions on the strip.

7. Type of Ground Truth Used

The ground truth used for the test set was:

• Viral Culture: This was the primary reference method.
• RT-PCR: Used to resolve discrepant results between the QuickVue test and viral culture. This is a highly sensitive and specific molecular method.

8. Sample Size for the Training Set

The document does not specify the sample size used for a "training set." As a lateral-flow immunoassay, the device itself is not an algorithm that requires a training set in the machine learning sense. Its design and reagents are developed through R&D, not through data-driven training of a model.

9. How Ground Truth for the Training Set Was Established

As stated above, this device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, the concept of establishing ground truth for a training set does not apply directly to this type of diagnostic device. The development of the monoclonal antibodies and assay parameters would involve extensive laboratory testing and validation using known positive and negative samples, but these are part of the R&D process rather than a "training set" for an algorithm.

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The QuickVue Influenza A + B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal wash and nasal aspirate specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. The test is intended for professional and laboratory use.

The QuickVue Influenza A + B test, the successor product to the QuickVue Influenza test, has two Test Line indicators - one for type A and one for type B. The two Test Line indicators allow for the separate identification of type A and type B viral antigens from the same specimen. If either Test Line turns pinkto-red, the test is positive for influenza. Nasal swabs, nasal wash and/or nasal aspirates serve as specimens for this test. The patient specimen is placed in a tube containing Extraction Reagent, during which time the virus particles in the specimen are disrupted, exposing internal viral antigens. After extraction, the Test Strip is placed in the Extraction Tube for 10 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip. If the extracted specimen contains influenza Type A and/or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip. If influenza Type A and B viral antigens are not present, or present at very low levels, only a blue procedural Control Line will appear. If no blue procedural Control Line develops, the result is considered invalid.

Here's a breakdown of the acceptance criteria and study information for the QuickVue® Influenza A + B test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria (e.g., a specific sensitivity or specificity percentage target). Instead, it states that "Substantial equivalence has been demonstrated between the QuickVue test and viral culture for the qualitative detection of influenza Type A and B antigens." This implies that the device's performance, as measured in comparison to viral culture, was deemed acceptable by the FDA for establishing substantial equivalence to predicate devices.

However, the specific quantitative performance metrics (sensitivity, specificity) from the clinical study are not provided in this summary.

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The text mentions a "multi-clinical field study" but does not give the number of clinical specimens.
• Data Provenance:
  • Country of Origin: Not explicitly stated.
  • Retrospective or Prospective: Retrospective. The text states: "a retrospective comparison of the QuickVue Influenza A + B test to viral culture was conducted in a multi-clinical field study."

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

This information is not provided in the document. The ground truth was established by "viral culture." The qualifications of those performing or interpreting the viral culture are not specified.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done? No. This type of study is not mentioned. The device is a "standalone" or "algorithm only" type of diagnostic, meaning human interpretation is based on the visible lines on the test strip, not assisted by an AI.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no AI assistance is mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was it done? Yes, implicitly. The QuickVue® Influenza A + B test is a lateral-flow immunoassay, which is a standalone device providing a direct result (pink-to-red test line, blue control line) without human-in-the-loop AI assistance. The clinical study evaluated the performance of this device on its own.

7. Type of Ground Truth Used

• Ground Truth: Viral culture. The text states: "Substantial equivalence has been demonstrated between the QuickVue test and viral culture..."

8. Sample Size for the Training Set

This information is not provided in the document. As this is an immunoassay and not an AI/machine learning device, the concept of a "training set" in the context of data for model development is typically not applicable. The device's "training" would be its design and optimization during manufacturing and R&D phases.

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

Not applicable, as a "training set" for an AI/ML model is not relevant for this immunodiagnostic device.

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The QuickVue Influenza A/B Test is intended for the rapid, qualitative detection of influenza Types A and B antigen directly from nasal swab, nasal wash and/or nasal aspirate specimens. The test is intended for use as an aid in the rapid diagnosis of acute influenza virus infection. The test is intended for professional and laboratory use.

The QuickVue Influenza A/B Test is a lateral-flow immunoassay using highly sensitive moroclonal antibodies that are specific for influenza antigens. The test is specific to influenza Types A and B antigen with no know cross-reactivity to normal flora or other known respiratory pathogens.

Here's a summary of the acceptance criteria and study information for the QuickVue Influenza A/B Test based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values (e.g., "sensitivity must be >90%"). Instead, it describes demonstrating "substantial equivalence" to viral culture. The reported performance is based on exceeding a general benchmark of agreement for laboratory personnel.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Two distinct studies are mentioned:
     • A "multi-clinical field study" for substantial equivalence to viral culture. The exact number of clinical specimens or patients is not provided.
     • "Physician's Office Laboratory studies" conducted at three geographically distinct sites in the United States. The exact number of tests performed or samples used in these POL studies is not provided.
   • Data Provenance:
     • Clinical specimens obtained from patients symptomatic for upper respiratory infection.
     • POL studies were conducted in the United States at three geographically distinct sites.
     • Both studies appear to be prospective, as they compare the QuickVue test to viral culture or assess user performance in real-time settings.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The primary ground truth for the clinical performance study was viral culture. The document does not specify the number or qualifications of experts interpreting the viral culture results. Viral culture itself is considered a gold standard in this context, and interpretation is typically handled by trained laboratory personnel or virologists, though this is not explicitly stated.
   • For the POL studies, "expected results" were used, implying a reference standard, but the origin or expert involvement in establishing these "expected results" is not detailed.

3. Adjudication method for the test set:

   • The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies between the QuickVue test and the reference standard (viral culture). It simply states a "comparison" was conducted.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a rapid diagnostic test (lateral-flow immunoassay), not an AI-based diagnostic requiring human reader assistance. The "user performance" study focused on the ability of doctors' office personnel to perform the test accurately, not on their improvement with technological assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the QuickVue Influenza A/B Test operates as a standalone device. Its performance is evaluated intrinsically through comparison to a reference standard (viral culture) for antigen detection. There is no "human-in-the-loop" component in the sense of a software algorithm assisting a human interpreter; the human conducts and reads the test directly.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the clinical performance study, the primary ground truth was viral culture. This is a laboratory-based diagnostic method considered a gold standard for influenza detection.

7. The sample size for the training set:

   • The document does not provide details on a separate "training set" or its sample size. For an immunoassay like this, the development typically involves extensive assay optimization and validation during R&D using various characterized samples, rather than a distinct "training set" in the machine learning sense. The clinical studies described are for validation of the final product.

8. How the ground truth for the training set was established:

   • As no explicit "training set" is described in the provided text for this immunoassay, how its ground truth was established is not detailed. However, for immunoassay development, ground truth for optimization would typically come from well-characterized clinical samples (e.g., confirmed positive/negative by PCR or viral culture) or spiked samples with known amounts of antigen.

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