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The BinaxNOW® G6PD (Glucose-6-Phosphate Dehydrogenase) Test is an in vitro enzyme chromatographic test for the qualitative detection of G6PD enzyme activity in human venous whole blood, collected in heparin or ethylenediaminetetraacetic acid (EDTA). The BinaxNOW® G6PD Test is a visual screening test used for differentiating normal from deficient G6PD activity levels in whole blood and is intended to aid in the identification of people with G6PD deficiency. Samples which generate deficient results should be assayed using a quantitative G6PD test method to verify the deficiency.

The BinaxNOW® G6PD test device consists of a lateral flow test strip comprised of a white sample pad and a reaction pad, which is located at the top of the strip. The reaction pad contains the reagents necessary for the G6PD enzymatic reaction and the subsequent reduction of a nitro blue tetrazolium dye into its concomitant blue formazan product. The resulting color change on the strip indicates enough G6PD activity is present to presume the sample is not deficient.

To perform the test, a whole blood sample is mixed with red blood cell (RBC) lysing reagent in a sample preparation vial and then transferred to the test device sample pad. The lysed blood sample migrates up the test strip, reconstituting reagents in the reaction pad. When the sample front (or liquid migration) covers the entire reaction pad, the device is closed.

Test results are read visually. If no change in the red color of the sample front is observed at the test read time, the sample is presumed to be deficient in G6PD enzyme activity. Samples normal in G6PD activity produce a distinct color change – the red sample color changes to a brown / black color on the upper half of the reaction pad.

Here's a breakdown of the acceptance criteria and study details for the BinaxNOW® G6PD Test, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document doesn't explicitly state numerical acceptance criteria for agreement percentages, but the reported performance levels clearly exceed commonly accepted efficacy thresholds for diagnostic devices (typically >90% sensitivity and specificity, or equivalent agreement).

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

• Sample Size: 246 subjects.
• Data Provenance:
  • Country of Origin: U.S.
  • Retrospective or Prospective: Prospective study conducted in 2007-2008.

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

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

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The ground truth was established by a "commercially available quantitative G6PD test."

5. 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

This is an in vitro diagnostic (IVD) device, not an AI-assisted diagnostic imaging device that involves human readers interpreting images. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed. The "reading" of the BinaxNOW test is a visual interpretation of a color change by a single operator.

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

The BinaxNOW® G6PD Test is a visual screening test, which inherently involves a "human-in-the-loop" for interpretation of the color change. It is not an algorithm-only device. Therefore, a standalone performance study in the context of an algorithm-only device is not applicable in the typical sense for this product. The studies presented are the standalone performance of the test as it is intended to be used (visually read).

7. The Type of Ground Truth Used

The ground truth was established by a "commercially available quantitative G6PD test." This is a reference method, often considered a "gold standard" for determining the actual G6PD activity levels.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" in the context of machine learning or AI. The BinaxNOW® G6PD Test is a lateral flow assay, not a machine learning algorithm that requires training data in the typical sense. The "performance summary" sections describe clinical validation studies rather than algorithm training.

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

As noted above, there isn't a "training set" for an algorithm in the context of this device. The development of the device itself would have involved laboratory optimization using known samples (with ground truth established by quantitative G6PD assays), but this is part of product development and not typically referred to as an "algorithm training set" in the regulatory submission for this type of IVD.

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The BinaxNOW® G6PD (Glucose-6-Phosphate Dehydrogenase) Test is an in vitro enzyme chromatographic test for the qualitative detection of G6PD enzyme activity in human venous whole blood, collected in heparin or ethylenediaminetetraacetic acid (EDTA). The BinaxNOW® G6PD Test is a visual screening test used for differentiating normal from deficient G6PD activity levels in whole blood and is intended to aid in the identification of people with G6PD deficiency. Samples which generate deficient results should be assayed using a quantitative G6PD test method to verify the deficiency.

The BinaxNOW® G6PD test device consists of a lateral flow test strip comprised of a white sample pad and a reaction pad, which is located at the top of the strip (2 U.S. patents pending). The reaction pad contains the reagents necessary for the G6PD enzymatic reaction and the subsequent reduction of a nitro blue tetrazolium dye into its concomitant blue formazan product. The resulting color change on the strip indicates enough G6PD activity is present to presume the sample is not deficient.

To perform the test, a whole blood sample is mixed with red blood cell (RBC) lysing reagent in a sample preparation vial and then transferred to the test device sample pad. The lysed blood sample migrates up the test strip, reconstituting reagents in the reaction pad. When the sample front (or liquid migration) covers the entire reaction pad, the device is closed.

Test results are read visually. If no change in the red color of the sample front is observed at the test read time, the sample is presumed to be deficient in G6PD enzyme activity. Samples normal in G6PD activity produce a distinct color change - the red sample color changes to a brown / black color on the upper half of the reaction pad.

Here's a breakdown of the acceptance criteria and the study details for the BinaxNOW® G6PD Test, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria revolve around the agreement of the BinaxNOW® G6PD Test results with a commercially available quantitative G6PD test, particularly for identifying G6PD deficiency and normal activity.

Study Details:

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

   • Sample Size: 246 subjects (for the initial clinical sample performance study).
   • Data Provenance: Prospective study conducted in 2007-2008 in the U.S.

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

   • The document does not specify the number or qualifications of experts used to establish the ground truth. The "ground truth" was established by a "commercially available quantitative G6PD test," implying a quantitative laboratory assay rather than human expert interpretation of the BinaxNOW® test results.

3. Adjudication method for the test set:

   • Adjudication method for the test set results is not explicitly mentioned. The BinaxNOW® G6PD Test is a visual screening test. The comparison was made against a "commercially available quantitative G6PD test," implying a direct numerical comparison against the quantitative assay's results.

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, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test (lateral flow, enzyme chromatographic) for G6PD deficiency, read visually, not an AI-powered diagnostic imaging tool. It involves a single visual reading of the color change on the strip.
   • The closest "multi-reader" equivalent mentioned is the Reproducibility Study, which involved "multiple operators" (6 operators) across "3 separate sites." However, this was to assess the consistency of the device's output and interpretation, not to compare human performance with/without AI assistance.

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

   • Yes, in effect, a standalone performance was done for comparing the device's output against the quantitative method. The BinaxNOW® G6PD Test is designed to be a standalone visual screening test. The "performance summary" directly compares its qualitative output (deficient/normal) to the quantitative method's results, indicating its performance as a standalone diagnostic tool. Human readers are involved in the interpretation of the visual result of the BinaxNOW® test, but the device itself is a qualitative biochemical assay, not an AI algorithm.

6. The type of ground truth used:

   • Quantitative Assay Results: The ground truth was established using results from a "commercially available quantitative G6PD test." This serves as the reference standard. A specific cut-off value of 4.2 U/gHb from the comparative method was used to define "deficient" and "normal" for comparison purposes.

7. The sample size for the training set:

   • The document does not explicitly mention a separate "training set" as would be typical for machine learning models. For this type of in-vitro diagnostic device, development and optimization often involve internal studies, but specific details on a "training set" size for a machine learning context are not provided because it's not an AI device. The clinical performance study used 246 subjects.

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

   • As noted above, a distinct "training set" with established ground truth in the context of an AI algorithm is not applicable here. The development and validation of the BinaxNOW® G6PD Test would have involved establishing performance characteristics against known G6PD activity levels, likely using quantitative methods, but this is a product development process rather than an AI model training process.

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