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SAS™ FluAlert A Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of Influenza A viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type B viral antigen or Influenza Type C viral antigen. This test is for professional use only.

Negative results do not preclude infection with influenza A and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.

The SASTM FluAlert A Test utilizes antibodies against influenza type A viral nucleoproteins. The SASTM FluAlert A Test begins with an extraction of Type A nucleoproteins. After the extraction has been completed, the sample is placed into the sample well of the test. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for influenza A viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of influenza A nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza A antigen, a "sandwich" immunocomplex is not formed and a negative result is indicated. To serve as a procedural control, a pink-colored control line will always appear in the control zone of each strip regardless of the presence or absence of influenza A nucleoproteins.

The provided text describes the SASTM FluAlert A Test, a rapid immunoassay for the presumptive in-vitro qualitative detection of Influenza A viral nucleoprotein antigens. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SASTM FluAlert A Test are based on its analytical sensitivity (Limit of Detection - LoD) for various influenza A viral strains. The reported performance demonstrates the concentration at which the device can detect these strains.

Note: The document implies that the device is intended to "detect" these strains, thus the acceptance criteria are that the device demonstrates a measurable Limit of Detection for each. The specific numerical thresholds for acceptance were not explicitly defined as pass/fail criteria in the provided text, but the reported LoD values demonstrate the device's capability.

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

The provided text describes an analytical sensitivity study (Limit of Detection) rather than a clinical test set with human samples.

• Sample Size for the test set: For each influenza viral strain tested, the study involved serial dilutions to determine the Limit of Detection (LoD). The exact number of replicates or individual test instances at each dilution is not specified, but the methodology implies multiple tests per dilution series to establish the LoD.
• Data Provenance: The strains tested were obtained from ATCC (American Type Culture Collection), a global non-profit biological resource center. These are cultured viral strains, not directly human clinical samples. The document states "a positive human specimen" was used to culture the FluA/California/04/2009 (H1N1) virus, but the LoD study itself used the cultured strain rather than direct clinical specimens for this particular virus. The study is therefore retrospective in the sense that it uses established and archived viral strains. The country of origin of the ATCC strains is not specified in this document.

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

There were no human experts used to establish ground truth for this particular analytical sensitivity study. The ground truth was established by the known titers of the viral strains obtained from ATCC. The document states: "This viral strain used in this study was obtained from ATCC with a known titer. SA Scientific, Ltd did not verify this titer."

4. Adjudication Method for the Test Set

Not applicable. This was an analytical study determining the Limit of Detection using cultured viral strains with known titers, not a study involving human adjudication of results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is an analytical sensitivity study of the device's ability to detect specific viral strains, not a study comparing human reader performance with or without AI assistance.

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

Yes, this was a standalone performance study from the perspective of the device. The study evaluated the SASTM FluAlert A Test's ability to detect influenza A viral nucleoprotein antigens without human interpretation being part of the primary measurement for the LoD. The "visual" aspect of the assay implies a human performs the reading, but the study focuses on the lowest concentration the device can detect, independent of variations in human interpretation during clinical use.

7. The Type of Ground Truth Used

The type of ground truth used was known viral titers provided by ATCC for the various influenza A strains. This is a form of analytical ground truth, based on established biological standards.

8. The Sample Size for the Training Set

No information is provided about a "training set" in the context of machine learning or algorithm development. The SASTM FluAlert A Test is described as an "immunoassay utilizing immunochromatographic technology," which typically means it relies on biochemical reactions (antibody-antigen binding) rather than an AI algorithm that requires a training set.

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

Not applicable, as no training set for an AI algorithm appears to have been used in the development or evaluation of this immunoassay device.

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