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The Trinity Biotech Uni-Gold™ Strep A test kit is intended for the rapid, in vitro qualitative detection of group A Streptococcal antigen from human throat swabs. It can also be used as a confirmation test of beta-haemolytic colonies obtained from blood agar plates. The test is intended for professional use in physicians offices as an aid in the rapid diagnosis of group A Streptococcal pharyngitis. The test may also be used in hospital laboratories as an aid in the rapid diagnosis of group A Streptococcal pharyngitis and the confirmation of group A Streptococcus from culture.

The extracted sample flows through an absorbent pad containing anti-Strep A antibody conjugated to colloidal gold which binds group A Streptoccal antigen if present, forming an antigen-antibody complex. As this complex travels along the membrane, it becomes immobilised at the test region, which is impregnated with a rabbit polyclonal anti-Strep A antibody, resulting in the formation of a pink/red line. A pink/red line will also appear in the control region of the test indicating proper functioning of the test. In the absence of group A Streptococcal antigen, a pink/red line will only appear in the control line.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

   • Accuracy Study (Test Set 1): 501 fresh throat samples. Data provenance is not explicitly stated regarding country of origin, but it is a retrospective or concurrent collection as it was tested "both in the immunoassay and by routine culture."
   • Comparison to Predicate Device (Test Set 2): 501 total specimens tested. Data provenance is not explicitly stated.
   • Culture Confirmation Study (Test Set 3):
     • Initial: 109 samples visually positive for Strep A on blood agar plates.
     • Second part (non-Strep A confirmation): 224 samples, of which 117 were identified as non-Strep A.
     • Third part (blinded and duplicate testing): 6 samples (2 Group A beta-haemolytic, 4 non-Group A beta-haemolytic).
   • All these studies appear to be "test sets" as they are used to evaluate the device's performance directly.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

   • For the core clinical accuracy and comparison studies, the "routine culture" is considered the ground truth. There is no specific mention of "experts" adjudicating these results, as routine culture itself serves as the reference standard in these diagnostic tests.
   • For the Culture Confirmation Study (third part), "2 independent physicians" conducted blinded, duplicate testing. Their qualifications are not further specified beyond "physicians."

4. Adjudication Method for Test Set:

   • In the primary clinical accuracy study, the Uni-Gold™ Strep A results were compared directly against "routine culture." There isn't an explicit adjudication method described beyond this direct comparison.
   • For the comparison between Uni-Gold™ Strep A and the predicate device, discordant results were later "resolved against culture" when calculating relative sensitivity/specificity/agreement. This implies that if the two devices disagreed, a third reference (culture) was used to determine the true positive/negative status for performance calculation. This is a form of an adjudication process, likely a 2+1 type (two devices, one gold standard for resolution).

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. The device is an immunoassay, not an imaging device that would typically involve human readers interpreting results with or without AI assistance. The studies performed compare the device's performance against a reference standard (culture) and a predicate device.

6. Standalone (Algorithm Only) Performance:

   • Yes, the performance values presented (sensitivity, specificity, agreement, concordance) are for the Uni-Gold™ Strep A test kit operating as a standalone device, without human-in-the-loop assistance in its core detection mechanism. The human interaction is usually limited to performing the test and reading the results, which is inherent to the use of such a diagnostic kit.

7. Type of Ground Truth Used:

   • Primary Ground Truth: Routine culture (specifically for Group A Streptococcus). This is a well-established laboratory method for identifying bacterial presence and is considered a high-quality reference standard for infectious disease diagnostics.
   • Secondary Ground Truth (for Culture Confirmation): Initial culture results confirmed by "Beta-haemolysis and morphology" and "Streptococcal latex grouping test" for further confirmation.

8. Sample Size for Training Set:

   • The document does not provide information about a separate "training set" for the Uni-Gold™ Strep A test kit. As an immunoassay (lateral flow assay), it is a biochemical test, not a machine learning algorithm that typically requires a distinct training phase with a dedicated dataset. The device's components and assays are developed and validated during the manufacturing process, rather than "trained" on data.

9. How Ground Truth for Training Set Was Established:

   • Not applicable, as there is no explicit "training set" in the context of this immunoassay device. The scientific principles and reagents are developed based on known biological interactions and established laboratory methods. Analytical studies (sensitivity, specificity) ensure the components function as intended.

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The Trinity Biotech Uni-Gold™ Strep A Test Kit is a rapid immunoassay for the qualitative detection of Streptococcal A antigen from throat swabs, or the confirmation of beta-hemolytic colonies obtained from blood agar plates.

The Trinity Biotech Uni-Gold™ Strep A Test Kit is intended for use in hospital laboratories and physicians' offices as an aid in the diagnosis of Group A Streptococcal pharyngitis.

Immunoassay: Strep A antigen, when present, binds to the anti-Strep A antibody conjugated to a gold dye. As this complex travels along the membrane, it becomes immobilized at the test region, resulting in the formation of a red line. Excess antibodygold conjugate further migrates along the membrane and binds to the control region, forming another red line. In the absence of Strep A antigen, a red line will only be formed at the control region.

Here's an analysis of the provided text to extract the acceptance criteria and study information:

Acceptance Criteria and Device Performance Study for Uni-Gold™ Strep A Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or percentage format. Instead, it describes analytical performance parameters that the device demonstrated. The primary "acceptance" for this 510(k) submission is substantial equivalence to the predicate device, which implies comparable performance in key areas.

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

The document focuses on analytical studies rather than clinical studies with patient samples for the test set.

• Analytical Sensitivity Test Set: Serial dilutions of S. pyogenes cultures. The exact number of dilutions or individual tests performed is not specified, only that testing continued until interpretations became "negative."
• Analytical Specificity Test Set: The sample size for the analytical specificity (cross-reactivity) test set includes 19 different organisms. For each organism, testing was performed at a concentration of approximately 1 x 10^6 (or 1 x 10^6 for Staphylococcus aureus).
• Data Provenance: The studies are described as "Laboratory studies" and did not involve human subjects. Thus, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical clinical sense. These are in-house, non-clinical evaluations.

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

This section is not applicable. The studies described are analytical (laboratory-based) and do not involve human interpretation of results for establishing ground truth. The "ground truth" for analytical sensitivity was known concentrations of S. pyogenes, and for analytical specificity, the known identity and concentration of non-Strep A organisms.

4. Adjudication Method for the Test Set

This section is not applicable as the studies are analytical and do not involve human adjudication of results in the way clinical studies often do. The results (positive/negative) would be determined by the visual presence or absence of a red line.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes laboratory analytical performance, not a study evaluating human reader performance with or without AI assistance.

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

Yes, the studies described are standalone in the sense that they evaluate the performance of the device itself (the immunoassay) without human-in-the-loop performance being a variable. The test results (red line present/absent) are interpreted directly from the device's output.

7. Type of Ground Truth Used

• Analytical Sensitivity: Known concentrations of Streptococcus pyogenes (Strep A) cultures.
• Analytical Specificity: Known identities and concentrations of various non-Strep A organisms.

8. Sample Size for the Training Set

This information is not applicable. The Uni-Gold™ Strep A Test Kit is an immunoassay (a rapid diagnostic test), not an AI/Machine Learning algorithm. Therefore, there is no "training set" in the context of AI development.

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

This information is not applicable as there is no training set for an AI algorithm.

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