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The REAADS IgG anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-B2GPI antibodies in human serum as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgG anti-B2GPI Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with purified human Beta-2 Glycoprotein I. Incubation allows the anti-B2GPI antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the B2GPI bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H,O,) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-B2GPI antibodies. Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 40 minutes. The assay makes use of a single point callbrator to measure the amount of IgG anti-B2GPI antibodies in patient samples.

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Acceptance Criteria and Study Details for REAADS IgG anti-B2GPI Test Kit

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for specificity, sensitivity, or correlation that the device had to meet to be considered acceptable. Instead, it describes the observed performance characteristics and asserts their equivalence to the predicate device and compliance with published literature.

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

• Sample Size Used for Test Set: Not explicitly stated. The document refers to "in-house studies" and "unselected SLE patients" but does not provide the number of patients or samples included in these studies.
• Data Provenance: Not explicitly stated. Given the context of "in-house studies," it is likely proprietary data from CORGENIX, INC. There is no mention of country of origin or whether it was retrospective or prospective data.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not mentioned. The document primarily focuses on the quantitative comparison of the new device to the predicate.

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

• MRMC Study Done? No. This device is an in-vitro diagnostic (IVD) assay, not an imaging or diagnostic device requiring human interpretation of visual data in the same way an MRMC study would apply. Therefore, a comparative effectiveness study involving human readers with and without AI assistance is not applicable.

6. Standalone Performance:

• Standalone Performance Done? Yes. The described performance metrics (specificity, sensitivity, correlation) are for the REAADS IgG anti-B2GPI Test Kit operating as a standalone assay, independent of human interpretation beyond typical laboratory procedures. The document assesses the algorithm's performance (the test kit's ability to detect and semi-quantitate antibodies) directly.

7. Type of Ground Truth Used:

• Type of Ground Truth: The document implies that the ground truth for establishing "specificity" and "clinical sensitivity" was clinical diagnosis of SLE patients and the presence/absence of IgG anti-B2GPI antibodies, likely determined by other established diagnostic methods or clinical criteria. The comparison to the predicate device (QUANTA Lite IgG anti B2GPI ELISA) suggests that the predicate's results served as a comparative "truth" for evaluating the new device's performance in terms of correlation. There is no mention of pathology or outcomes data being the primary ground truth.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not mentioned. The document does not describe the development or training of the assay (e.g., in a machine learning context). Instead, it describes a comparison of a newly developed assay to an existing predicate.

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

• How Ground Truth for Training Set Was Established: Not applicable. The document describes an ELISA kit, which is a biochemical assay. There is no mention of a "training set" or a process that would require establishing a ground truth for it, as would be the case for machine learning algorithms. The assay's performance is intrinsically linked to its biochemical design rather than learned parameters from a data set.

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