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The INCSTAR CMV IgM Capture ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgM antibodies to cytomegalovirus in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active CMV infection. The evaluation of paired CMV IgM sera can also aid in determining the stage of active CMV infection.

The INCSTAR CMV IgM Capture ELISA test kit utilizes the enzyme-linked immunosorbent assay (ELISA) based on the antibody capture technique. Diluted patient serum is incubated with mouse monoclonal antibody against human IgM (u chain specific) bound to the solid surface of a microtiter well. Patient IgM is "captured" by the surface bound antibody. The presence of patient anti-CMV IgM antibodies are then "detected" and bound by CMV antigen which is linked to an anti-CMV monoclonal antibody conjugated to horseradish peroxidase. Bound horseradish peroxidase is reacted with chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgM to CMV antigen present in the reaction solution

1. Table of Acceptance Criteria and Reported Device Performance

* The acceptance criteria are implicit in the claim of substantial equivalence to the BioWhittaker CMV CAP-M ELISA test. The reported performance falls within ranges typically considered acceptable for diagnostic assays in this context.

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

• Sample Size: 529 serum samples, representing 474 individuals.
• Data Provenance: The provenance is not explicitly stated in terms of country of origin, but the samples represent a mixed population of healthy donors, immunocompromised hosts, transplant patients, congenital CMV babies, and patients having various other illnesses. This suggests a clinical setting. The study appears to be prospective in the sense that the INCSTAR device was tested against an existing reference method, but the specific collection method for the 529 samples (e.g., whether they were newly collected for the study or retrospective samples from a biobank) is not detailed.

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

Not applicable. The ground truth was established by comparison to a predicate device, the BioWhittaker CMV CAP-M ELISA Test, and subsequently by a third commercial CMV IgM ELISA method (Gull CMV IgM ELISA) for discrepant results. This is a technical comparison rather than a human expert-driven ground truth.

4. Adjudication Method for the Test Set

A form of adjudication was performed for discrepant results:

• When results between the INCSTAR CMV IgM Capture ELISA Kit and the BioWhittaker CMV CAP-M ELISA Test disagreed, a third commercial CMV IgM ELISA method (Gull CMV IgM ELISA) was used.
• For the 21 samples where INCSTAR was positive and BioWhittaker was negative, 17 had sufficient quantity for resolution. Of these 17, 10 were found positive by Gull.
• For the 10 samples where INCSTAR was negative and BioWhittaker was positive, 9 had sufficient quantity for resolution. Of these 9, 8 were found negative by Gull.

This can be described as a two-plus-one (2+1) adjudication for discrepant samples, where the "1" is the Gull assay.

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

No. This study evaluates an in vitro diagnostic device, not an imaging or interpretation device that would typically involve human readers.

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

Yes, this was a standalone performance study. The INCSTAR CMV IgM Capture ELISA Kit's performance was evaluated purely based on its analytical output compared to a reference method, without human interpretation as part of its primary function.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a predicate device (BioWhittaker CMV CAP-M ELISA Test), supplemented by a second predicate device (Gull CMV IgM ELISA) for discrepant resolution. This is a technical ground truth based on established diagnostic assays rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a study for a diagnostic kit, not a machine learning algorithm requiring a separate training set. The device's performance characteristics are based on its inherent biochemical properties and manufacturing.

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

Not applicable, as there is no training set in this context.

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