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The Copalis™ CMV Total Antibody Assay is used for the qualitative detection of total antibodies (IgG and IgM) to cytomegalovirus in men and women of child-bearing age. The presence of antibodies in these populations is indicative of recent or prior infection. These assays are not intended for screening of blood or plasma donors. The Copalis™ TORC Total Antibody Assay and the Copalis™ CMV Total Antibody Assay can be used in both the clinical and physician office laboratories. These assays can also be used to determine the CMV immune status of transplant donors and recipients.

Coupled Particle Light Scattering (Copalis) technology provides a rapid method for the measurement of antibodies to specific viral or protozoal pathogens, The Copalis® CMV Total Antibody Assay is based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. Sized latex microparticles coated with inactivated CMV antigens aggregate in the presence of antibodies to CMV. After 10 minutes of agitation, the levels of aggregation are determined by discrimination of particle sizes and measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation per particle size relative to a cutoff value. The Copalis® CMV Total Antibody Assay detects the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor proficiency.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Copalis® CMV Total Antibody Assay:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: A total of 205 serum samples.
   • Data Provenance: The samples included both transplant donors and recipients, tested at 2 hospital laboratories. The text does not specify the country of origin, but it implies a clinical setting. The study is retrospective as it involves testing existing serum samples.

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

   • The document implies that the ground truth was established by comparing the Copalis® CMV Total Antibody Assay to two predicate devices: the Abbott CMV Total AB EIA and the Becton Dickinson CMVscan. It does not mention individual experts or their qualifications for establishing the ground truth beyond the performance of these predicate devices. Therefore, the "experts" in this context are the established predicate assays.

3. Adjudication method for the test set:

   • The document mentions "initial testing" and then "retest" for some discrepant results in transplant donors. Specifically, it states, "Two of the four false positive results observed on initial testing of transplant donors by the Copalis® system were concordant positive on retest." This suggests a form of adjudication by retesting or confirmation for discrepant results, but not a panel-based expert adjudication method like 2+1 or 3+1.

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:

   • This was not an MRMC comparative effectiveness study involving human readers and AI assistance. The device is an immunoassay for detecting antibodies, not an AI-powered diagnostic imaging or interpretation tool.

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

   • Yes, this study is inherently a standalone performance evaluation of the immunoassay device itself. The result (presence or absence of antibodies) is generated by the assay system without direct human interpretation of a complex output, beyond reading the result provided by the system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth was established by comparison to established predicate devices (Abbott CMV Total AB EIA and Becton Dickinson CMVscan). This is a common method for new diagnostic assays, where accepted, legally marketed assays serve as the reference standard.

7. The sample size for the training set:

   • The document does not mention a training set. This is typical for traditional immunoassay development, which relies on biochemical principles and calibration rather than machine learning models that require a separate training phase.

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

   • Not applicable, as no training set is mentioned or implied for this type of immunoassay device.

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