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The MSD CRP Kit is intended for in vitro diagnostic use in the quantitative determination of C-reactive protein (CRP) in human serum using the MESO SECTOR S 700 instrument. Measurement of CRP aids in the evaluation of infection, tissue injury, and inflammatory disorders. This test will be performed in a hospital or clinical laboratory setting by trained laboratory personnel. The target patient population for the MSD CRP Assay is symptomatic adults. Clinicians should utilize the results of the MSD CRP Assay for diagnosis of inflammatory diseases in conjunction with other clinical and laboratory findings.

The SECTOR S 700 instrument is intended for the in-vitro determination of analytes in bodily fluids. This instrument is not intended for Point-of-Care use.

The MSD CRP Assay Kit is a quantitative in-vitro diagnostic assay for conventional measurement of C-reactive protein in human serum. The CRP Assay Kit is designed for use with the MESO SECTOR® S 700 Instrument. The kit components include the 96-well CRP assay plate, CRP calibrator, CRP detection antibody, CRP diluent and CRP read buffer. The assay in the MSD CRP Kit is a sandwich immunoassay employing electrochemiluminescence (ECL) detection. In the instrument, a voltage is applied to the plate electrodes causing the captured labels to emit light. The instrument measures the intensity of emitted light from each spot to provide a quantitative measure of analyte in the sample.

The document provided describes the MSD CRP Assay Kit and MESO SECTOR S 700 Instrument, an in vitro diagnostic device for quantitative determination of C-reactive protein (CRP) in human serum.

Here's the breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful completion of the studies according to CLSI guidelines, with results falling within acceptable statistical ranges. The document states, "All results for analytical performance met the sponsor's predetermined acceptance criteria for each study."

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

• Precision/Reproducibility: Five serum samples tested for 20 days with duplicate runs, implying 5 samples x 2 runs/day x 20 days = 200 measurements per site across 3 sites, leading to 240 replicates per sample (total possibly 1200 replicates overall, although 1199 measurements are mentioned before outlier removal).
• Linearity: "Low" and "High" CRP serum pools were created, and eleven (11) serial dilutions were made from these. Four (4) replicate runs were performed on each dilution sample.
• Detection Limit (LoB): One hundred twenty (120) blank replicates.
• Detection Limit (LoD): One hundred twenty (120) low-level CRP samples (20 replicates of 6 low-level serum pools).
• Detection Limit (LoQ): Eight (8) replicates of six (6) low-level CRP pools.
• Analytical Specificity (Interference): Five serum samples for each interferent (endogenous/drugs), measured in five replicates across three reagent lots.
• Method Comparison: 120 serum samples.
• Expected Values/Reference Range: 120 apparently healthy individuals.

Data Provenance: The document generally refers to "human serum" and "serum samples." For the reference range study, it mentions "a representative adult U.S. population." The studies appear to be prospective, laboratory-based analytical studies designed to characterize the device's technical performance.

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

For this type of in vitro diagnostic device (quantitative immunoassay), ground truth is established through metrological traceability to certified reference materials and comparison against a legally marketed predicate device. Experts are typically laboratory personnel trained in performing such assays, but their specific number and qualifications are not detailed for establishing ground truth as it's not a diagnostic imaging or subjective interpretation task. The device calibrates against CRM474, which serves as the ultimate "ground truth" for CRP concentration.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative biochemical assay. Ground truth is determined by the measured concentration, calibrated against reference materials, not by expert consensus or adjudication of subjective findings.

5. 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

Not applicable. This is a standalone in-vitro diagnostic device for quantitative CRP measurement, not an AI-assisted diagnostic tool that would involve human readers or comparative effectiveness in that context.

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

Yes, the studies described are standalone performance evaluations of the device (assay kit + instrument) itself. The device quantifies CRP based on electrochemiluminescence, which is an automated process without human-in-the-loop performance in the sense of interpretive judgment.

7. The Type of Ground Truth Used

• Metrological Traceability: The calibrators are traceable to CRM474 reference material, which serves as the primary ground truth for the absolute concentration of CRP.
• Comparative Ground Truth: For method comparison, the results obtained from the legally marketed predicate device (Roche Diagnostics C-Reactive Protein (Latex) Assay and Roche Diagnostics Cobas Integra 800 Analyzer) serve as a comparative ground truth to demonstrate substantial equivalence.
• Statistical Definitions: For LoB, LoD, and LoQ, ground truth is established statistically according to CLSI guidelines based on measurements of blank, low-level, and spiked samples.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a distinct "training set" in the conventional sense. The device's calibration curve and analytical performance characteristics are established through the analytical studies described (e.g., linearity, precision, detection limits, traceability), which use a series of known concentration samples.

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

Not applicable, as there is no "training set" in the machine learning context. The calibration of the device relies on calibrators that are traceable to CRM474 reference material, establishing the ground truth for concentration measurements.

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