(234 days)
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."
| Performance Characteristic | Acceptance Criteria (Implied by CLSI guidelines and sponsor's predetermined criteria) | Reported Device Performance (MSD CRP Assay Kit) |
|---|---|---|
| Precision/Reproducibility | Based on CLSI EP05-A3 guidelines, percentage coefficient of variation (%CV) within acceptable limits. | Total %CV: |
| Level 1 (4.45 mg/L): 7.3% | ||
| Level 2 (8.47 mg/L): 8.2% | ||
| Level 3 (10.81 mg/L): 7.1% | ||
| Level 4 (57.18 mg/L): 7.2% | ||
| Level 5 (215.8 mg/L): 8.3% | ||
| Linearity/Assay Reportable Range | Based on CLSI EP06-A guidelines. Linear regression analysis with high R² and acceptable slope/intercept. | Linear Range: 3 - 160 mg/L |
| Regression Analysis (0.627 – 201 mg/L): | ||
| Slope: 0.942 (95% CI: 0.926 – 0.958) | ||
| Intercept: 0.0296 (-0.0389 – 0.0982) | ||
| R²: 0.997 | ||
| % Recovery: -8.9% — 0.0% | ||
| Hook Effect | No prozone effect observed within the linear range. | No prozone effect observed up to 800 mg/L. |
| Traceability | Traceable to an international reference material. | Traceable to CRM474 reference material. |
| Stability | Demonstrates sufficient shelf life for the kit components. | Supports a kit shelf life of 7 months (real-time stability for un-opened components). |
| Limit of Blank (LoB) | Determined according to CLSI EP17-A2. | 0.02 mg/L for all tested kit lots. |
| Limit of Detection (LoD) | Determined according to CLSI EP17-A2. | 0.039, 0.048, and 0.049 mg/L for tested kit lots. |
| Limit of Quantification (LoQ) | Defined as the lowest concentration with Total Error (TE) |
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).