(58 days)
This in vitro diagnostic procedure is a solid phase immunoassay intended for the quantitative determination of Myoglobin in human serum or heparin plasma on the Technicon Immuno 1 system. When used in combination with other clinical data such as presenting symptoms and EKG values, measurement of Myoglobin aides in the early phase diagnosis of Myocardial Infarctions.
The method described is an enzyme label sandwich assay using a monoclonal (mouse) capture and a polyclonal (goat) detector antibody. The monoclonal antibody is labelled with fluorescein and the polyclonal antibody labelled with alkaline phosphatase (ALP). The two reagents are the active compounds of the R1 and the R2 reagent, respectively. The solid phase consists of a suspension of magnetizable particles coated with antibody to fluorescein (mIMP reagent). Sample or calibrator, R1and R2 reagent and mIMP reagent are mixed simultaneously and incubated at 37 °C. In the presence of Myoglobin fluorescein-conjugate= Myoglobin=ALPa conjugate complex is formed and captured by the antiFluorescein antibodies on the magnetic particles. The particles are precipitated by an external magnetic field, washed and para-Nitrophenylphosphate is added as the enzyme substrate. The increase in absorbance due to the formation of p-Nitrophenolate is monitored spectrophotometrically at 405 and 450 nm. The concentration of Myoglobin in a sample. A Cubic Fit Through Zero is used to calculate the dose response curve. The assay is depicted schematically in fig. 1.
This document describes the performance characteristics of the MYOGLOBIN METHOD FOR THE IMMUNO 1 SYSTEM.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the document presents performance data to demonstrate the device's characteristics. The reported performance metrics are summarized below:
| Performance Characteristic | Reported Device Performance |
|---|---|
| Imprecision (Total CV) | |
| Sample 1 (14.8 ng/mL) | 5.5 % |
| Sample 2 (52.6 ng/mL) | 3.6 % |
| Sample 3 (75.6 ng/mL) | 3.9 % |
| Sample 4 (131.3 ng/mL) | 3.6 % |
| Sample 5 (247 ng/mL) | 4.4 % |
| Sample 6 (278.1 ng/mL) | 3.0 % |
| Sample 7 (639.7 ng/mL) | 3.6 % |
| Sample 8 (1557.6 ng/mL) | 3.6 % |
| Sample 9 (2718.9 ng/mL) | 3.4 % |
| Correlation with Behring Nephelometer A | |
| Correlation Equation (y = Immuno 1, x = BNA) | y = 1.02 × x + 1.05 |
| Slope (b) | 1.02 (Limits: 0.98 - 1.06) |
| Intercept (a) | 1.05 (Limits: -3.2 - 4.5) |
| Confidence of Correlation | 0.99314 |
| Interference (measured concentration as % of -2 pool) | |
| Bilirubin (25 mg/dL) | 100.3% - 101% |
| Albumin (6.5 g/dL) | 100.9% - 101.5% |
| Hemoglobin (1 g/dL) | 100.1% - 102% |
| Gamma Globulins (5.3 g/dL) | 78.6% - 103.5% (The result for 1+ (95) and 2+ (103.5) are presented in a confusing manner, but the measured concentrations are within a reasonable range of the -2 pool) |
| Triglycerides (supertrate) | 93.8% - 104.5% |
| Heparin (65 IU/mL) | 99.9% - 101.5% |
| Citrate (50 mg/mL) | 96% - 99% |
| Urea and Creatine (200 mg/dL Urea, 2.5 mg/dL Creatine) | 99.8% - 101.2% |
| Rheumatoid Factor (567 IU/mL) | 100.2% - 103.9% |
| Linearity (deviation from calculated) | |
| Range | -21% to 1.6% |
| Sample Dilution (Recovery) | |
| Serum samples dilated with Immuno 1 Sample Diluent B | 93.9% - 108% |
| Serum samples dilated with Immuno 1 Calibrator Level 1 | 93.2% - 107.2% |
| Plasma samples dilated with Immuno 1 Sample Diluent B | 99.9% - 105.4% |
| Plasma samples diluted with Immuno 1 Calibrator Level 1 | 88.9% - 111.8% |
| Hook Effect | No erroneous results within the calibration range for Myoglobin content |
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).