(21 days)
The Tina-quant® Myoglobin Assay is an immunoturbidometric assay for the quantitative determination of Myoglobin in serum and plasma using automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
The myoglobin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing myoglobin is transferred into a EDTA/glycine buffer solution (R1 reagent). In the second step, an aliquot of solution containing fine latex particles coated with polyclonal anti-human myoglobin antibodies (R2 reagent) is added to mixture of the first step. The antibody-coated particles will bind to the myoglobin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of myoglobin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of myoglobin in the sample is directly proportional to the amount of turbidity formed.
This document describes the Boehringer Mannheim Tina-quant® Myoglobin Assay, an immunoturbidometric assay for the quantitative determination of Myoglobin in serum and plasma. The study presented aims to demonstrate substantial equivalence to a predicate device, the Behring N Latex Myoglobin Assay.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" but rather presents a comparison of performance characteristics between the subject device (Tina-quant® Myoglobin) and its predicate (N Latex Myoglobin). The implication is that performance comparable to or better than the predicate device constitutes acceptable performance.
| Feature | Acceptance Criteria (Implied from Predicate) | Reported Tina-quant® Myoglobin Performance |
|---|---|---|
| Precision (Intra-Assay) | Low: N=20, Mean ~85 µg/L, SD ~2.0, %CV ~2.4 | Control 1: N=20, Mean 32.3 ng/mL, SD 0.8, %CV 2.6 |
| Mid: N=20, Mean ~160 µg/L, SD ~2.4, %CV ~1.5 | Control 2: N=20, Mean 71.3 ng/mL, SD 0.6, %CV 0.9 | |
| High: N=20, Mean ~310 µg/L, SD ~2.9, %CV ~0.9 | Control 3: N=20, Mean 471.5 ng/mL, SD 1.6, %CV 0.3 | |
| Precision (Inter-Assay) | Low: N=15, Mean ~85 µg/L, SD ~4.8, %CV ~5.6 | Sample 1: N=20, Mean 71.3 ng/mL, SD 0.6, %CV 0.9 |
| Mid: N=15, Mean ~160 µg/L, SD ~4.2, %CV ~2.6 | Sample 2: N=20, Mean 471.5 ng/mL, SD 1.6, %CV 0.3 | |
| High: N=15, Mean ~310 µg/L, SD ~5.0, %CV ~1.6 | ||
| Lower Detection Limit | 25 µg/L | 3.0 ng/mL |
| Linearity | 25.0 - 400 µg/L | 3.0 - 560 ng/mL |
| Method Comparison (vs. Predicate) | N/A (Predicate itself is the comparison) | Least Squares: y = 1.06x + 0.35, r = 0.989, SEE = 19.61, N = 41 |
| Passing/Bablok: y = 1.07x + 3.6, r = 0.989, SEE = 13.61, N = 41 | ||
| Interfering Substances | Bilirubin: No interference | Bilirubin: No interference at 60 mg/dL |
| Hemoglobin: No interference | Hemoglobin: No interference at 0.5 g/dL | |
| Lipemia: No interference | Lipemia: No interference at 1500 mg/dL | |
| Rheumatoid Factor: |
§ 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).