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CTK BIOTECH, INC.
Myoglobin Fluorescence ImmunoAssay Test
Model: MYO FIA Test
Description
The Myoglobin (MYO) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of MYO in human serum or plasma, with a cut-off level of 55.0 ng/mL, using the RaFIA system. The test is intended for in vitro diagnostic use only and was developed to detect the concentration of MYO within 15 minutes without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.
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Features
• Quantitative, non-subjective results
• Increased sensitivity and broader detection range compared to rapid tests
• Working range: 2.5-400.0 ng/mL
• Intra-lot precision was determined by testing of MYO reference materials using 10 test devices from the same lot. CV ≤ 15%
• Inter-lot precision was determined by testing of MYO reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
• MYO control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
• A serial concentration of MYO reference materials at 20.0-400.0 ng/mL was tested, and the correlation coefficient (R) is ≥0.9900.
• Increased sensitivity and broader detection range compared to rapid tests
• Working range: 2.5-400.0 ng/mL
• Intra-lot precision was determined by testing of MYO reference materials using 10 test devices from the same lot. CV ≤ 15%
• Inter-lot precision was determined by testing of MYO reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
• MYO control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
• A serial concentration of MYO reference materials at 20.0-400.0 ng/mL was tested, and the correlation coefficient (R) is ≥0.9900.
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Request Price/Quote
Tags: [Point-Of-Care Testing]
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