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This CK-MB Test Kit (Time Resolved Fluorescence Immunochromatographic Assay) is suitable for quantitative detection of Creatine kinase isoenzyme (abbreviated as CK-MB below)in human Serum/plasma/whole blood in vitro.
Intended Use
This CK-MB Test Kit (Time Resolved Fluorescence Immunochromatographic Assay) is suitable for quantitative detection of Creatine kinase isoenzyme (abbreviated as CK-MB below)in human Serum/plasma/whole blood in vitro.
Product Information
|
Production name |
Test samples |
Specifications |
|
CK-MB Quantitative Test Kit (TRFIA) |
serum/plasma/whole blood |
20T/Kit, 50T/Kit |
Storage Conditions and Expiry Date
The unopened kit was stored in 2℃~8℃ for 18 months. The product can be stored at temperature (20℃~30℃) for 30 days if expiry printed on the package is not exceeded. The temperature change during transportation (<37℃) has no effect on product quality. The reagent strip and the sample buffer are used in one-to-one mode, that is, a reagent strip is matched with a sample buffer to detect a blood sample.After unsealing, it can be stabilized for 1 hour at room temperature. Under normal humidity and light conditions, store and use according to the above requirements.
Product performance
Accuracy: the relative deviation from the target value of the enterprise reference should be within ±15% .
Minimum detection limit: no more than 0.25ng/mL.
Linear range :[1~75] ng/mL range, the kit correlation coefficient r≥0.9900.
Repeatability: coefficient of variation (CV)≤15%.
Inter-batch difference: coefficient of variation (CV)≤15% between batches
Stability: test the physical properties, accuracy, minimum detection limit, linear range and repeatability of the kit within one month of service life,Shall comply with the corresponding requirement
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