Ck-NAC 10mlx10
Ck-NAC 10mlx10
Technical Specifications
Intended Use
For the quantitative determination of creatine kinase activity in human serum. This test is used as an aid in the diagnosis and management of myocardial infarction and muscular diseases.
Assay Principle
The eastmed CK assay is based on a series of enzymatic reactions:
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Creatine Phosphate + ADP → (CK) Creatine + ATP
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ATP + Glucose → (HK) Glucose-6-Phosphate + ADP
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Glucose-6-Phosphate + NADP⁺ → (G6PDH) 6-Phosphogluconate + NADPH + H⁺
The rate of NADPH formation is measured photometrically by the increase in absorbance at 340 nm, which is directly proportional to the CK activity in the sample.
Kit Components
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Reagent 1 (R1): Lyophilized powder in 10 mL vials (10 vials per kit). Contains Hexokinase, Glucose-6-phosphate Dehydrogenase, ADP, AMP, NAC, ApA, Creatine Phosphate, and NADP.
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Reagent 2 (R2): Liquid buffer in a 100 mL bottle (1 bottle per kit). Contains Imidazole Buffer and Glucose.
Storage and Stability
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Unopened Kit: Store at 2°C - 8°C protected from light. Stable until the expiration date printed on the label.
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Reconstituted Reagent 1 (Working Solution): Once reconstituted with R2, the working solution is stable for 7 days when stored at 2°C - 8°C protected from light.
Test Parameters
| Parameter | Specification |
|---|---|
| Method | IFCC (Creatine Phosphate) |
| Sample Type | Human Serum (avoid hemolyzed or lipemic samples) |
| Sample Volume | 2 µL (Sample to Reagent Ratio 1:50) |
| Wavelength | 340 nm (Primary) |
| Temperature | 37°C |
| Assay Type | Kinetic |
Performance Data
| Characteristic | Specification |
|---|---|
| Measuring Range | 24 - 1500 U/L |
| Linearity | r ≥ 0.990 |
| Precision (CV) | Intra-assay ≤ 5% |
| Sensitivity | ΔA/min = 0.025 - 0.045 for a 300 U/L CK sample |
| Blank Absorbance | A₃₄₀ₙₘ ≤ 0.500 |
| Blank Rate | ΔA/min ≤ 0.002 |
Reference Intervals*
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Male: 38 - 174 U/L
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Female: 26 - 140 U/L
Each laboratory should establish its own reference ranges to reflect its local population.
Compatible Instruments
The eastmed CK Assay is suitable for use on open-channel clinical chemistry analyzers, including:
Mindray BS-200, Sinnowa D-280, Selectra-E, BIO-A25, Sunshine A8, and other semi-automated and automated systems.
Ordering Information
| Product Name | Catalog Number | Pack Size |
|---|---|---|
| Creatine Kinase (CK) Assay | EM-CK-0090 | 100 Tests |
For detailed instructions for use, warnings, and limitations, please refer to the complete package insert.
eastmed • Diagnostic Solutions
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