Creatine Kinase Isoenzyme (CK-MB) Assay Kit – Bulk Reagents

US$158.00

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Selling unit: per 100ml

Product Name

Common name: Creatine kinase isoenzyme (CK-MB) assay kit (immunosuppression method)

English name: Creatine kinase isoenzyme Kit (immune inhibition method)

Reagent Ratio

3:1, 4:1, 5:1, common ratio 4:1, other ratios need to be customized

Intended Use

CK-MB assay kit is mainly used for the in vitro quantitative detection of CK-MB in human serum.

Serum CK-MB is an important myocardial marker, mainly used in the diagnosis of acute myocardial infarction and also in the assessment of myocardial infarct size, and is currently considered to be the myocardial marker of choice in cases where troponin is not available. It is performed in combination with the measurement of AST and LDH to help in the diagnosis and differentiation of acute myocardial infarction.

Test Principle

CK consists of two subunits, M and B, to form three kinds of dimers, CK1 (BB), CK2 (MB), and CK3 (MM) are mainly present in the cytosol, in addition to a small amount of mitochondrial isoenzymes (CKm) in serum. CK activity is high in cardiac muscle (second only to skeletal muscle), with CK-MB isoenzymes accounting for about 13-22% (<1% in skeletal muscle), making it specific as an indicator of myocardial injury. This kit uses an immunosuppression method, using anti-human M serum, inhibiting the M subunit, and then measuring the remaining B subunit activity, multiplying by 2 to obtain the CK-MB isoenzyme activity.

CK

Creatine phosphate + ADP —→ Creatine + ATP

HK

ATP + glucose —→ glucose-6-phosphate + ADP

G6PDH

Glucose-6-phosphate + NADP+  +H2 O —→ Gluconic acid 6-phosphate + NADPH+H+

The rate of NADPH production was measured at 340 nm and the CK-MB isoenzyme activity was calculated.

Main Components

Reagent components included in the product.

Creatine Kinase Isoenzyme (CK-MB) Assay Kit

* The components of the kits are not interchangeable between batches.

*Reagent components not included in the product, but necessary for the test: outsourced normal and abnormal QCs and calibrators.

Storage Conditions And Expiration Date

The kit is stored at 2-8°C away from light and is valid for one year.

Reagents that have been opened are taken care not to be contaminated and the reagents are stabilized in the instrument compartment (2-8°C) for one month.

The reagents must not be frozen.

Applicable Instruments

Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 automatic biochemistry analyzer.

Sample Request

Serum, venous blood collection, to avoid hemolysis. Severe hemolysis can affect the results of the assay.

The samples are stable at room temperature (15-25°C) for 8 hours; at 2-8°C for 5-7 days; and frozen (-20°C) for 4 weeks.

Test Method

  1. Reagent preparation: liquid reagents are ready to use out of the bottle.
  2. Test conditions: (the following parameters are set in accordance with Toshiba TBA120, and different on-board parameters can be requested according to different testing instruments)

Creatine Kinase Isoenzyme (CK-MB) Assay Kit

Operation steps.

Creatine Kinase Isoenzyme (CK-MB) Assay Kit

*Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers.

  1. 3. Calibration procedure.

Calibration sera from Randox Laboratories Ltd UK are recommended.

  1. QC control procedures.

It is recommended to use quality control sera produced by Randox Laboratories Ltd UK, Landau Laboratory Diagnostics Ltd. It is recommended that each laboratory establish its own QC system and select appropriate QCs for quality control. The QC values should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.

  1. 5. Calculation.

Sample concentration = (sample ΔA /min) / (standard ΔA /min) × standard concentration

Reference Interval

0~24 U/L

The blood samples of 150 normal people were selected by clinical trials, measured by automatic biochemical analyzer, and the values obtained were processed statistically and reference ranges were calculated. It is recommended that each laboratory establish its own reference range of normal values.

It is recommended that each laboratory establish its own reference range of normal values.

Interpretation Of Test Results

The determination of CK-MB in serum is only one of the indicators used by clinicians to diagnose patients. Clinicians must also make a comprehensive judgment based on the patient’s physical symptoms, medical history, and other diagnostic items and diagnostic tools.

Limitations Of The Test Method

Ascorbic acid ≤ 30 mg/dL, bilirubin ≤ 40 mg/dL, and celiac disease ≤ 500 mg/dL did not interfere with the assay.

Product Performance Index

Appearance: The appearance of the kit should be neat and tidy, with clear identification of text symbols and intact reagent bottles; R1 is a colorless clarified liquid and R2 is a colorless clarified liquid, both without precipitation, suspension and flocculent.

Absorbance of reagent blank: wavelength 340 nm, optical diameter 1.0 cm, temperature 37°C, A0  ≤ 0.50.

Absorbance change of reagent blank: absorbance change of reagent blank at wavelength 340 nm and optical diameter 1.0 cm

△A/min ≤ 0.007.

Analytical sensitivity: The kit tests 130 U/L of the test substance with absorbance change rate ΔA/min ≥ 0.005.

Linearity interval: test serum samples, reagent linearity in the interval of 5 to 200 U/L, linear correlation coefficient |r| should not be less than 0.990; in the interval of 5 to 20 U/L, the absolute deviation of linearity should not exceed 2 U/L; in the interval of (20 to 200 U/L, the relative deviation of linearity should not exceed ±10%.

Precision: Repeatability CV ≤ 6%; relative extreme difference between batches ≤ 10%.

Accuracy: Relative deviation ≤ 10%.

Caution

  1. This product is for in vitro diagnosis only.
  2. Avoid contamination when using the reagent, the container used must be clean, and please take necessary precautions, do not swallow, and avoid contact with skin and mucous membrane.
  3. Do not mix R1 and R2 into a single reagent.
  4. When changing the reagent lot number, please recalibrate.
  5. There may be differences in the use of reagents from different manufacturers for the same sample.
  6. All sample cassette reaction waste should be treated as an infectious source and the operator needs to take the necessary protective measures.
  7. The reagent contains the preservative sodium azide (toxic), so please rinse thoroughly with water immediately if you accidentally get it in your eyes or mouth or on your skin, and seek medical attention if necessary. Sodium azide can react strongly with copper, lead and other metals to form azide metal, so please dilute the waste solution and flush the drainage pipe when disposing to avoid residue in the drainage pipe.
  8. test tubes and other instruments that have come into contact with the test sample should be disposed of in accordance with medical waste disposal methods.

Reference

  1. Stein W. Creatine kinase (total activity), creatine kinase isoenzymes and variants. in: Thomas L, ed. Clinical laboratory diagnostics. Frankfurt: TH-Books Verlagsgesellschaft; (1998). Frankfurt: TH-Books Verlagsgesellschaft; (1998). p.71-80.
  2. Moss DW, Henderson AR. clinical enzymology. in: Burtis CA, Ashwood ER, editors. tietz Textbook of Clinical Chemistry. 3rded. Philadelphia: W.B Saunders Company; (1999). Philadelphia: W.B Saunders Company; (1999). p. 617-721
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