The CK-MB Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human CK-MB in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).
Creatine Kinase MB (CK-MB) is an enzyme present in the cardiac muscle with a molecular weight of 87.0 kDa. Creatine Kinase is a dimeric molecule formed from two subunits designated as "M" and "B" which combine to form three different isoenzymes, CK-MM, CK-BB, and CK-MB. CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac muscle tissue. The release of CK-MB into the blood following MI can be detected within 3-8 hours after the onset of symptoms. It peaks within 9 to 30 hours, and returns to baseline levels within 48 to 72 hours. CK-MB is one of the most important cardiac markers and is widely recognized as the traditional marker for the diagnosis of MI. The CK-MB Rapid Test is a simple test that utilizes a combination of anti-CK-MB antibody coated particles and capture reagent to detect CK-MB in whole blood, serum or plasma. The minimum detection level is 5 ng/ml.
•Rapid test cassette with desiccant
• Buffer
• Disposable pipettes
• Package insert
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
Sample Collection&Storage
•The CK-MB Rapid Test can be performed using whole blood (from venipuncture or fingerstick), serum or plasma.
•To collect Fingerstick Whole Blood specimens:
Wash the patient's hand with soap and warm water or clean with an alcohol swab. Allow to dry.
Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
Add the Fingerstick Whole Blood specimen to the test device by using a capillary tube:
Touch the end of the capillary tube to the blood until filled to approximately 100 µL. Avoid air bubbles.
Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense the whole blood into the specimen well (S) of the test device.
Add the Fingerstick Whole Blood specimen to the test device by using hanging drops:
Position the patient's finger so that the drop of blood is just above the specimen well (S) of the test device.
Allow 3 hanging drops of fingerstick whole blood to fall into the specimen well (S) of the test device, or move the patient's finger so that the hanging drop touches the specimen well (S).
Avoid touching the finger directly to the specimen well (S).
•Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.
•Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
•Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
•If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
Allow the test, specimen and/or controls to reach room temperature (15- 30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Place the test device on a clean and level surface.
For Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 μL) to the specimen well (S) of the test device, then start the timer.
For Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 3 drops of venipuncture whole blood (approximately 75 μL) to the specimen well (S) of the test device, then add 1 drop of buffer(approximately 40μL) and start the timer.
For Fingerstick Whole Blood specimens:
•To use a capillary tube: Fill the capillary tube and transfer approximately 75 μL of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 1 drop of buffer(approximately 40 μL) and start the timer.
•To use hanging drops: Allow 3 hanging drops of fingerstick whole blood specimen (approximately 75 μL) to fall into the center of the specimen well (S) on the test device, then add 1 drop of buffer(approximately 40 μL) and start the timer.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret
results after 20 minutes.
About Us
Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
During the special period, Dewei also develop the reagent kits, like Virus Transport Medium with swab, Rapid test and Saliva Collection Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.
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