MI Cardiac Marker CK-MB Rapid Test Cassette with CE Certificate and 2 Years Shelf Life

【INTENDED USE】

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).

【INTRODUCTION】

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.

【PRINCIPLE】

The CKMB Rapid Test detects CKMB through visual interpretation of color development on the internal cassette. Anti-CKMB antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-CKMB antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there is enough CKMB in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

【MAIN CONTENTS】

• Rapid test cassette with desiccant

• Disposable pipettes

• Buffer

• Package insert

【PRECAUTIONS】

 This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially infectious, and handled observing usual safety precautions (e.g., do not ingest or inhale).

 Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.

 Read the entire procedure carefully prior to testing.

 Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

 Do not interchange or mix reagents from different lots.

 Humidity and temperature can adversely affect results.

 Used testing materials should be discarded according to local regulations.

【STORAGE AND STABILITY】

• 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】

• The CK-MB Rapid Test can be performed using whole blood (from venipuncture or fingerstick), serum or plasma.

• Only clear, non-hemolyzed specimens are recommended for use with thistest. Serum or plasma should be separated assoon as possible to avoid hemolysis.

• Perform testing immediately after specimen collection. Do not leave 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.

• Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.

• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.

• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents. • Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.

• There is a slight possibility that some whole blood specimens with very high viscosity or which have been stored for more than 2 days may not run properly on the test device. Repeat the test with a serum or plasma specimen from the same patient using a new test cassette.

【DIRECTION OF USE】

Allow the test, specimen and/or controls to reach room temperature (15- 30°C) prior to testing.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.

2. Transfer 1 drop of whole blood, serum or plasma specimen to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane.

3. Wait for the colored band(s) to appear. The result should be read within 15 minutes. Do not interpret the result after 20 minutes.

【INTERPRETATION OF RESULTS】

POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.

INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.

For further operation or performance details, please refer to final instruction manual.