The CK-MB Test Cassette (Whole Blood/Serum/Plasma) is a chromatographic immunoassay
for the quantitative detection of human CK-MB in human whole blood, serum or plasma as an
aid in the diagnosis of myocardial infarction (MI).
【SUMMARY】
Creatine Kinase MB (CK-MB) is an enzyme present in the cardiac muscle with a molecular
weight of 87.0 kDa.1Creatine 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. 2 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. 3 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 Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a
combination of antibody coated particles and capture reagents to quantitatively detect CK-MB
in whole blood, serum or plasma.
【PRINCIPLE】
The CK-MB Test Cassette (Whole Blood/Serum/Plasma) detects CK-MB based on
Fluorescence Immunoassay. The sample moves through the strip from sample pad to
absorbent pad. If the test sample contains CK-MB, it attaches to the CK-MB antibody which is
conjugated with fluorescent microspheres. Then the complex will be captured by the capture
antibody coated on the nitrocellulose membrane (Test line).The concentration of CK-MB in the
sample correlates linearly with the fluorescence signal intensity captured on the T line.
According to the fluorescence intensity of the test and product standard curve, the
concentration of CK-MB in the sample can be calculated by Reader to show CK-MB
concentration in specimen.
【REAGENTS】
The test kit include anti-CK-MB antibody conjugated fluorophores and CK-MB antibody coated
on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if the foil
pouch is damaged. Do not reuse.
3. This test 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).
4. Avoid cross-contamination of specimens by using a new specimen collection container for
each specimen obtained.
5. Do not eat, drink or smoke in the area where the specimens and tests 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.
6. Do not interchange or mix reagents from different lots.
7. Humidity and temperature can adversely affect results.
8. Used testing materials should be discarded in accordance with local regulations.
9. Read the entire procedure carefully prior to any testing.
10. The CK-MB Test Cassette is only operational in the analyzer. And tests should be applied
by professionally trained staff working in certified laboratories at some remove from the patient
and clinic at which the sample(s) is taken by qualified medical personnel.
【STORAGE AND STABILITY】
1. The kit should be stored at 4-30 °C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination. Do not use if
there is evidence of microbial contamination or precipitation. Biological contamination of
dispensing equipment, containers or reagents can lead to false results.
【SPECIMEN COLLECTION AND PREPARATION】
Preparation
Before performing the test, please make sure that all components are brought to room
temperature (15-30 °C). Cold buffer solution or moisture condensation on the membrane can
lead to invalid test results.
Blood Sample Taking
1. Collect the specimen according to standard procedures.
2. 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 used within 2 day of collection. Do not freeze whole blood specimens. Whole blood
collected by finger stick should be tested immediately.
3. 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.
Sample Dilution / Sample Stability
1. The specimen (75uL of serum / plasma/100uL of whole blood) can be added directly with
the micro pipette into the buffer.
2. Close the tube and shake the sample by hand for approximately 10 seconds so sample and
dilution buffer mix well.
3. Let the diluted sample rest for approximately 1 minute.
【MATERIALS】
Materials Provided
• Test Cassettes
• Specimen Collection Tubes with Extraction Buffer
• ID Card
• Package Insert
Materials Required But Not Provided
• Timer
• Centrifuge
• Pipette
• Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to Fluorescence Immunoassay Analyzer User Operation Manual for the complete
instructions for the use of the analyzer. The test should be conducted at room temperature.
Allow the test, specimen and buffer to reach room temperature (15-30 °C) prior to
testing.
1. Turn on the Analyzer power.
2. Take out the ID card and insert it into the ID Card Slot. Choose test mode and/or sample
type according to needs.
3. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best
results will be obtained if the assay is performed immediately after opening the foil pouch.
4. Place the test on a flat and clean surface.
Serum/plasma: Pipette 75μL of serum/plasma into the buffer tube; mix the specimen and the
buffer well.
Whole blood: Transfer 100μL of whole blood into the buffer tube with pipette; mix the
specimen and the buffer well.
5. Add diluted specimen with a Pipette: Pipette 75μL diluted specimen into the sample well.
Start the timer at the same time.
6. Test results should be interpreted at 15 minutes with the use of Fluorescence
Immunoassay Analyzer.
Caution: There are different test modes of the Fluorescence Immunoassay Analyzer. The
difference between them is incubation of the test cassette is outside or inside the analyzer.
Choose test mode accordingly and confirm sample type. Consult the user manual of the
analyzer for detailed operation information.
Operator must consult the Fluorescence Immunoassay Analyzer User Manual prior to use and
become familiar with the processes and quality control procedures.
【INTERPRETATION OF RESULTS】
Results read by Fluorescence Immunoassay Analyzer.
The result of tests for CK-MB is calculated by Fluorescence Immunoassay Analyzer and
display the result on the screen. For additional information, please refer to the user manual of
Fluorescence Immunoassay Analyzer.
Working range of CK-MB is 0.2-75ng/mL.
