Product Name
Creatinekinase MB Rapid Diagnostic Kit (Immunochromatography)
Intended Use
CK-MB is one of the most important myocardial markers, with well-established
roles in confirming acute myocardial infarction (AMI) and in monitoring
reperfusion during thrombolytic therapy following AMI.
Test Principle
The test utilizes antibodies including a recombinant protein on the nitrocellulose
membrane with colloidal gold marked mixed CK-MB antigen as a mark tracer.
The reagent is used to detect the CK-MB in serum/plasma/whole blood
according to the principle of double antibody sandwich method and gold
immunochromatography assay. The sensitivity can reach to 5ng/ml.
Main components
Sample pad, colloidal gold marked pad, nitrocellulose membrane, absorbent
paper and PVC board.
Sample requirement
1. Collect venous blood a clean and dry container according to the standard method. Separate the serum or plasma for testing. EDTA, sodium citrate, sodium oxalate, heparin can be used as the anticoagulants
2. After collection, separate the serum and plasma as soon as possible, in order to avoid hemolysis.
3. Use fresh blood. Samples may be stored at 2-8°C for 3 days, and should be stored at -20°C for 2 years. Do not freeze and thaw the sample repeatedly. Frozen refrigerated samples should be recovered to room temperature before detection.
Storage and Expiry
Store as packaged in the sealed pouch at 4-30°C, avoid hot and sunshine, dry
place, valid for 24 months. DO NOT FREEZE. Some protective measures should
be taken in hot summer and cold winter to avoid high temperature or
freeze-thaw.
Test Procedure
Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate to room temperature for 30 minutes (20°C-30°C) prior to testing. Do not open the inner packaging until ready, it must be used in one
hour if opened (Humidity: 20%~90%, Temp: 10°C-50°C) Strip and Cassette: Strip: 1. Take off the outer packing, put the strip onto the desk with the sample adding area of the strip up.
2. Drop 3 drops (100ul) of serum/plasma/whole blood vertically onto the sample pad of strip. If the blood is thick, add about 1 drop of (40-50μl) sample buffer onto the sample pad of strip.
3. Observe the test results immediately within 20 minutes, the result is invalid over 20 minutes.
WWHS Assay list | | | | | |
Cardiac | | | | | |
cat#. | Product Item | Specimen | Reaction Time | Measure Range | Clinical Range | Intended Use |
1 | cTnI | WB/Serum/Plasma | 12min. | 0.1-40ng/ml | <0.3ng/ml | several heart diseases including myocardial infarction and heart failure. |
2 | Myo | WB/Serum/Plasma | 12min. | 5-400ng/ml | <58ng/ml | acute myocardial infarction (AMI) in early stage. |
3 | CK-MB | WB/Serum/Plasma | 12min. | 1-200ng/ml | <5ng/ml | acute myocardial infarction (AMI) in early stage. |
4 | NT-proBNP | WB/Serum/Plasma | 10min. | 20-35000pg/ml | Under 75:0~347pg/mL, Over 75:0~449pg/mL | heart failure . |
5 | D-Dimer | WB/Plasma | 10min. | 40-10000ng/ml | <500ng/ml | disseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc. |
6 | cTnI+Myo+CKMB | WB/Serum/Plasma | 12min. | same with single item | same with single item | Triple marker of myocardial infarction. |
7 | ST2 | WB/Serum/Plasma | 10min. | 10-400ng/ml | <35ng/ml | heart failure . |
8 | Lp-PLA2 | WB/Serum/Plasma | 10min. | 10-900ng/ml | <175ng/ml | Risk evaluation of ACS and atherosclerotic ischemic stroke patients. |
9 | S100-β | WB/Serum/Plasma | 10min. | 0.05-10ng/ml | <0.2ng/ml | Cerebral infarction, cerebral injury. |

