DE Medical Technology Jiangsu Co.,Ltd

CE Certificate IVD Cardiac marker MYO Myoglobin Rapid test kit MYO diagnosticTest cassette

Intended Use
 
Myoglobin (Myo) is also 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
When specimen is added to sample pad, it moves through the conjugate pad and mobilizes gold Myo conjugate that is coated on the conjugate pad.The mixture moves along the membrane by 
capillary action and reacts with Myo antibody that is coated on the test region. If Myo is present,the result is
the formation of a colored band in the test region.If there is no Myo in the sample,the area will remain colorless.
 
Main components
Sample pad, colloidal gold marked pad, nitrocellulose membrane, absorbent paper and PVC board.
 
Specimen requirement
1. Collect venous blood into container without anticoagulant according to the standard method. 
Separate serum or plasma for testing.
2. If the specimen cannot be tested on the day of collection, store the serum or plasma specimen 
in a refrigerator or freezer. 
3. Bring the specimens to room temperature before testing. Do not freeze the specimen repeatedly.
 
Storage and Expiry
Store at room temperature 4-30 ℃, avoid hot and sunshine, dry place, not frozen, valid for 24months.
 
Test Procedure
1. Instructions must be read entirely before taking the test. Place the reagent at room temperature 
for 30 minutes before use to return to room temperature(20℃-30℃).Do not open the inner packaging before not ready, it must be used in one hour if opened
(Humidity:20%~90%,Temp:10℃-50℃).
2. Test Procedure
Cassette: Take off outer packing, using a pipette vertically drop 2 drops (100ul) specimen into the
circular groove of cassette with S.
3. Wait 10-15 minutes and read result. Do not read results after 15 minutes.
 
Interpretation of result 
Positive: Two red band appears, one in the test area (T), another in the control area(C) 
Negative: Only one red band (C) appears in the detection zone, (T) without the red band appears.
Invalid: No red lines appear or quality control areas (C) appear a red band, 
indicating that the operator error or reagent failure.