DE Medical Technology Jiangsu Co.,Ltd

CE Certificate IVD Cardiac marker CK-MB Rapid test kit Creative kinase-MB Test cassette

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 Rapid Test is based on the principle of double antibody sandwich immunoassay for the qualitative detection

of CK-MB in human serum or plasma. When specimen is added to sample pad, it moves through the conjugate

pad and mobilizes gold CK-MB conjugate that is coated on the conjugate pad. The mixture moves along

the membrane by capillary action and reacts with CK-MB antibody that is coated on the test region.

The sensitivity can reach to 5ng/ml.

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 test specimen in a refrigerator or freezer.

3. Bring the specimen to room temperature before testing. Do not freeze and thaw 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 (about 100ul) specimen

into the sample well.

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.