DE Medical Technology Jiangsu Co.,Ltd

CE Certificate IVD Cardiac marker MYO/cTnI Troponin I / CK-MB 3 in 1 Rapid test panel 

Intended Use

The myoglobin and creatine kinase MB parts are the main markers for the early diagnosis of myocardial infarction (AMI), but may be non-specific for clinical diagnostic purposes. The troponin is the specificity marker; the level of cTnI in blood is abnormal during 4 h after the onset of chest pain was moderate and will peak in 8-16 h. The rising level could be tested within 6-10days. Myo,CK-MB, cTnI mass concentration are sensitive markers for the diagnosis of acute AMI.

The rapid test kit is fast and sensitive for an in vitro qualitative detection of Myo, CK-MB and cTnI in human whole blood, which is for the early and differential diagnosis of myocardial infarction in emergency, intensive care unit, cardiac medicine, health posts and other institutions acute, provides an objective, comprehensive, efficient new means clinical diagnosis of myocardial infarction.

The test is based on the principle of double antibody sandwich immunoassay for the qualitative detection of CK-MB in human serum.

Myo,CK-MB,TnI mass concentration are sensitive markers for the diagnosis of acute AMI.

1)Rapid Troponin I Test is an immunoassay test based rapid in vitro test. cTnI test is designed

to measure the concentration of cTnI in human serum /plasma or whole blood specimens.

2)Myoglobin Test is an immunoassay test based rapid in vitro test. It is designed for qualitative

determination of myoglobin in human serum /plasma or whole blood specimens.

3)CK-MB Test is an immunoassay test based rapid in vitro test.It is desi- gned for qualitative determination of CK-MB in human serum /plasma or whole blood specimens.

Test Principle

The test is based on the principle of double antibody sandwich immunoassay for the qualitative detection of Myo,CK-MB, cTnI in human serum. Three cards were Myo, CK-MB and cTnI test strip. Each test strip has the control line C (Control) and the test line (Test), the control line coated with anti-mouse antibody and the test line was coated with anti-Myo, CK-MB and cTnI monoclonal antibodies. When specimen is added to sample pad, it moves through the conjugate pad and mobilizes gold Myo/CK-MB/cTnI conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with Myo/CK-MB/cTnI antibody that is coated on the test region. If Myo/CK-MB/cTnI is present, the result is the formation of a colored band in the test region. If there is no Myo/CK-MB/cTnI in the sample the area will remain colorless.

The detection thresholds were: Myo: 80ng/ml; CK-MB: 5ng/ml; cTnI: 1ng/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

Keep the test strip and the specimen back to room temperature If not ready, do not tear foil bag,
1. Remove the strip from the foil bag.

2. Add 2 drops(about 100μl) serum into the three specimen holes on the test card.

3. Read the test results in 10-20 minutes. Do not interpret results after 20 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.