Span Biotech Ltd.

One-Step Trop I /CK-MB/ Myo Combo Rapid Test

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.

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: 0.5ng/ml.

Compositions

Test cards, disposable plastic dropper, instructions

Requirements on Specimen

1. Whole blood for testing, if collect pls test asap.

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 80-100μl whole blood into the three specimen holes on the test card separately..

3. Read the test results within 20 minutes. Do not interpret results after 20 minutes.

Result Judgment

Positive: Two red band appears in the test area （T）, another in the control area（C）.

Negative: Only control line (C) a red band appears in the detection zone (T) without the red band appears.

Invalid:  Quality control area (C) does not appear red band, indicating that the operator error or reagent failure.

Limitations

This kit provides qualitative results only, and cannot determine the exact content of three cardiac markers. A patient suffering from acute myocardial infarction, physicians should be combined with clinical features and diagnosis of acute myocardial infarction symptoms and other Comprehensive judgments.

Attentions

1. Check whether the packaging is complete, it cannot be used if the contents are damaged.

2. The test card is used only for in vitro rapid diagnosis.

3. All specimens and the test cards and used the dropper might be a potential risk, should be considered infectious waste for incineration and other treatment.

4. Specimens cannot add anticoagulants, not tender a glass tube full bloom, carefully observe the test line, a faint line as long as there is positive to prevent undetected.

Storage and Expiry

Store at room temperature 4-30 ℃, avoid hot and sunshine, dry place, not frozen, valid for 24 months. This kit can be short-term room temperature transport, in summer and winter should take certain protective measures to avoid heat or freezing and thawing.