Product Description

                       Human CK-MB Rapid Test Kit (Dry Immunofluorescence Assay) 

Product Name: Human CK-MB Rapid Test Kit (Dry Immunofluorescence Assay)

Packaging Details：50,100T/box      Cat#: CG01C02S

Intended Use:    This immunoassay kit allows for the in vitro quantitative determination of Human CK-MB in serum, plasma and other biological fluids.

Primary Structure and Composition

Kits are composed of test cards and specifications. Test cards consist of plastic shell and strips. Primary components of casettes are sample pad, fluorescence pad NC membrane and absorbent paper.

Test Principle

Kit Principle:  Human CK-MB rapid test kit (dry fluorescent method)developed by our company contains two anti-Human CK-MB monoclonal antibodies（capture&detection）with high specificity and sensibility. Anti-Human CK-MB detection antibody is labeled by nano fluorescent microspheres and is coated on the fluorescence pad; Anti-Human CK-MB capture antibody is coated on T line of NC membrane.

If the sample contains Human CK-MB protein, the Human CK-MB protein in the sample will form a “nano fluorescent microspheres – Anti-Human CK-MB detection antibody – Human CK-MB protein – Anti-Human CK-MB capture antibody” sandwich complex and then agglomerate to generate fluorescent signal on the T line. The signal would be analysed by the POCT analyzer to convert to the concentraton of Human CK-MB in the sample.

The fluorescent pad was also coated with chicken IgY labeled by nano fluorescent microspheres, which will be combined with the Rabbit anti chicken IgY antibody precoated on the C line when samples pass. The signal of C line should be constant and then indicate the validation of the test.

Complement Instrument Principle: The detection card is inserted into POCT immune fluorescence quantitative analyzer of HG-98 /CagenBio-I, II, and III type. The instrument measuring system automatically scan the label and the signal to be detected. Then the optical signal is measured and analyzed, and the concentration of the measured substance is obtained.

Storage& Transport Condition

Storage Condition：Store in dry and cool place in 4~30℃；

Transport Condition：Prevent exposition, extrusion and moisture in general transport

Manufacture Date and Shelf Life

Manufacture date：on the out package

Shelf Life：12 months when 4~30℃ in the sealed pouch

Applicable Instrument

   It is applicable in HG-98type/CagenBio-I type、II type、III type POCT immunofluorescence instrument.

Specimen Collection and Preparation

1. Collect 1 to 2 ml fasting venous blood to put in the coagulation blood vessels, and collect 500μL serum when serum is precipitated.
2. It is recommended to collect and detect blood in drying tube with stopper.
3. Avoid using sample of hemolysis or milk condition.
4. Serum specimen can be stored at 2-8℃ for 7 days. For prolonged storage, please keep it at -20℃ and avoid repeated freezing and thawing.

Reference Ranges

Reference normal value is 140~180U/L and it is suggested that the hospital establish their own normal value and serum of quality control.

 Assay procedure

1. The test card was taken out from the reagent box, and add 60μL serum and plasma samples to the well of the test card.
2. Keep it still for 10min in room temperature.
3. After 10 minutes, put the test casette into the immune fluorescence quantitative analyzer to read data.
4. Immune fluorescence quantitative analyzer will measure and analyze optical signal, and the concentration of material will be quantified;
5. It is proposed to make calibration with assorting reagents or traceable calibration and calibration type is linear.

Specificity
1.The box should be clean and not broken, and the casettes appear no stain or scratches.

2.Sensitivity: The minimum detectability of human Human CK-MB is typically less than 1 U/L.

3.Accuracy: The recovery rate of deviation is less than ±15%.

4.Linear range: 1 ~1000U/L.

5.Precision: repeatability CV＜15%, and inter batch difference R＜20%.

Important Note:

1. The product is disposable, and can not be used repeatedly.
2. The test kit should be used within one hour after taking out, and the casettes taken out should not be put back.
3. Please accomplish numerical reading within 10 minutes because the detection results will be not accurate when the test casettes are put for long time.
4. The products are only applicable in in vitro detection.
5. Set up the relevant procedures in the immune analyzer, and the report is invalid when the quality control line is not detected, then it is recommended to retest.
6. Hook effect will appear when concentration of Human CK-MB protein in the serum of patients is too high, the sample should be diluted for assay, and the dilution factor should be multiplied.

FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES