Myo/Ck-MB/Ctni 3 in 1 Combo Test Cassette

Product Specifications

Prod Model:	MTN-002
Markets:	North America,South America,Eastern Europe,Southeast Asia,Africa,Oceania,Mid East,Eastern Asia,Western Europe
Sevices:	OEM ODM
Specimens:	Serum/Plasma
Specification:	Cassette
Usage:	Self-Testing, Profession-Testing, Home-Testing
Shelflife:	Two Years From Date or Manufacture
Sample:	Free
Read Time:	Within 10 Mins
Specificatio:	3.0mm 4.0mm
Type:	Test Strips & Test Tube
Material:	Plastic
Certification:	ISO13485
Ethylene Oxide Sterilization:	Without Ethylene Oxide Sterilization
Quality Guarantee Period:	Two Years
Group:	Adult
Logo Printing:	With Logo Printing
Type Of Face Mask:	No

Product Description

Product Description

Myo/CK-MB/cTnI 3 in 1 Combo Test Cassette
 

Application:
 
Features: high sensitivity, simple, easy and accurate
Formats: cassette
Specimen:  serum/plasma
Read Time: 20minutes
Storage: Room temperature
Shelf life: 18 months from date of manufacture
Specification: 3. 0mm, 4. 0mm, 5. 0mm or according to customers requirements.
Packing details: Cassette: 40pcs/polybag,50-65polybags/carton or 40pcs/box, 50boxes/carton.
Container loading: Cassette: 500,000pcs/20FT container.
Place of origin: China 
Muni Qty (PCS): 1000


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,cTnI 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.
 
Specification
 
It is used for qualitative determination of Myo/CK-MB/cTnI in human serum or Plasma for early detection of myocardia.
 
 
1)cTnI Test
 
Type:device 
 
Sensitivity:2ng/ml 
 
Specimen:Serum/Plasma
 
Package:1Test/Pouch,20Tests/Box 
 
 
2)MYO Test  
 
Type:device
 
Sensitivity:80ng/ml 
 
Specimen:Serum/Plasma 
 
Package:1Test/Pouch,20Tests/Box 
 
3)CK-MB Test  
 
Type:device
 
Sensitivity:5ng/ml 
 
Specimen:Serum/Plasma 
 
Package:1Test/Pouch, 
 
Above Products can be chosen to compose multi test panel 3 in 1.
 
REAGENTS AND MATERIALS PROVIDED
 
1. Each sealed in a foil pouch with three items inside:
a. One cassette device.
b. One plastic dropper.
c. One desiccant.
2. One package insert (instruction).
 
ASSAY PROCEDURE
 
Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
Step 3: Be sure to label the device with specimen's ID number.
Step 4: Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 2-3 drops (about 60- 90 μL) of specimen into the sample well making sure that there are no air bubbles.
Note: Add 1 drop of Saline or Phosphate-Saline buffer (common buffers used in clinic not provided in the kit) into the sample well if flow migration is not observed within 30seconds in the result window, which could occur with a highly viscous specimen.
Step 5: Set up the timer.
Step 6:Results can be read in 10 minutes. Positive results can be visible in as short as 1 minute.
Don't read result after 10 minutes. To avoid confusion, discard the test device afterinterpreting the result.
 
INTERPRETATION OF ASSAY RESULT
 
1. NEGATIVE RESULT: If only the C band is developed, the test indicates that no detectable cTnI is present in the specimen. The result is negative.
2. POSITIVE RESULT: If both C and T bands are developed, the test indicates that the level of cTnI is equal or higher than 1 ng /mL. The result is positive.
Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a positive determination is made.
3.INVALID: If no C band is developed, the assay is invalid regardless of color developmenton the T band as indicated below. Repeat the assay with a new device.
 

PERFORMANCE CHARACTERISTICS
 
Sensitivity:
The Troponin I Rapid Test can detect cTnI in serum or plasma with concentration of 1.0ng /mL or greater.
 
Interference testing:
The following substances were added to troponin I negative and 1.0 ng/mL troponin I spiked serum samples. No interference was found with any of the substances at the following
concentrations:
Bilirubin  10 mg/dL
Cholesterol  800 mg/dL
Hemoglobin  250 mg/dL
Triglyceride 1250 mg/Dl
 
Remarks:
 
-----The lowest price, best quality and flexible self-design package are all available, because we are the original manufacture in Pregnancy (HCG&LH), the infectious disease test series and drug of abuse test, we have got relevant certification (CE&ISO) in these test kits, if you have any questions or needs, pls feel free to contact us, you are most welcome any time, thanks.
 
------We are looking forward to sending you our best price after you confirm your Formats, Sensivity, Specification, Quantity, Package requirements, Deliver terms and Payment terms.

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