Singclean Creatine Kinase Isoenzyme MB (CK-MB) Rapid Test Kit (Fluorescence Immunochromatography)

• Type: IVD Reagent
• Material: Plastic
• Quality Guarante: 2 Years
• Sensitivity: 92.15%-99.05%
• Specificity: 97.47%-99.61%
• Accuracy: 97.19%-99.33%
• Model NO.: POCT
• Lead Time: 3-8 Days After Payment
• Certification: CE, Doc, ISO, Who(in Application)
• When to Test: Early Stage of Infection
• Symptoms: Fever, Cough, Fatigue, Shortness of Breath
• Test Time: 10-15 Minutes
• Sample: Nasal Swab
• Storage: 4-30 Degree
• Main Market: Europe
• Transport Package: Carton or Customized Package
• Specification: 20 tests/box, 1 test/box
• Trademark: Singclean or Customized brand
• Origin: China
• HS Code: 3002150050
• Production Capacity: 1 Million PCS/Week

Product Description

 

[Product name]

Creatine Kinase Isoenzyme MB (CK-MB) Test Kit (Fluorescence Immunochromatography)
 

[Packaging specifications]

10 tests/box, 20 tests/box, 25 tests/box, 30 tests/box, 50 tests/box, 100 tests/box.
 

[Intended use]

This kit is used for the quantitative determination of Creatine Kinase Isoenzyme MB (CK-MB) in human serum, plasma or whole blood samples in vitro.

There are four isozyme forms of Creatine Kinase (CK): muscle type (MM), brain type (BB), mixed type (MB), and mitochondrial type (MiMi), among which MB type is mainly present in myocardial cells. In myocardial infarction, creatine kinase increases within 6 hours of onset, peaks at 24 hours, and returns to normal within 3~4 days. Among them, Creatine Kinase Isoenzyme MB MB has high diagnostic specificity, so it has become one of the markers of myocardial infarction.
 

[Main components]

No.	Name	Component
1	Creatine Kinase Isoenzyme MB (CK-MB) Test Kit   (Fluorescence Immunochromatography)	Each bag contains a test card and a desiccant; the test   card consists of shell and a test strip, and the test strip consists of   sample pad, fluorescent pad (fixed with fluorescently labeled CK-MB   monoclonal antibody 1), Nitrocellulose membrane (coated with CK-MB monoclonal   antibody 2 and goat anti-mouse IgG), filter paper and PVC plastic sheet
2	Whole Blood Diluent	1 bottle of diluent for 10 tests/box, 20 tests/box, 25   tests/box and 30 tests/box; 2 bottles of diluent for 50 tests/box; 4 bottles   of diluent for 100 test/box; 3.0mL/bottle
3	ID card	1 pc/box

[Test method]
Please read the instructions of the test kit and the manual of the fluorescence immunoanalyzer carefully before use.
a) Bring the test kit and sample to be tested to room temperature.
b) Make sure the ID card matches the batch number of the kit, and insert the ID card into the card reading area of the instrument to read the information.
c) Open the inner package of the test kit, take out the test card; draw 70μL of serum plasma sample, drop vertically to the sampling place of the test card, and start timing; draw 70μL whole blood, drop vertically to the sampling place of the test card, and immediately add 1 drop of whole blood diluent at the sampling place and start timing.
d) After adding the sample, click "Start Test" on the screen of the fluorescence immunoanalyzer, and the test card will react at room temperature for 10 minutes; insert the test card into the test card slot of the fluorescence immunoanalyzer, and the instrument will automatically test the test card; The test results can be seen on the display screen of the fluorescence immunoanalyzer. Click "Print" on the screen to print the results.

[Positive judgment value or reference interval]
Normal reference value: <5ng/mL
Due to differences in geography, race, gender and age, it is recommended that each laboratory establish its own positive judgment value or reference interval.

[Interpretation of test results] (For reference only, not used as clinical diagnostic criteria, test results need to be combined with other clinical and laboratory data for clinical diagnosis)

Content of CK-MB (ng/mL)	Clinical application advice
0-5	Normal level
>5	It is suggested that the patient is at risk of   myocardial infarction. Note: CK-MB exceeds the normal level within 4~8 hours   after myocardial infarction; peaks within 12~24 hours; and returns to normal   level in about 3 days.