In-vitro diagnostic for detection of CK-MB in human blood/serum/plasma
Test Principle
Immunochromatography with fluorescence detection
Shelf Life
12 to 24 months (check packaging)
Test Time
10-15 minutes
Sample Type
Whole blood, serum, or plasma
Kit Contents
25 test cassettes, buffer, instruction manual
Sensitivity
High (See kit insert for details)
Intended Use
Cardiac biomarker detection (CK-MB)
Product Name
FIAflex CK-MB FIA Test 25T
Storage Temperature
2C to 30C
Specificity
High (See kit insert for details)
FIAflex CK-MB FIA Test 25T About
The FIAflex CK-MB FIA Test 25T isa fluorescence immunoassay (FIA) kit for the quantitative detection of creatine kinase-MB (CK-MB). It is used with a Fluorescent Immunoassay Analyzer and is intended for in vitro diagnostic use to aid in the diagnosis and management of Acute Myocardial Infarction (AMI), or heart attack. The "25T" in the name indicates the kit contains 25 tests.
CK-MB as a cardiac marker
Specificity: CK-MB is an enzyme found predominantly in heart muscle cells, making it a valuable marker for cardiac injury.
Timeframe: After a heart attack, CK-MB levels in the blood begin to rise in 3 to 6 hours, peak within 12 to 24 hours, and return to normal in about 48 to 72 hours.
Diagnostic shift: While historically a primary marker, the more specific and sensitive troponin test has now largely replaced CK-MB for heart attack detection. However, CK-MB may still be used in conjunction with other tests or in certain clinical situations.
Rapid and Reliable Cardiac Marker Detection
FIAflex CK-MB FIA Test 25T enables healthcare professionals to quickly assess CK-MB levels, which are critical in diagnosing cardiac events. Its advanced immunochromatographic method ensures precise detection in whole blood, serum, or plasma. Results are available within 10-15 minutes, streamlining urgent decision-making in clinical environments.
Easy-to-Use, Portable Testing Solution
The test kit is lightweight and designed for single use, offering high portability. Its simple operation enables manual application, with the option to use an FIA analyzer if required. Storage conditions are flexible (2C to 30C), and the kit's shelf life ranges from 12 to 24 months, as indicated on packaging.
Comprehensive Kit Contents for Versatile Application
Each kit includes 25 standard-sized, white plastic test cassettes, buffer solution, and a detailed instruction manual. The system is compatible with diverse sample types, ensuring practicality for hospital labs, emergency rooms, or near-patient testing environments without the need for wall mounting or integrated display.
FAQ's of FIAflex CK-MB FIA Test 25T:
Q: How does the FIAflex CK-MB FIA Test 25T work?
A: The test utilizes immunochromatography with fluorescence detection to identify CK-MB, a cardiac biomarker, in whole blood, serum, or plasma. The sample reacts with reagents in the cassette, producing a signal detected either visually or with an FIA analyzer for quantitative or qualitative results.
Q: What samples can be used with this CK-MB test?
A: Whole blood, serum, and plasma samples are all suitable for use with the FIAflex CK-MB FIA Test 25T, allowing flexibility in patient sample collection.
Q: When should the FIAflex CK-MB FIA Test 25T be used?
A: This test is intended for rapid detection of CK-MB when evaluating patients suspected of having cardiac events, such as myocardial infarction. Its fast turnaround is valuable during urgent clinical assessments.
Q: Where can the FIAflex CK-MB FIA Test 25T be utilized?
A: Due to its portability and minimal requirements, the test can be performed in hospital laboratories, emergency departments, near-patient settings, or mobile clinics, provided proper handling conditions are followed.
Q: What is the storage requirement for the FIAflex CK-MB FIA Test 25T kit?
A: The kit should be stored at temperatures between 2C and 30C. Always check the packaging for the applicable shelf life, which ranges from 12 to 24 months.
Q: How do I use the kit and what are its key benefits?
A: Follow the provided instruction manual to add the sample and buffer to a test cassette. Results are available in 10-15 minutes. The kit offers high sensitivity and specificity, rapid results, ease of use, and requires no specialized infrastructure beyond an FIA analyzer if quantitative measurement is desired.
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