FIAflex HbA1c FIA 25 Test

Price 10850.0 INR/ Box

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MOQ : 10 Boxes

About FIAflex HbA1c FIA 25 Test

The FIAflex HbA1c FIA 25 Test is a fluorescence immunoassay (FIA) used to quantitatively detect Glycated Hemoglobin (HbA1c) in whole blood. A box contains 25 test cartridges and is part of a point-of-care testing (POCT) system that requires a dedicated fluorescent immunoassay analyzer.

Manufacturers and distributors

The test system is produced by Acon Biotech and distributed by various companies. A related system using the same technology is also offered by Microsidd India under the "FIA Flex" brand.

Test overview

Intended use: The test aids in monitoring long-term glycemic control in people with diabetes. It can also identify individuals at risk of developing diabetes.
Sample type: The test uses human venous or fingertip whole blood specimens.
Technology: The kit utilizes fluorescence immunoassay (FIA) or time-resolved fluorescence immunoassay (TR-FIA), which can offer greater sensitivity and accuracy compared to conventional methods.
Analyzers: The test cartridges are used with a compatible fluorescent immunoassay analyzer, such as the FIAflex Fluorescent Immunoassay Analyzer or others.
Test time: The analyzer produces results in approximately 5 minutes.
Shelf life: The cartridges typically have a long shelf life, around 18 to 24 months, and can be stored at room temperature (230C).

Test principle

The test uses a sandwich immunoassay method and is interpreted by an analyzer.

A whole blood sample is mixed with a buffer and applied to the sample well of the test cartridge.
Fluorescent-labeled antibodies bind to the HbA1c in the blood sample.
This complex migrates along a nitrocellulose membrane to a test line, where it is captured by immobilized antibodies.
The analyzer detects the fluorescent signal. The intensity of the signal is proportional to the concentration of HbA1c and is used to calculate the percentage of HbA1c relative to total hemoglobin.

Performance characteristics

Correlation: Manufacturers claim a high correlation with reference methods like HPLC, with an R-squared value of 0.99.
Measuring range: The reported measuring range for these tests is generally between 3% and 14%, though specific ranges can vary by manufacturer.
Accuracy and precision: The test kits demonstrate good accuracy and precision, with a relative standard deviation and coefficient of variation (CV) for precision of 15%.

Typical procedure

Preparation: Bring the detection buffer and test components to room temperature.
Sample collection: Collect a whole blood sample via fingertip puncture or venipuncture.
Mixing: Add the specified volume of blood to the buffer tube and mix thoroughly.
Application: Transfer the diluted sample mixture to the sample well on the test cartridge.
Analysis: Insert the cartridge into the FIA analyzer. The analyzer will automatically start the test, display the result in about 5 minutes, and may print a report.