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FIAflex HbA1c FIA 25 Test

Name: FIAflex HbA1c FIA 25 Test
Brand: ASSURE MEDIQUIP
Price: 10850.0 INR
Availability: InStock

Price 10850.0 INR/ Box

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MOQ : 10 Boxes

FIAflex HbA1c FIA 25 Test Specification

Material
Plastic (cassette), Liquid (diluent)

Condition
New

Technology
Fluorescence Immunoassay (FIA)

Portable
Yes

Disposable
Test cassettes and transfer tubes are disposable

Wall Mounted
No

Measurement
Glycated Hemoglobin (HbA1c) in blood

Real-Time Operation
Yes

Operating Type
Manual, requires compatible FIA analyzer

Size
Kit box dimensions-standard test kit size

Weight
Lightweight (per test kit)

Color
White and teal (cassette and packaging)

Usage
For quantitative determination of HbA1c in blood

Attributes
Accurate, Rapid, Convenient

Sensitivity
High sensitivity, suitable for routine HbA1c monitoring

Sample Type
Whole blood (capillary, venous, or EDTA sample)

Kit Contents
25 test cassettes, 25 sample diluent tubes, 25 capillary transfer tubes, 1 insert

Minimum Sample Volume
Required < 10 L per test

Test Time
Results in approximately 5 minutes

Intended Users
Professional use in hospitals, laboratories, and clinics

Shelf Life
12-24 months from date of manufacture

Storage Condition
Store at 2-30C

Packaging Type
Individually packed cassettes for each test

FIAflex HbA1c FIA 25 Test About

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.

Fast and Accurate HbA1c Detection

The FIAflex HbA1c FIA 25 Test delivers high sensitivity and reliable results in approximately 5 minutes, streamlining diabetes management. Its precise fluorescence immunoassay technology ensures consistent results, essential for ongoing patient monitoring and clinical decisions.

Convenience and Portability

All test components are individually packed, making setup simple and testing straightforward. The portable kit is lightweight and does not require wall mounting, so it fits easily into any clinical environment, whether hospital, lab, or mobile clinic.

User-Friendly and Safe Operation

Each kit includes disposable plastic cassettes and transfer tubes to maintain hygiene and ensure user safety. Operation is manual and straightforward when paired with a compatible FIA analyzer, minimizing training requirements for healthcare professionals.

FAQ's of FIAflex HbA1c FIA 25 Test:

Q: How do I use the FIAflex HbA1c FIA 25 Test kit for measuring HbA1c levels?

A: To use the kit, collect a whole blood sample (capillary, venous, or EDTA), add it to the sample diluent tube, and use the capillary transfer tube to apply the mixture to a test cassette. Insert the cassette into a compatible FIA analyzer to receive quantitative HbA1c results in about 5 minutes.

Q: What sample types does the FIAflex HbA1c test accept, and what is the minimum sample volume required?

A: The FIAflex HbA1c test is compatible with capillary, venous, or EDTA whole blood samples. A minimum of less than 10 L of blood is required for each test.

Q: When should this test be used, and how frequently can it monitor HbA1c levels?

A: The test is intended for routine monitoring and assessment of HbA1c in patients, aiding in diabetes management and diagnosis. Frequency of testing should be determined by healthcare protocols and patient needs.

Q: Where is the FIAflex HbA1c FIA 25 Test designed to be used?

A: This test is intended for professional use in hospitals, laboratories, and clinics. Its portable design also makes it suitable for point-of-care and mobile health settings.

Q: What is the shelf life and storage condition for the FIAflex HbA1c test kit?

A: The kit should be stored at 2-30C and has a shelf life of 12 to 24 months from the date of manufacture, ensuring flexibility in inventory management.

Q: What are the benefits of using this test kit for HbA1c measurement?

A: Benefits include rapid results, high sensitivity, accuracy, ease of use, and minimal sample volume. Its portable and disposable design enhances workflow efficiency and patient safety.

Q: Is the kit compatible with real-time operation, and does it require any special equipment?

A: Yes, the test supports real-time operation but requires a compatible FIA analyzer to process and display results. No wall mounting or additional equipment is needed.

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