HbA1c Fast Test Kit

 (Immunofluorescence Assay)

Intended Use

HbA1c fast test kit is intended for the quantitative measurement of HbA1c in human whole blood samples. This test is used as an aid for monitoring glycemic control in diabetics. In addition, it can identify people at risk of developing the disease and ongoing monitoring.

About HbA1c

Hemoglobin is the protein molecule in red blood cells with the main function transport oxygen and carbon dioxide in blood. HbA1c belongs to the glycated hemoglobin, a fraction formed by the attachment of various sugars to the Hb molecule and is proportional to average blood glucose concentration over the previous four weeks to three months. One advantage of using HbA1c for diagnosis is that the test does not require a fasting blood sample. Although HbA1c testing is mainly used for monitoring blood sugar control in patients with diabetes, the World Health Organization (WHO) now recommends that HbA1c can be used as a diagnostic test for diabetes, provided that stringent quality assurance tests are in place and assays are standardised to criteria aligned to the international reference values.

Contents

1. For Getein1100/Getein1180

Package specifications: 25 tests/box, 10 tests/box

1) HbA1c test card in a sealed pouch with desiccant

2) Capillary pipet

3) Sample diluent

4) User manual: 1 piece/box

5) SD card: 1 piece/box

2. For Getein1600

Package specifications: 2×24 tests/kit, 2×48 tests/kit

1) Sealed cartridge with 24/48 Getein HbA1c test cards

2) User manual: 1 piece/box

Materials required for Getein1600:

1) Sample diluent: 1 bottle/box

2) Box with pipette tips: 96 tips/box

3) Mixing plate: 1 piece/box

Note: Do not mix or interchange different batches of kits.

Specifications

Applicable Device

Getein1100 Immunofluorescence Quantitative Analyzer

Getein1180 Immunofluorescence Quantitative Analyzer

Getein1600 Immunofluorescence Quantitative Analyzer

Clinical Application

1. As an aid in diabetes screening.

2. Diagnose and monitor long term glycemic control.

3. Predict the risk for the development of complications.

4. Diagnose and monitor GDM.

5. Differential diagnose stress hyperglycemia and diabetes.