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Test Kit is for In-vitro diagnostic (IVD) use to determine Glycated Hemoglobin (HbA1c) quantitatively from human blood. It is useful at initial assessment and long-term monitoring of glycemic control. 


  • NGSP and IFCC certified. 
  • Boronate Affinity Chromatography
  • Lab-quality precision and accuracy

Specifications

Simple Procedure

  Principle
Boronate affinity chromatography
  Sample Type
Whole blood (capillary or venous)
  Sample Volume
 5 𝛍L
  Test Result
HbA1c
  Test Range

NGSP  3-15%, IFCC 9-140 mmol/mol

eAG 39-384 mg/dL, 2.2-21.3 mmol/L

  Precision
CV < 3%
  Test Time
Less than 4 minutes
  Calibration 

Tosoh G11 (HPLC)

Performance

Precision
Within-run
Day-to-day
Lv.1
Lv.2
Lv.3
Lv.1
Lv.2
Lv.3
HbA1c (%)
4.7
6.1
9.9
4.7
6.1
9.8
SD (%)
0.13
0.16
0.26
0.13
0.15
0.24
CV (%)
2.9
2.7
2.6
2.7
2.5
2.4

Contents

Name
Quantity
Package
Remark
TC/Test Cartridge
25 x 1
Individual pouch
Disposable
R1/Reagent
25 x 1
Zipper bag
Disposable
W1/Wahing Solution
1
Bottle
For 25 tests
IC/Item Card
1
-
-
IFU/Instructions for use
1
-
-

Test Principle