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Hemoglobin A1c (HbA1c) in Whole Blood |
for Bio-Rad Diamat™ and Modular HPLC Systems
Complete Kit, Order No. 11000

 

Diabetes mellitus is a chronic disease that is associated with abnormally high blood glucose levels. The determination of HbA1c is an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus. Due to its excellent specificity and reproducibility, High Pressure Liquid Chromatography (HPLC) is still considered as the "gold standard" method for the determination of HbA1c.

The HbA1c values, obtained with the method of RECIPE, are traceable to the value level of the DCCT (Diabetes Control and Comparison Trial). The kit can be applied on the analyzer Diamat™ or any conventional modular HPLC system and features in robustness and cost efficiency. The life time of the analytical column is > 1000 analyses.

 
  • "Gold standard" for HbA1c determination

  • Traceability to the DCCT value level

  • Robust and cost-efficient analysis

  • Column life time: > 1000 analyses


Test Data

  

 

HPLC Parameters
for Modular HPLC Systems / for Diamat™
Linearity:
The method is linear over the whole range of physiologically relevant HbA1c values (approx. 3 - 16 % HbA1c).
Intraassay precision: 1 - 2 %
Interassay precision: 2 - 3 %
 

Dependence on the amount of total hemoglobin:
The HbA1c value is independent on the amount of total hemoglobin in a range from 6 - 24 g/dl total hemoglobin.
 
Pump: Ternary gradient pump /
Ternary gradient pump
Flow rate: 1.5 ml/min /
1.1, 1.5 or 1.8 ml/min
Injection volume: 20 µl / 20 µl
Injection interval: 5 min / 8-, 5- or 3 min programme
UV/VIS-Detector: 415 nm / 415 nm
HPLC Thermostat: 23 °C / 23 °C

 

Sample Preparation

 

11000_flow

 

Chromatogramms
ClinCheck® Hemoglobin Control, Level I ClinCheck® Hemoglobin Control, Level II
11000_chrom1   11000_chrom2
HbA1a: 1.1 min, HbA1b: 1.6 min, HbF: 2.1 min,
HbA1c: 2.8 min, HbA0: 4.0 min		   HbA1a: 1.1 min, HbA1b: 1.6 min, HbA1c: 2.7 min,
HbA0: 4.0 min

 

Hemoglobin A1c (HbA1c) in Whole Blood |
for Bio-Rad Diamat™ and Modular HPLC Systems
Complete Kit, Order No. 11000

Ordering Information

Order No. Description Quantity
11000  ClinRep® Complete Kit for Hb A1c in Whole Bloodfor 1000 assays 1 pce. 
 
  Components of the Complete Kit (order no. 11000):  
11001 ClinRep® Reagent Kit 1 pce.
11011 Reference Standard 10 x 5 ml
11030 Analytical Column with test chromatogram 1 pce.
  Manual 1 pce.
  Quick Reference 1 pce.
 
  Components of the Reagent Kit (order no. 11001)  
11007 Buffer 1 2400 ml
within the kit: 2 x order no. 11007
11008 Buffer 2 2400 ml
11009 Buffer 3 2100 ml
within the kit: 2 x order no. 11009
11013 H Hemolysis Reagent 1300 ml
11014 W Washing Solution 2100 ml
 
  Accessories:  
11020 ClinRep® Sample Preparation Kit for Capillary Blood (for 50 assays) 1 set
  containing:  
  50 Sample vials with 1 ml hemolysis reagent each, 1 Capillary holder  
  1 Capillary dispenser with 50 heparinized capillaries à 5 µl  
11021 50 Sample vials with 1 ml of hemolysis reagent each 20 sets
11022 Capillary dispenser, cont. 50 heparinized capillaries à 5 µl 20 pcs.
11023 Capillary holder 20 pcs.
11024 Sample vials 1.5 ml without cap 1000 pcs.
11026 Hemolysis Reagent esp. for capillary blood sampling (heavy metal free) 2000 ml
11027 Sample vials 1.5 ml with purple cap 1000 pcs.
11038 Printerpaper 10 rolls
FK3000 Thermocult Incubator (37°C) 1 pce.
FK5810 PEEK tubing (connection of prefilter and column) 1 pce.
FK5820 Stainless steel prefilter holder 1 pce.
FK5821 Replacement filter for stainless steel prefilter holder 10 pcs.
 
  ClinChek® Controls:  
11080 Hemoglobin Control, Level I, ready for use 10 x 5 ml
11081 Hemoglobin Control, Level II, ready for use 10 x 5 ml
11082 Hemoglobin Control, Level I, II, ready for use 2 x 5 x 5 ml
11092 Diabetes Control, lyophil., Level I, II 2 x 5 x 0.5 ml

 

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