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Hemoglobin A1c (HbA1c) in Whole Blood |
for Variant™ and Modular HPLC Systems
Complete Kit, Order No. 11100

 

This RECIPE HbA1c test kit is designed for the application on the Bio-Rad analyzer Variant™. However, the kit can also be used with any conventional modular HPLC system.

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 features in robustness and cost efficiency (column life time > 1000 analyses).

  
  • "Gold standard" for HbA1c determination

  • Traceability to the DCCT value level

  • Robust and cost-efficient analysis


Test Data

  

 

HPLC Parameters
Linearity: The test 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: binary gradient pump
Flow rate: 2.0 ml/min
Injection volume: 20 µl
Injection interval: 3 min
UV/VIS-Detector: 415 nm
HPLC Thermostat: 28 °C

 

Sample Preparation

11100_flow

 

Chromatograms
ClinCheck® Hemoglobin Control, Level I ClinCheck® Hemoglobin Control, Level II
11100_chrom1   11100_chrom2
HbA1a: 0.40 min, HbA1b: 0.55 min, HbF: 0.75 min,
HbA1c: 1.07 min, HbA0: 1.61 min		   HbA1a: 0.39 min, HbA1b: 0.55 min, HbF: 0.76 min,
HbA1c: 1.03 min, HbA0: 1.61 min


Hemoglobin A1c (HbA1c) in Whole Blood |
for Variant™ and Modular HPLC Systems
Complete Kit, Order No. 11100

Ordering Information

Order No. Description Quantity
11100  ClinRep® Complete Kit for Hb A1c in Whole Blood for 1000 assays 1 pce. 
 
  Components of the Complete Kit (order no. 11100):  
11101 ClinRep® Reagent Kit 1 pce.
11011 Reference Standard 10 x 5 ml
11130 Analytical Column with test chromatogram 1 pce.
  Manual 1 pce.
  Quick Reference 1 pce.
 
  Components of the Reagent Kit (order no. 11001)  
11107 Buffer 1 2400 ml
within the kit: 2 x order no. 11007
11108 Buffer 2 2400 ml
within the kit: 2 x order no. 11008
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.
11138 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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