HbGold Consumables

For HbGold Analyzer

Pink Reagent Kit
Consumables Use Control & Calibration
Part No Description Size MSDS
Reagents
014-080 Gold Kit 80 to 100 tests  
Controls      
014-175 HbA1c Control (2 level) 2 x 3 x 0.3mL
014-165 HbA2 Control 2 x 3 x 0.3mL  
Accessories      
014-299 Microbiocide-D (for decontamination) 500mL  

Reagents :

The Gold Kit contains the column, reagents and hemolyzer sufficient for running 100 HBA1c tests, or 80 HbA2 tests.

Click on the appropriate View button on the Consumables tab above for further Material Safety Data Sheet information.


Controls :

The Glycated Hemoglobin two-level Control kit contains 6 vials (3 vials of each of 2 levels). Each vial contains a preparation of freeze-dried whole blood.
Store unopened at 2 - 8 °C. After reconstitution the material is stable for 7 days at 2 - 8 °C.
You can find the allowed ranges of each Lot on the Control & Calibration tab, above.

The HbA2 and HbF control kit contains 3 vials of each of the 2 levels of freeze dried whole blood, and one vial of diluent.
Store unopened at 2 - 8 °C. After reconstitution the material is stable for 3 days at 2 - 8 °C.
You can find the acceptable limits of each Lot on the Control & Calibration tab, above.

Control Lot M-162934. Please note that this Lot requires a slightly different reconstitution method. After reconstitution the shelf life is only 3 days. Level 2 for this Lot contains HbS. Please read the Product Insert for more details.


Control Values :

HbA2 Quality Control Kit (014-165)  
Kit Lot Number  M-0170584   Expiration Date  30 June 2008
  Level 1 Level 2
Method    HbGold HbA2 Value Acceptable Limits Value Acceptable Limits
HbF 2.5 1.3 - 3.8 7.2 6.1 - 8.3
HbA2 2.6 2.0 - 3.3 4.5 3.6 - 5.4

HbA2 Quality Control Kit (014-165)     
Kit Lot Number  M-162934    Expiration Date  31 August 2007
  Level 1 Level 2
Method    HbGold HbA2 Value Acceptable Limits Value Acceptable Limits
HbF 2.6 1.2 - 4.1 7.0 5.6 - 8.5
HbA2 2.5 2.1 - 2.9 5.6 4.5 - 6.7
HbS     30.0 25 - 35

HbA2 Quality Control Kit (014-165)  
Kit Lot Number  M-158726    Expiration Date  30 June 2006
  Level 1 Level 2
Method    HbGold HbA2 Value Acceptable Limits Value Acceptable Limits
HbF 2.6 1.6 - 3.6 7.8 6.8 - 8.8
HbA2 2.2 1.9 - 2.5 4.3 3.9 - 4.7

Glycated Hemoglobin Two Level Control Kit (014-175)  
Kit Lot Number  M-162932    Expiration Date  31 Oct 2007
  Level 1 Level 2
Method Value Guidance Range Value Guidance Range
HbGold HbA1c (non-aligned) 4.8 3.7 - 5.8 8.3 6.6 - 9.9
DS5 HbA1c NGSP Aligned 5.3 4.2 - 6.4 9.5 7.9 - 11.1
DS5 HbA1c IFCC Aligned 3.5 2.4 - 4.6 8.2 6.5 - 9.9
G15 HbA1c NGSP Aligned 5.4 4.7 - 6.1 9.5 8.5 - 10.5
G15 HbA1c IFCC Aligned 3.5 2.7 - 4.3 8.3 7.3 - 9.3