DS5 Consumables

For DS5 HbA1c Analyzer

Pink Reagent Kit
Consumables Use Control & Calibration
Part No Description Size MSDS
Reagents
014-350 DS5 (300 Test) Pink Kit 300 tests
Controls      
014-175 HbA1c Control (2 level) 2 x 3 x 0.3mL
Calibrator      
014-380 Calibrators 1 and 2 2 x 4 x 0.3mL
Accessories      
270-815 Barcode Reader Kit    
270-350 G15 upgrade Kit    
003-605S Paper Roll, thermal printer 1  
014-291 Pipette tips (long) 200  
014-299 Microbiocide-D (for decontamination) 500mL  
250-106S Pump Tube Cassette 1  

Reagents :

The DS5 300 Test Kit includes 4 columns, 1 Pump Tube Cassette, reagents, hemolyzer and thermal paper sufficient for running 300 tests.

Click on the appropriate View button on the Consumables Tab for further Material Safety Data Sheet information. Click on the View button on the Control & Calibration tab for the Product Insert instructions for further details of the preparation and handling.


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. Use by the expiration date for the Lot. 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.


Calibrators :

The Glycated Hemoglobin two-level Calibrator kit is designed to allow calibration to either the American NGSP system or the International IFCC system.
You need one calibrator kit per DS5 300 Test Kit.
It contains 4 vials of each of 2 levels and 2 vials of diluent. Each vial is a preparation of freeze-dried human whole blood.
Store unopened at 2 - 8 °C. Use by the expiration date for the Lot. After reconstitution the material is stable for 1 day at 2 - 8 °C.
You can find the assigned values of each Lot on the Control & Calibration Tab, above.


Control Values :

Glycated Hemoglobin Two Level Control Kit (014-175)     
Kit Lot Number  M-0187868    Expiration Date  19 Jan 2012
Method Level 1 Value Level 1 Guidance Range Level 2 Value Level 2 Guidance Range
DS5 HbA1c NGSP Aligned 5.4 4.3 - 6.5 10.1 8.4 - 11.8
DS5 HbA1c IFCC Aligned 3.6 2.5 - 4.7 8.6 6.8 - 10.4
G15 HbA1c NGSP Aligned 5.7 4.9 - 6.5 11.0 9.9 - 12.1
G15 HbA1c IFCC Aligned 3.9 3.1 - 4.7 9.6 8.4 - 10.8

Glycated Hemoglobin Two Level Control Kit (014-175)     
Kit Lot Number  M-0182715    Expiration Date  12 Mar 2011
Method Level 1 Value Level 1 Guidance Range Level 2 Value Level 2 Guidance Range
DS5 HbA1c NGSP Aligned 5.2 4.1 - 6.3 8.4 7.0 - 9.8
DS5 HbA1c IFCC Aligned 3.3 2.3 - 4.3 6.8 5.4 - 8.2
G15 HbA1c NGSP Aligned 5.4 4.7 - 6.1 8.5 7.6 - 9.4
G15 HbA1c IFCC Aligned 3.6 2.8 - 4.4 7.0 6.2 - 7.8
HbGold HbA1c (non-aligned) 5.1 4.1 - 6.1 7.3 6.2 - 8.4

Glycated Hemoglobin Two Level Control Kit (014-175)     
Kit Lot Number  M-178385    Expiration Date  30 Apr 2009
Method Level 1 Value Level 1 Guidance Range Level 2 Value Level 2 Guidance Range
DS5 HbA1c NGSP Aligned 5.7 4.5 - 6.9 10.6 8.9 - 12.3
DS5 HbA1c IFCC Aligned 3.9 2.7 - 5.1 9.2 7.3 - 11.1
G15 HbA1c NGSP Aligned 5.9 5.1 - 6.7 11.3 10.1 - 12.5
G15 HbA1c IFCC Aligned 4.1 3.2 - 5.0 10.0 8.8 - 11.2
HbGold HbA1c (non-aligned) 5.1 4.1 - 6.1 10.3 8.7 - 11.9

Calibrator Values :

Glycated Hemoglobin Two Level Calibrator Kit (014-380)  
Kit Lot Number  M-0187000    Expiration Date  10 Jul 2011
  Level 1 Level 2
Lot No's MO-0187002 MO-0187004
Reference System Level 1 HbA1c Value Level 2 HbA1c Value
NGSP 5.30 11.08
IFCC 3.44 9.76