HbGold ConsumablesFor HbGold Analyzer |
 |
| 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 |
|
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| 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 | |
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| 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 |