Automated POCT HbA1c Analyzer For Glycated Hemoglobin Test
Intended Use
Automated POCT HbA1c Analyzer is a device that used for detection of glycosylated hemoglobin (HbA1c) in human blood.
The LD-100 is a one-step operation HbA1c analyzer. For the measurement of glycated hemoglobin by the well-established borate affinity method. Small amount of sample and easy operation which is aimed to help manage diabetes for patients and professionals in laboratory, clinic and hospital. Flexible workflow, easy to use with lab-quality results. LD-100 helps you to be more efficient in your lab workflow.
Feature
• Boronate affinity Method: The HbA1c assay has no interference from common Hb variants
• Ease of use: One-step operation the instrument is ready for use.
• Less than 3-minute test time
• A compact, lightweight instrument, Compact Size - To Minimize Space Requirements.
• With no need for bulky liquid reagents, LD-100 also free up more space in laboratories, clinics, blood banks, and other situations.
• Traceable to the IFCC Reference Method for HbA1c；Results reporting unit: IFCC units (mmol/mol) and NGSP units (%%).
Reliable
| IFCC calibrator | Normal | Abnormal | Normal | Abnormal |
| Mean HbA1c% | 5.4 | 9.6 | 5.3 | 9.2 |
| CV (%) | 2.5% | 1.9% | 2.4% | 1.8% |
Performance Parameters
- Accuracy: Is tested with the reference material as samples, and the relative deviation of the determination results of the analyzer should be within the range of ±8%.
- Precision:Samples with a concentration of 4.0%-6.5% are detected, sample coefficient of variation (CV) of the test results is not more than 3%.
- Linearity:In the range of 4%-16% of HbA1c, the linear correlation coefficientrof the test results should be no less than 0.9900.
- Stability:Within 8 hours after the instrument is turned on and stable, the relative deviation of the test results is not more than ±3%.
- Functions of the analyzer:The function of report output in English; Abnormal alarm function.
Certificate
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Automated POCT HbA1c Analyzer Whole blood Sample For Glycated Hemoglobin Test Images
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