HbA1c Analyzer Fully Automated POCT Analyzer Detect Glycosylated Hemoglobin In Human Blood
The HbA1c Analyzer Fully Automated POCT Analyzer Detect Glycosylated Hemoglobin In Human Blood LD-100 is an IVD(In Vitro Diagnostic Device) device for measuringHemoglobin A1c by the well established method of boronate affinity. It is able to analyze bothcapillary whole blood and venous blood. LD-100 is designedto help controlling diabetes and it is intended to be used by patients and professionals at home,laboratories, clinics and hospitals. Same as all diagnositc tests, do not make a definitivediagnosis of diabetes based on the result of a single test. A physician should make a diagnosisafter all clinical and laboratory findings are evaluated.
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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