HbA1c Test Analyzer LD-100 POCT Testing Analyzer Fully Automatic Hematology Detection Analyzer
Intended Use
LD-100 (POCT) One-Step HbA1c Testingf Analyzer is intended for the determination of hemoglobin A1c(HbA1c) content in human whole blood. It is a semi-automatic instrument used to analyze glycated hemoglobin which can be used to detect of HbA1c in medical units at all levels in daliy life. LD-100 analyzer uses the fluorescent immunoturbidimetry, he percentage of glycosylated hemoglobin in total hemoglobin can be determined.
Specifications
| Model | LD-100 |
| Device category: | Fixed |
| Power connection | Detachable power supply cord |
| Measurement Time | Less than 3 minutes |
| Sample Volume | 4ul |
| Sample Type | Whole blood |
| Data storage | 7000 |
| Measurement Range | HbA1c 4.0~15%(NGSP Unit)
eAG 68-385mg/dl(mmol/l) |
| Operating Condition | Temperature:15~35℃
Humidity:15~80%R.H |
| Storage Condition | Analyzer:10-60℃; Test kit: 2~8℃ |
| Voltage | 12VDC-3.33A |
| Analytical wave-length | 510nm and 580nm. |
| Certification | NGSP, IFCC |
PRINCIPLE
- Uses the (borate affinity) fluorescent immunoturbidimetry
- Push a mixture containing a fluorescent borate conjugate into an integrated test cup and mix to dissolve sufficiently.
- The blood samples in the sample collector are then pushed into the buffer and mixed to release the hemoglobin from the red blood cells.
- The total concentration of hemoglobin depends on the initial reduced fluorescence signal.
- Fluorescent borate conjugates bind to glycosylated hemoglobin, and glycosylated hemoglobin is determined by detecting the decrease of fluorescent active ingredients.
- The percentage of glycosylated hemoglobin in total hemoglobin can be determined.
Feature
- One-Step Testing, Automatic Detection
- Protable and convenient
- Fast test speed and High Accuracy
- Battery Integrated
- Cv<3%, Excellent Correlation With HPLC
- RFID For Batch Management
- Color touch screen without extra instrument
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% |
Use Step
- Place cartridge in analyzer
- Push bead into reagents
- Insert sample into cartridge
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.
Certificated
