HbA1c Analyzer LD-100 POCT HbA1c Analyzer Protable Real-Time Detection HbA1c Analyzer
Intended Use
LD-100 POCT HbA1c Analyzer is intended for the percent determination of hemoglobin A1c (HbA1c) in human whole blood. Which is a semi-automatic instrument used to analyze glycated hemoglobin and it's suitable for the detection of HbA1c in medical units at all levels.
Specifications
| Model | LD-100 |
| Method | Boronate Affinity |
| Operating Type | 1-Step, fully automatic |
| Measurement Time | Less than 3 minutes |
| Sample Type | Whole blood |
| Sample Volume | 4ul |
| Measurement Range | HbA1c 4.0~15%(NGSP Unit)
eAG 68-385mg/dl(mmol/l) |
| Data storage | 7000 |
| Operating Condition | Temperature:15~35℃
Humidity:15~80%R.H |
| Storage Condition | Analyzer:10-60℃; Test kit: 2~8℃ |
| Voltage | 12VDC-3.33A |
| Device category | Fixed |
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 Operation, simple use process easy to test HbA1c
- Protable, easy to carry
- Fast tets speed, Real-time detection
- Battery Integrated
- Portable, Compact
- Cv<3%, Excellent Correlation With HPLC
- RFID For Batch Management
- Color touch screen
- External printer (Blue-tooth)
- USB Port
- LIS Support
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:The 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%.
- Result reporting unit:Glycated hemoglobin (HbA1c) is reported by default in IFCC units (mmol/mol) and NGSP units (%).
- Precision:Samples with a concentration of 4.0%-6.5% are detected, and the sample coefficient of variation (CV) of the test results is not more than 3%.
- Appearance:The appearance of the instrument is neat and clean, and there is no obvious peeling, abrasion, disbonded coating and dirt on the surface coating; The nameplate and logo should be clear. All fasteners should not be loosened. Various adjusting elements can rotate flexibly and function normally. Readouts should be clear on the display screen.
- Linearity:In the range of 4%-16% of HbA1c, the linear correlation coefficient r of the test results should be no less than 0.9900.
- Stability:Within 8 hours after the instrument is turned on and stable, the same normal sample is tested, and 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.
- Permission: The authority is the first-level authority, and the login authority is the first-level authority
Certificated
