HbA1c One-step Portable Analyzer
Pending 
INTENDED USE
The LD-100 HbA1c One-step Portable Analyzer is a state-of-the-art, point-of-care (POCT) device designed for rapid and accurate measurement of glycosylated hemoglobin (HbA1c). Utilizing the reliable Boronate Affinity method, this compact analyzer delivers laboratory-quality results in under three minutes, making it an essential tool for diabetes management in hospitals, clinics, pharmacies, and even home care settings.
SKU:
LD-100
Categories: Clinical Diagnostics, Diabetes Blood Glucose Monitoring
Description
MAIN FEATURES AND BENEFITS:
- One-Step HbA1c Testing: Streamlined workflow for quick and easy operation, ideal for busy healthcare environments and home use.
- Boronate Affinity Method: Ensures high accuracy and excellent correlation with HPLC, the gold standard in HbA1c testing.
- Fast Results: Obtain precise HbA1c readings in less than 3 minutes, supporting timely clinical decisions.
- Portable and Compact Design: Lightweight (≤ 0.8 kg) and small footprint (192 x 128 x 108 mm), perfect for bedside, outpatient, or remote care.
- User-Friendly Interface: 3.5″ touch screen for intuitive operation, suitable for both healthcare professionals and patients.
- Flexible Sample Types: Accepts whole blood and fingertip blood samples with a minimal volume of just 4µl.
- Large Memory Storage: Stores up to 10,000 sample results, supporting efficient patient data management.
- Advanced Connectivity: Features Bluetooth for external printer support, USB port, and LIS compatibility for seamless integration with hospital information systems.
- RFID Batch Management: Ensures traceability and quality control of test kits.
- Reliable Performance: Coefficient of Variation (CV) <3%, with IFCC calibrator validation for both normal and abnormal ranges.
SPECIFICATIONS
|
Model
|
LD-100
|
|
Method
|
Boronate Affinity
|
|
Reagent Specification
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25, 50, 100 Tests/Kit
|
|
Measurement Time
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< 3 Minutes
|
|
Sample Type
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Whole Blood, Fingertip Blood
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|
Sample Volume
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4µl
|
|
Measurement Range
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HbA1c: 4.0% ~ 15% (NGSP), 20.22 ~ 140.45mmol/mol (IFCC)
|
|
Result Storage
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10,000 Sample Results
|
|
Operation Condition
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Temperature: 15℃ ~ 32℃ , Humidity: 10% – 80%
|
|
Shelf-Life of Test Kit
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12 Months
|
|
Voltage
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24V, 2.5A
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|
Net Weight
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≤ 0.8 Kg
|
|
Dimensions
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192(L) x 128(W) x 108(H)mm
|
|
Temperature
|
Analyzer: -20℃~55℃ Test Kit: 2℃~8℃
|
|
Display
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3.5″ Touch Screen
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|
Other Features
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External Printer (Bluetooth), USB Port, LIS Support
|
RELIABILITY
| IFCC Calibrator | Normal | Abnormal | Normal | Abnormal |
| Mean HbA1c% | 5.4 | 9.6 | 5.3 | 9.2 |
| CV (%) | 2.50% | 1.90% | 2.40% | 1.80% |
ACCURACY

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