HbA1c One-step Portable Analyzer

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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.

 

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
25, 50, 100 Tests/Kit
Measurement Time
< 3 Minutes
Sample Type
Whole Blood, Fingertip Blood
Sample Volume
4µl
Measurement Range
HbA1c: 4.0% ~ 15% (NGSP), 20.22 ~ 140.45mmol/mol (IFCC)
Result Storage
10,000 Sample Results
Operation Condition
Temperature: 15 ~ 32℃ , Humidity: 10% – 80% 
Shelf-Life of Test Kit
12 Months
Voltage
24V, 2.5A
Net Weight
≤ 0.8 Kg
Dimensions
192(L) x 128(W) x 108(H)mm
Temperature
Analyzer: -20℃~55℃         Test Kit: 2℃~8℃
Display
3.5″ Touch Screen
Other Features
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

Accuracy comparison     Accuracy comparison 2

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