Labnovation HbA1c Analyzer LD-100 Latest Analyzer For HbA1c Testing
POCT With NGSP Certificated CV<3%
Intended Use
The LD-100 is a one-step operation HbA1c analyzer. For the
measurement of glycated hemoglobin by the well-established borate
affinity method. Small amount of sample and easy operation which is
aimed to help manage diabetes for patients and professionals in
laboratory, clinic and hospital. Flexible workflow, easy to use
with lab-quality results. LD-100 helps you to be more efficient in
your lab workflow.
• Boronate affinity test principle for HbA1c: The HbA1c assay has
no interference from common Hb variants
• Ease of use: only a simple black/white calibration at start up,
and the instrument is ready for use. Lot-specific test calibration
by the operator is not necessary.
• Less than 3-minute test time
• Small sample size, Ideal for measurements of small series
• A compact, lightweight benchtop instrument；Portable — battery
operation possible
• Minimal maintenance required
• Traceable to the IFCC Reference Method for HbA1c；Results
reporting unit:IFCC units (mmol/mol) and NGSP units (%%).
Specification
| Moder | LD-100 | Storage Condition | Analyzer:10-60℃； Test Kit:2-8℃ |
| Method | Boronate Affinity | Shelf-Life of Test Kit | 9 months |
| Operating Type | 1-Step, fully automatic | Voltage | 12VDC-3.33A |
| Measurement Time | Less than 3 minutes | Sample Volume | 4μ |
| Sample Type | Whole Blood | Weight | 800g |
| Measurement Range | HbA1c 4.0-15%(NGSP Unit) eAG 68-385mg/dl(mmol/l) | Dimensions | 192(L)×128(W)×108(H) mm |
Storage environment:
| Temperature:
20 ~55 C; Humidity: 10%~93% | Other Features | USB Port, Lis Support
|
Working Principles
HbA1c Analyzer uses the (borate affinity) fluorescent
immunoturbidimetry. Push a mixture containing a fluorescent borate
conjugate into an integrated test cup and mix to dissolve
sufficiently.
Calibration interface
When the instrument has been in use for a long time, if the
deviation of the test value id found to be large, it is necessary
to click the "Calibration" button and enter the calibration
procedure to calibrate the 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% |
Performance Indicators
- Result reporting unit : Glycated hemoglobin (HbA1c) is reported by
default in IFCC units (mmol/mol) and NGSP units (%).
- 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%.
- 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%.
- 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%.
Warning
- The HbA1c Analyzer is designed and tested according to class A
equipment in GB 4824. In the family environment, the equipment may
cause radio interference, which requires protective measures.
- It is forbidden to use this equipment beside strong radiation
sources (such as unshielded radio frequency sources), otherwise it
may interfere with the normal operation of the equipment.
Certificate
