LD-100 Analyzer POCT Best Performance IFCC&NGSP Certificated
Battery Integrated One Step Use HbA1c Analyzer
Intended Use
Labnovation HbA1c Analyzer LD-100 POCT 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. LD-100 is small and light, it can be used to detect of
HbA1c in medical units at all levels. Fually Automatic system can
help the test half work with double results.
Specifications
| Model | LD-100 |
| Sample Type | Whole blood |
| Sample Volume | 4ul |
| Test Time | Less than 3 minutes |
| Data storage | 7000 |
| Method | Fluorescent Immunoturbidimetry |
| Operating Type | 1-Step Operation, Fully automatic system |
| 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
|
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. 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.
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
Glycated hemoglobin (HbA1c) is reported by default in IFCC units
(mmol/mol) and NGSP units (%).
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%.
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%.
In the range of 4%-16% of HbA1c, the linear correlation coefficient
r of the test results should be no less than 0.9900.
Within 8 hours after the instrument is turned on and stable, the
same normal sample is tested, and POCT HbA1c Analyzer V1.0 2 the
relative deviation of the test results is not more than ±3%.
Certificate
Attention
The HbA1c Analyzer meets the emission and immunity requirements
specified in the relevant Section of GB/T 18268.26, as shown in the
table below.
- Users have the responsibility to ensure the electromagnetic
compatibility environment of the equipment, so that the equipment
can work properly.
- It is recommended that the electromagnetic environment be evaluated
before the equipment is used.
