Product Details
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
Company Profile
Labnovation Technologies, Inc. is an original manufacturer
established in Shenzhen, China since 2001. We are dedicated in
developing and manufacturing IVD instruments and reagents including
HbA1c analyzer and reagents, rapid test reader & reagents,
hematology reagents, clinical chemistry reagents, electrolyte
reagents, wash solution and urine test reagents.
Labnovation products are developed in house, tested extensively in
clinics and passed strict quality controls. All of our products are
CE marked and approved by SFDA. In the past 15 years, our products
have been exported to 110 different countries and used in 8000
hospitals worldwide. We provide both ready-to-use final products
and bulk OEM reagents, including ready-to-use reagents,
concentrated, and powder.
With an investment of 10% of our annual sales into R&D, we
release new products every years. We win more and more domestic and international cooperation by
company reputation and products quality while we actively take part
in fairs like MEDICA,AACC, ARBA HEALTH and so on through which we
are well-known by the companies in this field.