Fully Automated HbA1c

Analyzer
LD-560

Experience in HbA1c

2012 2013 2014 2016 2018 2019

Invested in R&D LD-560

LD-500
HPLC
HPLC
LD-100
Patents 22+ LD-600
Boronate Affinity
HPLC
POCT
H 1 Overview

b
AH
2 Product Features

1 b 3 Competitors Analysis
c A
1
c

Overview
01 02 03
What is Diabetes? Status of Diabetes Authority of HbA1c

Diabetes is a chronic, metabolic According to WHO, about 537 ADA, EASD and IDF
disease characterized by million people worldwide have unanimously recommended
elevated levels of blood glucose diabetes, and 1.5 million deaths are HbA1c as an auxiliary screening
(or blood sugar), which leads directly attributed to diabetes each and diagnostic indicator for
over time to serious damage to year. diabetes in 2009, and finally
the heart, blood vessels, eyes, officially increased HbA1c as an
kidneys and nerves. indicator in the 2010 edition of
Recommendations for HbA1c testing the ADA diagnostic guidelines
as one of the diagnostic
Every Patient with diabetes is adviced to have their HbA1c tested indicators of diabetes.
for 2-4 times annually.

537 million

Diabetes
2021 2030 2045

8 billion
537 643 783
Diabetes Development Process

1 2 3 4

Impaired fasting blood

Impaired glucose tolerance sugar
WHO Standard:
Normal WHO Standard： Diabetes
6.1-7.0mmol/L
Fasting blood sugar <7mmol/L diagnosed
3.89-6.10mmol/L ADA Standard: HbA1c>6.5%
After oral administration of 75g of
5.6-7.0mmol/L
glucose, the blood sugar measured Fasting blood sugar>7.8mmol/L
in 2 hours is between 7.8- Random blood sugar>11.1mmol/L
11.1mmol/L

1
Glycated Hemoglobin is the product of irreversible enzymatic
reaction between sugars in blood and hemoglobin in erythrocyte
referred to as HbA1（including HbA1a, HbA1b, HbA1c ）
2
HbA1c’s content mainly depends on the blood glucose
concentration and the contact time between blood glucose and
hemoglobin, which can reflect the average blood glucose level in
the 120 days before the measurement.

Enzymatic reactions 3
The ratio of HbA1c to total hemoglobin (%) is used clinically to
represent the concentration of HbA1c, and the HbA1c level of
normal people is 4-6%.
 The Element of
Hemoglobin

Hb

• HbF • HbA • HbA2 • Hb(Variant)

• 0.5% • 97% • 2.5% • HbS, HbD, HbC,
• β-Thalassemia • β-Thalassemia HbE and ect.

• HbA0 • HbA1
• Non-glycated Hb • Glycated Hb
• 94% • 6%

HbA1a HbA1b HbA1c

Product of the combination between HbA and Form from the combination betwee HbA and
fructose / lactose glucose, and is 60-70% of total HbA1

Clinical Detection
Application Significance
As an indicator of diabetes screening and
diagnosis.
Health Check-up
Screening
Evaluating the overall control of blood sugar
Finding problems in the treatment
Blood Sugar
Guiding the adjustment of the treatment plan
Monitoring for diabetics.

Complication risk HbA1c is controlled at 6.5%, which can greatly

control reduce diabetic patients risk of various
complications.
Application Scenarios

Primary Medical
Institutions
Women’s and Children's
Hospitals
Diabetes Specialist
Hospitals
Elderly Care
Institutions
Laborator
y

Product Features
The Fully Automated HbA1c Analyzer is used in conjunction with
suitable reagents for the quantitative detection of glycosylated
hemoglobin (HbA1c) in human blood.

10-30 daily samples

90 seconds / Test
10” LCD touch screen
28 kgs only

1 HPLC-Gold Standard Methodology

2 Pricise and Reliable: CV<2%

3 Full Automatic Smart System

4 Quality & Performance

5 User Friendly
HPLC Principle

Gold Standard ➢ Considered the gold standard for diabetes diagnosis

➢ The excellent precision measurement result by HPLC includes information
High Accuracy of each peak and chromatogram. The result will be shown in both IFCC &
NGSP units.

CV<2%, Good correlation with imported brands

40
40

30
30

20

20

10

10
0
0 10 20 30 40

0
0 10 20 30
Correlation between LD-560 and Tosoh G8 & Bio-Rad D10
 Full Automatic Smart System

➢ Auto Washing at startup

➢ One click start testing
➢ Primary Tube Sampling
with Cap Piercing

➢ Autoloader for 20 ➢ Easy to change reagents

tubes ➢ Reagent level alarm
➢ Automatic scanning of
barcode

Quality Assurance
IFCC & NGSP ISO Certificated
Certificated
 User Friendly

Auto washing
Carousel injection
Auto washing for self maintenance at startup
Reagent level alarm

Log function Carousel design support random insertion of samples

Reagent remaining monitoring function

Log function for easy query includes

consumables replacement records, calibration
records,
maintenance records, cumulative sample
statistics, etc.

Variant Mode & Fast Mode

Variant Mode
• Detection for HbA2 & HbF
• Fully compatible with Bio-Rad’s
calibrators (HbA2 & HbF)

Fast Mode:
• Test speed: 90s/T
• Original HbA1c control and
Calibrator
Reagent Comsumables
Warranty
Device: 1 Year
Sampling Probe: 6 Months

Reagent Type & Specification Column Test Control &Calibrator

Eluent A 300T*2 (1000ml*2） Quantity specification
Level 1 (low) & Level 2(high)
Eluent B 300T*2 (250ml*2)
600T 3000T Level 1: 0.1ml*3
Hemolysis 300T*2 (2300ml*2)
Level 2: 0.1ml*3
Eluent C(Variant
300T*2 (650ml*2)
Mode）
Validity 2 years 2 years 1 year (2℃ – 8℃)
2 Months (after open) 7 Days (after open)

Specifications
Methodology High Performance Precision CV≤2%
Liquid Chromatography
(HPLC)
Test Mode Fast Mode, Variant Mode Report Range 3%-18%
Test Speed 90s/Test Parameter HbA1c, HbF, HbA1a, HbA1b,
HbA0, HbA2(Optional)
Autoloader 20 Samples Sample Type Whole Blood, Pre-Diluted Blood
Capacity
Column Capacity 3000T Filter 600T
Storage 5000 Sample Result Reagent Kit Eluent A, Eluent B, Eluent
C(Variant Mode), Hemolysin,
Control, Calibrator
Weight 28 Kgs Dimension 378(L)*380(W)*510mm(H)
 Competitors Analysis

v
s Bio-Rad D10 Labnovation LD-560
Model
Model

Principle HPLC HPLC

Variant Mode √ √

Screen Small black LCD display 10” LCD touh screen

Test Speed 3 min/T 90s/T

Sample Loading 10 tubes 20 tubes

Capacity

Sample Loading Method By manual Continuous automatic sample loading

Precision (CV) CV≤2.5% CV<2.0%

Column Test Quantity 400T 3000T

Weight 35kg 28kg

Dimension 53.4cm(L)*40.2cm(W)*49.5cm(H) 37.8cm(L)*38cm(W)*51cm(H)

 v
s Tosoh HLC-723G8 Labnovation LD-560
Model
Model

Principle HPLC HPLC

Variant Mode √ √

Screen Small black LCD display 10” LCD touh screen

Test Speed 96 s/T 90 s/T

Sample Loading 90 tubes 20 tubes

Capacity

Data storage 800 5000

Precision (CV) CV<2% CV<2.0%

Column Test Quantity 3000T 3000T

Weight 36.5kg 28kg

v
s
Arkray HA-8380V Labnovation LD-560

Model

Principle HPLC HPLC

Variant Mode √ √

Test Speed Fast Mode: 100s/T 90s/T

Variant Mode: 160s/T

Sample loading capacity 10 20

Precision (CV) <1.0% <2.0%

Linear range 3-20% 3-18%

Data storage 300 5000

Column Test Quantity 2500T 3000T

 v
s Lifotronic H8 Labnovation LD-560
Model
Model

Principle HPLC HPLC

Variant Mode √ √

Screen 10.1” TFT LCD Touch Screen 10” LCD touh screen

Test Speed Fast Mode: 1.5min/T 90s/T

Variant Mode: 2.2min/T

Sample loading capacity 10 tubes 20 tubes

Data storage 4000 5000

Precision (CV) CV<1.5% CV<2.0%

Column Test Quantity 800T 3000T

Reagent Level Alarm √ √

Weight 50kg 28kg

v Lifotronic
s Lifotronic H9 Labnovation LD-560
Model 102万

Model 49.2

Principle HPLC HPLC

Variant Mode √ √

Screen 8” TFT LCD Touch Screen 10” LCD Touch screen

Test Speed Fast Mode: 1.2min/T Fast Mode: 90s/T

Variant Mode: 1.6min/T Variant Mode: 140s/T

Data storage 4000 5000

Precision (CV) CV≤1% CV<2.0%

Column Test Quantity 1500T 3000T

Reagent Level Alarm √ √

Weight 50kg 28kg

Conclusion

Market positioning Competitive Strategy

10-30 customers per day Replacement of biochemical analyzer,
POCT HbA1c analyzer, imported brand
HPLC

Competitive Advantage Trend Analysis

• Gold standard HPLC method • Prevalence >10%
• CV<2% • Enormous diabetics population: 537 million
• Fully automatic • Rise of aging population
• Control & Calibrators from original • To be added into Routine physical examination
manufacturer

Appreciate for
Your listening

Copyright Ⓒ 2022 Shenzhen Labnovation Technologies, Inc. All rights reserved.