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A GLOBAL LEADING IVD REAGENT RAW MATERIALS AND ONE-STOP SOLUTIONS PROVIDER
One-Stop Solution ForImmunoturbidimetric Reagent
Development
C
DE F G H I J K L
MN
OQ
RS
TV
W
XYZADEF
G
H
PU
About Fapon
One-Stop Solution for Immunoturbidimetric Reagent Development
Service Features
Fapon Biotech Inc., (Fapon) is a leading IVD reagent raw materials and one-stop solutions company established in 2001.
As the market leader in China, Fapon has been offering innovations to more than 700 customers worldwide, crossing over
North America, Europe, Asia Pacific and the Middle East for shaping the world a better healthcare environment.
As Asia’s largest IVD reagent raw materials provider, Fapon excels in reagent raw materials development, offering
various cooperation options in the area of immunoturbidimetric reagent.
1
2
3
4
OEM service
Jointly development of new projects
1 Applicable to use in an extensive range of technological platforms
● Semi/Automatic Biochemistry Analyzers
● Specific Protein Analyzer
● Dry Chemistry
● POCT
Flexible multi-parameter customizable to achieve single/multi-point calibrations
2
High reaction rate reaching 2.5 to 10mins per test 3
Techniques to scale up for mass production4
Customized development for various parameter portfolio
Strategic cooperation in target markets
Reagent Performance
Content
Raw Material Overview
01
01
01
01
01
02
02
02
02
03
04
05
06
07
08
01
04
1.Apolipoprotein
2.Renal Function
3.Inflammation
4.Immunoglobulin & Complement
5.Rheumatism
6.Myocardial Markers
7.Nutrition
8.Diabetes
9.Calibrator
10.Heterophilic Immunoglobulin Elimination Reagent
Customizable Reagent Service Overview 03
1.Hemoglobin A1c (HbA1c)
2.C-Reactive Protein (CRP)
3.Anti-Streptolysin O (ASO)
4.Rheumatoid Factors (RF)
5.Urinary Microalbumin (mALB)
6.Serum Amyloid A (SAA)
7.Lipoprotein (a) (Lp(a))
8.Apolipoprotein_A1 (ApoA1)
9.Apolipoprotein B (ApoB)
10.Myoglobin (MYO)
11.D-Dimer (DD)
12.Neutrophil Gelatinase-Associated Lipocalin (NGAL)
13.Cystatin C (Cysc)
14.β-2 Microglobulin (β-2M)
15.Retinol Binding Protein (RBP)
16.Phosphoglucose Isomerase (PGI)
09
10
11
12
13
14
15
16
17
18
19
Raw Material Overview1. Apolipoprotein
Catalog No. Product Recommendation
2. Renal Function
BBNNGALN103
BBNB2MN101
BBNRBPN101
BBNRBPN102
BBMALBN101
BBNCYSN101
BBNCYSN102
NGAL
β-2M
RBP
RBP
mALB
Cysc
Cysc
Description
Rabbit Anti Human NGAL, Affinity Purified Antibody
Rabbit Anti Human β-2M, Affinity Purified Antibody
Rabbit Anti Human Retinal Binding Protein, Affinity Purified Antibody
Goat Anti Human Retinal Binding Protein, Affinity Purified Antibody
Goat Anti Human Urine Microalbumin, Serum
Rabbit Anti Human Cystatin C, Affinity Purified Antibody
Goat Anti Human Cystatin C, γ Fraction
For Latex-enhanced Immunoturbidimetry
For Latex-enhanced Immunoturbidimetry
For Latex-enhanced Immunoturbidimetry
For Latex-enhanced Immunoturbidimetry
For Latex-enhanced Immunoturbidimetry
For Latex-enhanced Immunoturbidimetry
For Latex-enhanced Immunoturbidimetry
Catalog No. Product Recommendation
3. Inflammation
BBNCRPN101
BBNCRPN102
BBNCRPN103
BBNCRPN104
CRP
CRP
CRP
CRP
Description
Rabbit Anti Human C-Reactive Protein, Affinity Purified Antibody
Mouse Anti Human C-Reactive Protein, Affinity Purified Antibody
Mouse Anti Human C-Reactive Protein, Affinity Purified Antibody
Goat Anti Human C-Reactive Protein, Affinity Purified Antibody
For Latex-enhanced Immunoturbidimetry
For Latex-enhanced Immunoturbidimetry
For Latex-enhanced Immunoturbidimetry
Catalog No. Product Recommendation
BBNAPOA1N101
BBNAPOBN101
ApoA1
ApoB
Description
Goat Anti Human Apolipoprotein A1, Serum
Goat Anti Human Apolipoprotein B, Serum
For Immunoturbidimetry
For Immunoturbidimetry
For Immunoturbidimetry/Latex-enhanced Immunoturbidimetry
For Immunoturbidimetry/Latex-enhanced Immunoturbidimetry
Catalog No. Product Recommendation
5. Rheumatism
GBNSLON101
GBNSLON106
GBNIGGN101
GBNCCPN101
SLO
SLO
RF
CCP
Description
Streptolysis O (SLO) Recombinant Antigen
Streptolysis O (SLO) Recombinant Antigen
Human IgG Polymers
Cyclic Citrullinated Peptide Antigen
For Latex-enhanced Immunoturbidimetry
For Latex-enhanced Immunoturbidimetry
For Latex-enhanced Immunoturbidimetry
Catalog No. Product Recommendation
4. Immunoglobulin & Complement
BBNIGAN102 IgA
Description
Goat Anti Human IgA (α Chain Specific), Serum For Immunoturbidimetry
Fapon Biotech Inc. 01
Catalog No. Product Recommendation
9. Calibrator
GBNAPOA101
GBNAPOB101
GBNLPA102
GBNLPA103
GBNCYSN101
GBNALBN101
GBNNGALN101
GBNB2MN101
GBNRBPN101
GBNIGAN103
GBNIGMN102
GBNIGN101
GBNPAN101
GBNCRPN101
GBNSAAN101
GBNDIMN101
GBNMYON101
FPZ0174-1
ApoA1
ApoB
Lp(a)
Lp(a)
Cysc
mALB
NGAL
β-2M
RBP
IgA
IgM
Mix (IGA, IGM, IGG, C3, C4)
PA
CRP
SAA
D-Dimer
MYO
ASO
ApoA1 Calibrator, High Level
ApoB Calibrator, High Level
Lp(a) Calibrator, High Level
Lp(a) Calibrator, High Level
Cysc Calibrator, High Level
mALB Calibrator, High Level
NGAL Calibrator, High Level
β2-M Calibrator, High Level
RBP Calibrator, High Level
IgA Calibrator, High Level
IgM Calibrator, High Level
IgA/C3/C4 Calibrator, High Level
PA Calibrator, High Level
CRP Calibrator, High Level
SAA Calibrator, High Level
D-Dimer Calibrator, High Level
MYO Calibrator, High Level
ASO Calibrator, High level
Description
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Calibrator raw material
Catalog No. Product Recommendation
6. Myocardial Markers
BBMYON101
BBNCTNIN103
MYO
cTnI
Description
Rabbit Anti Human Myoglobin, Affinity Purified Antibody
Goat Anti Human Troponin I, Affinity Purified Antibody
For Latex-enhanced Immunoturbidimetry
For Latex-enhanced Immunoturbidimetry
Catalog No. Product Recommendation
7. Nutrition
BBNPAN101 PA
Description
Goat Anti Human Pre-Albumin,Serum For Immunoturbidimetry
Catalog No. Product Recommendation
8. Diabetes
BBNHBAN102 HbA1c
Description
Anti-HbA1c Monoclonal Antibody For Latex-enhanced Immunoturbidimetry
Fapon Biotech Inc.02
Customizable Reagent Service Overview
10. Heterophilic Immunoglobulin Elimination ReagentComposed by a complex of bioactive protein, it can effectively remove false positive reaction caused by HAMA, Rf and other heterophilic materials. By applying it in Reagent 1, it can effectively improve the performance of immunoturbidimetry reagent by increasing clinical correlation, accuracy and sensitivity.
Catalog No. Product Recommendation
HIER-E-014
HIER-E-014C
HIER-E-015
HIER-E-015D
HIER
HIER
HIER
HIER
Description
Heterophilic Immunoglobulin Elimination Reagent
Heterophilic Immunoglobulin Elimination Reagent
Heterophilic Immunoglobulin Elimination Reagent
Heterophilic Immunoglobulin Elimination Reagent
For Goat Polyclonal Antibody
For Goat Polyclonal Antibody
For Rabbit Polyclonal Antibody
For Rabbit Polyclonal Antibody
Test Name Reagent Ratio
Reaction Time
MethodsTurbidimetry Nephelometry
Sensitivity Detection Limit
Calibration Mode Applicable InstrumentOne Point Multi Point
HbA1c
CRP
ASO
RF
mALB
SAA
Lp(a)
ApoA1
ApoB
MYO
DD
NGAL
Cysc
β-2M
RBP
PA
CCP
PGI
PGII
IgA
MB
3:1
1:1~10:1
1:1.7~10:1
3:1~10:1
1:1~9:1
4:1~10:1
3:1~6:1
3:1~6:1
3:1~6:1
2:1~6:1
1:1~10:1
3:1~6:1
2:1~6:1
2:1~6:1
2:1~5:1
3:1~10:1
3:1
3:1
3:1
5:1
2:1~6:1
1.5~5mins
45s~5mins
2~5mins
2~5mins
2~5mins
2-5mins
2~5mins
2~5mins
2~5mins
2~5mins
2-5mins
2~5mins
1~5mins
1~5mins
2~5mins
2~5mins
2~5mins
2~5mins
2~5mins
2~5mins
2~5mins
2%
0.1mg/L
20IU/ml
3IU/ml
2mg/L
0.3mg/L
5mg/L
0.02g/L
0.08g/L
10ng/ml
0.1mg/L
25ng/ml
0.1mg/L
0.2mg/L
0.5mg/L
2mg/L
5IU/ml
1ng/ml
2ng/ml
0.1mg/ml
10ng/ml
>Δ 5 mA.1%(4% at 660nm)
Clinical Chemistry AnalyzerSpecific Protein AnalyzerHematology Analyzer
Clinical Chemistry AnalyzerSpecific Protein Analyzer
Clinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein Analyzer
Clinical Chemistry AnalyzerSpecific Protein Analyzer
Clinical Chemistry AnalyzerSpecific Protein AnalyzerHematology Analyzer
Clinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein Analyzer
Clinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein Analyzer
>Δ 8 mA.mg/L(5.0mg/L at 600nm)
>Δ 0.6 mA.IU/ml(100IU/ml at 570nm)>Δ 1 mA.U/ml(30U/ml at 600nm)>Δ 1.0 mA.mg/L(50mg/L at 546nm)
>Δ 0.3 mA.mg/L(10mg/L at 570nm)
>Δ 0.5 mA.mg/L(100mg/L at 600nm)>Δ 100 mA.g/L(0.5g/L at 700/340nm)>Δ 120 mA.g/L(0.5g/L at 700/340nm)>Δ 0.3 mA.ng/ml(100ng/ml at 570nm)>Δ 0.15 mA.ug/L(1ug/L at 570nm)>Δ 0.2 mA.ng/ml(150ng/ml at 570nm)>Δ 24 mA.mg/L
(0.5mg/L at 546nm)>Δ 20 mA.mg/L
(2mg/L at 600nm)
>Δ 0.2 mA.mg/L(100mg/L at 700/340nm)
>Δ 6 mA.mg/L(20mg/L at 600nm)
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
Fapon Biotech Inc. 03
>Δ0.2mA.IU/ml(28IU/ml 546nm)
Clinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein AnalyzerClinical Chemistry AnalyzerSpecific Protein Analyzer
>Δ2mA.ng/mL(2ng/L 570nm)>Δ2mA.ng/mL(2ng/L 570nm)>Δ0.2mA.mg/ml(1mg/L 340nm)>Δ0.3mA.ng/ml
(100ng/ml 570nm)
√
√
√
√
√
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√
√
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√
Reagent Performance1. Hemoglobin A1c (HbA1c)
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated HbA1c monoclonal antibodies with the HbA1c antigens in the samples. The turbidity level reflects on the concentration level
of HbA1c, which its amount could be obtained through the concentration-absorbance calibration curve.
Performance:◎ Wide measuring range: 2~16%
◎ Stable for 30 days on board (2~8℃)
◎ Excellent correlation with HPLC
◎ No cross-reaction with other variants
Customizable Parameters:
◎ Reaction time: 1.5~5mins
◎ Detection method: turbidimetry/nephelometry
◎ Sensitivity: >0.6mA.IU/ml (100IU/ml at 570nm)
Linearity: 2%-16%
4°C Stability (Open Vial): CV <10%
Intended Use: For quantitative determination of HbA1c in blood samples, a marker for identifying diabetes and cardiovascular risk.
Test Principle:
Mea
sure
d C
once
ntra
tion%
Mea
sure
d C
once
ntra
tion%
Day (s)
Mea
sure
d C
once
ntra
tion
with
FP
HbA
1c%
Theoretical Concentration% Measured Concentration with HPLC Assay%
Fapon Biotech Inc.04
02468
1012141618
0 5 10 15 20
y = 1.0005x + 0.0038R² = 1
0
2
4
6
8
10
12
14
0 2 4 6 8 10 12 14
y = 1.012x - 0.2344R² = 0.9862
0.0
2.0
4.0
6.0
8.0
10.0
12.0
0 5 10 15 20 25 30 35
Correlation with HPLC Assay: R²≥ 0.98
2. C-Reactive Protein (CRP)
Performance:◎ Wide measuring range:0.1~320.0mg/L
◎ High sensitivity: 0.1mg/L
◎ Excellent correlation: R²≥ 0.998
◎ Extensive applicability
Customizable Parameters:◎ Reagent ratio: 1:1~10:1
◎ Reaction time: 45s~5mins
◎ Detection method: turbidimetry/nephelometry
◎ Calibration mode: single or multi point
Linearity: 0.1-320mg/L Hook Effect: >1200mg/L
Clinical Relevance: R² ≥ 0.998 Stressed Stability at 37°C
0.00
50.00
100.00
150.00
200.00
250.00
0.00 50.00 100.00 150.00 200.00
Fapon Biotech Inc. 05
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated CRP antibodies with the CRP antigens in the samples. The turbidity level reflects on the concentration level of CRP, which its
amount could be obtained through the concentration-absorbance calibration curve.
Intended Use: For quantitative determination of CRP in serum samples, a general marker for body inflammation.
Test Principle:
Theoretical Concentration (mg/L)
Mea
sure
d C
once
ntra
tion
(mg/
L)
Theoretical Concentration with Kit A (mg/L)
Mea
sure
d C
once
ntra
tion
with
FP
-CR
P (m
g/L)
Mea
sure
d C
once
ntra
tion
(mg/
L)
Theoretical Concentration (mg/L)
Mea
sure
d C
once
ntra
tion
(mg/
L)y = 1.0109x + 0.6705R² = 0.9993
0.0 50.0
100.0 150.0 200.0 250.0 300.0 350.0
0.0 100.0 200.0 300.0 0.0
100.0
200.0
300.0
400.0
500.0
0 500 1000 1500 2000 2500
y = 1.0078x + 0.7912R² = 0.9987
Low Value
8 10 122 4 60
80
100
120
20
40
60
0
Day (s)
High Value
3. Anti-Streptolysic O (ASO)
Customizable Parameters: ◎ Reagent ratio: 1:1.7~10:1
◎ Reaction time: 2~5mins
◎ Detection method: turbidimetry/nephelometry
◎ Calibration mode: single or multi point
Fapon Biotech Inc.06
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated ASO antibodies with the ASO antigens in the samples. The turbidity level reflects on the concentration level of ASO antigens,
which its amount could be obtained through the concentration-absorbance calibration curve.
Intended Use: For quantitative determination of ASO in serum and plasma samples, a marker for infectious disease.
Test Principle:
Linearity: 0-1200IU/ml Hook Effect: >6000IU/ml
Compared with Kit A: R²= 0.998 Stressed Stability at 37°C
0
50
100
150
200
250
300
350
400
450
0 5 10 15 20
Low Value
Median Vlaue
High Value
Day (s)
Mea
sure
d C
once
ntra
tion
(IU/m
l)M
easu
red
Con
cent
ratio
n w
ith F
A-A
SO
(IU
/ml)
Mea
sure
d C
once
ntra
tion
(IU/m
l)
Theoretical Concentration (IU/ml)
Theoretical Concentration with Kit A (IU/ml)
Theoretical Concentration (IU/ml)
0
200
400
600
800
1000
1200
0 400 600 1200
y = 1.0106x - 1.2347R² =1
10008002000
1000
2000
3000
4000
5000
6000
7000
8000
9000
0 1000 2000 3000 4000 5000 6000 7000
0
200
400
600
800
1000
1200
1400
0 200 400 600 800 1000 1200
y = 1.05x + 0.2045R² = 0.9984
4. Rheumatoid Factors (RF)
Customizable Parameters: ◎ Reagent ratio: 3:1~10:1
◎ Reaction time: 2~5mins
◎ Detection method: turbidimetry/nephelometry
◎ Calibration mode: multi-point
Linearity: 5-150IU/ml Hook Effect: >400IU/ml
Fapon Biotech Inc. 07
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated human gamma globulin with the RF antigens in the samples. The turbidity level reflects on the concentration level of RF,
which its amount could be obtained through the concentration-absorbance calibration curve.
Intended Use: For quantitative determination of RF in serum and plasma samples, a marker for rheumatoid arthritis.
Test Principle:
Mea
sure
d C
once
ntra
tion
(IU/m
l)
Theoretical Concentration (IU/ml)Theoretical Concentration (IU/ml)
Mea
sure
d C
once
ntra
tion
(IU/m
l)
Stressed Stability at 37°C
Concentration(IU/ml)
Opt
ical
Den
sity Day 0
Day 1
Day 8
Day 15
Day 24
y = 1.0384x - 1.649R² = 0.9988
0
50
100
150
200
0 100 150 200500
1000
2000
3000
4000
5000
6000
0 100 200 300 600
7000
8000
400 500
0
1000
2000
3000
4000
5000
6000
0 50 150
7000
8000
100-1000
5. Urinary Microalbumin (mALB)
Performance:◎ Reaction time: 2mins
◎ High sensitivity: 2mg/L
◎ Detection method: turbidimetry
◎ Excellent correlation: R²>0.99
Fapon Biotech Inc.08
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated mALB antibodies with the mALB antigens in the samples. The turbidity level reflects on the concentration level of mALB,
which its amount could be obtained through the concentration - absorbance calibration curve.
Intended Use: For quantitative determination of Microalbumin (mALB) in serum and human urine samples, a marker for renal diseases.
Test Principle:
Linearity: 5-400mg/L
Mea
sure
d C
once
ntra
tion
((m
g/L)
Mea
sure
d C
once
ntra
tionv
(mg/
L)
Theoretical Concentration (mg/L) Theoretical Concentration (mg/L)
Hook Effect: >1000mg/L
y = 1.0232x - 1.6479R² = 0.9988
Compared with Kit A: R²>0.99 Stressed Stability at 37°C
Low Value
Median Vlaue
Day (s)
Kit
A M
easu
red
Con
cent
ratio
n (m
g/L)
Mea
sure
d C
once
ntra
tion
(IU/m
l)
Measured Concentration with FP-mALB (mg/L)
0
100
200
300
400
500
0 100 200 300 400 500 0
2000
4000
6000
8000
10000
12000
0 1000 2000 3000 4000
0
20
40
60
80
100
0 50 100 150
y = 1.2224x - 4.0404
R² = 0.9972
120
140
160
180
0
50
100
150
200
250
300
0 5 10 15
350
Fapon Biotech Inc. 09
6. Serum Amyloid A (SAA)
Performance:◎ Wide measuring range: 0.3~300mg/L (Serum)
◎ High sensitivity: 0.3mg/L
◎ Excellent correlation: R2>0.98
◎ Sample dilution unneeded
Customizable Parameters:◎ Reagent ratio:4:1~10:1
◎ Reaction time: 2~5mins
◎ Detection method: turbidimetry/nephelometry
Clinical Relevance: R² ≥ 0.98 Stressed Stability at 37°C
Days
0
50
100
150
200
250
300
350
0 100 200 300 400
Rec
over
y (m
g/L)
Theoretical Value (mg/L)
0
5000
10000
15000
20000
25000
0 500 1000 1500 2500Mea
sure
d C
once
tratio
n (m
g/L)
2000
y = 0.9741x + 1.8047R² = 0.9803
0
50
100
150
200
250
300
350
0 50 100 150 200 250 300 350 400
Mea
sure
d C
once
ntra
tion
with
FP
-SA
A( m
g/L)
0
2000
4000
6000
8000
10000
12000
14000
16000
0 50 100 150 200 250 300 350
Concentration (mg/L)
0 day 1 day 3 day 7 day 14 day
Opt
ical
Den
sity
Measured Concentration with Kit A (mg/L)
Theoretical Concentration (mg/L)
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated SAA antibodies with the SAA antigens in the samples. The turbidity level reflects on the concentration level of SAA, which its
amount could be obtained through the concentration-absorbance calibration curve.
Intended Use: For quantitative determination of SAA in serum, plasma and whole blood samples, an acute phase marker for body inflammation.
Test Principle:
y = 0.9655x + 3.8871R² = 0.9962
Linearity: 0.3-300mg/L Hook Effect: >1600mg/L
7. Lipoprotein (a) (Lp(a))
Performance:◎ Wide measuring range: 5~250nmol/L
◎ High sensitivity: 5nmol/L
◎ Excellent relevance: R²≥0.99
◎ Extensive applicability
Customizable Parameters:◎ Reagent ratio: 3:1~6:1
◎ Reaction time:2~5mins
◎ Detection method: turbidimetry
◎ Calibration mode: multi point
Fapon Biotech Inc.10
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated Lp(a) antibodies with the Lp(a) antigens in the samples. The turbidity level reflects on the concentration level of Lp(a), which
its amount could be obtained through the concentration-absorbance calibration curve.
Intended Use: For quantitative determination of Lp(a) in serum and plasma samples, a marker for atherosclerotic diseases.
Test Principle:
Mea
sure
d C
once
ntra
tion
(nm
ol/L
)
Mea
sure
d C
once
ntra
tion
(nm
ol/L
)
Theoretical Concentration (nmol/L)
Hook Effect: >1500nmol/L
y = 1.0395x - 0.1209R² = 0.9985
Theoretical Concentration (nmol/L)
Compared with Kit A: R²>0.997 Stressed Stability at 37°C
Concentration (nmol/L)
Mea
sure
d C
once
ntra
tion
with
FP
-Lp(
a)
(nm
ol/L
)
Opt
ical
Den
sity
Measured Concentration with Kit A (nmol/L)
y = 0.9817x + 2.3967R² = 0.9973
Day 0
Day 1
Day 3
Day 5
Day 8
Day15
0
50
100
150
200
0 100 200 300
250
300
0
5000
10000
15000
20000
25000
0 500 1000 1500 2000
250
250
200
200
150
150
100
100
50
500
00
2000
4000
6000
8000
10000
12000
0 50 100 150 200 250
14000
Linearity: 5-250nmol/L
8. Apolipoprotein_A1 (ApoA1)
Performance:◎ Excellent correlation: R²>0.99
◎ Reagent ratio:3:1~6:1
◎ Reaction time:2~5mins
◎ Detection method: turbidimetry
Linearity: 0.2-0.4g/l Hook Effect: >6g/l
Compared with Kit A: R²>0.99 Stressed Stability at 37°C
Day (s)
Apo
A1(
g/l)
Mea
sure
d C
once
ntra
tion
(g/l)
Mea
sure
d C
once
ntra
tion
(g/l)
Mea
sure
d C
once
ntra
tion
with
FP
-Apo
A1
(g/l)
Measured Concentration with Kit A (g/l)
Theoretical Concentration (g/l) Theoretical Concentration (g/l)
Fapon Biotech Inc. 11
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated ApoA1 antibodies with the ApoA1 antigens in the samples. The turbidity level reflects on the concentration level of ApoA1,
which its amount could be obtained through the concentration - absorbance calibration curve.
Intended Use: For quantitative determination of ApoA1 in plasma samples, a marker for evaluating the risk of atherosclerotic cardiovascular disease.
Test Principle:
y = 0.9579x + 0.0242R² = 0.9992
0
0.5
1
1.5
2
2.5
3
0 0.5 1 1.5 2 2.5 30
5000
10000
15000
20000
25000
0 1 2 3 4 5 6 7
y = 0.9782x + 0.0369R² = 0.9919
0.000
0.500
1.000
1.500
2.000
2.500
3.000
0 0.5 1 1.5 2 2.50.000 0.200 0.400 0.600 0.800 1.000 1.200 1.400 1.600 1.800 2.000
0 2 4 6 8
Low Value Mid Value High Value
9. Apolipoprotein B (ApoB)
Performance:◎ Excellent correlation: R²>0.99
◎ Reagent ratio:3:1~6:1
◎ Reaction time:2~5mins
◎ Detection method:turbidimetry
Apo
B (m
g/dL
)
Mea
sure
d C
once
ntra
tion
(mg/
dL)
Theoretical Concentration (mg/dL)
Linearity: up to 250mg/dL
Theoretical Concentration (mg/dL)
Mea
sure
d C
once
ntra
tion
(mg/
dL)
Hook Effect: >500mg/dL
Mea
sure
d C
once
ntra
tion
with
FP
-Apo
B (m
g/dL
)
Measured Concentration with Kit A (mg/dL) Day (s)
Fapon Biotech Inc.12
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated ApoB antibodies with the ApoB antigens in the samples. The turbidity level reflects on the concentration level of ApoB, which
its amount could be obtained through the concentration - absorbance calibration curve.
Intended Use: For quantitative determination of ApoB in plasma samples, a marker for evaluating the risk of developing cardiovascular disease.
Test Principle:
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
0 100 200 300
y = 0.9695x + 1.8438R² = 0.9903
0
20
40
60
80
100
120
140
160
180
200
0 20 40 60 80 100 120 140 160 180 200
0
50
100
150
200
250
300
0 50 100 150 200
y = 1.0002x + 0.0011R² = 1
Low Value Mid Value High Value
00.20.40.60.8
11.21.41.61.8
2
0 2 4 6 8
Stressed Stability at 37°CCompared with Kit A: R²>0.99
Fapon Biotech Inc. 13
10. Myoglobin (MYO)
Performance:◎ Wide measuring range: 10~800ng/ml
◎ High sensitivity: 10ng/ml
◎ Excellent relevance: ≥0.99
◎ Extensive applicability
Customizable Parameters:◎ Reagent ratio: 2:1~6:1
◎ Reaction time: 2~5mins
◎ Detection method: turbidimetry/nephelometry
◎ Calibration mode: multi point
Linearity: 10-800ng/ml Hook Effect: >20000 ng/ml
Clinical Relevance: R²≥0.99 Stressed Stability at 37°C
Day (s)
Mea
sure
d C
once
ntra
tion
(ng/
ml)
Low Value SampleHigh Value Sample
Mea
sure
d C
once
ntra
tion
(ng/
ml)
Mea
sure
d C
once
ntra
tion
(ng/
ml)
Mea
sure
d C
once
ntra
tion
(ng/
ml)
Measured Concentration with Kit A (ng/ml)
Therotical Concentration (ng/ml) Therotical Concentration (ng/ml)
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated MYO antibodies with the MYO antigens in the samples. The turbidity level reflects on the concentration level of MYO, which
its amount could be obtained through the concentration-absorbance calibration curve.
Intended Use: For quantitative determination of MYO in serum and plasma samples, a marker for heart diseases.
Test Principle:
0
200
400
600
800
1000
0 200 400 600 800 1000
y = 1.0075x + 1.4615
R² = 0.9999
010002000300040005000600070008000
0 5000 10000 15000 20000
y = 0.988x + 2.5732R² = 0.998
0
100
200
300
400
500
600
700
800
900
0 100 200 300 400 500 600 700 800 900 0
50
150
250
350
450
0 4 82 6 10
100
200
300
400
500
11. D-Dimer (DD)
Performance:◎ Wide measuring range: 0.1~60μg/ml
◎ High sensitivity: 0.1μg/ml
◎ Excellent correlation: R2>0.97
◎ Extensive application
Customizable Parameters:◎ Reagent ratio: 1:1~10:1
◎ Reaction time: 2~5mins
◎ Detection method: turbidimetry/nephelometry
-500
0
500
1000
1500
2000
2500
3000
3500
4000
4500
-10 0 10 20 30 40 50 60 70
0 day 1 day 3 day 7 day 14 day
Opt
ical
Den
sity
Stressed Stability at 37°C
0
10
20
30
40
50
60
70
0 10 20 30 40 50 60 70
Mea
sure
d C
once
ntra
tion
(μg/
ml)
Theoretical Concentration (μg/ml)
Linearity: 0.1-60μg/ml
0
10
20
30
40
50
60
70
80
90
0 50 100 150 200 250 300 350
Theoretical Concentration (μg/ml)
Mea
sure
dC
once
ntra
tion
(μg/
ml)
Hook Effect: >300μg/ml
y = 1.0045x - 0.3998R² = 0.9795
0
10
20
30
40
50
60
70
0 10 20 30 40 50 60 70
Mea
sure
d C
once
traito
nw
ith F
P-D
D (
μg/m
l)
Measured Concentration with Kit A (μg/ml) Concentration (μg/ml)
Fapon Biotech Inc.14
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated DD antibodies with the DD antigens in the samples. The turbidity level reflects on the concentration level of DD, which its
amount could be obtained through the concentration-absorbance calibration curve.
Intended Use: For quantitative determination of DD in plasma samples, a marker for thrombosis.
Test Principle:
Clinical Relevance: R² ≥ 0.97
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated NGAL antibodies with the NGAL antigens in the samples. The turbidity level reflects on the concentration level of NGAL,
which its amount could be obtained through the concentration-absorbance calibration curve.
12. Neutrophil Gelatinase-Associated Lipocalin (NGAL)
Performance:◎ High sensitivity: 25ng/ml
◎ Excellent precision: CV<5%
For quantitative determination of NGAL in serum samples and human urine, a marker for kidney disease.
Customizable Parameters:◎ Reaction time: 5mins
◎ Detection method: turbidimetry
◎ Linearity: 20~5000ng/L
Intended Use:
Test Principle:
Linearity: 20~5000ng/L
y = 1.0192x + 23.093R² = 0.9991
0
1000
2000
3000
4000
5000
6000
0 1000 2000 3000 4000 5000 6000
Mea
sure
d C
once
ntra
tion
(ng/
ml)
Theoretical Concentration (ng/ml)-2000
0
2000
4000
6000
8000
10000
12000
14000
16000
0 5000 10000 15000 20000 25000 30000 35000
Mea
sure
d C
once
ntra
tionv
(ng/
ml)
Theoretical Concentration (ng/ml)
Fapon Biotech Inc. 15
Hook Effect:>20000ng/ml
13. Cystatin C (Cysc)
Performance:◎ Reagent ratio: 2:1~6:1
◎ Reaction time: 1~5mins
◎ Excellent correlation: R²>0.99
◎ Detection method: turbidimetry/ nephelometry
Fapon Biotech Inc.16
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated Cysc antibodies with the Cysc antigens in the samples. The turbidity level reflects on the concentration level of Cysc, which its
amount could be obtained through the concentration - absorbance calibration curve.
Intended Use: For quantitative determination of Cysc in serum samples, a marker for kidney function.
Test Principle:
Linearity: up to 10mg/L
Compared with Kit A: R²>0.99 Stressed Stability at 37°C
Day (s)
Con
cent
ratio
n (m
g/L)
Mea
sure
d C
once
ntra
tion
with
Kit
A (m
g/L)
Measured Concentration with FP-Cysc (mg/L)
Mea
sure
d C
once
ntra
tion
(mg/
L)
Mea
sure
d C
once
ntra
tion
(mg/
L)
Theoretical Concentration (mg/L) Theoretical Concentration (mg/L)
Hook Effect: >30mg/L
y = 1.0016x + 0.0401R² = 0.9993
0
2
4
6
8
10
12
0 2 4 6 8 10 1202468
10121416
0 5 10 15 20 25 30
y = 0.9992x + 0.0426R² = 0.9967
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
10.00
0.00 2.00 4.00 6.00 8.00
Low Value High Value
10 1550
3.5
1.5
2.5
0
3
0.5
1
2
14. β-2 Microglobulin (β-2M)
Performance:◎ Reagent ratio: 2:1~6:1
◎ Reaction time: 1~5mins
◎ Excellent correlation: R²>0.99
◎ Detection method: turbidimetry
Linearity: up to 24mg/L Hook Effect: >80mg/L
Compared with Kit A: R²>0.99 Stressed Stability at 37°C
Con
cent
ratio
(mg/
L)
Low Value High Value
Mea
sure
d C
once
ntra
tion
(mg/
L)
Mea
sure
d C
once
ntra
tion
(mg/
L)
Mea
sure
d C
once
ntra
tion
with
K
it A
(mg/
L)
Measured Concentration with FP-β2M (mg/L)
Theoretical Concentration (mg/L) Theoretical Concentration (mg/L)
Fapon Biotech Inc. 17
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated β-2M antibodies with β-2M antigens in the samples. The turbidity level reflects on the concentration level of β-2M, which its
amount could be obtained through the concentration - absorbance calibration curve.
Intended Use: For quantitative determination of β-2M in blood and urine samples, a marker for kidney function.
Test Principle:
y = 1.0073x - 0.0225R² = 0.9975
y = 0.9898x - 0.1363R² = 0.9994
30
30
25
25
20
20
15
15
10
10
5
50
0
1800016000140001200010000
8000600040002000
10.00 20.00 30.00 40.00 50.00 60.00 70.00 80.000
0
25.00
25.00
20.00
20.00
15.00
15.00
10.00
10.00
5.00
5.000.00
0.00 10 1550
141618
6
10
0
Day (s)
12
24
8
15. Retinol Binding Protein (RBP)
Performance:◎ Reagent ratio: 2:1~5:1
◎ Reaction time: 2~5mins
◎ Excellent correlation: R²>0.99
◎ Detection method: turbidimetry/nephelometry
Compared with Kit A: R²>0.99
Mea
sure
d C
once
ntra
tion
(mg/
L)
Theoretical Concentration (mg/L)
Linearity: up to 240mg/L
Theoretical Concentration (mg/L)
Mea
sure
d C
once
ntra
tion
(mg/
L)
Mea
sure
d C
once
ntra
tion
with
Kit
A (m
g/L)
Measured Concentration with FP-RBP (mg/L) Day (s)
Fapon Biotech Inc.18
The RBP in the samples agglutinate with the latex coated antibody in the reagents to form antigen-antibody complex, the concentration
level of RBP can be determined by the turbidity method.
Intended Use: For quantitative determination of RBP in human blood and urine samples, a marker for renal and liver function as well as nutritional
diseases.
Test Principle:
Hook Effect: >300mg/L
0
50
100
150
250
0 50 100 150
y = 0.991x + 0.4795R² = 0.999
200
2000
5000
10000
15000
20000
25000
0 500 1000 1500-5000
20.0
40.0
60.0
80.0
100.0
120.0
140.0
160.0
180.0
200.0
20.0 40.0 60.0 80.0 100.0 120.0 140.0 160.0 180.0
y = 1.0334x - 3.4395R² = 0.9959
RB
P (m
g/L)
Stressed Stability at 37°C
Day (s)
20253035404550
0 2 4 6 8 10
80
90
100
110
120
130
140
0 2 4 6 8 10 12
Low Value
High Value
RB
P (m
g/L)
Stressed Stability at 37°C
Fapon Biotech Inc. 19
16.Phosphoglucose Isomerase (PGI)
Performance:◎ Reagent ratio: 3:1
◎ Reaction time: 2~5mins
◎ Excellent correlation: R²>0.98
◎ Detection method: turbidimetry
◎ Detection limit: 2.0ng/ml
Linearity: 02-200ng/ml Compared with Kit A: R²>0.99
Mea
sure
d C
once
ntra
tion(
ng/m
l)
Mea
sure
d C
once
ntra
tion
with
Kit
A (n
ng/m
L)
Theoretical Concentration (ng/ml) Measured Concentration with FP-PGI (mg/L)
Adopting the Latex-enhanced Turbidimetric Immunoassay methodology to produce turbidity via the reaction of the latex particle
coated PGI antibodies with the PGI antigens in the samples. The turbidity level reflects on the concentration level of PGI, which its
amount could be obtained through the concentration - absorbance calibration curve.
Intended Use: For quantitative determination of PGI in serum samples, a marker for gastric cancer.
Test Principle:
y = 0.9968x + 0.3427R² = 0.9968
y = 1.0678x + 0.6064R²= 0.9914
0
50
100
150
200
250
0 50 100 150 200 2500
200
400
600
800
1000
1200
1400
0 200 400 600 800 1000 1200
Fapon Biotech Inc.
http://en.fapon.com LinkedIn: faponbiotech
No.5 Hualian RD, Taiwan High-tech Industrial Park, Songshan Lake, Guangdong, China 52380886-769-22898886 86-769-22898886-8800 [email protected]