One-Stop Solution For Immunoturbidimetric Reagent

A GLOBAL LEADING IVD REAGENT RAW MATERIALS AND ONE-STOP SOLUTIONS PROVIDER

One-Stop Solution ForImmunoturbidimetric Reagent

Development

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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








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





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


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





4. Immunoglobulin & Complement

BBNIGAN102 IgA

Description

Goat Anti Human IgA (α Chain Specific), Serum For Immunoturbidimetry

Fapon Biotech Inc. 01


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



















6. Myocardial Markers

BBMYON101

BBNCTNIN103

MYO

cTnI

Description

Rabbit Anti Human Myoglobin, Affinity Purified Antibody

Goat Anti Human Troponin I, Affinity Purified Antibody




7. Nutrition

BBNPAN101 PA

Description

Goat Anti Human Pre-Albumin,Serum For Immunoturbidimetry


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.


HIER-E-014

HIER-E-014C

HIER-E-015

HIER-E-015D

HIER

HIER

HIER

HIER

Description

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)

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√

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√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√


＞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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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%


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


◎ 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



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)


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


◎ Calibration mode: single or multi point



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



◎ Calibration mode: multi-point

Linearity: 5-150IU/ml Hook Effect: ＞400IU/ml



coated human gamma globulin with the RF antigens in the samples. The turbidity level reflects on the concentration level of RF,


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



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


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



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)



coated SAA antibodies with the SAA antigens in the samples. The turbidity level reflects on the concentration level of SAA, which its


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



◎ Reaction time:2~5mins


◎ Calibration mode: multi point



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)


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


Linearity: 0.2-0.4g/l Hook Effect: ＞6g/l


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)



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)



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


10. Myoglobin (MYO)

Performance:◎ Wide measuring range: 10~800ng/ml

◎ High sensitivity: 10ng/ml

◎ Excellent relevance: ≥0.99





◎ 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)


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




-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


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)



coated DD antibodies with the DD antigens in the samples. The turbidity level reflects on the concentration level of DD, which its


Intended Use: For quantitative determination of DD in plasma samples, a marker for thrombosis.

Test Principle:

Clinical Relevance: R² ≥ 0.97


coated NGAL antibodies with the NGAL antigens in the samples. The turbidity level reflects on the concentration level of NGAL,


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


◎ 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)


Hook Effect:＞20000ng/ml

13. Cystatin C (Cysc)

Performance:◎ Reagent ratio: 2:1~6:1


◎ Excellent correlation: R²＞0.99

◎ Detection method: turbidimetry/ nephelometry



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


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)



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)





Linearity: up to 24mg/L Hook Effect: ＞80mg/L


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)




coated β-2M antibodies with β-2M antigens in the samples. The turbidity level reflects on the concentration level of β-2M, which its


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)





Compared with Kit A: R²＞0.99

Mea

sure

d C

once

ntra

tion

(mg/

L)


Linearity: up to 240mg/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)


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:


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)


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)



16.Phosphoglucose Isomerase (PGI)

Performance:◎ Reagent ratio: 3:1




◎ 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)


coated PGI antibodies with the PGI antigens in the samples. The turbidity level reflects on the concentration level of PGI, which its


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]

One-Stop Solution For Immunoturbidimetric Reagent

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