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Fapon Biotech Inc. A GLOBAL LEADING IVD REAGENT RAW MATERIALS AND ONE-STOP SOLUTIONS PROVIDER Raw Material Catalogue for Tumor Markers

Raw Material Catalogue for Tumor Markers

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Page 1: Raw Material Catalogue for Tumor Markers

Fapon Biotech Inc.

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

Raw Material Catalogue for Tumor Markers

Page 2: Raw Material Catalogue for Tumor Markers

What are Tumor Markers? Tumor Markers Overview

Pro-GRP

CYFRA211

CA242

CA724

CA153

SCCA

PGI/II

CA125

CA199

HE4

CA50

AFP

CEA

PSA

02

03

05

07

09

11

13

15

20

22

24

27

29

31

34

Table of Contents02

01 Fapon Biotech Inc.

Page 3: Raw Material Catalogue for Tumor Markers

What are Tumor Markers?A tumor marker (TM) is a substance secreted or discharged by cancer cells

into body fluids or tissues, or a substance that is produced by a host in

response to the presence of new organisms in the body that has entered

body fluids or tissues. For clinical application, TMs refer to the relevant

detectable substances in serum or other body fluids. Some TMs are absent

from the normal human body, but present in embryos. Others are present

at elevated levels in cancer patients as compared with those in the normal

human body. Determination of the presence or level of TMs can aid the

diagnosis of tumors and the analysis of the course of disease, provide guidance

for treatment, and monitor recurrence or metastasis, as well as the

determination of prognosis.

Tumor Markers Overview

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

02Fapon Biotech Inc.

Disease

Lung Cancer

Gastric Cancer

Colorectal Cancer

Pancreatic Cancer

Liver Cancer

Gynecologic Cancer(Ovarian & Cervical)

Testicular Cancer

Prostate Cancer

Breast Cancer

Tumor Markers

CEA, CYFRA211 (NSCLC), Pro-GRP (SCLC)

CA724, PGI/II

CEA, CA199, CA50

CEA, CA199, CA242, CA50

AFP

SCCA, CA125, HE4

AFP

PSA

CA153

Page 4: Raw Material Catalogue for Tumor Markers

Pro-GRP is highly sensitive and specific to small cell lung cancer (SCLC). As

Pro-GRP is produced in very small (or zero) quantities in the presence of

benign lesions and other cancers (including non-SCLCs), thus Pro-GRP

detection is useful to apply in diagnosis and differential diagnosis.

When Pro-GRP immunoassay is applied to SCLC diagnosis, the patient's

renal function must be examined to rule out elevated serum levels of

Pro-GRP due to reduced glomerular filtration rates. Using in combination of

renal dysfunction serum creatinine> 141 μmol/L, patient's Pro-GRP levels

will be elevated.

Pro-GRP

Recommended Pairing

Pro-GRP AntibodyAntibody

UsageSubtypeBuffer

Storage ConditionShelf Life

Purity

BENGRPS101 BENGRPS102 BENGRPS103 BENGRPS104 BENGRPS105 BENGRPS106

Coating Coating Coating Coating Labeling Coating

IgG1 IgG1 IgG1 IgG1 IgG2a IgG110mM PB + 150mM NaCl + 0.1%Proclin300, pH7.4

-20℃±5℃

≥90%

3 years

Catalog No.

BENGRPS104

BENGRPS105

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

03 Fapon Biotech Inc.

Page 5: Raw Material Catalogue for Tumor Markers

Clinical Correlation

Pairing Antigen

CLIA Linearity

Summary: Fapon's Pro-GRP exhibits excellent linearity, with a linear range of 3-5000 pg/mL and R up to 0.999.

Summary: There is an excellent clinical correlation between Fapon's Pro-GRP and the values of international top brand.

-500000

0

500000

1000000

1500000

2000000

2500000

3000000

3500000

4000000

4500000

0 1000 2000 3000 4000 5000 6000

Val

ue

Antigen Concentration (pg/ml)

Pro-GRP CLIA Linearity

Pro-GRP Clinical Correlation

Reagent Value of International Top Brand (pg/ml)

FAPO

N's

Val

ue (p

g/m

l)

04Fapon Biotech Inc.

18 kDa25mM Tris-HCL, 0.1% SDS, pH8.0

For immune molecules or standards3 years

E.coliCatalog No.

HostMolecular Weight

Bu�er SolutionUsage

Shelf Life

2

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

y = 0.849x + 38.41R² = 0.966

y = 799.1x - 12184R² = 0.999

GENGRPN101

Page 6: Raw Material Catalogue for Tumor Markers

CY211 Antibody

Recommended Pairing

With a sensitivity of 80%, CYFRA211 is utilized in the diagnosis of lung

cancer, especially non-small cell lung cancer (NSCLC). CYFRA211 can be

used for early diagnosis and is associated with tumor growth, patient

survival rates, lymph node involvement, cancer staging, etc. Therefore, it

can be used for disease progression detection and post-operative

follow-ups. Serum CYFRA211 levels in lung cancer patients who have

undergone chemotherapy are associated with treatment efficacy.

Reduced CYFRA211 levels indicate better efficacy and stable conditions,

whereas elevated levels indicate disease progression.

CYFRA211

05 Fapon Biotech Inc.

BEJCYFS101

Labeling

IgG2b

BEJCYFS102

Labeling

IgG2b

Antibody

Usage

Subtype

Bu�er

Storage Condition

Shelf Life

Purity

BENCYFN105

Coating

IgG2a

10mM PB + 150mM NaCl + 0.1% Proclin300, pH7.4

-20℃ ± 5℃

3 years

≥ 90%

Catalog No.

BENCYFN105

BEJCYFS101

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

Page 7: Raw Material Catalogue for Tumor Markers

Clinical Correlation

CLIA Linearity

Pairing Antigen

Summary: There is a good linear correlation between Fapon's CY211 and the reagent values of international top brand.

Summary: Fapon's CY211 exhibits excellent linearity, with a linear range of 0.1-500 ng/ml and R² of 0.999.

06Fapon Biotech Inc.

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

For immunoassays or calibrators20mM PB + protective protein, pH7.4

20.3 kDa5.6

-20℃ ± 5℃3 years

E.coliCatalog No.

HostUsageBu�er

Molecular WeightIsoelectric Point

Storage TemperatureShelf Life

0

100000

200000

300000

400000

500000

600000

700000

800000

900000

0 100 200 300 400 500 600

CY211 CLIA Lnearity

Antigen Concentration (ng/ml)

Val

ue

0 20 40 60 80 100 120 140 160-20

0

20

40

60

80

100

120

140

y = 0.8737x - 5.5226R² = 0.986

CY211 Clinical Correlation

Reagent Value of International Top Brand (ng/ml)

FAPO

N's

Val

ue

(ng/

ml)

y = 1521.8x + 667.51R² = 0.999

GENCAY211N101

Page 8: Raw Material Catalogue for Tumor Markers

It is a thorny issue to detect pancreatic cancer , benign liver and gallbladder

diseases using tumor markers. Receiver operating characteristic (ROC)

curve analysis of tumor markers in pancreatic cancer shows that CA242 has

a sensitivity of 70%-80% when the false positive rate in detection falls

within 10% (the specificity exceeds 90%). It serves as an independent in

dicator that helps clinicians differentiate benign and malignant conditions.

CA242

Recommended Pairing

CA242 Antibody

07 Fapon Biotech Inc.

BECCA242S103

Coating

IgM

BENCA242S101

Coating/Labeling

IgG1

Antibody

Usage

Subtype

Bu�er

Storage Condition

Shelf Life

Purity

BECCA242S102

Coating/Labeling

IgG1

10mM PB + 150mM NaCl + 0.1% Proclin300, pH7.4

-20℃ ± 5℃

3 years

≥ 90%

Catalog No.

BECCA242S103

BECCA242S102

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

Page 9: Raw Material Catalogue for Tumor Markers

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

08Fapon Biotech Inc.

Clinical Correlation

CLIA Linearity

Pairing Antigen

Summary: There is an excellent clinical correlation between Fapon's CA242 and the values of international top brand.

Summary: Fapon's CA242 exhibits excellent linearity, with a linear range of 0.1-500 U/ml and R² of 0.998.

0

20

40

60

80

100

120

0 20 40 60 80 100 120 140 160

CA242 Clinical Correlation

Reagent Value of International Top Brand (U/ml)

FAPO

N's

Val

ue (

U/m

l)

-100000

0

100000

200000

300000

400000

500000

600000

700000

800000

0 200 400 600 800 1000 1200 1400 1600

CA242 CLIA Lnearity

Antigen Concentration (U/ml)

Val

ue

GENCA242N101Native

For immunoassays or calibrators0.9% NaCl + protective protein

-20℃ ± 5℃3 years

Catalog No.Host

UsageBu�er

Storage TemperatureShelf Life

y = 0.6543x + 3.3098R² = 0.949

y = 496.04x - 3461.3R² = 0.998

Page 10: Raw Material Catalogue for Tumor Markers

CA724 Antibody

Recommended Pairing

The positive rate of serum CA724 in patients with gastric cancer is 59%.

The positive rate of combined detection (together with CA199 and CEA) is

greater than 70%. Serum CA724 demonstrates a high specificity for the

diagnosis of malignant lesions, and is rarely detected in normal cells and

benign lesions.

In addition, CA724 exhibits a certain positive detection rate in patients

with colorectal cancer, breast cancer, cholangiocarcinoma, lung cancer

and ovarian cancer. Its positive rate in patients with concomitant distant

metastasis is even higher.

CA724

Catalog No.

BECCA724S107

BEJCA724S105

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

BECCA724S107

Coating

IgG1

BEJCA724S105

Labeling

IgG1

10mM PB + 150mM NaCl + 0.1% Proclin300, pH7.4

-20℃ ± 5℃

3 years

≥ 90%

Antibody

Usage

Subtype

Bu�er

Storage Condition

Shelf Life

Purity

BECCA724S106

Labeling

IgG1

BECCA724S105

Coating

IgG1

09 Fapon Biotech Inc.

Page 11: Raw Material Catalogue for Tumor Markers

CLIA Linearity

Pairing Antigen

Clinical Correlation

0

100000

200000

300000

400000

500000

600000

0 10050 200 300250150 350

CA724 CLIA Linearity

Val

ue

Antigen Concentration (U/ml)

Summary: There is an excellent linear correlation between Fapon's CA724 and the reagent values of international top brand.

Summary: Fapon's CA742 exhibits excellent linearity, with a linear range of 1.2-300 U/ml and R² of 0.999.

0

20

40

60

80

100

120

140

0 50 100 150 200 250 300 350

CA724 Clinical Correlation

Reagent Value of International Top Brand (U/ml)

FAPO

N's

Val

ue (

u/m

l)

GENCA724N101Native

For immunoassays or calibrators0.9% NaCl + protective protein

-20℃ ± 5℃3 years

Catalog No.Host

UsageBu�er

Storage TemperatureShelf Life

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

10Fapon Biotech Inc.

y = 0.3972x + 1.7056R² = 0.957

y = 1768.9x + 166.36R² =0.999

Page 12: Raw Material Catalogue for Tumor Markers

CA153 is mainly present in several types of adenocarcinomas, such as

breast cancer, lung adenocarcinoma, ovarian cancer and pancreatic

cancer. With a low sensitivity, serum CA153 levels rarely exceed 30 kU/L in

early breast cancer, but with progressive breast cancer, 60%~80% cases

have CA153 levels above 30 kU/L. CA153 is highly associated with breast

cancer and can be used to determine breast cancer progression and

metastasis, as well as monitor treatment efficacy and recurrence. Serum

CA153 levels decrease after the effective treatment of breast cancer, and

increase in the event of metastasis or recurrence.

CA153

CA153 Antibody

Recommended Pairing

11 Fapon Biotech Inc.

Catalog No.

BECCA153S103

BEJCA153S105

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

BECCA153S102

Coating

IgG1

BEJCA153S102

Labeling

IgG1

BECCA153S103

Coating

IgG1

BEJCA153S104

Labeling

IgG1

BEJCA153S105

Labeling

IgG1

AntibodyUsage

SubtypeBuffer

Storage ConditionShelf Life

Purity

10mM PB + 150mM NaCl + 0.1% Proclin300, pH7.4

-20℃ ± 5℃

3 years

≥ 90%

Page 13: Raw Material Catalogue for Tumor Markers

Clinical Correlation

Pairing Antigen

CLIA Linearity

Summary: There is a good correlation between Fapon's CA153 and the reagent values of international top brand.

Summary: Fapon's CA153 exhibits excellent linearity, with a linear range of 0.4-200 U/ml and R of 0.998.

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

12Fapon Biotech Inc.

GENCA153N101Native

For immunoassays or calibrators0.9% NaCl + protective protein

-20℃ ± 5℃3 years

Catalog No.Host

UsageBu�er

Storage TemperatureShelf Life

CA153 Clinical Correlation

Reagent Value of International Top Brand (U/ml)

FAPO

N's

Val

ue (U

/ml)

0

500000

1000000

1500000

2000000

2500000

0.0 50.0 100.0 150.0 200.0 250.0

CA153 CLIA Linearity

Antigen Concentration (U/ml)

Val

ue

2

y = 0.8109x + 20.865R2 = 0.879

y = 10158x + 31842R² = 0.998

Page 14: Raw Material Catalogue for Tumor Markers

13 Fapon Biotech Inc.

SCCA Antibody

Recommended Pairing

The squamous cell carcinoma antigen (SCCA) is a tumor marker associated

with various organs. Increased SCCA can be seen in many types of

cancers, including cervical, ovarian, lung (non-small cell lung cancer), skin,

head and neck, gastrointestinal and urinary tract. Because SCCA level

rarely increases at the early stage cancer, thus it is uncommon to use

SCCA for cancer screening. The SCCA elevation is closely related to tumor

malignancy, often indicates cancer deterioration that accompanied by

metastasis, therefore SCCA is used for treatment monitoring and prognostic

evaluation. And specifically, SCCA elevation is detected in 70% advanced

cervical cancers and 90% recurrent cervical cancers.

SCCA

BEJSCCAS101

Labeling

Antibody

Usage

Subtype

Bu�er

Storage Condition

Shelf Life

Purity

BECSCCAS101

CoatingIgG1

10mM PB + 150mM NaCl + 0.1%Proclin300,pH7.4

-20℃ ± 5℃

3 years

≥ 90%

Catalog No.

BECSCCAS101

BEJSCCAS101

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

Page 15: Raw Material Catalogue for Tumor Markers

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

14Fapon Biotech Inc.

Clinical Correlation

CLIA Linearity

Summary: There is a good correlation between Fapon's SCCA and the reagent values of international top brand.

Summary: Fapon's SCCA exhibits excellent linearity, with a linear range of 0.4-500 ng/ml and R² of 0.999.

0

2

4

6

8

10

12

14

0 5 10 15 20 25 30 35

SCCA Clinical Correlation

Reagent Value of International Top Brand (ng/ml)

FAPO

N's

Val

ue (

ng/m

l)

-1000000

0

1000000

2000000

3000000

4000000

5000000

6000000

0 100 200 300 400 500 600

SCCA CLIA Linearity

Antigen Concentration (ng/ml)

Val

ue

y = 11133x - 35780R² = 0.999

y = 0.2801x + 3.3758R2 = 0.968

Page 16: Raw Material Catalogue for Tumor Markers

PGI Antibody

Recommended Pairing

PGI/IIPepsinogen (PG) is a precursor of pepsin that reflects the number of chief

cells. PG is classified into two types, knowing as PGI and PGII. Gastric

mucosal lesions affect PG-secreting cells and result in the change of PG

levels in serum. PGI levels elevate when gastric acid secretion increases

and reduce when gastric acid secretion decreases or gastric corpus

atrophy progresses. Therefore, PGI serves as an indicator for the detection

of gastrin cell functions.

PGII levels are associated with gastric mucosal lesions. Elevated PGII levels

may indicate fundic gland atrophy, glandular epithelium metaplasia and

dysplasia. PGI secretion and PGI/PGII levels decrease in patients with

intestinal metaplasia, atypical hyperplasia and gastric cancer. Therefore,

serum PGI/PGII levels are effective markers for the early diagnosis of

gastric cancer.

15 Fapon Biotech Inc.

Catalog No.

BECPGIS101

BEJPGIS101

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

BEJPGIS101

Labeling

IgG1

Antibody

Usage

Subtype

Bu�er

Storage Condition

Shelf Life

Purity

BECPGIS101

Coating

IgG1

10mM PB + 150mM NaCl + 0.1% Proclin300, pH6.0

-20℃ ± 5℃

3 years

≥ 90%

Page 17: Raw Material Catalogue for Tumor Markers

y = 1.0027x - 3.6671R² = 0.966

-50

0

50

100

150

200

0 20 40 60 80 100 120 140 160

FAPO

N's

Val

ue (n

g/m

l)

Raw Material Value of International Top Brand (ng/ml)

PGI Clinical Correlation

Clinical Correlation

0

20

40

60

80

100

120

140

160

180

0 50 100 150 200 250

FAPO

N's

Val

ue (n

g/m

l)

PGI Clinical Correlation

Reagent Value of International Top Brand (ng/ml)

Summary: There is an excellent correlation between Fapon's PGI and the raw material values of international top brand.

Summary: There is an excellent correlation between Fapon's pairing values and the reagent values of international top brand.

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

16Fapon Biotech Inc.

y = 0.7763x + 4.7998R² = 0.963

Page 18: Raw Material Catalogue for Tumor Markers

CLIA Linearity

-500000

0

500000

1000000

1500000

2000000

2500000

0 50 100 150 200 250

Val

ue

Antigen Concentration (ng/ml)

PGI CLIA Linearity

Summary: Fapon's PGI exhibits excellent linearity, with a linear range of 1-200 ng/ml and R² of 0.998.

17 Fapon Biotech Inc.

y = 11752x - 21827R² = 0.998

Page 19: Raw Material Catalogue for Tumor Markers

Clinical Correlation

PGII Antibody

Recommended Pairing

0

10

20

30

40

50

60

70

0 10 20 30 40 50 60 70

FAPO

N's

Val

ue (n

g/m

l)

Raw Material Value of International Top Brand (ng/ml)

PGII Clinical Correlation

Summary: There is an excellent correlation between Fapon's pairing values and the raw material values of international top brand.

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

18Fapon Biotech Inc.

Catalog No.

BECPGIIS102

BEJPGIIS102

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

y = 1.0102x + 0.6362R² = 0.995

BECPGIIS101

Coating

IgG1

10mM PB + 150mM NaCl + 0.1%Proclin300,pH7.4

Antibody

Usage

Subtype

Bu�er

Storage Condition

Shelf Life

Purity

BECPGIIS102

Coating

IgG1

10mM PB + 150mM NaCl + 0.1% Proclin300, pH7.4

-20℃ ± 5℃

3 years

≥ 90%

BEJPGIIS102

Labeling

IgG1

10mM PB + 150mM NaCl + 0.1% Proclin300, pH6.0

Page 20: Raw Material Catalogue for Tumor Markers

-100000

0

100000

200000

300000

400000

500000

600000

0 20 40 60 80 100 120

Val

ue

Antigen Concentration (ng/ml)

PGII CLIA Linearity

0

10

20

30

40

50

60

70

0 10 20 30 40 50 60

PGII Clinical Correlation

FAPO

N's

Val

ue (n

g/m

L)

Reagent Value of International Top Brand (ng/ml)

CLIA Linearity

Summary: There is an excellent correlation between Fapon's pairing values and the reagent values of international top brand.

Summary: Fapon's PGII exhibits excellent linearity, with a linear range of 1-100 ng/ml and R² of 0.999.

19 Fapon Biotech Inc.

y = 1.043x + 0.6835R² = 0.976

y = 5577.9x +1385.6R² = 0.999

Page 21: Raw Material Catalogue for Tumor Markers

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

20Fapon Biotech Inc.

CA125 Antibody

Recommended Pairing

The antigenic determinant of CA125 is associated with a large molecular

weight glycoprotein of the ovarian cavity epithelium during embryonic

development. CA125 can be used to detect common non-mucinous

epithelial ovarian cancers, but it may not be helpful in the detection of

endometrial carcinoma and clear cell carcinoma.

CA125

Catalog No.

BECCA125S105

BENCA125S101

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

BECCA125S105

Coating

IgG2a

BECCA125S108

Coating

IgG1

Antibody

Usage

Subtype

Bu�er

Storage Condition

Shelf Life

Purity

BENCA125S101

Labeling

IgG1

BECCA125S104

Coating

IgG1

10mM PB + 150mM NaCl + 0.1% Proclin300, pH7.4

-20℃ ± 5℃

3 years

≥ 90%

Page 22: Raw Material Catalogue for Tumor Markers

0

50

100

150

200

250

300

0 50 100 150 200 250 300

CA125 Clinical CorrelationFA

PON

's V

alue

(u/m

l)

Reagent Value of International Top Brand (U/ml)

0200000400000600000800000

100000012000001400000160000018000002000000

0 1000 2000 3000 4000 5000 6000

CA125 CLIA Linearity

Antigen Concentration (U/ml)

Val

ue

Pairing Antigen

Clinical Correlation

CLIA Linearity

Summary: There is a good linear correlation between Fapon's CA125 and the reagent values of international top brand.

Summary: Fapon's CA125 exhibits excellent linearity with a linear range of 2-5000 U/ml and R² of 0.993.

21 Fapon Biotech Inc.

GENCA125N101Native

For immunoassays or calibrators0.9% NaCl + protective protein

-20℃ ± 5℃3 years

Catalog No.Host

UsageBu�er

Storage TemperatureShelf Life

y = 371.87x + 17668R² = 0.993

y = 1.012x - 16.309R² = 0.920

Page 23: Raw Material Catalogue for Tumor Markers

CA199 Antibody

Recommended Pairing

CA199 is a tumor marker in colorectal cancer and pancreatic cancer. The

quantitative detection and auxiliary monitoring of serum CA199 levels in

patients with pancreatic cancer have been approved by the FDA. CA199

aids the post-operative monitoring of pancreatic cancer and colorectal

cancer. Elevated CA199 levels indicate tumor recurrence, which can be

detected 1-7 months earlier than ultrasound and clinical diagnosis. Therefore,

CA199 serves as an important indicator that reflects the prognosis of

patients and determine whether they have relapsed after surgery.

CA199

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

22Fapon Biotech Inc.

BECCA199S103

Coating

IgM

10mM PB + 150mM NaCl + 0.1% Proclin300, pH7.4

-20℃ ± 5℃

3 years

≥ 90%

Antibody

Usage

Subtype

Bu�er

Storage Condition

Shelf Life

Purity

BECCA199S104

Coating

IgG1

BECCA199S104

Labeling

IgG1

Catalog No.

BECCA199S104

BECCA199S104

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

Catalog No.

BECCA199S104

BECCA199S103

Recommended Usage

Labeling

Coating

Application Platform

ELISA/CLIA

Page 24: Raw Material Catalogue for Tumor Markers

-1000

0

1000

2000

3000

4000

5000

0 1000 2000 3000 4000 5000

CA199 Clinical CorrelationFA

PON

's V

alue

(U/m

L)

Reagent Value of International Top Brand (U/mL)

CLIA Linearity

Clinical Correlation

Summary: There is a good linear correlation between Fapon's CA199 and the reagent values of international top brand.

Summary: Fapon's CA199 exhibits excellent linearity, with a linear range of 1.2-5000 U/ml and R² of 0.999.

23 Fapon Biotech Inc.

y = 0.9925x + 20.182R² = 0.878

GENCA199N101Native

For immunoassays or calibrators0.9% NaCl + protective protein

-20℃ ± 5℃3 years

Catalog No.Host

UsageBu�er

Storage TemperatureShelf Life

Pairing Antigen

CA199 CLIA Linearity

Antigen Concentration (U/ml)

Val

ue

y = 386.96x + 1184.1R² = 0.999

0

500000

1000000

1500000

2000000

2500000

0 1000 2000 3000 4000 5000 6000

Page 25: Raw Material Catalogue for Tumor Markers

Studies have found that HE4 sensitivity to early ovarian cancer can reach

as high as 45.9% at 95% specificity compared with benign diseases. HE4

levels decrease after ovarian cancer surgery and increase as early as 30

weeks before clinical recurrence. HE4 levels are highly associated with

disease progression in ovarian cancer patients. Therefore, HE4 serves as

an important indicator for the post-operative follow-ups on ovarian

malignant tumors as well as a sensitive indicator for the monitoring of

early recurrence.

HE4

HE4 Antibody

Recommended Pairing

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

24Fapon Biotech Inc.

Catalog No.

BECHE4S102

BEJHE4S102

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

BEJHE4S102

Labeling

IgG1

Antibody

Usage

Subtype

Bu�er

Storage Condition

Shelf Life

Purity

BECHE4S102

Coating

IgG2a

10mM PB + 150mM NaCl + 0.1% Proclin300, pH7.4

-20℃ ± 5℃

3 years

≥ 90%

Page 26: Raw Material Catalogue for Tumor Markers

CLIA Linearity

Clinical Correlation

0

50000

100000

150000

200000

250000

0 500 1000 1500 2000

CLIA Linearity of HE4

Valu

e

Antigen Concentration (pmol/L)

Summary: There is a good linear correlation between Fapon's HE4 and the reagent values of international top brand.

Summary: Fapon's HE4 exhibits excellent linearity, with a linear range of 15-1500 pmol/l and R² of 0.993.

25 Fapon Biotech Inc.

0

200

400

600

800

1000

1200

1400

1600

0 500 1000 1500

HE4 Clinical Correlation

Reagent Value of International Top Brand (pmol/L)

FAPO

N's

Valu

e (p

mol

/l)

y = 1.0087x - 1.6807R² = 0.981

y = 137.91x + 5716.4R² = 0.993

Page 27: Raw Material Catalogue for Tumor Markers

Pairing Antigen

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

26Fapon Biotech Inc.

For immunoassays or calibrators20mM PB + protective protein, pH7.4

11 kD6.03

-20℃ ± 5℃3 years

E.coliCatalog No.

HostUsageBu�er

Molecular WeightIsoelectric Point

Storage TemperatureShelf Life

GENHE4N101

Page 28: Raw Material Catalogue for Tumor Markers

CA50 is a tumor marker for pancreatic cancer and colorectal cancer. The

normal reference levels of serum CA50 vary with different measurement

methods and usually fall within the range of 14-20 kU/L. Elevated CA50

levels are indicative of benign pancreatic diseases (12%-46%),

cholangiopathies (35%-38%), and liver diseases (22%-59%). CA50 has a

positive rate of 80%-97% in the diagnosis of pancreatic cancer. Its positive

rate in the diagnosis of rectal cancer varies according to the severity of the

disease: Dukes' A19%-43%, B30%-59%, C53%-73%, D53%-73%. The

positive rate of elevated CA50 levels also varies according to the type of 40

gastric cancer, 58%-70% in cholangiocarcinoma, and 14%-78% in liver

cancer. The positive rate of elevated CA levels is lower in patients with

other malignant tumors (including breast cancer, lung cancer, kidney

cancer, prostate cancer, bladder cancer, ovarian cancer, etc.).

CA50

CA50 Antibody

Recommended Pairing

27 Fapon Biotech Inc.

Catalog No.

BENCA50S101

BENCA50S101

Recommended Usage

Coating/Labeling

Application Platform

ELISA/CLIA

BENCA50S101Antibody

Usage

Subtype

Bu�er

Storage Condition

Shelf Life

Purity

BENCA50S101

Coating/Labeling

IgM

10mM PB + 150mM NaCl + 0.08%NaN3, pH7.4

-20℃ ± 5℃

3 years

≥ 90%

Page 29: Raw Material Catalogue for Tumor Markers

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

28Fapon Biotech Inc.

Pairing Antigen

CLIA Linearity

0

200000

400000

600000

800000

1000000

1200000

1400000

1600000

1800000

0 50 100 150 200 250

CA50 CLIA Linearity

Valu

e

Antigen Concentration (U/ml)

Summary: Fapon's CA50 exhibits excellent linearity, with a linear range of 0.37-273.3 U/ml and R² of 0.997.

y = 7725.4x + 3923.6R² = 0.997

GENCA50N101

Native

For immunoassays or calibrators

0.9% NaCl + protective protein

-20℃ ± 5℃

3 years

Catalog No.

Host

Usage

Bu�er

Storage Temperature

Shelf Life

Page 30: Raw Material Catalogue for Tumor Markers

By radioimmunoassay, the positive rate of serum AFP in patients with

primary liver cancer ranges is between 60%-85%. High incidences of liver

cancer have been proven to occur in case of serum AFP concentration

> 200 ug/L, which persists for more than 8 weeks, or when serum AFP

concentration reaches 300-500 ug/L, which persists for 2-4 weeks or even

goes higher after the medical reexamination. Changes in AFP levels in

primary liver cancer should be observed after surgery or chemotherapy. In

general, AFP should return to normal levels within 2 months. If the AFP

level rises again following a decrease, it may indicate incomplete treatment

or recurrence. If the AFP level remains high, fluctuates or increases after

treatment, it indicates a worsening condition and a poor prognosis.

AFP

AFP Antibody

Recommended Pairing

29 Fapon Biotech Inc.

Catalog No.

BECAFPS102

BECAFPS107

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

10mM PB + 150mM NaCl + 0.1% Proclin300, pH7.4

-20℃ ± 5℃

3 years≥90%

AntibodyUsage

SubtypeBuffer

Storage Condition

Shelf LifePurity

BECAFPS101

Labeling

IgG1

BECAFPS103

Labeling

IgG1

BECAFPS104

Coating

IgG1

BECAFPS102

Coating

IgG1

BECAFPS107

Labeling

IgG1

BECAFPS105

Labeling

IgG1

BECAFPS106

Labeling

IgG1

Page 31: Raw Material Catalogue for Tumor Markers

Clinical Correlation

0

200

400

600

800

1000

1200

1400

1600

0 200 400 600 800 1000 1200 1400

FAPO

N's

Valu

e (n

g/m

l)

Reagent Value of International Top Brand (ng/ml)

AFP Clinical Correlation

CLIA Linearity

0

1000000

2000000

3000000

4000000

5000000

6000000

7000000

0 200 400 600 800 1000 1200 1400

AFP CLIA Linearity

Valu

e

Antigen Concentration (ng/ml)

Pairing Antigen

Summary: There is an excellent linear correlation between Fapon's AFP and the reagent values of international top brand.

Summary: FAPON's AFP exhibits excellent linearity, with a linear range of 0.484-1210 ng/ml and R² of 0.991.

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

30Fapon Biotech Inc.

GENAFPN101Native

For immunoassays or calibrators0.9% NaCl + protective protein

-20℃ ± 5℃3 years

Catalog No.Host

UsageBu�er

Storage TemperatureShelf Life

y = 0.944x + 24.835R² = 0.953

y = 4895.5x + 69253R² = 0.991

Page 32: Raw Material Catalogue for Tumor Markers

CEA Antibody

Recommended Pairing

CEASerum CEA has a high positive rate in the detection of digestive tract

malignancies such as colon cancer, rectal cancer, gastric cancer, esophageal

cancer, gallbladder cancer and pancreatic cancer. The maximum detection

rate of colorectal cancer is 74%, while the average range is between

50%-66%. Serum CEA levels may also rise in patients with certain non-digestive

tumors such as lung cancer, breast cancer, ovarian cancer and prostate

cancer.

31 Fapon Biotech Inc.

Catalog No.

BECCEAS103

BENCEAS103

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

BECCEAS102

Coating

IgG1

BENCEAS101

Labeling

IgG1

BECCEAS101

Coating

IgG1

BENCEAS103

Labeling

IgG1

BECCEAS103

Coating

IgG1

AntibodyUsage

SubtypeBuffer

Storage ConditionShelf Life

Purity

10mM PB + 150mM NaCl + 0.1% Proclin300, pH7.4

-20℃ ± 5℃

3 years

≥ 90%

Page 33: Raw Material Catalogue for Tumor Markers

Clinical Correlation

0

200

400

600

800

1000

1200

1400

1600

0 500 1000 1500 2000

CEA Clinical Correlation

FAPO

N's

Valu

e (n

g/m

l)

Reagent Value of International Top Brand (ng/ml)

CLIA Linearity

0

100000

200000

300000

400000

500000

600000

700000

0 200 400 600 800 1000 1200

Antigen Concentration (ng/ml)

CEA CLIA Linearity

Valu

e

Summary: There is an excellent linear correlation between Fapon's CEA and the reagent values of international top brand.

Summary: Fapon's CEA exhibits excellent linearity, with a linear range of 0.4-1000 ng/ml and R² of 0.999.

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

32Fapon Biotech Inc.

y = 636.72x + 1608.8R² = 0.999

y = 0.7275x + 19.505R² = 0.959

Page 34: Raw Material Catalogue for Tumor Markers

Pairing Antigen

33 Fapon Biotech Inc.

GENCEAN101

Native

For immunoassays or calibrators

0.9% NaCl + protective protein

-20℃ ± 5℃

3 years

Catalog No.

Host

Usage

Bu�er

Storage Temperature

Shelf Life

Page 35: Raw Material Catalogue for Tumor Markers

PSAMore than 85% of patients with prostate cancer have elevated blood levels

of PSA. However, elevated PSA levels may also indicate benign prostate

conditions. It can be used in conjunction with other tests to determine early

prostate cancer. The serum PSA levels should be halved within 2-3 days

after prostate cancer surgical treatment. If no significant decrease is

observed after one week, residual cancer tissue may still be present. If

post-operative levels increase rather than decrease, the patient may suffer

from distant metastasis, in particular, bone metastasis, as well as a poor

prognosis.

PSA Antibody

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

34Fapon Biotech Inc.

BECPSAS103

Coating

IgG1

BECPSAS101

Coating

IgG1

BECPSAS102

Coating

IgG1

BENPSAN101

Labeling

IgG1

BENPSAN102

Labeling

IgG1

AntibodyUsage

SubtypeBuffer

Storage ConditionShelf Life

Purity

10mM PB + 150mM NaCl + 0.1% Proclin300, pH7.4

-20℃ ± 5℃

3 years

≥ 90%

Page 36: Raw Material Catalogue for Tumor Markers

-200

0

200

400

600

800

1000

1200

1400

0 100 200 300 400 500 600 700

Reagent Value of International Top Brand (ng/ml)

FAPO

N's

Valu

e (n

g/m

l)

PSA Clinical Correlation

Recommended Pairing

Clinical Correlation

CLIA Linearity

-500000

0

500000

1000000

1500000

2000000

2500000

3000000

3500000

4000000

0 20 40 60 80 100 120

PSA CLIA Linearity

Valu

e

Antigen Concentration (ng/ml)

Summary: There is an excellent linear correlation between Fapon's PSA and the reagent values of international top brand.

Summary: Fapon's PSA exhibits excellent linearity, with a linear range of 0.1-100 ng/ml and R² of 0.999.

35 Fapon Biotech Inc.

Catalog No.

BECPSAS103

BENPSAN101

Recommended Usage

Coating

Labeling

Application Platform

ELISA/CLIA

y = 34027x - 436.44R² = 0.999

y = 2.0146x - 11.882R² = 0.969

Page 37: Raw Material Catalogue for Tumor Markers

Fapon Biotech Inc.No.5 Hualian RD, Taiwan High-tech Industrial Park, Songshan Lake, Guangdong, 523808 China

+86-769-22898886

[email protected]

+86-769-22898886-8800

RMTM-INMK-201910 LinkedIn: faponbiotech