10
YOUR GOOD PARTNER ON IVD RAW MATERIALS YOUR GOOD PARTNER ON IVD RAW MATERIALS CUSAg IVD RAW MATERIALS WUHAN HUAMEI BIOTECH CO.,LTD ADDR: No.818 Gaoxin Avenue, Wuhan Hi-tech Medical Devices Park, Donghu High-tech Development Zone 430206, Wuhan City, Hubei Province, P.R. China. TEL: FAX: +86-27-87196150 EMAIL:[email protected] WEB: www.cusag.org +86-27-87196282 Ext.837/853 CUSAg IVD RAW MATERIALS DIVISION

YOUR GOOD PARTNER ON IVD RAW MATERIALS - cusag.org · are meaningful for assessing risk of coronary artery disease and stroke. Anti-Human Lp-PLA2 Monoclonal Antibodies Seven highly

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: YOUR GOOD PARTNER ON IVD RAW MATERIALS - cusag.org · are meaningful for assessing risk of coronary artery disease and stroke. Anti-Human Lp-PLA2 Monoclonal Antibodies Seven highly

YOUR GOOD PARTNER ON IVD RAW MATERIALS

YOUR GOOD PARTNER ON IVD RAW MATERIALS

C U S A g I V D R A W M A T E R I A L S

WUHAN HUAMEI BIOTECH CO.,LTDADDR: No.818 Gaoxin Avenue, Wuhan Hi-tech Medical Devices Park, Donghu High-tech Development

Zone 430206, Wuhan City, Hubei Province, P.R. China.

TEL: FAX: +86-27-87196150

EMAIL:[email protected] WEB: www.cusag.org

+86-27-87196282 Ext.837/853

CUSAg IVD RAW MATERIALS DIVISION

Page 2: YOUR GOOD PARTNER ON IVD RAW MATERIALS - cusag.org · are meaningful for assessing risk of coronary artery disease and stroke. Anti-Human Lp-PLA2 Monoclonal Antibodies Seven highly

01

Cardiovascular disease is a general term for cardiovascular and cerebrovascular diseases. It refers to ischemic or hemorrhagic diseases of the heart, brain and whole body caused by hyperlipidemia, blood viscosity, atherosclerosis and hypertension. Such as coronary heart disease, heart disease, stroke and so on. Cardiovascular disease is the number one cause of death, accounting for 30%. Detection of cardiovascular markers helps differential diagnosis and prognosis of early and end-stage cardiovascular disease.

Patelet-activating factor acetylhydrolase (Lp-PLA2), which is synthesized and secreted by mature macrophages and lymphocytes, and regulated by inflammatory mediators, has pro-inflammatory and atherogenic effects. Lp-PLA2, as an independent risk factor reflecting atherosclerotic plaque rupture and thrombotic events, is highly accurate and is an accurate risk assessment marker for patients at high risk for acute atherothrombotic recurrence. Biomarkers for diagnosis of cardiovascular diseases, such as myeloperoxidase (MPO), Fatty acid-binding protein (H-FABP) and Human

Fibrin/Fibrinogen degradation(FDP), play an important role in the diagnosis and risk assessment of heart disease, efficacy observation, prognosis estimation and other aspects.

CUSAg provides a variety of high-quality diagnostic raw materials related to cardiovascular diseases, including Lp-PLA2, MPO, H-FABP, FDP, etc. They have been validated by multiple platforms, and could be used for R&D of diagnostic kits on CLIA, LFIA and LETIA.

01

02

08

12

15

17

IntroductionCatalogue

Introduction

Lipoprotein-associated phospholipaseA 2 (Lp-PLA2)

Myeloperoxidase(MPO)

Heart-type FattyA cid-Binding Protein (H-FABP)

Fibrin/Fibrinogen degradation products(FDP)

References

Page 3: YOUR GOOD PARTNER ON IVD RAW MATERIALS - cusag.org · are meaningful for assessing risk of coronary artery disease and stroke. Anti-Human Lp-PLA2 Monoclonal Antibodies Seven highly

2 3

Lipoprotein-associated phospholipase A2 (Lp-PLA2)

Lipoprotein-associated phospholipase A2 (Lp-PLA2) also known as platelet-activating factor acetylhydrolase (PAF-AH) is a phospholipase A2 enzyme in humans. Lp-PLA2 is a 45 kDa protein of 441 amino acids encoded by the PLA2G7 gene.

Some recent studies have shown that Lp-PLA2 is an independent risk marker for OLE_LINK7OLE_LINK8cardiovascular diseaseOLE_LINK7OLE_LINK8 (CVD), including coronary heart disease (CHD), and ischemic stroke. In these studies, increased concentrations of Lp-PLA2 were seen in many people who were diagnosed with CHD and ischemic stroke, regardless of other risk factors. These findings make relatively the new

test potentially useful among the growing number of cardiac risk markers used to determine a person's risk of developing CVD.

Lp-PLA2 is specific for vascular inflammation and is a circulating measure of the progression of rupture-prone plaque. Following production by inflammatory cells, this enzyme cleaves oxidized phospholipids, generating pro-inflammatory molecules and oxidized fatty acids. Elevated Lp-PLA2 levels can predict the development of coronary artery disease in apparently healthy individuals and the risk of future adverse cardiac and cerebrovascular events. The Lp-PLA2 tests are meaningful for assessing risk of coronary artery disease and stroke.

◎ Anti-Human Lp-PLA2 Monoclonal AntibodiesSeven highly selective anti-human Lp-PLA2 monoclonal antibodies were recently developed by CUSAg, which make possible the development of highly sensitive and rapid sandwich immunoassays. All recommended MAb combinations were evaluated in medium-scale clinical trials with blood samples from normal and patients with atherosclerosis or cerebral infarction.

Specification

Target species

Host animal

Cell line used for fusion

Immunogen

Purification method, purity

Presentation

Application

Catalog Number

Properties

Human

Mice Balb/c

Sp2/0

Human Lp-PLA2

CSB-DA113BmN① CSB-DA113BmN③

CSB-DA113BmN④ CSB-DA113BmN⑤ CSB-DA113BmN⑥

CSB-DA113BmN⑦ CSB-DA113BmN⑧ CSB-DA113BmN⑨

CSB-DA113BmN②

All MAbs were tested in pairs as capture and detection antibodies to select the best two-site MAb combinations for the development of a quantitative sandwich immunoassay. Calibration curves for several best two-site combinations, which utilized different anti Lp-PLA2 MAbs, are shown in Fig.1. Detection antibodies were labeled with horse reddish peroxidase (HRP). The best selected MAb combinations for the development of quantitative human Lp-PLA2 immunoassays are (capture-detection respectively):

Calibration Curve1

1

1

MAb combination A: CSB-DA113BmN①- CSB-DA113BmN③MAb combination C: CSB-DA113BmN③- CSB-DA113BmN①MAb combination E: CSB-DA113BmN④- CSB-DA113BmN⑤MAb combination F: CSB-DA113BmN⑦- CSB-DA113BmN②

Fig.1 Calibration curve for Lp-PLA2 sandwich chemiluminescence

immunoassay (CLIA)

Fig.2 Calibration curves in particle-enhanced turbidimetric immunoassay

Cardiovascular Disease Cardiovascular Disease

A. CLIA platform

B. LETIA platform

Lp-PLA2 antigens specifically react with anti-human Lp-PLA2 antibodies which were precoated on latex beads, resulting in agglutination and increase in turbidity. The calibration curves were fitted according to the relationship between absorbance values and Lp-PLA2 concentrations (Fig. 2).

Protein G affinity chromatography,>90% (SDS-PAGE)

Mab solution in PBS with 15mM NaN (pH 7.4)3

CLIA,LETIA,LFIA,ELISA and others

MAb combination G: CSB-DA113BmN⑧- CSB-DA113BmN⑨MAb combination H: CSB-DA113BmN⑧- CSB-DA113BmN⑥

Page 4: YOUR GOOD PARTNER ON IVD RAW MATERIALS - cusag.org · are meaningful for assessing risk of coronary artery disease and stroke. Anti-Human Lp-PLA2 Monoclonal Antibodies Seven highly

4 5

81 clinical samples from apparently healthy donors and apparently patients with atherosclerosis or cerebral infarction were detected with the CUSAg CLIA Lp-PLA2 assays using MAb combination A, C, and E, and compared to commercially available ELISA kit. In addition 72 serum samples were imultaneously tested by commercial Lp-PLA2 activity kit and CUSAg CLIA using MAb combination F. As shown in Fig. 3, these results reveal our home-grown MAb combinations can be applied on double-MAb-sandwich-immunoassays.

An amount of samples from donors (n=60) were respectively detected by the high-quality kit (enzymic method) and Lp-PLA2 LETIA. The results revealed good correlation between CUSAg Lp-PLA2 LETIA assays and other comparison kit.

Clinical Comparison12

Cardiovascular Disease Cardiovascular Disease

0 100 200 300 400 500 600

Comparison Assay(ng/mL)

CU

SA

g L

p-pL

A2

MA

b C

ombi

nati

on E

(ng/

mL

)

100

0

200

300

400

500

600

700

Fig.3 Determination of clinical samples on CLIA using CUSAg MAb combinations

A. CLIA platform

B. LETIA platform

C. Thermal Stability

Fig.4 Detection of serum samples by CUSAg Lp-PLA2 LETIA and commercial kit

All the anti-human Lp-PLA2 monoclonal antibodies presented in PBS buffer without any preservative were stored at -20°C, 2-8°C and 37°C for 15 days, respectively. During this period,the titers of six MAbs were determined, respectively. As shown the relative titers

of CSB-DA113BmN① , CSB-DA113BmN③and CSB-DA113BmN⑦ treated at 37°C or

2-8°C were similar with that at -20°C,but the titers of CSB-DA113BmN② , CSB-DA113BmN④ and CSB-DA113BmN⑤ weakly decrease at 37°C.

Serum Lp-PLA2 Activity(IU/L)0

CU

SA

g M

Ab

Com

bina

tion

F(n

g/m

L)

50

0

100

150

200

250

300

350

500 1000 1500 2000

CU

SA

g L

p-pL

A2

MA

b C

ombi

nati

on C

(ng/

mL

)

400

350

300

250

200

150

100

50

00 50 100 150 200 250 300

Comparison Assay(ng/mL)

0 50 100 150 200 250 300

150

250

200

100

50

0

300

CU

SA

g L

p-pL

A2

MA

b C

ombi

nati

on A

(ng/

mL

)

Comparison Assay(ng/mL)

CSB-DA113BmN④ CSB-DA113BmN⑤ CSB-DA113BmN⑦

CSB-DA113BmN① CSB-DA113BmN② CSB-DA113BmN③

Page 5: YOUR GOOD PARTNER ON IVD RAW MATERIALS - cusag.org · are meaningful for assessing risk of coronary artery disease and stroke. Anti-Human Lp-PLA2 Monoclonal Antibodies Seven highly

◎ Anti-Human Lp-PLA2 Polyclonal Antibodies

Anti-human Lp-PLA2 polyclonal antibody was recently developed by CUSAg, which makes possible the development of latex enhanced turbidimetric Immunoassay. Our in-house assays were evaluated in medium-scale clinical trials with blood samples from normal and patients with atherosclerosis or cerebral infarction.

SpecificationProperties

Target species

Host animal

Immunogen

Purification method,Purity

Presentation

Application

Catalog Number

Human

Rabbit

Human Lp-PLA2

Protein G affinity chromatography, >90%(SDS-PAGE)

Mab solution in PBS with 15 mM NaN (pH 7.4)3

LETIA

CSB-DA113BRN

Lp-PLA2 antigens specifically react with anti-human Lp-PLA2 polyclonal antibodies which were precoated on latex beads, the degree of the turbidity caused by the aggregate can be determined turbidimetrically at 570 nm and is proportional to the amount of Lp-PLA2 in the sample. The calibration curve was fitted according to the relationship between absorbance values and Lp-PLA2 concentrations.

Calibration Curve11

Fig.1 Calibration curve for Lp-PLA2 latex enhanced

turbidimetric Immunoassay.

131 clinical samples from apparently healthy donors and apparently patients with atherosclerosis or cerebral infarction were detected with the CUSAg LETIA Lp-PLA2 assays using polyclonal antibody, and compared to commercially available diagnostic kits. As shown in Fig.2, these results reveal our polyclonal antibody can be applied on immunoassays.

12 Clinical Comparison

Fig.2 Determination of clinical samples on CUSAg LETIA platform

A certain amount of excellent Lp-PLA2 protein (Cat: CSB-DP113B) is also offered by CUSAg . It could be used as calibrator in immunoassay.

125

250

500

1000

344

667

1402

2876

326

660

1303

2783

5.2%

1.0%

7.1%

3.2%

◎ Lp-PLA2 Protein

Anti-human Lp-PLA2 polyclonal antibodies presented in PBS buffer without any preservative were stored at 37°C and -20°C for 6 days, respectively. And then the antibodies were prepared into latex reagents and used to detect Lp-PLA2 antigens. Table 1 revealed the detection performance of polyclonal antibodies exposed at 37°C had no significant change compared to that at -20°C. These results showed that the antibody was thermostable.

Thermal Stability13

Table 1. Comparison of detection performances of anti-human Lp-PLA2 polyclonal antibodies at 37°C and-20°C for 6 days

Lp-PLA2Concentration

(ng/mL)

ΔABS(antibodies stored

at -20℃ for 6 days)

ΔABS(antibodies streatedat -37℃ for 6 days)

Relative bias

(%)

6 7

Cardiovascular Disease Cardiovascular Disease

Page 6: YOUR GOOD PARTNER ON IVD RAW MATERIALS - cusag.org · are meaningful for assessing risk of coronary artery disease and stroke. Anti-Human Lp-PLA2 Monoclonal Antibodies Seven highly

Myeloperoxidase(MPO)

Myeloperoxidase (MPO) is a hemoprotein that is abundantly expressed in neutrophils and secreted during their activation. The 150-kDa MPO protein is a cationic homodimer consisting of two covalently bound subunits, each consists of a heavy chain (MW 60kDa) and a light chain (MW 15kDa).

MPO plays an important role in inflammatory response by zapping microorganisms and destroying a variety of target materials through catalyzing chloride ion oxidation to hypochlorous acid in the phagocytic cells. On the other hand, MPO causes oxidative modification of low density lipoprotein (LDL) to a high uptake form that is considered to be a key event in the promotion of atherogenesis. For this reason, MPO is believed to participate in the initiation and progression of cardiovascular diseases. At present, MPO is considered to be one of the most promising cardiovascularmarkers and the rise of MPO levels indicates the increased risk of atherosclerosis and coronary heart disease (CHD).

MPO level can be increased significantly within two hours for chest pain. Hence, MPO is an early warning marker of myocardial infarction and can be earlier to predict the risk of disease t h a n t r o p o n i n T, C K - M B a n d C R P. F o r p a t i e n t s w i t h c h e s t p a i n , MPO is then important and clinically significant in the diagnosis of ACS.

◎ Anti-MPO monoclonal antibodies

Two latest anti-MPO monoclonal antibodies (Catalog Number: CSB-DA406HmN① ,CSB-

DA406HmN②)have been developed by CUSAg. This product is sold for in vitro diagnosis. Anti-MPO monoclonal antibodies have been repeatedly tested in several aspects, such as accuracy, repeatability and stability by immunoturbidimetric assay and chemiluminescent immunoassay. What’s more, multiple clinical samples have been respectively tested by self-made anti-MPO antibodies and two domestic high-quality kits, the results show good correlation between them.

The concentration of human MPO(ng/mL)

ΔA

BS

The concentration of human MPO(ng/mL)

RL

U

8 9

SpecificationProperties

Target species

Host animal

Cell line used for fusion

Immunogen

Purification method, Purity

Presentation

Application

Catalog Number

Human

Mice Balb/c

Sp2/0

Human myeloperoxidase

Protein G affinity chromatography, >90%(SDS-PAGE)

Mab solution in PBS with 15 mM NaN (pH 7.4)3

CLIA,LETIA,ELISA,LFIA

CSB-DA406HmN CSB-DA406HmN① ②

The human MPO protein reacts with the anti-human MPO antibody coated onto latex microspheres, resulting in agglutination and increase in turbidity. The changes in absorbance are then measured using a spectrometer to quantitatively measure the MPO concentration in the samples. As shown in Figure 1, there is a significant linear correlation between the MPO concentration and delta absorbance.

The best two-site MAB combinations have been selected for the quantitative detection of MPO with double monoclonal antibody sandwich method, CSB-DA406HmN① as capture antibodies and CSB-DA406HmN② labeled with horse reddish peroxidase(HRP) as detection antibodies. The calibration curve between MPO concentration and relative light units is fitting by four-

2parameter logistic model.(R =0.9996)

Calibration Curve11

A. Latex Enhanced Turbidimetric Immunoassay(LETIA)

B. Chemiluminescent Immunoassay(CLIA)

Fig.1 The calibration curve for MPO in immunoturbidimetric assay

Fig.2 The calibration curve for MPO chemiluminescent immunoassay

Cardiovascular Disease Cardiovascular Disease

Page 7: YOUR GOOD PARTNER ON IVD RAW MATERIALS - cusag.org · are meaningful for assessing risk of coronary artery disease and stroke. Anti-Human Lp-PLA2 Monoclonal Antibodies Seven highly

A set of MPO calibrators with the concentration of 0,10,20,50,100,250,500,1000

ng/mL was detected on CUSAg LFIA platform using two anti-MPO monoclonal antibodies. The capture antibody was stripped on the nitrocellulose membrane, and the detection antibody was conjugated to colloidal gold. The best selected MAb combination for the development of semi-quantitative human MPO immunoassays is (capture-detection): CSB-DA406HmN② -CSB-DA406HmN①

C. Lateral flow immunoassay (LFIA)

Fig.3 Semi-quantitative detection of MPO protein in colloidal gold immunochromatogragphic assay

0 10 20 50 100 250 500 1000

unit: ng/mL

Anti-MPO monoclonal antibodies were evaluated by immunoturbidimetric assay in medium-scale clinical trials with random blood samples from donates (n=72). Fig.4 shows the comparison of MPO concentrations determined via the self-made antibodies and two high-quality kits (A and B). Results reveal good agreement between CUSAg immunoassays and comparison assays.

Clinical comparison12

A. Latex Enhanced Turbidimetric Immunoassay(LETIA)

com

par

iso

n A

ssay

(ng/

mL

)

CUSAg MPO MAbs(ng/mL)

CUSAg immunoassays and kit A

CUSAg immunoassays and kit B

Fig.4 Comparisons of CUSAg MPO immunoassays and high-quality kits

Samples from donors containing the healthy and patients with myocardial injury were respectively detected using the CLIA MPO assays, A and B. CLIA MPO assays can distinguish healthy donors from patients. What’s more, the results show good correlation between CLIA MPO assays and comparison kits.

B. Chemiluminescent Immunoassay(CLIA)

Fig.5 The comparisons between CLIA MPO and A Fig.6 The comparisons between CLIA MPO and B

com

par

iso

n A

ssay

(ng/

mL

)

CUSAg MPO MAbs(ng/mL)

com

par

iso

n A

ssay

(ng/

mL

)

CUSAg MPO MAbs(ng/mL)

Samples from apparently healthy donors and patients were detected with the CUSAg LFIA MPO assay. As shown in Fig.7, the detection signals of T line were proportional to the concentration of the MPO in the sample tested by commercial kit.

C. Lateral flow immunoassay (LFIA)

Fig.7 Semi-quantitative detection of the concentration of the MPO in the blood samples

55.0 73.4 88.2 164 183.6 196.9 216.2 223.0 238.3

unit: ng/mL

10 11

Cardiovascular Disease Cardiovascular Disease

Page 8: YOUR GOOD PARTNER ON IVD RAW MATERIALS - cusag.org · are meaningful for assessing risk of coronary artery disease and stroke. Anti-Human Lp-PLA2 Monoclonal Antibodies Seven highly

Heart-type Fatty Acid-Binding Protein (H-FABP)

Heart-type Fatty Acid-Binding Protein (H-FABP) is a small cytoplasmic protein (15 kDa) released from cardiac myocytes following an ischemic episode. Like the nine other distinct FABPs that have been identified, H-FABP is involved in active fatty acid metabolism where it transports fatty acids from the cell membrane to mitochondria for oxidation.

H-FABP is a sensitive biomarker for myocardial infarction and can be detected in the blood within one to three hours of the pain. H-FABP is 20 times more specific to cardiac muscle than myoglobin, it is found at 10-fold lower levels in skeletal muscle than heart muscle and the amounts in the kidney, liver and small intestine are even lower again. H-FABP is recommended to be measured with troponin to identify myocardial infarction and acute coronary syndrome in patients presenting with chest pain. H-FABP measured with troponin shows increased sensitivity of 20.6% over troponin at 3–6 hours following the onset of chest pain.

In addition to its diagnostic potential, H-FABP also has prognostic value. Alongside D-dimer, NT-proBNP and peak troponin T, it was the only cardiac biomarker that proved to be a statistically significant predictor of death or MI at one year. This prognostic information was independent of troponin T, ECG and clinical examination. The risk associated with raised H-FABP is dependent upon its concentration.

◎ Anti-Human H-FABP Monoclonal Antibodies Two excellent anti-H-FABP monoclonal antibodies, which were recently produced by CUSAg, make possible the development of highly sensitive sandwich immunoassays. Detection range and sample measurement were characterized with CUSAg in-house H-FABP assay utilizing antibody pair CSB-DA006AmN② and CSB-DA006AmN①.

12 13

10

10

3.96

108.23

0.14

5.16

3.4

4.8

Specification

Target species

Host animal

Cell line used for fusion

Immunogen

Purification method,Purity

Presentation

Application

Catalog Number

Properties

Human

Mice Balb/c

Sp2/0

Human H-FABP

Protein G affinity chromatography, >90%(SDS-PAGE)

Mab solution in PBS with 15 mM NaN (pH 7.4)3

CLIA, LETIA, LFIA etc.

CSB-DA006AmN① CSB-DA006AmN②

CSB-DA006AmN② was coated onto 96-well microplate, and CSB-DA006AmN① was labeled with HRP, 0-250 ng/mL H-FABP were tested on our CLIA platform, as shown in Fig.1, the calibration curve was fitted with four parameters logistic regression.

Calibration Curve11

MAb pair A: CSB-DA006AmN②- CSB-DA006AmN①

Fig.1 Calibration curves for H-FABP in sandwich chemiluminescence immunoassay (CLIA)

A two member buffered protein based panel was assayed, using a single lot of reagents, in replicates of ten at two separate times on CUSAg CLIA platform. As shown in table 2, the system showed excellent precision with CV<5%.

Precision12

Panel n SD %CVMean Con.(ng/L)

Control 1

Control 2

Known concentrations of H-FABP were added to five aliquots of human serum. The concentration of H-FABP was determined using CUSAg CLIA platform and the resulting percent recovery was calculated. The percent recovery of the CUSAg CLIA H-FABP assay using MAb pair A ranged from 100.6% to 103.6% with an average of 102.1%.

Recovery13

Cardiovascular Disease Cardiovascular Disease

RU

L

H-FABP Concentration(ng/mL)

Page 9: YOUR GOOD PARTNER ON IVD RAW MATERIALS - cusag.org · are meaningful for assessing risk of coronary artery disease and stroke. Anti-Human Lp-PLA2 Monoclonal Antibodies Seven highly

14 15

Plasmin is a kind of serine protease. when free from inhibitors, it digests fibrin /fibrinogen.The Products generated from fibrin /fibrinogen decomposition by plasmin are collectively referred to as FDP. FDP is a mixture of peptide fragment, such as X-fragment, Y-fragment, D-fragment, D-Dimer. Their molecular weights depend on the extension of the digestion.

FDP are present in clotting and fibrinolysis activity. Measurement of FDP products may be useful in diagnosing clinical coagulation. In particular, disseminated intravascular coagulation syndrome (DIC), which is known to develop due to severe hyperfibrinolysis or hypercoagulation, is diagnosed and followed-up by measuring the FDP level as one of essential indices.

◎ Anti-Human FDP Monoclonal Antibodies

Two latest anti-FDP monoclonal antibodies have been developed by CUSAg. On the LETIA, multiple clinical samples have been respectively tested by self-made anti-FDP antibody and high-quality kit, the results had good correlation between them . This product can be used for IVD assay development.

Fibrin/Fibrinogen degradation products(FDP)

23 clinical blood samples were separately tested using CUSAg H-FABP antibody pair on the CLIA platform. Data from this study were compared to that of commercial diagnostic kit, the results reveal good agreement between CUSAg immunoassays and comparison assay.

Clinical Comparison14

Fig.2 Clinical comparison of CUSAg H-FABPimmunoassays and commercial diagnostic kit

SpecificationProperties

Target species

Host animal

Cell line used for fusion

Immunogen

Purification method, Purity

Presentation

Application

Catalog Number

Human

Mice Balb/c

Sp2/0

Human FDP

Protein G affinity chromatography, >90%(SDS-PAGE)

Cardiovascular Disease Cardiovascular Disease

A certain amount of excellent H-FABP protein (Catalog Number CSB-DP006A) is also offered, it could be used as calibrator in immunoassay.

◎ H-FABP protein

Mab solution in PBS with 15 mM NaN (pH 7.4)3

ELISA, LETIA and other possible application

CSB-DA444HmN①

CSB-DA444HmN②

Page 10: YOUR GOOD PARTNER ON IVD RAW MATERIALS - cusag.org · are meaningful for assessing risk of coronary artery disease and stroke. Anti-Human Lp-PLA2 Monoclonal Antibodies Seven highly

16 17

参考文献11 Calibration Curve

12

The human FDP reacts with the anti-human FDP antibody-coated latex, resulting in agglutination and increase in turbidity. Turbidity changes are then measured by using a spectrometer to quantitatively measure the FDP concentration in the sample. The linear relationship is shown in Figure 1. There is significant linear correlation between the FDP concentration and absorbance.

Fig.1 Calibration curve for FDP on

CUSAg LETIA platform

Clinical analysis

Fig.2 Comparison between FDP LETIA and diagnostic kit

An amount of samples from donors (n=54) were respectively detected by the high-quality kit and FDP

LETIA.The results revealed good correlation between FDP between CUSAg FDP LETIA assays and other

comparison kits, and the sensitivity reached to 1 µg/mL.

Cardiovascular Disease Cardiovascular Disease

1.Carlquist JF, Muhlestein JB, Anderson JL. Lipoprotein-associated phospholipase A2: a new biomarker for cardiovascular risk assessment and potential therapeutic target. 2007 Sep;7(5):511-7.

2.Davidson MH, Corson MA, et al. Consensus panel recommendation for incorporating lipoprotein-associated phospholipase A2 testing into cardiovascular disease risk assessment guidelines. Am J Cardiol. 2008 Jun 16;101 (12A):51F-57F.

3.F D Kolodgie, et al. Pathologic assessment of the vulnerable human coronary plaque. Heart. 2004 Dec; 90(12): 1385–1391.

4.Carlquist JF, Muhlestein JB, Anderson JL. Lipoprotein-associated phospholipase A2: a new biomarker for cardiovascular risk assessment and potential therapeutic target. Expert Rev Mol Diagn. 2007 Sep: 7(5):511-7.

5.Davidson MH, Corson MA, et al. Consensus panel recommendation for incorporating lipoprotein-associated phospholipase A2 testing into cardiovascular disease risk assessment guidelines. Am J Cardiol. 2008 Jun 16: 101 (12A):51F-57F.

6.F D Kolodgie, et al. Pathologic assessment of the vulnerable human coronary plaque. Heart. 2004 Dec; 90(12): 1385–1391.

7. Tanaka T, Hirota Y, Sohmiya K, Nishimura S,

Kawamura K (Apr 1991). "Serum and urinary human heart fatty acid-binding protein in acute myocardial infarction". Clinical Biochemistry. 24 (2): 195–201.

8. Watanabe K, Wakabayashi H, Veerkamp JH,

O n o T , S u z u k i T ( M a y 1 9 9 3 ) . "Immunohistochemical distribution of heart-type fatty acid-binding protein immunoreactivity in

normal human tissues and in acute myocardial infarct". The Journal of Pathology. 170 (1): 59–65.

9. Glatz JF, van Bilsen M, Paulussen RJ, Veerkamp

JH, van der Vusse GJ, Reneman RS (Jul 1988). "Release of fatty acid-binding protein from isolated rat heart subjected to ischemia and reperfusion or to the calcium paradox". Biochimica et Biophysica Acta. 961 (1): 148–52.

10. McCann CJ, Glover BM, Menown IB, Moore

MJ, McEneny J, Owens CG, Smith B, Sharpe PC, Young IS, Adgey JA (Dec 2008). "Novel biomarkers in early diagnosis of acute myocardial infarction compared with cardiac troponin T". European Heart Journal. 29 (23): 2843–50.

11.Imoto K, Yasumuro Y, Taki M, etal. Clinical significance of a new fibrinogen/fibrin degradation products(FDP) test using plasma samples for the diagnosis of fibrinogenolysis and fibrinolysis [J]. 2001 Mar; 49(3):283-9.

12.Sato N, Takahashi H, Nikuni K,etal. Persistent discrepancy between FDP and D-dimer in a patient with acute leukemia [J]. 1995 Mar; 36(3):212-7.

13.Saito M, Asakura H, Jokaji H, etal. Role of D dimer in patients with elevated fibrinogen degradation products in serum: further study in chronic myelogenous leukemia [J].1990; 84(3):149-55.

ΔA

BS

FDP Concentration(μg/mL)