d-dimer - medixbiochemica · 2017-07-21 · d-dimers are fragments of fibrin that form when blood...

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ANTIBODIES D-DIMER Klovinpellontie 3, FI-02180 Espoo, Finland [email protected] www.medixbiochemica.com Copyright © 02/2017 Medix Biochemica. All rights reserved. Actim and MedixMAB are trademarks or registered trademarks of Medix Biochemica. Medix Biochemica reserves the right to make changes and improvements to any of the products described in this document without prior notice. www.medixbiochemica.com FIGURE 3. Medix Biochemica’s D-dimer antibodies are suitable for sandwich ELISA detection of D-dimer in patient samples. The patient samples, of varying D-dimer concentrations, were analyzed using clones 1405, 1402, and 1403 of Medix Biochemica’s monoclonal antibodies. Standard ELISA conditions that were not specifically optimized for any of the antibodies were applied, which bring variance into the results in samples containing lower D-dimer concentrations. The D-dimer concentrations had been measured earlier utilizing a Siemens Innovance® D-Dimer test. References: 1. Pulivarthi S, Gurram MK. Effectiveness of D-Dimer as a Screening Test for Venous Thromboembolism: An Update. N Am J Med Sci. 2014; 6:491–499. 2. Olson JD, Cunningham MT, Higgins RA, Eby CS, Brandt JT. Arch Pathol Lab Med. 2013;137:1030–38. 3. Jacobs B, Obi A, Wakefield T. Diagnostic biomarkers in venous thromboembolic disease. J Vasc Surg Venous Lymphat Disord. 2016;4:508–17. 4. Soomro AY, Guerchicoff A, Nichols DJ, Suleman J, Dangas GD. The current role and future prospects of D-dimer biomarker. Eur Heart J Cardiovasc Pharmacother. 2016;2:175–84. 5. Walker JB & Nesheim ME. The molecular weights, mass distribution, chain composition, and structure of soluble fibrin degradation products released from a fibrin clot perfused with plasmin. J Biol Chem. 1999;274:5201–12. 6. Bio-rad. Clinical Diagnostics. Coagulation Quality Controls: Liquichek™ D-Dimer Quality Control. Available at: http://www.bio-rad.com/en-cn/product/liquichek-d- dimer-quality-control (Accessed 10/2016). Medix Biochemica has over 30 years of experience in developing and producing premium-quality monoclonal antibodies for a variety of markers. The company’s extensive antibody selection is manufactured using optimized, serum and protein free, industrial-scale in vitro production methods. Fully characterized and purified antibodies ensure optimal batch-to- batch consistency. Combined with flexibility and expert customer service, these qualities have made Medix Biochemica one of the most important antibody suppliers for the IVD community. Patient sample (390 ng/ml) Patient sample (810 ng/ml) Patient sample (890 ng/ml) 300 000 250 000 200 000 150 000 100 000 50 000 0 1405 + Biotinylated 1402 Signal (CPS) Patient sample (390 ng/ml) Patient sample (810 ng/ml) Patient sample (890 ng/ml) 80 000 70 000 60 000 50 000 40 000 30 000 20 000 10 000 0 1405 + Biotinylated 1403 Signal (CPS) MedixMAB monoclonal antibodies - pure, reliable, and consistent.

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Page 1: D-DIMER - Medixbiochemica · 2017-07-21 · D-dimers are fragments of fibrin that form when blood clots are degraded by plasmin. Under normal conditions, D-dimers are not present

ANTIBODIES

D-DIMER

Klovinpellontie 3, FI-02180 Espoo, [email protected]

Copyright © 02/2017 Medix Biochemica. All rights reserved. Actim and MedixMAB are trademarks or registered trademarks of Medix Biochemica. Medix Biochemica reserves the right to make changes and improvements to any of the products described in this document without prior notice.

www.medixbiochemica.com

FIGURE 3. Medix Biochemica’s D-dimer antibodies are suitable for sandwich ELISA detection of D-dimer in patient samples. The patient samples, of varying D-dimer concentrations, were analyzed using clones 1405, 1402, and 1403 of Medix Biochemica’s monoclonal antibodies. Standard ELISA conditions that were not specifically optimized for any of the antibodies were applied, which bring variance into the results in samples containing lower D-dimer concentrations. The D-dimer concentrations had been measured earlier utilizing a Siemens Innovance® D-Dimer test.

References:1. Pulivarthi S, Gurram MK. Effectiveness of D-Dimer as a Screening Test for Venous

Thromboembolism: An Update. N Am J Med Sci. 2014; 6:491–499.

2. Olson JD, Cunningham MT, Higgins RA, Eby CS, Brandt JT. Arch Pathol Lab Med.

2013;137:1030–38.

3. Jacobs B, Obi A, Wakefield T. Diagnostic biomarkers in venous thromboembolic

disease. J Vasc Surg Venous Lymphat Disord. 2016;4:508–17.

4. Soomro AY, Guerchicoff A, Nichols DJ, Suleman J, Dangas GD. The current role

and future prospects of D-dimer biomarker. Eur Heart J Cardiovasc Pharmacother.

2016;2:175–84.

5. Walker JB & Nesheim ME. The molecular weights, mass distribution, chain

composition, and structure of soluble fibrin degradation products released from a

fibrin clot perfused with plasmin. J Biol Chem. 1999;274:5201–12.

6. Bio-rad. Clinical Diagnostics. Coagulation Quality Controls: Liquichek™ D-Dimer

Quality Control. Available at: http://www.bio-rad.com/en-cn/product/liquichek-d-

dimer-quality-control (Accessed 10/2016).

Medix Biochemica has over 30 years of experience in developing and producing premium-quality monoclonal antibodies for a variety of markers. The company’s extensive antibody selection is manufactured using optimized, serum and protein free, industrial-scale in vitro production methods. Fully characterized and purified antibodies ensure optimal batch-to-batch consistency. Combined with flexibility and expert customer service, these qualities have made Medix Biochemica one of the most important antibody suppliers for the IVD community.

Patient sample(390 ng/ml)

Patient sample(810 ng/ml)

Patient sample(890 ng/ml)

300 000

250 000

200 000

150 000

100 000

50 000

0

1405 + Biotinylated 1402

Sign

al (

CPS)

Patient sample(390 ng/ml)

Patient sample(810 ng/ml)

Patient sample(890 ng/ml)

80 000

70 000

60 000

50 000

40 000

30 000

20 000

10 000

0

1405 + Biotinylated 1403

Sign

al (

CPS)

MedixMAB monoclonal antibodies - pure, reliable,

and consistent.

Page 2: D-DIMER - Medixbiochemica · 2017-07-21 · D-dimers are fragments of fibrin that form when blood clots are degraded by plasmin. Under normal conditions, D-dimers are not present

D-dimers are fragments of fibrin that form when blood clots are degraded by plasmin. Under normal conditions, D-dimers are not present in the plasma, but their blood concentration increases in many pathological conditions, such as thrombosis, malignancies, and severe inflammation.

In clinical diagnostics, D-dimer testing is used as a sensitive method for ruling out pulmonary embolism (PE) and deep venous thrombosis (DVT). Furthermore, D-dimer testing helps in the diagnosis of disseminated intravascular coagulation (DIC), as well as in monitoring patients during and after anticoagulant treatment for recurrent DVT.

Medix Biochemica provides high-quality MedixMAB monoclonal IgG antibodies with versatile specificities for the reliable detection of D-dimer in blood or plasma samples.

D-DIMER ANTIBODIES

TABLE 1. Medix Biochemica’s product portfolio includes 7 different mouse monoclonal antibodies* against human D-dimer.

D-dimer antibody Product code Subclass

1401 100204 IgG3

1402 100205 IgG2b

1403 100228 IgG2a

1404 100479 IgG1

1405 100480 IgG1

1406 100481 IgG1

1407 100482 IgG1

*) All antibodies are offered in the concentration of 5 mg/ml.

“Monoclonal antibodies that support reliable diagnosis of

pulmonary embolism, venous thromboembolism, and

disseminated intravascular coagulation”

Versatile detection of fibrin degradation products and fibrinogenMedix Biochemica’s monoclonal D-dimer antibodies have been designed to have varying specificities towards fibrinogen and fibrin degradation products (FDPs) (Table 2).

TABLE 2. Medix Biochemica’s monoclonal D-dimer antibodies bind to fibrin degradation products (FDP-D, FDP-X, and FDP-Y) and fibrinogen with differing specificities. The molecular configuration of the fragments has been described in Walker & Nesheim, 1999.

D-dimer antibody FDP-E FDP-D FDP-X FDP-Y Fibrinogen

1401 – – – + –

1402 – + + + +

1403 – + + + +

1404 – + – – –

1405 – + – – –

1406 – + + + –

1407 – + + + –

Suitable for detection of D-dimer in clinical samples using sandwich ELISAThe pairing properties of MedixMAB D-dimer antibodies have been extensively tested and proven suitable for sandwich ELISA applications. For highly specific and sensitive D-dimer detection, the recommended antibody pair is:

• Clone 1405 (capture) and 1402 or 1403 (label)

FIGURE 1. Medix Biochemica D-dimer antibodies are suitable for sandwich ELISA applications. D-dimer monoclonal antibodies were tested in sandwich ELISA using Bio-Rad Liquichek™ D-Dimer Quality Control materials. The 100% level equals to 3200 D-dimer ng/ml (Fibrinogen Equivalent Units; FEU). The combination of clones 1405 (capture) and 1403 (label; biotinylated, detection using Eu-labeled streptavidin) resulted in the least amount of non-specific binding combined with high detection sensitivity.

FIGURE 2. Sandwich ELISA standard curves for anti-D-dimer antibodies 1405 (capture) and 1402 or 1403 (label).

THE BINDING PROPERTIES OF MEDIXMAB D-DIMER ANTIBODIES AGAINST DIFFERENT FDP’S

• Antibodies 1404 and 1405 bind only to the D-dimer monomer

(FDP-D; ~94 kDa) of these FDP’s tested.

• Antibodies 1406 and 1407 strongly bind to the D-dimer monomer

(FDP-D), as well as to two other fibrin degradation products FDP-X

(~240 kDa) and FDP-Y (~175 kDa).

• Clones 1402 and 1403 bind to fibrinogen in addition to fibrin

degradation products. These antibodies can be used as a label

antibody in D-dimer assays together with a capture antibody that

does not recognize fibrinogen.

• None of the D-dimer antibodies binds to the smallest fibrin

degradation product FDP-E (~50 kDa).

1401+Biot.1403

Buffer

BioRad D-Dimer Liquidcheck Level 1= 550 ng/ml

BioRad D-Dimer Liquidcheck Level 2= 1600 ng/ml

BioRad D-Dimer Liquidcheck Level 3= 3200 ng/ml

1404+Biot.1403

1405+Biot.1403

1406+Biot.1403

1407+Biot.1403

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

1 10 100 1000 10 000

1405 + Biotinylated 1402

1405 + Biotinylated 1403

1000 000

100 000

10 000

1000

Log D-dimer concentration (ng/ml)

Log

Sign

al (

CPS)