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redcoon België GENTAUR BVBA

VAT BE0473327336

Av. de l Armee 68 B4

1040 Brussels BELGIUM

  Tel + 32 16 58 90 45 

Fax + 32 16 50 90 45

GENTAUR France SARL

SIRET 48423788800017

Rue Lagrange, 9

75005 Paris, France

 Tel 01 43 25 01 50

Fax 01 43 25 01 60 

GENTAUR Germany

Marienbongard 20

52074 Aachen, Germany

Tel  0241 56 00 99 68                   

Fax 0241 56 00 47 88 

GENTAUR Pol Sp. Z.o.o.

Ulica Ogarna 15/19B m2

80-826 GDANSK

Tel 00 48 58 760 77 08

Fax: 00 32 16 50 90 45

GENTAUR Italy

23015 Milano, Italy

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Fax 02 36 00 65 94

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OUR SUPPLIERS

KOMABIOTECH
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Sacace Biotechnologies S.r.l.
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22100 Como Italy

Spherotech, Inc.
27845 Irma Lee Circle, Unit 101
Lake Forest, IL 60045

Exalpha Biologicals, Inc.
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Shirley, MA 01464

SCETI K.K
BIOSCIENCE
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EY Laboratories, Inc. Headquarters
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EXBIO Praha, a.s.
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252 42  Vestec
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 ID-PNH Test
 
ID-Diluent 2 / additional reagent required ID-PNH Test
Name
 
ID-Diluent 2 / additional reagent required

 
Description
 
Modified LISS for red cell suspensions
(Id-n°: 05761)

 

 
Pkg. size
Profiles or single test
REF
2 x 100 mL
 
009260
1 x 500 mL
 
009280

Name
 
ID-PNH Test

 
Description
 
ID-Card
(Id-n°: 50620)

Reagents
(Id-n°: 45270)

Rapid test for the diagnosis and therapy monitoring of paroxysmal nocturnal hemogloginuria (PNH).

 
Configuration
 
Reagent 1:
ID-PNH-Gel card with rabbit antiserum against mouse immunoglobulines.

Reagent 2:
Monoclonal antibodies directed against DAF and MIRL respectively, and negative control, ready-to-use, 1.4 mL.

Additionally required: Diluent 2.

A negative control is included in reagent 2.

 
Principle
 
Gel agglutination assay for PNH via detection of DAF and MIRL by specific monoclonal antibodies. Cells with these antigens bind the mouse antibodies.

After centrifugation through the gel, cells carrying antibodies, confirming the presence of MIRL or DAF, will show a positive reaction. This denotes that the patient does not have PNH.

Negative results or double population confirm the presence of PNH.

Test characteristics:

• very rapid: result in <30 min
• very simple procedure
• very reliable performance*
• economical: unused microtubes in the card can be used at a later time

* Gupta R, et al. A prospective comparison of four techniques for diagnosis of paroxysmal nocturnal hemoglobinuria. Int J Lab Hematol. 2007;29:119-26



 
Diag. appl.
 
A test for the exclusion or confirmation of PNH should be considered in patients with otherwise unexplained thrombembolic complications, or in patients with hemolysis or hemorrhage, anemia, and other symptoms.

Patients with PNH have a defective gene called PIG-A, involved in the biosynthesis of glycosyl-phosphatidylinositol (GPI). Without GPI, important regulatory proteins (e.g. CD55 or “DAF”, and CD59 or “MIRL”) cannot bind to the cell surface and protect blood cells from attacks of complement. This may result in a break down of erythrocytes and release of hemoglobin which causes the urine to turn dark during an episode (or “paroxysm”) of hemolysis, though this is not found in all cases.

PNH is an acquired condition induced by exposure to chemicals or certain antibiotics. In many patients their PNH cells may disappear from the blood after some time. Repeating a test for PNH may help to identify patients who are likely to have a spontaneous cure.

Treatment of PNH includes immune-suppressive drugs, supplementation with iron and folic acid. Blood transfusions or anticoagulation may be needed. Soliris™ (Eculizumab, Alexion Pharmaceuticals, Inc., a humanized antibody against complement C5) is a new drug used to treat PNH*. Eculizumab treatment reduces the risk of clinical thromboembolism in patients with PNH**.

*Rother RP, et al. Discovery and development of the complement inhibitor eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria. Nat Biotechnol. 2007;25:1256-64.

**Hillmen P, et al.. Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria.Blood. 2007 1;110:4123-8.



 

 
Pkg. size
Profiles or single test
REF
1 x 12
24 Profiles
040021
3 x 1 x 1.4 mL
20 Tests
040025