Aniara News

HYPHEN BioMed evaluation :
A verification has been conducted using HYPHEN heparin assay kits (anti-IIa method, kit A221025) using the new USP vs the NIBSC UFH standard, and including HYPHEN UFH internal reference calibrators and quality controls, to verify homogeneous performance.

Products:
Reference Product IVD (510k) IVD (CE mark) RUO
A222301 Biophen UFH Calibrator x x
A223101 Biophen UFH Control x x
A221025 Biophen Heparin antiIIa (2 stages) x


Summary of results:

Conclusion:

With the tested A221025 device, the measured values are in compliance with the expected values, and homogeneous between the new USP standard, the WHO/NIBSC standard for UFH, and internal reference standards and quality controls validated in HYPHEN.

Using A221025 kit, the measured values for the USP standard are measured in compliance with the expected values (theorical expected concentrations of the tested dilutions, from nominal concentration attributed as per USP method).

Measuring the APC Resistance V associated with Factor V-L, quantitatively
With The Hyphen Biomed Kit
FDA Approved (510K)

Click here for product page

Clinical background

The Factor V-L is insensitive to the action of Activated Protein C. Its presence induces a prolonged coagulant activity in blood (due to a prolonged survival of Factor Va activity), following activation of coagulation. Patients with Factor V-L (mutation R506Q), are exposed to an increased thrombotic risk. This risk, already present in heterozygous patients, where the Normal Factor V and Factor V-L are both present, is strongly enhanced in homozygous patients, who only have Factor V-L.
HEMOCLOT Quanti. V-L (ACK065L) kit is a clotting method proposed for measuring Factor V-L (Factor V Leiden) concentration in citrated plasma, by its resistance to the action of Activated Protein C (APC). The assay is performed in the presence of Activated Protein C. In presence of APC and Protein S (in excess), the prolongation of clotting time is directly related to the concentration of Normal Factor V, and inversely related to the amount of Factor V-Leiden (mutation R506Q).inhibition IIa Fibrinogen (in excess) Fibrin (Coagulation) II (in excess) PLPCa2+Or No inhibition PLPCa2+APC / PSXaVV-L

Assay characteristics

.Quantitative reagent for measuring Factor V-L.
.No interference of plasma factor deficiencies (Other than that of Factor V).
.Excellent discrimination between Heterozygous, Homozygous and Normals.
.Single test method performed with only a Clotting Time (CT).

Assay principle

The HEMOCLOT QuantiV-L Kit is a clotting method, triggered by purified Factor Xa, containing Phospholipids and Calcium, and is performed on the diluted tested plasma, in presence of Activated Protein C and Protein S. In the first step, the diluted plasma is mixed with purified clotting Factors (clotting mixture containing Prothrombin, Fibrinogen, Protein S and Activated Protein C (APC)), in a constant and optimized concentration. Then, the purified Factor Xa in presence of Phospholipids (PLP) is added. Clotting is initiated by the addition of Calcium (Ca2+). The clotting time is then recorded. Clotting time measured is inversely proportional to the concentration of factor V-L. There is an inverse linear relationship, on a bi logarithmicgraph paper, between the factor V-L concentration and the corresponding clotting time.

HEMOCLOT Quanti. V-L is now CE Marked and 510(k) approved

For more product information please follow this link.


Jonas Kingo
Executive Vice President of Global Marketing and Sales
www.aniara.com
A true partnership is a win win for everybody

ANIARA OFFERS THE MOST COMPLETE RANGE OF CHROMOGENIC ASSAYS OR BIOREAGENTS FOR HEPARIN TESTING FROM HYPEN BIOMED.

TWO-STAGE METHODS:

Anti-Xa: (USP COMPLIANT KIT)
Working range 0 to 2 IU/mL in plasma (1:10),
or 0 to 0.2 IU/mL in purified systems.
The method of choice for testing heparin, in
compliance with pharmacopoeias.
Can be used for pentasaccharide
(Arixtra /Fondaparinux) and Orgaran.
Exogenous AT III supplied in the assay.

Anti-IIa: (USP COMPLIANT KIT)
Working range 0 to 1 IU/mL in plasma
(1:25), or 0 to 0.04 IU/mL in purified systems.
Highly sensitive; can be used for testing
Heparin, in compliance with pharmacopoeias.
Working range can be adjusted through the
dilution used.
Exogenous AT III supplied in the assay.


KINETICS/COMPETITIVE METHODS:

Anti-Xa:
The method of choice for the current testing
of heparin in clinical samples.
Can be used for UFH, LMWH (hybrid curve),
Orgaran or Arixtra, on an extended range
(0 to 2 IU/mL).
Endogenous AT III present in the tested
plasma.
Assay variant with exogenous AT III.
Anti-IIa (USP COMPLIANT KIT)
The method of choice for testing heparin
anti-IIa activity on a wide range of
concentrations, without diluting the sample (0
to 6 IU/mL).
Appropriate assay for testing drugs in
purified systems or coated devices.
Exogenous AT III supplied in the assay.
In compliance with the latest USP guidelines. Our thrombin is in highly purified alpha format optimized for chromogenic assays. All assays can be used on laboratory automated instruments A full range of calibrators and controls (UFH/LMWH/Arixtra /Orgaran), established against the NIBSC International Standards for UFH and LMWH, are available.
*WE ALSO OFFFER A FULL RANGE OF BIOREAGENTS AS WELL FOR HEPARIN TESTING.

NEW CONCEPT FOR FV-LEIDEN Second generation for screening for APC-R. Reducing cost up to 50%/test compared to the old way of screening for APC-R. This new method is only available through Hyphen BioMed/Aniara.

For more information please follow the link below:

http://www.aniara.com/mm5/merchant.mvc?Screen=PROD&Store_Code=ANIA&Product_Code=ACK065K&Category_Code=FACTORVLEIDEN


HEMOCLOT Quanti. V-L (ACK065L) kit is a clotting method proposed for measuring Factor V-L (Factor V Leiden) concentration in citrated plasma, by its resistance to the action of Activated Protein C (APC). The assay is performed in the presence of Activated Protein C. In presence of APC and Protein S (in excess), the prolongation of clotting time is directly related to the concentration of Normal Factor V, and inversely related to the amount of Factor V-Leiden (mutation R506Q).

Assay characteristics

- Quantitative reagent for measuring Factor V-L.

- No interference of plasma factor deficiencies (Other than that of Factor V).

- Excellent discrimination between Heterozygous, Homozygous and Normal's.

- Single test method performed with only a Clotting Time (CT).


Literature Links:

- Quantitative Assay for Measuring Factor V-Leiden Concentration in Plasma by its Resistance to the Action of Activated Protein C - Hemoclot Quanti-V-L (Ref. ACK065K)

- New Quantitative Assay for Factor V-Leiden - Measuring APC Resistance Associated with Factor V-Leiden Quantitatively (Ref. ACK061K/ACK061L)

- Quantitative Measurement Of Factor V-Leiden With a New, One Step, Calibrated, Clotting Assay (Ref. ACK061K/ACK061L)

- Classification of Factor V-Leiden Carriers by Quantitatively Measuring it's Procoagulant Activity Comparatively to that of Factor V (Ref. ACK065K, ACK061K, ACK071K and ARK009A)

- Quantitative Measurement of Factor V Leiden in Heterozygous and Homozygous Patients for the R506Q Factor V Mutation (Ref. ACK065K, ACK061K, ACK071, ARK009A)


ISTH Poster:

http://www.aniara.com/pdf/FVL.pdf

Product SKU and Pricing Information

HEMOCLOT Quanti V-L 510K/CE Cleared Clotting Set of 3x20 tests ACK065K $225

Factor V-L Calibrator 510K/CE Cleared Set of 3 (4x1 ml) ASC065K $125

V-L CAL (Undiluted) 510K/CE Cleared 2x3x0.5 ml A222401 $125

BIOPHEN Normal Control Plasma 510k/CE Cleared 12x1 ml A223201 $175

Act PC-r Control Plasma 510K/CE Cleared 12x0.5 ml A223405 $195

Aniara is happy to announce a full assortment of kits and reagents for testing Heparin anti IIa and anti Xa activity in purified or plasma system. With the new guidelines from USP recommending now using a Heparin anti IIa activity assay and also doing a ratio with anti IIa and anti Xa.

We are please to inform all industrial clients, that need to implement this by August, 09. Aniara/Hyphen BioMed offer a two day training session at Hyphen BioMed's facility's in France. The meeting will discuss our products and include a wet shop where you will get the chance to setup the anti IIa and anti Xa assays either by using our kits or our bio reagents based on the USP guidelines or EP guidelines.

Aniara is happy to be in the forefront and the leader in this field and is happy with helping updating your current QC methods to meet the new guidelines in time.

For more information about these products please follow the link:



For more information or if you would like your local Account Executive to contact you please send an email to info@aniara.com

Thank you

Aniara

I would also like to commend your company for expediting the shipment of the Zymutest HIA IgG, IgA, IgM kit during the holiday period. We had a very sick child for whom doctors need this testing. Your company came through with overnight shipping and we were able to do the test the next day. We really appreciate this kind of customer service.

Thank you,

Diane Meares, MT (ASCP) SH
Senior Medical Technologist
Special Hematology Laboratory
Wake Forest University Health Sciences

Aniara is very happy to inform that we have added another exceptional team member to our group.

Her name is Kathaleen Atkinson and she will be responsible for Sales and customer service in United States.

She has 21 years of experience as a Sales Representative for MERCK Pharmaceuticals and she has a Nurse background with Lab experience. We are very excited about her joining our growing family.



Jonas Kingo
Executive Vice President of Global Marketing and Sales
www.aniara.com
A true partnership is a win win for everybody!