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DSI is the exclusive provider of the Diagnostica Stago Hemostasis product lines in the United States and offers a complete system of coagulation instruments and optimized reagent kits for research as well as for routine analysis. Diagnostica Stago, Inc. is the U.S. subsidiary of Diagnostica Stago, S.A.S. France, a leader in the development and manufacture of Hemostasis products.

A total quality approach plays an integral part in the corporate culture at Stago. We are committed to a better understanding of hemostasis and thrombosis to provide clinical and research laboratories with the most advanced analyzer/reagent systems. In the United States, Diagnostica Stago, Inc. has been servicing the clinical and research hemostasis laboratory community for over 25 years with the same commitment to customers as Diagnostica Stago has maintained in Europe over the last 55 years.

STA R Max®, Excellence born from Expertise

Second member of the Max Generation, STA R Max® is an analyser designed for high volume laboratories. Innovative and scalable, it adapts to all lab organisations.
Innovative and scalable, the STA R Max® adapts to all lab organisations, connected to an automation track system or not; and brings productivity and reliability to laboratories for theirroutine and specialised haemostasis assays.


• Highest loading capacities to enhance the walkaway capabilities: 215 samples, 70 reagent positions, 1000 cuvettes on board
• True STAT management to ensure fast TAT
• Auto verification capabilities
• TAT report to monitor performances
• Ready to operate – 24/7 availability and no time required to restart.
• New hardware design to enhance ergonomics of use
• Intuitive user interface ensuring a seamless integration for the laboratory staff
Expert rules available on demand
• Extended traceability that meets quality requirements
• Innovative services: support to accreditation, remote diagnosis.
• Viscosity-Based (Mechanical) Detection System enabling immediate delivery of accurate and precise results
o Insensitivity to any type of coloured plasma
o Maximum precision for weak clot detection
o Standardisation between Stago systems
• Quality of reagents offering maximum sensitivity and reproducibility for all tests
• Environmentally friendly design providing economic savings: limited and contained fluidic waste system and reduction of disposable waste (1 cuvette = 1 test)
• Adaptability to all labs organisation: automation ready, no modifications required and same performance in standalone or connected to TLAs
• Common tubes size accepted with automatic positioning of barcode
• Wide range of dedicated reagents, quality controls and calibrators

Stago Receives Advanced Clearance for STA®-Liatest® D-Di from US FDA

September 9, 2014 US FDA has cleared STA®-Liatest® D-Di for the exclusion of the diagnosis of PE. STA®-Liatest® D-Di is the first high-sensitivity, rapid, automated D-Dimer assay that receives clearance with a clinical study design compliant with the latest and most stringent guidelines on the subject published by the Clinical Laboratory Standards Institute (CLSI), H59-A.
In addition to the previous outcome studies (over 4,000 patients with suspected DVT and PE), this new clearance confirms that STA®-Liatest®D-Di can be safely used.
Stago offers you a reliable, fully automated, ready-to-use testing system with STA®-Liatest® D-Di reagents and new liquid controls.
For more than 10 years, STA®-Liatest® D-Di has been the established standard of care for quantitative D-Dimer assays in thousands of hospitals, medical centers and private laboratories with more than 1 million patient results reported.
In the meantime, considering the critical role that D-Dimer can play in the diagnostic algorithm for the exclusion of VTE and the broad number of assays available, in 2011 the CLSI published a new guideline that provides recommendations for D-dimer performance (for the exclusion of VTE).
In order to fulfill its commitment to the scientific community and demonstrate compliance with this new CLSI guideline, Stago has conducted a large 2-year, multi-national, prospective management study, including pre-test probability assessment, objective imaging results and 3-month patient follow-up.
With more than 2,000 patients for the PE and DVT arms in 12 sites in 5 countries, this study (DiET) is, to date, the largest VTE study undertaken to support clinical utility of D-dimer in the management of patients suspected with VTE.
More importantly, through this study, the excellent performance of the STA®-Liatest® D-Di has been confirmed, particularly its high accuracy to exclude PE in patients with a low or moderate risk:
In addition to the previous outcome studies (over 4,000 patients with suspected DVT and PE), this new clearance confirms that STA®-Liatest®D-Di can be safely used.
Stago offers you a reliable, fully automated, ready-to-use testing system with STA®-Liatest® D-Di reagents and new liquid controls.

Additional Liquid Reagent! Take control of your D-Dimer testing

D-Dimer is an essential parameter for most labs: D-Dimer results are critical for making an appropriate diagnosis and for optimal patient management. It is performed routinely and in an emergency setting (24/7)
Your D-Dimer Quality Controls play an essential role to validate the test system's performance:
• Check the accuracy and reliability of results reported by your D-Dimer testing system for all patient samples on a daily basis
• Evaluate the precision in various operating conditions
• Monitor the consistency of results over a prolonged period of time
• Comply with quality management recommendations.
Stago offers a reliable, fully automated, ready-to-use testing system with STA®-Liatest® D-Di Plus and STA®-D-Di Control.
STA®-D-Di Control are:
Compliant with international quality management recommendations
2 assayed quality controls located at ideal levels:
Control 1 ~ 0.75 µg/mL FEU
Control 2~ 2.30 µg/mL FEU
Adapted to your day-to-day D-Dimer testing activity
• Liquid, ready-to-use: convenient for minimising handling procedures errors
• Extended stability: 72h on board STA-R® and STA Compact®, stable for 15 days after opening when stored at 2-8°C
• 2 mL vials: allows several QC runs per day
A key component of your system thanks to barcode-based management of product data
• Autopopulation of dedicated ranges guarantees the safety of the system
• Optimal management of volumes, stability, expiry dates, batch numbers etc
STA®-D-Di Control - Cat. Nr. 00868
Packaging 2 x 6 x 2 mL - Liquid
On-board stability: 72h on STA-R® and STA Compact®
Stability at 2-8°C: 15 days
Associated reagents:
- STA®-Liatest® D-Di Plus* - Cat. Nr. 00662
- STA®-Liatest® D-Di - Cat. Nr 00515
Associated D-Di EQA program Qualiris QC D-Dimer** - Cat. Nr 01049
* Not available in USA and Canada.
** QC availability depending on the program subscription

new

How to measure apixaban by Stago!

STA®-Apixaban Calibrator and STA®-Apixaban Control are the newest innovative products in the Anticoagulant Line. Used in combination with the STA®-Liquid Anti-Xa, they offer the measurement of apixaban plasmatic concentration.
This Anti-Xa specific method features a wide working range and a high sensitivity in the low range. Fully automated and easy to use, it offers robust results in less than 6 minutes.
• with the STA®-Liquid Anti-Xa reagent
• and dedicated calibrators and controls
• provides results in ng/mL
• wide working range: 20 to 500 ng/mL
• high sensitivity in the low range
• excellent correlation with the reference method LCMS
Easy to use Anti-Xa reagent
• liquid, ready to use
• fully automated, barcoded vials
• results in less than 6 minutes
• liquid, ready to use
• fully automated, barcoded vials
• results in less than 6 minutes
• References
1. Becker RC et al., Chromogenic laboratory assays to measure the factor-Xa inhibiting properties of apixaban - an oral, direct and selective factor Xa inhibitor. J Thromb Thrombolysis 2011; 32:183-187
2. Barret YC et al., Clinical laboratory measurement of direct factor Xa inhibitors: Anti-Xa assay is preferable to prothrombin time assay. Thromb Haemost 2010; 104:1263-1271

STA®-Liatest® D-Di Plus, Less interferences for even More Confidence

As part of Stago's continuous improvement commitment, STA® -Liatest® D-Di Plus* was developed as an evolution of the STA® -Liatest® D-Di, one of the most published D-Dimer assays, also FDA approved for aid in the diagnosis of Venous ThromboEmbolism (VTE).
In STA® -Liatest® D-Di Plus, the addition of a blocking agent improves the analytical and diagnostic performances of the assay by minimizing interferences to heterophilic antibodies, including rheumatoid factors (RF) and Human Anti-Mouse Antibodies (HAMA).
Less Interferences for more efficacy
Immunoassays, which are commonly used in the diagnostic testing, may be prone to interferences with heterophilic antibodies, when present in patient plasmas. The prevalence of these interferences with D-Dimer assays in the diagnosis of VTE is low but may cause an overestimation of the result.

STA® -Liatest® D-Di Plus has been developed to minimize these interferences:
• HAMA: buffer contains a blocking agent
• RF: No interference up to 1,000 IU/mL

By minimizing the interferences from heterophilic antibodies, STA® -Liatest® D-Di Plus has been designed to show improved specificity for even more efficacy.
More Performances for more efficiency
• Validated:
STA® -Liatest® D-Di Plus is intended for use for aid in the diagnosis of Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE)
• Adapted to STAT (available 24/7):
o Precalibrated
o Stable 15 days on board on STA® line analysers
• Easy-to-use:
Automated, ready-to-use reagent with standardised results across Stago analysers
• Reliable:
Low coefficients of variations (CV) across international proficiency testing program reports
Select the best D-Dimer test for cost-effectiveness and safety.
STA® -Liatest® D-Di has been clinically validated in outcome studies of over 4,000 patients with suspected DVT and PE to be used to safely aid in the diagnosis of VTE.
Using the 0.5 μg/mL (FEU) threshold in conjunction with a pre-test probability assessment, the STA® -Liatest® D-Di has consistently produced low CVs across proficiency program specimens and has been used safely for more than 10 years. STA® -Liatest® D-Di is currently the most frequently used D-Dimer test on the market.

Perfectly correlated with STA®-Liatest® D-Di and thanks to the addition of a blocking agent, STA® -Liatest® D-Di Plus benefits from all the references and widely known advantages of STA®-Liatest® D-Di.

CY-QUANT VASP/P2Y12: A new kit to make VASP testing more accessible

According to peer-reviewed literature, VASP is the most specific biomarker of P2Y12 receptor inhibition. Unlike other assays currently on the market, it is not interfered by aspirin, P2Y1, anti-GPIIb-IIIa drugs, VWF level and platelet count. With more than 1,000 publications, VASP is validated and suitable for testing utilising all anti-P2Y12 drugs currently on the market and in development.
Benefits of VASP based assays including the following:
• Ease of use: Whole blood is used as the sample, resulting in minimising of preanalytical issues
• Ease of transportation and processing: Small blood volumes (<160 µL), long sample stability (up to 48 hours)
• No reagent waste: Unitary testing, suitable for low to high activity

Since 2003, Stago has offered the CE labelled PLT VASP/P2Y12 for use with flow cytometers. Now, a new CE kit called CY-QUANT VASP/P2Y12 is available. This whole-blood ELISA will allow VASP biomarker to be available to all laboratories not equipped with a flow cytometer.

CY-QUANT VASP/P2Y12 main characteristics:
• A 96-well microplate based adaptation of PLT VASP/P2Y12 gold standard assay
• Strips divisible in unitary well - Use only what you need
• Highly significant correlation with the PLT VASP/P2Y12 assay (n=80; r=0.95; p<0.001)
• Only 160 μL citrated whole blood needed
• Sample stability up to 24h at room temperature
• Kit size suitable for low to high activity (from 1 to 23 tests in duplicate per run)
• Easy to use & compatible with all types of microplate reader (450 nm)

STA®-Liquid Fib

STA®-Liquid Fib is the lastest innovation in our routine line. This new liquid reagent for the quantitative determination of fibrinogen levels is based on the reference Clauss clotting method combined with the mechanical clot detection system. STA®-Liquid Fib is a pratical and robust reagent designed to give reliable results.
Fibrinogen functions in primary haemostasis in support of platelet aggregation and in secondary haemostasis in the formation of an insoluble fibrin clot.
It is the final clotting factor activated in the coagulation cascade.

Inherited and acquired disorders can alter the quantity (afibrinogenemia and hypofibrinogenemia) and function (dysfibrinogenemia) of plasma fibrinogen.

Hypofibrinogenemia is generally asymptomatic, but afibrinogenemia and dysfibrinogenemia
may lead to bleeding and/or thrombosis.

Test based on the gold standard method, for maximum reliability
• Clauss method which is the reference method for routine tests
• Extremely reliable patient results across a large measuring range

Benefits of mechanical detection
• More reproducible than photo-optic detection in fibrinogen assays
• Insensitive to sample turbidity following massive transfusion
• No interferences from lipaemia, icterus, haemolysis
Superior analytical performance (characteristics)
• Wide working range : 0.4 -12 g/L covering any clinical situation
• Excellent precision
• correlates perfectly with STA®-Fibrinogen 5 and STA®-Fib 2

The reagent that makes life easier: results in less than 5 minutes!
• Liquid format: ready to use reagent
• Precalibrated and barcoded with standardized results across Stago analysers

Economical solution adapted to any workload through optimised reagent management
• A single 4 mL format
• Extended stability up to 10 days on-board and 2 months at 2 – 8°C

Megamix Line: Expand the limits of MP analysis with 2 new products

In addition to functional assays currently available at Stago (STA®-Procoag PPL and CAT) Megamix products are two new tools designed for standardising Microparticle (MP) quantitative analysis by flow cytometry. These products assist in the process of setting-up a standardised MP gate to ensure a good inter-instrument and inter-lab reproducibility. They are also used as a day-to-day QC to check instrument consistency.
Increase in MPs reflects thrombotic and/or inflammatory events. Elevated MPs levels occur in many pathologic situations such as cancer, cardiovascular diseases, auto-immune diseases or inflammatory syndrome.
MPs quantification allows for diagnosis of such pathologies, monitoring & follow-up and evaluation of drug efficacy.
• Megamix (Cat. Nr. 00420): For FSC-optimised instruments (e.g Beckman Coulter FC500®), containing a mix of 0.5/0.9/3 µm fluorescent beads to set-up a MP gate analysis from 0.5 to 1.0 µm MP-equivalents (large MPs).

Because small MPs are also of great interest, Stago releases two new products suitable for new models of flow cytometers:
• Megamix-Plus FSC: For high sensitivity FSC-optimised instruments (e.g Beckman Coulter Gallios® or Navios®), containing a mix of 0.1/0.3/0.5/0.9 µm fluorescent beads.
• Megamix-Plus SSC: For SSC-optimised instruments (e.g Becton Dickinson line), kit containing a mix of 0.16/0.2/0.24/0.5 µm fluorescent beads.

These two new kits allow for setting-up a MP gate analysis from 0.3 to 1.0 µm MP-equivalents (small & large MPs).

STA Compact Max®: Innovation born from Expertise

STA Compact Max® is the new generation of analyser developed by the Coagulation Company to meet labs' expectations.
The Compact STA Max® is a genuine synthesis of Stago's know-how and possesses the main qualities of a Haemostasis system that you are entitled to expect.
Max Reliability
Continuous improvement of quality of service can sometimes be challenged by increasing workloads and volume testing in a highly demanding environment.
Thanks to its RELIABILITY, the STA Compact Max® allows you to work with confidence, in every situation.
Max Innovation
Laboratory improvements, patient safety and productivity enhancement are a permanent concern for Stago. We are committed to invest in research andINNOVATION to develop reagents, systems and solutions that provide maximum benefit for our customers.
Max Performance
Adapting to a changing environment, delivering accurate and timely answers to clinicians are some of the challenges that the laboratory must face everyday.
The STA Compact Max® was developed to guarantee the PERFORMANCE required answering your needs.
Max Efficiency
Laboratories are facing strong economic pressure and functional constraints such as facilities consolidation and staff shortage - “the need to do more with less”. The STA
Compact Max® helps you to cope with these challenges by improving your EFFICIENCY both operationally and environmentally.


Following all our explorations of the haemostasis systems, the STA Compact Max® benefits from all the assets of the bar-coded reagents STA® line.

Thus, the latest addition to Stago's multiparametric system range allies an innovation design with new features.

STA®-ImmunoDef VIII & STA®-ImmunoDef IX

As part of Stago's continuous improvement commitment, STA®-ImmunoDef VIII* & STA®-ImmunoDef IX* kits have been developed as a new generation of Deficient Plasmas with enhanced performances. Factors VIII and IX measurement allows characterising clinically significant conditions such as
Haemophilia A and B. Robust and reliable reagents should be available for an easier daily laboratory practice.
Haemophilia A is the most common of the serious haemorrhagic diseases. It is caused by a deficiency in factor VIII (anti-haemophilia factor A) and affects around 1 in 5000 male infants at birth.

Haemophilia B is a disease caused by a congenital deficiency in factor IX (anti-haemophilia factor B) that affects around one in 30 000 male infants at birth.

Optimum analytical performance for even more reliable patient results is achieved thanks to extended working range with one calibration curve, perfect correlation of low patient results and very good precision on the entire working range.

Adapted reagents whatever the clinical context, especially for the diagnosis and monitoring of haemophilia
• Reagents on board stability extended to 8 hours
• Stability and robustness of calibrations: no systematic calibration needed
Efficient reagents for an easier laboratory practice
These reagents comply with current international guidelines:
• Calibrators & controls assayed against WHO International Standards for standardized results
• Residual activity of immunodepleted factor < 1% ensures reliability for patient's with low results
• Other coagulation factors at normal levels for specific measurements
• Addition of VWF (STA®-ImmunoDef VIII) adapted to Bethesda and Nijmegen inhibitor assays

New range of STA®-Routine QC quality control plasmas: The best range for routine laboratory tests

To fulfil regulatory requirements, laboratories must perform regular internal quality control (IQC) on at least two concentration levels (normal and abnormal) to check and confirm the performance of their testing systems.
Assayed (titrated) IQC plasmas are used to evaluate the precision and accuracy of the reagent-analyser combination and therefore to ensure the reliability of your patients’ results.
Stago’s new STA®-Routine QC range provides:
• several concentration levels reflecting most clinical scenarios (normal, abnormal, and ultra-abnormal)
• extended 24-hour stability and a 2-ml vial, enabling several series of IQC tests to be performed each day while optimising your operating budget
• multiparameter controls whose values are assayed against international standards
• automatic management of all your data via barcodes (values, batch number, stability, expiry date, etc.).
Two new assayed IQC plasmas are now available for routine testing:
• STA®-Routine QC 2 ml Ref. 00554 (normal and abnormal level) for the following parameters: PT (sec, %, and INR), APTT, fibrinogen, thrombin time, and antithrombin activity.
• STA®-Routine QC P Plus Ref. 00714 (ultra-abnormal level) for the following parameters: PT (sec and %), APTT, fibrinogen, thrombin time, and antithrombin activity.

STA®-Rivaroxaban Calibrator & STA®-Rivaroxaban Control (CE marked)

Rivaroxaban is a new oral anticoagulant, direct factor Xa inhibitor, developed by Bayer HealthCare and sold under the trade name Xarelto®. It is approved in three indications in Europe: prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors, treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults and prevention of VTE in adult patients undergoing elective hip or knee replacement surgery.
In the US, Xarelto is approved for stroke prevention in AF patients and prevention of VTE in hip or knee surgery.
In total, Rivaroxaban is approved in more than 110 countries worldwide. This makes Rivaroxaban a future major player in the anticoagulants world.
STA®-Rivaroxaban Calibrator & Control is a new solution for the determination of Rivaroxaban concentration to support the examination of patients in different clinical situations.
Including Rivaroxaban calibrators and controls, this solution uses an anti-Xa method (STA®-Liquid Anti-Xa), insensitive to analytical and biological variables, with a wide working range.
Results are expressed in ng/mL of Rivaroxaban [1]
Reagents are offered with all the standard guarantees:
• barcoded reagents for optimal ease of handling and traceability
• results available in a few minutes only, adapted to STAT samples requirement
• fully automated on STA-R® and STA-Compact®, with dedicated tests setups

STic Expert® HIT

For every Heparin Induced Thrombocytopenia (HIT) suspicion. A rapid and specific exclusion of Heparin Induced Thrombocytopenia in 10 minutes. Diagnosing and treating Heparin Induced Thrombocytopenia (HIT) represent a challenge for many clinicians. STic Expert® HIT is a significant step forward in HIT diagnosis.
Patients with HIT have a very high thrombosis risk. They require alternative anticoagulant treatments which increase the bleeding risk. In the absence of a rapid and reliable laboratory assay, many clinicians simply replace heparin based on clinical suspicion only. However, only ~10% of suspected HIT suspicions are actually confirmed by appropriate tests. Current immunoassays can rule out HIT but have limitations, especially a high number of falsely positive tests, long time to result, complex handling, and reagent wastage.
The STic Expert® HIT kits match all laboratory requirements:
• Reliability: 100% NPV
exclusion of HIT when combined with the pretest clinical score
• High specificity: 93%
reduction of falsely positive results and therefore of the number of confirmatory tests required
• Time saving
result available in 10 minutes
• Easy and ready to use
unitary test, available 24/7 STAT compliant for laboratories of all sizes
• Cost effectiveness
reduction of cost of HIT outsourcing and no need for extra equipment
2 packaging sizes available:
STic Expert HIT 5: 5 tests per kit* (Cat. Nr. 01058)
STic Expert HIT 20: 20 tests per kit* (Cat. Nr. 01059)
* individual tests in blister packs

STA®-Procoag-PPL


The only available automated test to determine the procoagulant activity of phospholipids.
Midway between plasma haemostasis and cellular haemostasis are microparticles rich in procoagulant phospholipids. Increased procoagulant activity features in many diseases, including:
• cardiovascular diseases,
• certain types of cancer,
• inflammatory syndromes,
• infectious diseases,
• obstetric complications, etc.
STA®-Procoag-PPL, an easy to use standardised automated test, can be used to measure changes in procoagulant activity, facilitating study of this activity. phospholipids.

Procoagulant activity comes from phospholipids present at various sites:
• circulating microparticles
• activated platelets
• activated red and white cells.
This test has numerous benefits:
• Rapid: < 4 min
• Easy to use
• Excellent reproducibility
• Flexible: suitable for testing samples individually or in series
• Close to physiological characteristics: it may be used in PPP (platelet-poor plasma), PRP(platelet-rich plasma) or whole blood to investigate all sources of procoagulant phospholipids.
Results are expressed as coagulation times: the shorter the coagulation time the greater the procoagulant activity of the phospholipids being studied.
This new marker may be of value in:
• diagnostics, as a pre-thrombotic marker
• prognostics, as an early marker for certain diseases
• therapeutics, as an indicator for monitoring of anticoagulant therapy.

Thus, with STA®-Procoag-PPL, Stago adds to its range of flow cytometry and thrombin generation reagents for microparticle analysis.

Asserachrom® VIIa–AT

This innovating test is an indirect marker of Tissue Factor exposure In Vivo.
Tissue Factor (TF), a potent initiator of the blood clotting time system, is an integral membrane protein present on the surface of certain cell types located outside the vasculature and on circulating microparticles.
A primary step in the coagulation cascade is the formation of [VIIa-TF] complex that activates both factor IX and factor X by proteolysis and initiates the coagulation process.
In many thrombotic situations, Factor VIIa–AT complexes are higher in patients' plasmas:
• Antiphospholipids syndrome
• Premature myocardial infarction
• Acute promyelocytic leukaemia
The Asserachrom® VIIa-AT is an assay to perform Factor VIIa-Antithrombin complexes is also an indirect measurement test of Tissue Factor activation.

Thanks to an anti-human Factor VIIa monoclonal antibody, Asserachrom® VIIa-AT is a specific, reliable, quantitative and reproducible test.

STA Coag Connexion®*

Your connexion to coagulation expertise.
STA Coag Connexion® is the specialised software for managing and supervising Stago systems.
More Productive & Effective
• Reduced response time & Optimised resources
• Standardised technical validation prevents unneeded, costly repeat analysis
• Real-time observation of overall activity via a unique dashboard
Additional advantages for Accreditation
Functions complying with accreditation norms and requirements:
• Total tracking
• User rights management
• Statistical tools specific to coagulation conform to new method validation requirements
• Transfer and storage of backup data on CD-ROMs or USB key
More Reliable & Safe
• Reduced risk of errors and the time saved can be better used on processing abnormal results
• Standardised decision processes help reduce variability when interpreting results
• Effective Quality Control (QC) management
• Centralised and remote QC management
* Availability depending upon the country

STA®-Liquid Anti-Xa: the solution of choice for UFH, LMWH and Fondaparinux monitoring

Stago offers a comprehensive range for anticoagulant monitoring. The new STA®-Liquid Anti-Xa is a specific, easy to use and reliable test. Fully automated test on STA® line analysers, it is the solution of choice for UFH, LMWH and fondaparinux monitoring and apixaban/rivaroxaban testing.
Heparin is an injectable anticoagulant widely used inemergency situations requiring immediate effect.
Different pharmaceutical grades of heparin have been developed, and can be classified into 3 main groups:
• Unfractionated Heparins (UFH),
• Low Molecular Weight Heparins (LMWH)
• Fondaparinux (FDX)
• Apixaban
• Rivaroxaban
The main risks associated with those drugs arebleeding and heparin induced thrombocytopenia (HIT), a common prothrombotic complication of UFH and LMWH therapies.
Monitoring UFH anticoagulant activity is mandatory because of its unpredictable effect andhigh variations among patients. LMWH and Fondaparinux have to be monitored in special cases only, where risk of accumulation is high (renal deficiencies) or in case ofunexplained bleeding events.
In order to prevent HIT, platelets monitoring is mandatory for UFH and LMWH in all cases.

The new STA®-Liquid Anti-Xa assay is the solution of choice for UFH, LMWH and fondaparinux monitoring and apixaban/rivaroxaban testing.
It is based on the inhibition of a known amount of factor Xa by the patient's sample heparin combined with antithrombin. The residual factor Xa activity assessed by a colorimetric test will be inversely proportional to the heparin concentration.
Unlike the aPTT, the anti-Xa assay is not influenced by additional coagulation factors of the intrinsic and common pathways and inhibitors. It is not affected by concomittant VKA therapy. It is less affected by other preanalytical variables such as anticoagulation,specimen collection and processing.

STA®-Liatest® FM, the new marker for DIC

To better diagnose DIC and for a reliable vital prognosis, Stago has developed STA®-Liatest® FM, a new quantitative and fully-automated assay for fibrin monomers determination.
DIC: a complicated syndrome
Disseminated Intra-Vascular Coagulation (DIC) is an acquired syndrome resulting in an excessive systemic activation of coagulation.
This leads to consumption coagulopathy involving excessive formation of thrombin and fibrin and excessive consumption of platelets, coagulation factors and inhibitory systems.
This process can lead to the formation of disseminated thromboses (microvascular thrombi) withhaemorrhagic signs, potentially leading to organ failure with risk of multiple organ dysfunction syndrome (MODS).

DIC is not an illness on its own but rather a complication or an effect of progression of other illnesses.
The principal causes of DIC are:
• Sepsis and septic shock
• Obstetrical complications
• Malignant tumors
• Intoxication (poisons, drugs,…)
• Tissue injuries (polytraumas, extensive burns…)
• Severe liver failure
• Immunological disorders

DIC diagnosis
ISTH has proposed a scoring system based on laboratory tests for overt and non-overt DIC diagnosis.
The scoring for DIC adds a better prognostic value for patient mortality than the use of clinical scores alone.
The haemostasis tests to perform are the platelets count, the Quick time, the fibrinogen level and a fibrin-related marker level (soluble fibrin, fibrin degradation products).
A notation is attributed to each test result (between 0 and 3). The sum corresponds to the DIC score.
The STA®-Liatest® FM advantages

• Accurate and quantitative result
• High specificity by using monoclonal antibodies against fibrin monomers
• Fully automated test and easy to use
• Diagnosis of strong DIC thanks to a wide linear working range: 5 to 150 µg/mL
• Ready-to-use reagents and buffers

Asserachrom® HPIA – IgG

A new tool for the diagnosis and exclusion of heparin-induced thrombocytopenia (HIT)
Heparin-Induced Thrombocytopenia (HIT) is a common prothrombotic complication of UFH and LMWH therapies.
HIT is caused by antibodies directed against heparin-platelet factor 4 complexes (H-PF4). These are capable of activating platelets, but also endothelial cell and monocytes, inducing tissue factor expression, thrombin generation and fibrin clot formation. The platelet and blood coagulation activation events contribute to the thromboses observed in many patients with HIT.
The diagnosis of HIT is based on clinical criteria (scoring system: 4T's) and is confirmed by in-vitro demonstration of H-PF4 antibodies using functional and immunoassays (EIAs). This combination (pre-test scoring + laboratory testing) provides the highest predictivity for HIT.

Functional assays rely on the ability of the H-PF4 antibody to activate platelets in the presence of heparin, while the immunoassays confirm the presence of the antibody without consideration for its ability to cause platelet activation.

In addition to the existing Asserachrom® HPIA, Stago has developed Asserachrom® HPIA-IgG (Cat. Nr. 00624), a highly sensitive and specific ELISA for detecting H-PF4 antibodies of the IgG class.
In clinical studies performed on >400 samples, Asserachrom® HPIA-IgG demonstrated100% sensitivity, high specificity and concordance with the serotonin release assay of ~92%. This new kit has maintained the high sensitivity of the polyspecific Asserachrom® HPIA (100%), with a superior specificity (92.3%).
Asserachrom® HPIA – IgG is provided in a strip format adapted for the economic analysis of a small test series. Together with excellent reproducibility this allows for an accurate detection of HIT antibodies. The kit can be adapted to automated ELISA instruments.
Setting new standards in the laboratory diagnosis of HIT, Asserachrom® HPIA – IgG results can be used in combination with clinical data for determining the most appropriate anticoagulation therapy in patients with suspected HIT.