Stago completes its anticoagulant line with a new reagent, STA-ECA II, for the measurement of dabigatran plasma concentration in patients under  treatment, in case of emergency (hemorrhage, urgent surgery or invasive procedure). STA-ECA II is an ecarin-based chromogenic assay which specifically measures the anticoagulant effect of direct thrombin inhibitors like dabigatran. The use of dedicated calibrators and controls is necessary. This assay is insensitive to lupus anticoagulant, heparin and variations in levels of coagulation factors and fibrinogen. Available on STA R Max, STA-R and STA Compact Max, STA-ECA II shows excellent analytical performances down to 15 ng/mL in the low range, with a high correlation to the reference technique for dabigatran measurement, LC-MS using “total dabigatran” protocol. With a long on-board stability (3 days) and at 2-8°C (28 days), this reagent is suitable for all types of laboratory activities.

In the USA and Canada this product is classified as “For Research Use Only”.

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The HbA1c value correlates with the average blood glucose level over the last 8-12 weeks and is used for monitoring and diagnosis of diabetes. DiaSys offers HbA1c net FS as a liquid-stable and ready-to-use 2-component assay. Due to the enzymatic test principle, excellent precision is ensured. Interference from a variety of hemoglobin variants like HbS, HbC, HbD, HbE, or HbF can be excluded. HbA1c net FS is characterized by a wide measuring range from 20 to 150 mmol/mol IFCC (4-6% DCCT/NGSP) and high on-board and calibration stability of up to 6 weeks. Moreover, this assay is standardized against the IFCC reference method and traceable according to the DCCT/NGSP network.

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Orion Diagnostica’s QuikRead go CRP test received clearance from the US FDA to market the device for clinical laboratories. The QuikRead go test system measures C-reactive protein (CRP) in whole blood, plasma and serum in 2 minutes. The system consists of a small device and a ready-to-use reagent kit with all the materials for performing the test. This easy-to-use system is in wide use worldwide. The tests available for the system outside US includes CRP, CRP+Hb, Strep A and iFOBT.  Measurement of CRP aids in the evaluation of injury to body tissues, and infection and inflammatory disorders. The advantages of measuring CRP lie in it being a sensitive, early, and reliable reflector of the acute-phase response. Quantitative measurement of CRP concentration has been reported to be a sensitive indicator of the efficacy of antimicrobial therapy and the course of bacterial infections. The rise in CRP level is non-specific.

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Randox Quality Control announces the new Acusera Calibration Verification range for Beckman and Roche Cobas instruments. The new linearity sets cover a wide range of clinical testing including; cardiac markers, therapeutic drugs and proteins. Designed with convenience in mind, the new range will ultimately help laboratories to meet CLIA requirements for calibration verification and the assessment of linearity. All products are supplied liquid ready-to-use, in varying levels and are available in multiple configurations to meet the specific needs of individual analysers while challenging the instrument’s complete reportable range. The unique combination of analytes will also enable laboratories to reduce the number of individual products they require resulting in significant cost and time savings. Complementing the new linearity sets is the Randox Data Reduction Software. Easily accessed online, the software provides instant access to automatically generated charts, statistics and real-time peer group data.
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Two new EliA IgG tests for detecting anti-Thyroglobulin (anti-TG) and anti-Thyroid Peroxidase (anti-TPO) autoantibodies in serum or plasma have received FDA clearance and are performed on the fully-automated Phadia 250/2500/5000 Laboratory Systems. Thyroid autoimmunity comprises a number of distinct but pathogenically related autoimmune disorders of the thyroid gland, such as Graves’ disease or Hashimoto’s thyroiditis. Among other things, these diseases are characterized by the presence of autoantibodies, such as anti-Thyroid Simulating Hormone (TSH) receptor, anti-thyroglobulin (TG) or anti-thyroid peroxidase (TPO). More than 98 percent of Hashimoto’s thyroiditis patients have autoantibodies directed to TG or TPO or both. EliA anti-TG and anti-TPO tests quantitatively measure a patient’s autoantibodies to thyroglobulin or thyroid peroxidase, providing information that helps clinicians in the diagnosis of autoimmune thyroid diseases. These new EliA tests, formerly offered as ImmunoCAP tests, provide higher sensitivity with similar or higher specificity. Optimized sensitivity and specificity minimizes false negative or positive results, and maximizes detection of patients with serious disease.

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