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Tag Archives: Streck

FDA clears Streck quality controls for bloodstream infections

Sept. 26, 2023—Streck announced that its MDx-Chex for BC-GP and MDx-Chex for BC-GN quality controls, designed to verify the performance of the Luminex Verigene Blood Culture Gram-Positive (BC-GP) and Gram-Negative (BC-GN) tests for blood stream infection and sepsis, have been granted FDA clearance for use in diagnostic procedures.

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FDA clears Streck MDx-Chex for BCID2

Jan. 31, 2022—Streck’s MDx-Chex for BCID2, a quality control designed to meet the standards for verifying the performance of the BioFire BCID2 panel assay for sepsis, has been granted FDA clearance for in vitro diagnostics use.

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Streck launches rapid, modular qPCR instrument

January 2021—Streck has launched its Zulu RT, a rapid, modular qPCR instrument. The instrument consists of four independent thermal modules. A user can operate any combination of modules­—one module for a small sample set, leaving other modules for other users, or up to four modules simultaneously for a large sample set. It can perform a 40-cycle, six-channel real-time PCR in less than 20 minutes.

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Streck, Orgentec distribution agreement, 12/17

December 2017—Streck and Orgentec Sasu, a distributor in France that specializes in the in vitro diagnosis of autoimmunity, infectious diseases, molecular biology, internal/external quality control, biochemistry, and sedimentation rate, have signed an exclusive distribution agreement for Streck’s cell stabilization and molecular products.

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Streck distribution agreements, 9/17

September 2017—Streck and Inter Medico, a privately owned Canadian distributor of medical diagnostic and research-related products, have signed a distribution agreement for Streck’s cell stabilization and molecular products. Inter Medico will have exclusive distribution rights in Canada to those Streck products.

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Improved urinalysis control, 8/17

August 2017—Streck UA-Cellular Complete, a comprehensive cellular and chemistry analyte urinalysis control, is an integrated urinalysis control for the Siemens Clinitek Atlas/Sysmex UF-1000i and Arkray Aution Hybrid AU-4050 integrated systems. UA-Cellular Complete features true cellular components (no latex or other synthetic material) and provides three concentrations of combined urinalysis control to represent the various patient sample scenarios.

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Streck assay added to Mindray instrument, 3/17

March 2017—Streck’s Para 12 Extend, a hematology control with three distinct populations of lymphocytes, mononuclears, and granulocytes, is now assayed for the Mindray BC-3600. Varying percentages are also offered in the low abnormal, normal, and high abnormal levels to test the accuracy and precision of the reported white cell populations.

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Streck adds Makler to sperm count assays, 2/17

February 2017—Streck’s Sperm-Chex and Sperm-Chex Post VC, both with stabilized sperm cells, are now assayed for the Makler Counting Chamber. Sperm-Chex has two clinically significant levels of control to simulate the sperm cell concentration that technologists encounter in patient samples. It has the same chamber loading and optical characteristics as a patient sample. Sperm-Chex verifies the sperm analysis process and tests the technologist’s proficiency in sperm cell quantification and qualification.

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Streck signs distribution agreement, 10/16

October 2016—Streck and Diesse Diagnostica Senese S.p.A., an Italian manufacturer of in vitro diagnostic systems, are introducing the Diesse Mini-Cube, an automated instrument for erythrocyte sedimentation rate testing in EDTA tubes. Streck will be the exclusive distributor of the Mini-Cube in the United States and Canada.

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Blood collection device, 8/16

August 2016—Streck’s Cell-Free DNA BCT, for the collection and preservation of whole blood samples, is available as a 2.0 mL draw tube. The formaldehyde-free preservative reagent contained in Cell-Free DNA BCT inhibits nuclease-mediated degradation of cf-DNA and stabilizes nucleated blood cells, which prevents the release of cellular genomic DNA. Samples are stable for up to 14 days at temperatures between 6°–37°C, allowing convenient sample collection, transport, and storage.

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Urine preservative product, 10/15

Lab Sensor Solutions will partner with MarketLab to distribute T-Tracks, which tracks, in real time, the temperature and location of clinical samples in transit, preventing laboratory specimen spoilage and loss and ensuring regulatory compliance. T-Tracks data are delivered to lab personnel’s desktops, laptops, and mobile devices.

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Flow cytometry control, 9/15

New products featured by Streck this year included CD-Chex CD103 Plus, a flow cytometry control. It includes CD103, CD30, CD38, CD56, CD138, and cytoplasmic lambda in a single control and provides reference values for CD38. The control includes rare leukemia and lymphoma CD markers that are absent in normal whole blood.

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Linearity control assay, 7/15

July 2015—Streck’s Calibration Verification Assessment (CVA) is now assayed for the Horiba ABX Micros 60 instrument. CVA is an assayed linearity control kit used to determine the patient reportable range of three-part and five-part hematology instruments.

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Flow cytometry control, 6/15

June 2015—Streck has introduced CD-Chex TdT Plus, a flow cytometry control assayed for TdT, CD1a, CD34, and cCD3. CD-Chex TdT Plus can be used as quality control material for evaluating intracellular and surface antigens including CD1a, CD2, CD4, CD5, CD7, CD8, CD34, cytoplasmic CD3, and nuclear TdT (terminal deoxynucleotidyl transferase).

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Instrumentation added to assays, 12/14

December 2014—Streck’s A1c-Cellular Linearity, an HbA1c linearity/calibration verification material with intact red blood cells, is now assayed for the Trinity Biotech Premier Hb9210 and Ultra2 instruments. A1c-Cellular Linearity is a five-level assayed linearity material used to assess instrument accuracy and verify the patient reportable range of the HbA1c parameter.

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Flow cytometry controls, 8/14

August 2014—Streck added markers to CD-Chex CD117 Plus, a commercially available positive procedural control for CD117, and now CD25 and CD71. CD-Chex 117 Plus eliminates the need for laboratories to hold and validate patient samples to use as a control for CD117, CD25, and CD71.

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HbA1c control, 9/13

Streck’s A1c-Cellular Linearity, an HbA1c linearity/calibration verification material with intact red blood cells, is now assayed for Roche Diagnostics’ Cobas c 311. It is a five-level assayed linearity material used to assess instrument accuracy and verify the patient reportable range of the HbA1c parameter. The product does not require reconstitution, which reduces the potential for human errors and saves time. ...

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Flow cytometry control for CD117, 6/13:96

Streck’s CD-Chex CD117 is a flow cytometry control for CD117. The control eliminates the need for laboratories to hold and validate patient samples to use as a control for CD117, saving time and money. CD-Chex CD117 is designed to represent abnormal peripheral blood leukocytes similar to a hematolymphoid neoplastic patient sample. The product has surface CD117 that is detectable with fluorescent monoclonal antibodies by flow cytometry. The CD117 positive abnormal leukocytes are distinguishable from normal leukocytes on the basis of light-scatter properties, a low level of CD45 expression, and heterogeneous CD117 expression.

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Calibrator, control for hematology system, 4/13:88

Streck’s CVA, an assayed linearity control kit used to determine the patient reportable range of three- and five-part hematology instruments, is now assayed for Beckman Coulter’s UniCel DxH 800. CVA establishes an instrument’s reportable range and verifies linearity, testing the instrument’s extreme upper and lower limits, ensuring that patient results are valid.

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HbA1c control assay, 3/13

Streck’s A1c-Cellular HbA1c control with intact red blood cells is now assayed for Roche Diagnostics’ Cobas c311. A1c-Cellular tests the entire HbA1c procedure, including the lysing of the red blood cell. This step ensures that the entire system—instrument and reagents—is working properly and providing accurate patient results. The control is easy to use; it does not require reconstitution, which reduces the potential for human error.

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