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Tag Archives: Bio-Rad Laboratories

Bio-Rad launches bulk urine, CSF negative controls

July 2023—Bio-Rad Laboratories launched two Exact Diagnostics products, Bulk Urine Negative and Bulk CSF Negative controls. The bulk urine negative control is intended to be validated as an independent external quality run control to monitor the absence of adenovirus, BK virus, Candida auris, Chlamydia trachomatis, cytomegalovirus, John Cunningham virus, Mycoplasma genitalium, Neisseria gonorrhoeae, Trichomonas vaginalis, and Zika virus in various molecular assays. The bulk CSF negative control is an independent external quality run control intended to monitor the absence of Anaplasma phagocytophilum, Babesia microti, Bartonella quintana, Borrelia burgdorferi, Ehrlichia chaffeensis, enterovirus, herpes simplex virus 1 and 2, and varicella-zoster virus in various molecular assays.

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Bio-Rad launches Exact Diagnostics CT/NG, STI run controls 

Oct. 28, 2022—Bio-Rad Laboratories has launched two Exact Diagnostics products, CT/NG Positive Run Control, intended to be used with Chlamydia trachomatis and Neisseria gonorrhoeae molecular assays, and STI Negative Run Control, which monitors the absence of Chlamydia trachomatis and Neisseria gonorrhoeae in various molecular assays, the company says, and can be used to detect errors in laboratory testing procedures, including potential contamination events, while controlling for sample adequacy assessment.

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Bio-Rad adds SARS-CoV-2 S gene delta-kappa variants control

January 2022—Bio-Rad Laboratories launched its Exact Diagnostics SARS-CoV-2 S Gene Delta-Kappa Variants Control for research testing. The control includes lineages B.1.617.1, B.1.617.2 (AY sublineages), and B.1.617.3. The product is an addition to the company’s SARS-CoV-2 S gene variants controls alpha, beta, epsilon, and gamma, which were released in August.

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Bio-Rad RP positive run control for SARS-CoV-2

December 2021—Bio-Rad announced its Exact Diagnostics RP Positive Run Control for syndromic respiratory panels is now available with inactivated whole virus for SARS-CoV-2. The unassayed external quality control contains 23 respiratory analytes in one vial and is intended to monitor the performance of clinical respiratory assays. The control is a combination of whole, intact virus and bacteria that have been heated or chemically inactivated and synthetic RNA transcripts.

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Bio-Rad launches InteliQ Diabetes Control

July 2021—Bio-Rad Laboratories launched its InteliQ Diabetes Control, the 10th product offered in the InteliQ format. The InteliQ Diabetes Control includes three distinct levels that aim to address HbA1c precision monitoring needs of a wide range of test methods. InteliQ quality controls are designed to empower labs to automate their QC workflow with load-and-go efficiency, and users have access to the Unity data management program.

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Bio-Rad FDA clearances

October 2019—Bio-Rad Laboratories received FDA 510(k) clearance for its IH-500, an automated random access system for blood typing and screening, designed for small to medium-size laboratories. The system can process Bio-Rad’s range of IH gel cards for ABO blood grouping, reverse testing, phenotyping, Rh subgroups, antibody screening, antibody identification, single antigen testing, direct AHG testing, and crossmatching. In a separate ...

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FDA clears digital PCR test for monitoring CML therapy

Feb. 19, 2019—Bio-Rad Laboratories announced that its QXDx AutoDG ddPCR System, which uses the company’s droplet digital PCR technology, and the QXDx BCR-ABL %IS Kit received FDA clearance. The system and kit, when used together, can monitor molecular response to treatment in patients with chronic myeloid leukemia. “Bio-Rad is proud to announce our first FDA-cleared liquid biopsy test in oncology,” ...

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Newsbytes, 10/15

October 2015—A decade later, online laboratory handbook gets makeover: Ten years ago, when Massachusetts General Hospital created an online laboratory handbook, the event crowned many hours of programming and coding by a team of pathologists, who were convinced their labors would dramatically streamline access to information.

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