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Bio-Rad Laboratories Enhanced Exact Diagnostics RP Positive Run Control

Bio-Rad Laboratories has launched an enhanced version of its Exact Diagnostics RP Positive Run Control for syndromic respiratory panels. The new version contains inactivated whole SARS-CoV-2 virus. Intended to monitor the performance of clinical respiratory panel assays, the positive control set now contains a total of 23 respiratory analytes in a single vial and can be used to assess the entire molecular diagnostic process, including extraction, detection, and amplification.

Thermo Fisher Scientific MagMAX Wastewater Ultra Nucleic Acid Isolation Kit

Thermo Fisher Scientific has launched the MagMAX Wastewater Ultra Nucleic Acid Isolation Kit. The kit is meant to support the efforts of public health laboratories and researchers who have been developing SARS-CoV-2 surveillance methods using wastewater to help identify asymptomatic carriers on college campuses, monitor regional spread among communities, and capture emerging viral mutations, the company said. 

The MagMAX Wastewater Ultra Nucleic Acid Isolation Kit is compatible with a range of input volumes from 200 µl to 500 mL, and works with various upfront concentration methods, including ultracentrifugation, precipitation, and filtration. For labs in need of an automated viral enrichment method, the MagMAX Wastewater Ultra Nucleic Acid Isolation Kit with virus enrichment uses Dynabeads technology to automate and streamline sample concentration.

Amprion SynTap Biomarker Test

Amprion has launched the SynTap Biomarker Test, a laboratory-developed test for the detection of a-synuclein aggregates, which is associated with a range of brain diseases. The test is for use in helping to diagnose synucleinopathies including Parkinson's disease, Lewy Body dementia, and multiple system atrophy. It can also help distinguish underlying synucleinopathies in other neurodegenerative diseases such as Alzheimer's disease. The test is based on Amprion's Seed Aggregation Assay, and it identifies prion-like a-synuclein aggregates in a few drops of cerebrospinal fluid. It is intended to be used with other clinical and diagnostic results to manage patients.

Hologic Novodiag Automated MDx System

Hologic announced the broad European launch of its Novodiag system, a fully automated molecular diagnostic system for on-demand testing of infectious diseases and antimicrobial resistance. The launch follows Hologic's acquisition of Mobidiag in June 2021 and will bring the benefits of the Novodiag system to a broader range of customers in Europe. The Novodiag system, launched on a limited basis in 2018, combines real-time PCR and microarray testing. Multiple pathogens can be identified in a single sample, providing a fast way to pinpoint patients most at risk with targeted and syndromic on-demand testing.

Transplant Genomics OmniGraf

Transplant Genomics has launched OmniGraf, a diagnostic that combines the company's TruGraf blood gene expression test and Viracor's Trac donor-derived cell-free DNA assays. For renal transplant recipients, OmniGraf Kidney represents the first diagnostic tool that combines cell free DNA and gene expression data, the company said. Combining gene expression and the donor-derived cell-free DNA testing capabilities enables Omnigraf Kidney to provide a comprehensive view of both subclinical acute rejection and clinical acute rejection. The test requires 6 milliliters of blood, which can be obtained via a routine phlebotomy draw.

Thermo Fisher Scientific SpeciMAX Stabilized Saliva Collection Kit

Thermo Fisher Scientific has launched the Thermo Scientific SpeciMAX Stabilized Saliva Collection Kit, which is designed to safely collect saliva for research. The kit preserves viral nucleic acids in a non-hazardous stabilization solution that inactivates common respiratory viruses for safer sample collection, the company said. It comes with an easy-to-use, spill-resistant funnel, a screw cap to secure the sample after collection, and a standardized size tube that fits into viral RNA extraction automation workflows for high-throughput sample processing.

The stabilized solution is non-hazardous, does not contain guanidinium to avoid interaction with bleach, and is compatible with all disinfection protocols. The stabilization agent preserves nucleic acid in saliva samples at ambient temperature for up to 14 days for RNA and viral nucleic acid, and up to two years for gDNA.

The new kit also complements Thermo Fisher's SpeciMAX Saliva Collection Kit for raw saliva, which the company released in June. Both products come individually packaged and barcoded, require just 1 mL of saliva, and are a standardized 6 mL size.

Veritas Intercontinental: MyPrenatalWES

Veritas Intercontinental has launched myPrenatalWES, a prenatal diagnostic test for pregnancies with a high risk of genetic alterations, for example those with fetal structural anomalies. The test sequences the fetal exome and analyzes the data for copy number variants and pathogenic variants in genes related to fetal anomalies.

Beckman Coulter DxU Iris Workcell

Beckman Coulter has launched its DxU Iris Workcell, a fully automated system to streamline the urinalysis workflow. According to the Danaher subsidiary, the platform can reduce manual reviews to 4 percent. Urinalyses comprise up to 30 percent of all samples received in the lab, many of which require a manual inspection. The DxU Iris Workcell reduces sample subjectivity and variability, resulting in faster turnaround time and improved test results, Beckman Coulter said. The system pairs its DxU 850m Iris or DxU 840m Iris urine microscopy analyzer with Arkray's Aution Max 4030 urine chemistry analyzer. The workcell was developed with proprietary digital flow morphology technology with auto-particle recognition software, which enables labs to deliver standardized results leveraging AI technology.

Ortho Clinical Diagnostics Immediate Spin Crossmatch Serology Test

Ortho Clinical Diagnostics has launced an Immediate Spin Crossmatch (ISXM) test on the company's Ortho Vision and Ortho Vision Max analyzers to help detect incompatibility between donors and recipients in blood transfusions. ISXM is a serological test used in blood transfusions to detect ABO blood type incompatibility between donor red blood cells and recipient serum or plasma.

Verichem Laboratories Electrolyte Standard Kit, ISE Standard Kit

Verichem Laboratories has launched the Electrolyte Standard Kit and the ISE Standard Kit. Both are liquid stable, ready-to-use kits with reference materials for calibration and calibration verification of clinical electrolyte testing systems. The Electrolyte Standard Kit contains chloride, ionized calcium, lithium potassium, and sodium and has a 21-month stability claim. The ISE Standard Kit contains chloride, litium, potassium, and sodium and has an 18-month stability claim. Both kits are free of azides, glycols, surfactants, and other potentially interfering substances. They also feature NIST-certified and traceable concentration levels, Verichem said.