Clinical Lab Manager
TECAN NGS DREAMPREP™
Tecan has announced the launch of NGS DreamPrep™, a fully-automated approach to nextgeneration sequencing (NGS) library preparation for research use. This new approach offers quality controlled, sequencing-ready NGS libraries in just a matter of hours, with minimal manual interaction and no sample loss. NGS DreamPrep™ is a full walkaway solution that combines the Tecan Fluent® liquid handler and Infinite® plate reader, together with Celero™ DNA-Seq and Universal Plus mRNA-Seq library preparation kits—an optimized solution that brings significant improvements in speed, flexibility, accuracy, and precision.
BIOCARE MEDICAL VALENT® IVD AUTOMATED STAINING PLATFORM
Biocare Medical, LLC has announced the release of the VALENT IVD automated staining platform, which merges high-throughput and quality staining with a powerful and intuitive user interface. VALENT overcomes the limitations of closed systems with its unique open platform, allowing reagents from multiple sources and providing toptier IHC results. It provides an easy-to-use fully automated platform, 48-slide capacity, multiplex IHC capability, and high-quality staining. With VALENT, the IHC protocol is completely automated, performing fast, non-toxic online deparaffinization and utilizing a novel, patent-pending, continuous antigen retrieval dispense technology.
DIASORIN MOLECULAR GROUP B STREP ASSAY
The FDA has cleared DiaSorin Molecular LLC’s new Simplexa™ GBS Direct assay for diagnostic use. Designed for use on the LIAISON ® MDX instrument, the highly sensitive assay enables qualitative detection of Group B Streptococcus (GBS) nucleic acid from 18- to 24-hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. Assay results can be used as an aid in determining the colonization status of antepartum women. The new assay can replace traditional culture testing methods and features an efficient, fast workflow.
SIEMENS HEALTHINEERS ASSAYS FOR INFECTIOUS DISEASE AND ONCOLOGY
Siemens Healthineers has achieved 12 pre-market approvals from the FDA for its infectious disease and oncology testing menu. This milestone means the company’s Atellica ® Solution now provides laboratories in the U.S. with a comprehensive menu on a single laboratory platform for patients’ in vitro diagnostic testing needs. The infectious disease tests new to the Atellica Solution include HIV (HIV Ag/Ab Combo (CHIV) and HIV 1/O/2 Enhanced (EHIV)) and Hepatitis B and C (Anti-HBs 2, HBsAg II, HBsII Confirmatory, HBc IgM, HBc Total, HBeAg, and HCV), and provide physicians with testing options for hepatitis screening, diagnosis, and monitoring.
BD PHOENIX™ CPO DETECT TEST
Carbapenemase-producing organisms (CPOs) represent a prominent antimicrobial resistance (AMR) threat to public health because these dangerous microbes are often resistant to nearly all available antibiotics. BD (Becton, Dickinson and Company) has received FDA clearance of the BD Phoenix™ CPO detect test, which will allow hospitals to identify infections caused by CPOs. The test may help hospitals contain the spread of AMR by shortening the time it takes to detect CPOs, thereby enabling the earlier implementation of infection control procedures and the initiation of appropriate antibiotic therapies designed for treating these infections. The test streamlines laboratory workflow by routine, concurrent testing of CPO and susceptibility to one panel. Conventional phenotypic methods for CPO detection can take up to 96 hours, whereas the BD Phoenix™ CPO detect test can accurately detect CPOs in under 36 hours.
BECKMAN COULTER DXONE WORKFLOW MANAGER
Laboratories today are under increased pressure to manage costs and resources, while balancing increasing test volumes. Beckman Coulter has announced the U.S. release of its DxONE Workflow Manager, the first and only cloud-based middleware offered by a major in-vitro diagnostics organization, designed to help low-volume laboratories deliver timely results for patient care by enhancing consistency, accuracy, and efficiency. With a limited number of middleware solutions on the market available to support low-volume laboratories, DxONE Workflow Manager fills an industry need to help these laboratories streamline workflow and maximize staff time. The system features an intuitive interface designed for ease of use, with visual cues that facilitate rapid decision making.
RENISHAW RA816 BIOLOGICAL ANALYZER
The new Renishaw RA816 biological analyzer is a compact benchtop Raman imaging system, designed for biological and clinical research. It enables biologists and clinicians to identify and assess biochemical changes associated with disease formation and progression, providing the full range of biochemical information without needing prior knowledge of specific molecular targets, or time-consuming labeling or staining. Users are able to reveal detailed information from biological samples, from the distribution of exogenous and endogenous compounds within tissue, to the detection of protein secondary structure changes due to drug interaction and tissue injury.
ORTHO CLINICAL DIAGNOSTICS VITROS® HIV COMBO TEST
Ortho Clinical Diagnostics has announced that its VITROS® Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS® HIV Combo test) received approval from the FDA for use on Ortho’s VITROS® ECi/ECiQ Immunodiagnostic Systems. The VITROS HIV Combo test was previously approved for use on Ortho’s VITROS® 5600 Integrated System and Ortho’s VITROS® 3600 Immunodiagnostic System. VITROS® HIV Combo, a fourth-generation test, detects both HIV-1 and HIV-2 antibodies and the p24 antigen. By detecting the antigen itself, rather than only the antibodies to the antigen, Ortho’s VITROS HIV Combo detects HIV-1 acute infection earlier than previous generations of tests.