Product Focus – ADLM Round-up

Sept. 30, 2024

Automated method for reliable cerebrospinal fluid cell counts

The GloCyteAutomated Cell Counter for CSF delivers accurate cell counts for cerebrospinal fluid (CSF) samples in under 5 minutes. By eliminating cell count variability and reducing the turnaround time on every sample, GloCyteaims to ensure reliable diagnostics and enhance both lab productivity and patient care.

Advanced Instruments

Ready-to-use daily quality controls

Control LQ HbA1c (K067M-8) is intended to simulate human patient whole blood samples for the purpose of monitoring the precision of laboratory testing procedures for the following assays: Glycohemoglobin A1c. Package Size: 8 x 1.0 mL. Vial Stability: 50 days at 2-8°C.

AUDIT MicroControls

Rapid AST results for bloodstream infections

VITEK REVEAL enables AST results directly from blood culture, delivering results in approximately 3 hours, according to BMX.1.129899 Clinical Trial Summary Report (proprietary, bioMérieux). Load after ~3 minutes of sample preparation. It offers antimicrobial coverage for gram-negative bloodstream infections. The design allows for high throughput in a small tabletop footprint.

bioMérieux

Next generation specialty immunoassay QC

Bio-Rad’s Specialty Immunoassay Plus (SPIA Plus) is a liquid immunoassay quality control designed to monitor the precision of laboratory specialty IA testing procedures. Available in barcoded, load-and-go InteliQ and standard vial Liquichek configurations; it features high-demand, clinically relevant analytes, including Procalcitonin, IL-6, Active Vitamin B12, TRAb, TSI, Fructosamine, and more.

Bio-Rad

Say goodbye to exhausting verifications

Validation Manager by BYG4lab is the first fully digital, centralized software for method verifications/validations, enabling laboratories to:

- Complete verification/validation projects 6x faster than with traditional approaches

- Reduce data management time by 95%

- Cut routine quality work by 20%

- Standardize quality verification/validation reporting across all departments

BYG4lab

Laboratory accreditation

COLA's accreditation program offers rigorous evaluation and support to medical laboratories. Our Surveyors and Technical Advisors take an educational approach to ensure adherence to quality standards, technical proficiency, and best practices. COLA accreditation aims to enhance patient care and safety by promoting consistent, accurate, and reliable testing processes in healthcare facilities.

COLA

Full-featured, customizable lab management software

With a user-specific, customizable homescreen, CGM LABDAQ is designed to streamline laboratory workflows and assist in maximizing reimbursements, connectivity, patient safety, regulatory compliance, data integrity, security, and scalability.

New in 2024, CGM LABDAQ v24.4 includes improvements to auditing, microbiology rules, and billing rules.

CompuGroup Medical

Addressing the challenges of immunofluorescence testing

The UNIQO 160 (model no. YG 2900-0101) is a fully automated system designed for immunofluorescence testing, processing up to 160 samples within one device. It supports a range of testing protocols, executes up to 18 workflows per run, and includes EUROLabOffice 4.0 software for seamless integration with LIS networks.

EUROIMMUN (Part of Revvity)

Detect the “Big 5” in 15 minutes

NG-Test CARBA 5, available exclusively in the U.S. from Hardy Diagnostics, is the only rapid, multiplex, phenotypic, lateral flow, FDA cleared assay capable of detecting KPC, OXA-48-like, VIM, IMP, and NDM carbapenemases produced by Enterobacterales and Pseudomonas aeruginosa. Detects the gene expression!

Hardy Diagnostics

DPYD mutation detection

The Seraseq DPYD DNA Mutation Mix (Material Number: 0750-9502) is a highly multiplexed reference material designed for the validation and performance evaluation of molecular assays, detecting 39 clinically significant DPYD gene mutations. It features variants at clinically relevant frequencies in a well-characterized genomic background (GM24385), verified by digital PCR and NGS.

LGC Group

Next generation hospital glucose meter

Nova’s Next Generation StatStrip Glucose Hospital Meter System, the only meter FDA-cleared for use with all critically ill patient samples, includes features that make hospital glucose testing easier and cybersecure. New features include a Linux OS, wireless charging, RFID data entry, sealed battery casing, hematocrit range 5% - 75%, and rugged external meter casing.

Nova Biomedical

Confidence in capillary sampling

Unistik 3 Side Activated Safety Lancets are designed to reduce pain for patients during sampling while giving healthcare professionals complete confidence and control during capillary blood sampling. Unistik 3 permanently retracts to help protect against accidental needlestick injuries and features laser-etched lot numbers for complete traceability.

Owen Mumford

The only FDA cleared POC hs-TnI

The PATHFAST Analyzer is designed to deliver quick, accurate, and dependable results to inform clinical decisions based on Chemiluminescence and Magtration technologies. PATHFAST runs the only POC high sensitivity Troponin I in the US, with 6% CV at the 99th percentile of URL, with optimal precision at very low concentrations in 17 minutes.

Polymedco

Higher collection and elution of specimens

Puritan sterile, patented HydraFlock featuring multi-length microfibers, each with a floret structure that effectively absorbs and elutes more specimens when compared to traditional spun fiber swabs. Available in various tip shapes and sizes, ideal for pediatrics, nasopharyngeal sampling, and several other collection sites when maximum absorbency and elution are required.

Puritan Medical Products

GMP compliant diagnostic lab management software

Sapio LIMS is an end-to-end informatics platform designed to support high-throughput clinical and molecular diagnostics labs. It is 21 CFR Part 11 and EU Annex 11-compliant and features a physician portal, automated accessioning and order processing, configurable no-code workflow creation, automated reporting, built-in scientific tools, and much more.

Sapio Sciences

Reduced turnaround-time for small clinical samples

The SARSTEDT Tempus600 is a dedicated system for sending specimen tubes quickly and reliably to the laboratory. Sample tubes are placed directly into a sending station and arrive within seconds to the laboratory for processing without carrier batching. Samples arrive continuously as sent, reducing peaks for faster, more predictable workflow.

SARSTEDT

Multiplex LC-MS/MS system

Shimadzu’s Nexera QX Multiplex LC-MS/MS System eliminates waiting for column equilibration and system flushing by using multiple, alternating sample introduction streams for continuous operation of the mass spectrometer. Dedicated software provides an automated single point of control for multiple UHPLC streams and the mass spectrometer for a multiplexed workflow.

Shimadzu Scientific Instruments

Meet demand, on demand

Atellica CI Analyzer with Sample Handler is a mid-volume integrated chemistry and immunoassay clinical testing analyzer, featuring a broad menu; advanced sample management functions built-in such as sorting, archiving, onboard refrigerated calibration and QC, decapping, and sealing.  The analyzer processes up to 1,120 test results per hour.

Siemens Healthineers

Compact HPLC analyzer for A1c testing

The Tosoh G8 Analyzer utilizes the Ion-Exchange HPLC method of HbA1c measurement with less than 2% CVs. Suitable for high throughput HbA1c testing in the laboratory or clinic environment, the Tosoh G8 is designed to provide a reliable, accurate, and precise result. The compact analyzer detects and presumptively identifies commonly occurring hemoglobin variants.

Tosoh

Clinical reference materials for urine chemistries 

VERICHEM offers clinical laboratorians an extensive line of liquid stable and ready-to-use biosynthetic clinical reference materials for the calibration verification of urine chemistry assays. This multi-level offering, with verified concentration levels, includes the analytes Albumin, BUN, Calcium, Chloride, Creatinine, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, and Uric Acid.

VERICHEM LABORATORIES

Hemolysis detection in POC blood gas testing

For the first time in point-of-care blood gas testing, hemolysis is flagged in just 45 seconds on the new GEM Premier 7000 with iQM3. Continuously monitoring the analytical process, before, during, and after each sample measurement, it detects, corrects, and documents sources of error, for quality-assured results.

Werfen

Molecular quality controls in swab format

ZeptoMetrix NATtrol Flu/RSV/SARS-CoV-2 positive and negative molecular control swabs are designed to provide accurate and reliable test results. Designed for convenience, these ready-to-use controls offer easy ambient shipping and storage. They are made with safe, non-infectious whole organisms that are designed to mimic a clinical specimen and can be used across various molecular testing platforms and assays.

ZeptoMetrix