March 2018 Product Focus – IVD

The ÍSED Sedimentation Rate (ESR) Analyzer from Alcor Scientific is a fully automated ESR analyzer that samples directly from the primary tube, requires only 100µL of sample, and generates results in 20 seconds. The ÍSED can run up to 180 samples per hour. It has a 20-tube capacity and requires no preliminary mixing and no additional sample tubes. Alcor Scientific

The new AMPIPROBE Women’s Health Panel is a molecular diagnostic test that allows for the detection of 13 pathogens associated with women’s health and STDs on a single collection device. The Panel is a highly sensitive and specific multiplex nucleic acid amplification test developed with Enzo’s proprietary technology. It allows for the detection of bacterial vaginosis (BV), trichomoniasis (TV), vulvovaginal candidiasis (VVC), and STIs such as chlamydia trachomatis (CT) and neisseria gonorrhoeae (NG). Enzo

KRONUS offers a commercially available 3-Screen ELISA which allows for the simultaneous detection and measurement of autoantibodies to GAD, and/or IA-2 and/or ZnT8 in a simple, highly robust, user-friendly assay format. †For research use only. Not for use in diagnostic procedures. KRONUS

Available thru MedTest, the BA-800M Chemistry Analyzer has a throughput of 800 photometric test results per hour with an overall throughput of 1,200 tests per hour with ISE. The Sample Delivery Module provides a sample capacity of 440 positions, providing large-volume labs hours of unmanned operational time. The reagent consumption design minimizes reagent usage, resulting in the lowest consumption cost per test. Advanced features of the BA-800M Analyzer include: continuous reagent loading, reagent bubble detection, water quality monitor, one-key STAT touch button, probe liquid level detection, and sample probe clot and collision recovery, which provides the lab with smooth operational and enhanced workflow efficiencies. MedTest

Nova’s Stat Profile Prime features ZERØ maintenance cartridges and MicroSensor technology for exceptional value in a critical care whole blood analyzer. This design optimizes the life of each cartridge, improves uptime, and eliminates waste, downtime, and costs of older cartridge-based systems. The 10-test menu includes pH, PCO2, PO2, Na, K, iCa, Cl, glucose, lactate, and hematocrit. NOVA Biomedical

The cobas HPV test provides specific genotyping information for HPV 16 and HPV 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one test and from one patient sample. The cobas HPV test is performed on the cobas 4800 System, which offers walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up, and real-time PCR amplification and detection to help labs achieve maximum efficiency. The system also runs Roche tests for CT/NG (chlamydia/gonorrhea), HSV 1 and 2 (herpes simplex virus), MRSA/SA (methicillin-resistant Staphylococcus aureus and Staphylococcus aureus) and C. difficile, as well as BRAF, EGFR, and KRAS mutations. Roche

The ARKRAY ADAMS A1c HA-8180V is a fully automated analyzer that utilizes HPLC technology to perform HbA1C testing. The analyzer eliminates interference from most common hemoglobin variants and generates accurate, precise results. The HA-8180V has low precision claims (CV ≤1%), and provides clinicians confidence in results at critical decision-making levels to diagnose and treat diabetes. The analyzer is simple to operate; continuous sampling enables users to load racks and walk away. Automatic on-board sample mixing ensures that each sample is thoroughly mixed. Results are generated in ninety seconds. Intelligent result review eliminates routine chromatogram review. ARKRAY

Chronic myeloid leukemia (CML) is characterized by the “Philadelphia chromosome,” a translocation that results in BCR-ABL gene fusion. Tyrosine kinase inhibitors have transformed CML into a manageable chronic disease, but the standard of care for monitoring response, measuring BCR-ABL mRNA, falls short of clinicians’ needs. Current methods are not sensitive enough to determine whether a patient can discontinue therapy without risking disease recurrence. There also remains significant measurement variation between and within laboratories. The QXDx BCR-ABL % IS kit is a sensitive diagnostic that enable researchers to accurately measure deep molecular responses from the blood of CML patients, so it can better help clinicians in disease management decisions. Bio-Rad

The Atellica Solution is a highly flexible immunoassay and clinical chemistry solution featuring patented bi-directional magnetic sample-transport technology that is 10 times faster than conventional conveyors. The transport technology, together with a multi-camera vision system, intelligent sample routing, and automatic QC and calibration capabilities, gives laboratories independent control over every sample to speed patient results to clinicians.
Atellica Solution can handle more than 30 sample container types including pediatric and tube top sample cups that can be aspirated from the primary tube. Using the same reagents and consumables across different analyzer configurations, labs can streamline inventory control and deliver consistent patient results. Product availability varies by country. Siemens