June 2017 Product Focus – Analyzers (plus New Products)

May 23, 2017
Cell counter for CSF

The GloCyte Automated Cell Counter for CSF is an FDA-approved analyzer that delivers consistent TNC and RBC counts and timely turnaround with just 30 µL of sample per test. It uses a novel combination of fluorescence imaging technology and a one-of-a-kind sample cartridge. It is linear down to 0 cells/µL for both TNC and RBC and reduces manual mistakes. AI Companies

Automated ESR analyzer

The iSED is a fully-automated ESR analyzer that is capable of analyzing samples in 20 seconds, using just 100µl of blood directly from the primary EDTA collection tube. The 20-position iSED has a continuous, random access feed and is also compatible with BD Microtainer MAP Microtubes without any additional sample manipulation, making it effective for pediatric testing and avoiding QNS issues. No batching, pipetting, sample splitting, or duplicate primary tubes are necessary. The analyzer interfaces with any LIS, measures 14.3 x 10.5 x 13.4 inches, and is manufactured in the United States. ALCOR

Clinical chemistry system

The ACE Axcel Clinical Chemistry System offers advances that enhance in-office laboratory testing. Its comprehensive menu of routine and specialized assays provides an effective tool in the diagnosis and management of diabetes, heart disease, metabolic syndrome, and anemia, as well as other diseases. Processing up to 285 tests/hour, the ACE Axcel offers touch screen functionality, an intuitive user interface, and Internet connectivity, with no external water or waste supply required. Alfa Wassermann

Simplified urinalysis testing

The AUTION HYBRID AU-4050  is a fully automated and integrated urine analyzer that consolidates two technologies to perform urine chemistry and sediment analysis. The compact analyzer measures 31.5 inches wide. This provides the ability to standardize technology throughout a healthcare network. The hybrid analyzer employs flow cytometry technology to reduce subjective sediment interpretations. Superior bacteria detection is achieved with a dedicated reaction chamber, specific stain, and amorphous interference removal. Along with reduced subjectivity, a reduction in hands-on time can be seen with auto-verification rates up to 92 percent. ARKRAY

Helicobacter pylori test

AutoGenomics Inc. has developed a test to detect Helicobacter pylori and mutations at 2142G and 2143G on the 23S Ribosomal RNA. Several publications indicate that these mutations are responsible for causing resistance to clarithromycin, the first line drug prescribed for eradicating H. pylori.  The INFINITI H. pylori QUAD Assay can be performed on AutoGenomics’ INFINITI Plus and INFINITI High Throughput System (HTS), which utilize a proprietary multiplexing microarray technology. The INFINITI H. pylori Assay is for Research Use Only and not for use in diagnostic procedures. AutoGenomics is currently conducting clinical studies for 510K submission for this assay to the FDA. AutoGenomics

Multiplex testing includes QC

The BioPlex 2200 System combines proprietary random access multiplex testing with innovative software and QC features to maximize workflow and ensure result accuracy. Fully automated, it eliminates batch testing, providing reproducible results with fast turnaround times. This System supports a variety of autoimmune, infectious disease, and specialty assays, such as the fifth-generation HIV Ag-Ab assay and the Vitamin D assay.
BioPlex immunoassays use magnetic beads infused with fluorescent dyes and coated with Ag/Ab ligands, allowing simultaneous detection of multiple analytes from a single sample. The BioPlex 2200 can process a minimum of 150 individual bead results per assay. BioRad

Immunoassay instrument based on CLEIA

The LUMIPULSE G1200 is a robust, mid-sized, fully automated immunoassay instrument based on CLEIA (chemiluminescent enzyme immunoassay) technology. This unique and user-friendly system includes features to simplify workflow with continuous access loading and unloading of samples. Other features include disposable tips to eliminate contamination and sample carry over, a unitized test cartridge to reduce waste of reagent and eliminate cross contamination, 120 tests/hour, 30 minute time to result for all assays, stand alone or capable of connecting to track systems, and faster calibration using less reagent (most assays use 2-3 point calibration). Fujirebio

Blood lead analyzer

These FDA-approved blood lead analyzers use electrochemistry to provide quantitative results in three minutes, using just 50 µL of blood. LeadCare Ultra offers throughput and convenience for high-volume clinical labs, while LeadCare Plus makes it cost-effective for labs to bring lead testing in house at virtually any volume. These compact systems feature electronic calibration, require no set-up or routine maintenance, and don’t need highly trained staff to operate them. LeadCare II is a CLIA-waived blood lead analyzer for use at the point of care. Magellan Diagnostics

800 photometric tests per hour

The BA-800M Chemistry Analyzer was launched in early 2017. The analyzer offers a throughput of 800 photometric test results per hour and an overall throughput of 1,200 tests per hour with ISE. The Sample Delivery Module offers 440 sample positions, providing large volume laboratories hours of unmanned operational time. The design of this analyzer minimizes reagent usage per test, insuring that the laboratory is recognizing the lowest operating cost per test. The BA-800M can be twinned to increase the capacity for labs with expanding test volumes. The advanced features of the BA-800M Analyzer provide the laboratory with smooth and enhanced operational and workflow efficiencies. MedTest

Cardiac biomarker analyzer

This cardiac biomarker analyzer is available in the U.S. with a 5.1 percent CV for Troponin I at the 99th percentile cutoff.  With the flexibility to run whole blood or plasma samples, PATHFAST allows for up to six simultaneous tests in under 17 minutes. The test menu includes Troponin I, CK-MB, NTproBNP, D-Dimer, hsCRP, and Myoglobin. With measurement unaffected by hemolysis (up to 1000 mg/dL), results can be obtained quickly and with accuracy and precision. PATHFAST

Chemiluminescence-based immunoassay

The FastPack IP is a chemiluminescence-based immunoassay analyzer that is designed for the physician’s office laboratory. With its simple three-step operation (pipette sample, load the pack, press RUN) and its rapid turnaround time (7-12 minutes depending on assay), the FastPack IP will fit into any workflow. The system’s menu consists of Vitamin D, Testosterone, PSA, TSH, T4, and hCG. The FastPack IP minimizes the need for callback of patients as it allows diagnosis and treatment in a single visit. Sekisui Diagnostics

POC PT/INR coagulation analyzer

The Xprecia Stride Coagulation Analyzer is a POC PT/INR device cleared by FDA based on the new rules published in March 2016. It delivers fast, reliable Prothrombin Time/International Normalized Ratio (PT/INR) testing for POC monitoring and management of oral anticoagulation therapy with warfarin, a vitamin K antagonist. No bigger than a smartphone and weighing just 10.5 oz., the Xprecia Stride Coagulation Analyzer can be brought directly to the patient’s finger for efficient and comfortable blood sample application. The analyzer uses fresh capillary whole blood, and results are expressed as INR. It utilizes the same Dade Innovin reagent used by Siemens Healthineers central lab analyzers to minimize any potential for variability. Studies have shown the performance to be equivalent to a reference laboratory hemostasis system, with results available within minutes. Siemens Healthineers

Compact chemistry analyzers

The Indiko series, Indiko and Indiko Plus, are fully automated random access bench-top analyzers. Analyzer, system reagents and consumables form a fully supported system for therapeutic drug monitoring and drugs of abuse testing. The user menu is intuitive, and the continuous way of working, adding samples, reagents, and cuvettes without interrupting the ongoing analysis, gives walk-away freedom. The low-volume cuvette design enables small sample and reagent volumes and minimal water consumption. On-board sample capacity is up to 108, and any mix of sample cups or tubes can be used. Thermo Fisher Scientific

New Products

Forensic DNA grade consumables

A new product line sealed with the new purity grade “Eppendorf Forensic DNA Grade” complies with the stringent requirements of the recently released ISO18385. This standard specifies the demands on manufacturers of products which are used in forensic DNA laboratories to further minimize the risk of contamination. Eppendorf confirms the compliance for every production lot and provides lot-specific certificates. The comprehensive approach of this product line assures an excellent purity and performance level as well as optimized packaging that supports contamination and error-free handling. The Forensic DNA grade products encompass consumables for DNA extraction, sample processing, and PCR setup as well as for sample storage.

Tissue cassette printer

The Signature Cassette Printer is designed for use in pathology and histology labs to print high-resolution text, graphics and bar codes directly onto tissue cassettes. The increasing use of 2D bar codes for accurate specimen identification also requires the use of a latest-generation direct-to-cassette printer. The Signature Cassette Printer utilizes thermal transfer ink ribbons. Advantages include: 1) virtual silence while printing; 2) no smell or smoke; 3) does not require proprietary cassettes and no fume removal system is required; 4) no ink tanks or print heads that dry out, need maintenance, and have short expiration dates; 5) crisp, clear text, graphics, and bar codes that won’t smear or rub off during or after processing;  and 6) the ability to print color on white cassettes, eliminating the need for colored cassettes. An exclusive feature of the Signature Cassette Printer is that a smaller lab can start with the manual-feed SCP-M. When processing volumes increase, it can add the robotics module later. The same SCP-M printer is simply placed on top of the robotics module and connected via a USB communications cable.

Robotics and lab automation enclosures

SHEMCO enclosures are designed to enclose robots and other lab automated processes by providing exhaust air systems or HEPA filtered clean workstations. Robots are beneficial in many applications, and are proven to increase efficiency and productivity. Robots integrated into existing facilities are shown to increase output and improve quality, while providing additional flexibility in the production process. Enclosures are built to protect robotic processes from contamination and personnel from hazardous fumes. Utilizing a flexible, modular design, HEMCO Enclosures are engineered and built to exact customer size and design requirements. HEMCO offers a wide selection of standard sizes in vented or HEPA filtered models.

Centrifuge cell windows

A line of sapphire UV cell windows for Beckman centrifuges that simplify field replacement and are impervious to acids, alkalis, plasma, and body fluids are available from Meller Optics, Inc. of Providence, RI. These Sapphire Centrifuge Windows are resistant to most acids, alkalis, plasma, and body fluids, making them ideal for use where chemical-, scratch-, and high-pressure resistance are required. Ideally suited for Beckman centrifuges and similar instruments, they feature a scribed arrow on their edges to project the optic axis and simplify installation alignment. Available for OEMs and end-users, they measure 19.03 mm dia. ±0.03 mm by 5 mm thick ±0.10 mm and are offered wedged one or two degrees and plano; with chambers 0.35 mm x 45 degrees in two places; and have a 30-5 scratch-dig surface finish. For less demanding applications, windows made from quartz are offered with a 10-5 scratch-dig surface finish and a 16.00 mm central clear aperture.
Meller Optics, Inc.