December 2016 Product Focus – POCT (plus New Products)

Wireless point-of-care system

The new wireless BD Veritor Plus System gives healthcare providers and laboratorians objective, lab-quality immunoassay test results within minutes. This fast and accurate CLIA-waived solution streamlines the point-of-care diagnostic workflow and allows providers to quickly review patient results and determine the appropriate treatment in a single consultation, while the patient is still on site. The new system can help detect infectious diseases such as influenza A and B, respiratory syncytial virus (RSV), and group A strep. BD Diagnostics

HbA1c analyzer

The Quo-Test HbA1c analyzer now comes with a connectivity package, using POCT1-A2 communication protocol as standard. Patient demographic information and additional test commentary can be added to each test result, using either the standard barcode scanner or the new add-on keyboard. This enables patient results to be linked and traced throughout the system. Operator IDs can be added to test results, significantly improving the traceability and security applied to every HbA1c reading. In addition to these functions, enhanced quality control is available with multiple user-defined QC lockout options, ensuring that tests can only be run according to localized QC procedures. EKF

Blood gas analyzer

CueSee Hypoxic is ideal for lowering the reportable range of pO2 down to ~15 mmHg on any blood gas analyzer. The buffered hemoglobin matrix provides high precision like that of patient samples. Its oxygenation curve allows for its 10-minute open ampule stability. Highly commutable to provide similar results on point-of-care and bench-top blood gas analyzers, it is suitable for quality control, method comparisons, and validating the low end of the Analytical Measurement Range (AMR), satisfying regulatory requirements for reporting critically low pO2 results. Eurotrol

Immunoassay analyzer

The FastPack IP System is a fully automated quantitative immunoassay analyzer designed for use in physician office laboratories. Utilizing sophisticated chemiluminescence technology, it provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button. It requires minimal space while offering a test menu that will make a clinical impact at the point of care. It also enhances practice efficiency and reduces labor costs; improves patient satisfaction; immediately adjusts therapy; is appropriate for small, medium, and large practices; and boasts an extensive testing menu for vitamin D, testosterone, PSA, TSH, FREE T4 and hCG.Sekisui Diagnostics

Multi-parameter hematology control

Para 4 is a multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Assays include: HemoCue B-Hemoglobin Photometer and Hb 201+ analyzer; Separation Technology, Inc. HemataSTAT II; Spun Hematocrit; and Phase Platelet (Low and Normal values only). Para 4 is available in plastic dropper vials for easy sample allocation with hemoglobin and hematocrit instruments, and is also available in glass vials for auxiliary methods. Para 4 has 110-day closed-vial stability and 14-day open-vial stability. Streck

Point-of-care analyzers

Samsung point-of-care analyzers provide fast, easy, and accurate whole blood testing. Thermo Fisher Scientific is the exclusive global distribution and development partner for the LABGEO portfolio:

1) LABGEOPT10 chemistry panels provide results in 7 minutes using 70µL sample.
2) LABGEOIB10 cardiac marker panels, PCT (sepsis), TSH, and ß-hCG provide results in 20 minutes using 500µL sample.
3) LABGEOHC10 (HC30A for USA) hematology analyzer provides results in 45 seconds using 25µL sample. FDA approval pending. Thermo Fisher

Point-of-care blood lead analyzer

LeadCare II is a CLIA-waived blood lead analyzer that offers a simple, in-office solution to determine a child’s blood lead burden. Using electrochemistry, the portable system features electronic calibration and test kits with everything needed for 48 tests. Now celebrating its 10th anniversary, LeadCare II is convenient—CLIA -waived and simple to use; efficient—three minute result while patient is in the office; accurate—quantitative result with 50 µL of blood; and reimbursable—CPT 83655. Magellan

Coagulation analyzer

The Xprecia Stride coagulation analyzer is a POC PT/INR device cleared by the FDA based on the new rules published in March 2016. It delivers fast, reliable Prothrombin Time/International Normalized Ratio (PT/INR) testing for point-of-care 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 Xprecia Stride 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

NEW PRODUCTS

Molecular flu/RSV test

With the flu season upon us, healthcare providers no longer need to choose between a fast test result or an accurate test result for patients who are suspected of influenza infection. Now, they can have both, with Xpert Xpress Flu/RSV from Cepheid, a new test that delivers reference-quality molecular test results in as little as twenty minutes. Xpert Xpress Flu/RSV is twice as fast as its predecessor, Xpert Flu/RSV XC, but has comparable performance characteristics. The new assay features a novel design, which employs multiple targets for each virus. The built-in redundancy provides very high test sensitivity, avoiding the impact of seasonal drift that has been a problem historically with molecular tests, while maintaining high specificity. This assay is the first in a series of tests from Cepheid that will deliver results in 30 minutes or less. It is available immediately in the EU and all countries recognizing the CE-Mark. Cepheid

pH bench meter

A new, high performance bench meter that provides accurate pH and ORP (oxidation-reduction potential) measurements and has a smart touch-screen interface is being introduced by Alliance Scale, Inc. of Canton, MA. The Alliance-Ohaus Starter 5000 pH Bench Meter has an IP54 ABS plastic housing for protection from water and dust and an in-use cover for extra working protection, along with a moveable standalone electrode holder. Featuring a 4.3” H backlit LCD color touch-screen, similar to a smart phone, it permits one-touch toggling of pH and ORP measurement modes and has RS232 and USB ports for GLP/GMP output with a real-time clock. Standard features include a 1,000 measurement memory, 10 sensors for calibration storage, eight predefined buffer groups, and three endpoint modes. Measurement range is -2.00 to 20.00 pH; -30° to 130°C; -2000 to +2000 mV with 0.001 pH; 0.01 mV; 0.1°C resolution. It operates on 9 vdc and includes an AC adapter. Alliance Scale

Blood glucose linearity and control kits

AUDIT MicroControls, Inc., has announced the following new additions to its complete line of calibration verification/linearity and daily quality control products. These ready-to-use liquid products are intended to be used with quantitative assays on clinical laboratory analyzers, simulating human patient samples: (1) The Linearity DROP LQ Blood Glucose is a ready-to-use liquid, consisting of five levels that demonstrate a linear relationship to each other when assayed for glucose. This product has an open vial stability of 7 days when stored at 2-8°C. (2) The Control DROP LQ Blood Glucose is a ready-to-use liquid, intended to simulate human patient samples for use as assayed quality control materials for glucose. This product has an open vial stability of 7 days when stored at 2-8°C. Audit MicroControls

IL5 high-speed camera

Fastec Imaging’s IL5 High-Speed 5MP Camera is easily mounted on a microscope, enabling users to record high-speed video of microscopic events. Both spatial and temporal magnification work in tandem to clarify understanding in applications such as microfluidics, where particles often move through the field of view very quickly. With four models to choose from, boasting crisp, clean video from 2560 x 2080 @ 230fps to 800 x 600 @ 1650fps, there is an IL5 to fit any application needs. All models record over 3200 fps at VGA resolution and more than 18,000 fps at smaller resolutions. Able to save images to an SSD or SD card while recording high-speed bursts of hundreds or even thousands of images at a time, the IL5 is always ready for the next high-speed snapshot. The IL5 is a cost-effective solution to record high-speed events for slow motion analysis. Built for flexibility and ease of use, the Fastec IL5 camera can be controlled over Gigabit Ethernet via Fastec FasMotion software on a PC/Mac or via the built-in web interface with a web browser on a PC, Mac, tablet, or even smartphone. Using the (LR) FasCorder Mode, users can operate the camera as a regular camcorder to record and pause as needed and follow the action, stop recording and review what they have, and then append additional footage at will, even after a power cycle. Unlike traditional high-speed camera systems that only record for a few seconds and require careful triggering, the IL5’s Long-Record (LR) option can record at high speed for many minutes at high resolutions, to many hours at reduced resolutions. Fastec Imaging