American Association for Clinical Chemistry
Better health through laboratory medicine
2008 New Product Review

 


ADVIA Centaur ® System Cyclosporine Assay

The new ADVIA Centaur System Cyclo-sporine Assay from Siemens Healthcare Diagnostics allows lab professionals to mainstream immunosuppressant drug testing into routine workflow. With a simplified extraction method and fully-automated processing, test results can be reported in as little as 18 minutes. This one test can accommodate C0 and C2 testing and is highly specific to the cyclosporine parent compound. With cyclosporine testing from Siemens, you can be confident that you are assisting your physicians in providing optimal patient management. *Pending FDA clearance.

 


 
ADVIA Centaur® CP System HAV Assays 
 

ADVIA Centaur System HAV Assays (HAV Total and HAV IgM) are the first FDA-cleared hepatitis assays for use on the ADVIA Centaur CP Immunoassay System. Availability of ADVIA Centaur System HAV assays on the ADVIA Centaur CP Immunoassay System allows further consolidation of hepatitis and routine immunoassays for medium-volume labs. In a ReadyPack® format, the ADVIA Centaur Systems HAV assays are high performance and may also be used on the ADVIA Centaur and the ADVIA Centaur XP Immunoassay Systems. For the first time, high- and medium-volume labs may offer a testing service with concordant hepatitis test results. *Expected release: Summer 2008

 


ADVIA Centaur® System DHEAS Assay*

The new ADVIA Centaur System DHEAS Assay from Siemens Healthcare Diagnostics allows labs to optimize their fertility testing by further consolidating assays on a single platform. It features a wide reportable range, high specificity, and a turnaround time of 18 minutes or less. The new Siemens DHEAS assay is available for use on the ADVIA Centaur XP and ADVIA Centaur CP systems, meeting both mid-volume and high-volume fertility testing needs. It is the latest Siemens assay addition to a continually expanding fertility menu. *In development.

 


DCA Vantage™ Analyzer

Siemens Healthcare Diagnostics announces the launch of the DCA Vantage Analyzer, a POC diabetes patient management platform providing HbA1c, microalbumin/creatinine, and albumin-to-creatinine tests for diabetes management. The system delivers the simplicity and convenience required at the POC with no sample or reagent preparation steps. The DCA Vantage Analyzer also enables clinicians to quickly and accurately generate patient trending reports or view them onboard. Data can be shared easily with other caregivers with powerful features such as connectivity to LIS, operator ID entry, QC reminders, test lock-out, remote access, and adjustable correlation to reference methods.


ADVIA 2120i Hematology System

Siemens Healthcare Diagnostics introduces the next generation of practical automation for hematology with the ADVIA 2120i Hematology System. The ADVIA 2120i Hematology System combines proven flow cytometry-based analysis capabilities with an easy-to-use touch screen user interface to provide excellent first-pass efficiency. Reduced maintenance requirements and the SMART integrated slide making and staining of the optional ADVIA Autoslide make the ADVIA 2120i Hematology System an excellent choice to reduce manual steps in your lab. The ADVIA 2120i Hematology System uses the same reagents as the ADVIA® 120 Hematology System and is fully compatible with the ADVIA® LabCell® Automation Solution to adapt to various-sized testing environments.

 


Dimension® EXL TM with LOCI® Module

Siemens Healthcare Diagnostics is pleased to demonstrate the Dimension EXL with LOCI Module Integrated Chemistry System, the next level of proven, best-in-class chemistry and immunoassay integration available on a single platform. The Dimension EXL with LOCI Module Integrated Chemistry System will feature LOCI advanced chemiluminescence technology and will include automated calibration, control procedures, and alerts through the QCC PowerPak™ onboard system. With more than 90 available assays, the Dimension EXL with LOCI Module Integrated Chemistry System will provide chemistry and immunoassay testing on one analyzer for lower cost of ownership. *Expected release: October 2008
 


STAT-Site® M β-Hydroxybutyrate Test System

Introducing the STAT-Site M ß-Hydroxybutyrate test system, composed of a palm-size reflectance analyzer and reagent card that measures ß-hydroxybutyrate using a single drop of human serum or plasma. The test is important for the diagnosis of diabetic ketoacidosis (DKA) and monitoring the results of its treatment. Since ß-hydroxybutyrate is the most abundant and stable ketone body produced, it is the more reliable indicator of ketosis and is the ketone test recommended by the ADA. With quick and quantitative results, the STAT-Site M ß-HB offers several advantages over traditional testing, including an improvement in linearity when compared with its predecessor and negligible interference from other ketones. *Pending FDA clearance.
 


Streck Cell Preservative™

Streck Cell Preservative™ solution is formulated to stabilize cellular antigens for immunophenotyping by flow cytometry. Samples collected in Streck Cell Preservative are stable for up to 7 days at room temperature, allowing for convenient sample transport and storage. Data has been collected supporting the use of Streck Cell Preservative with bone marrow aspirates, tissue samples, and peripheral blood samples.


Cyto-Chex® BCT™ 

Cyto-Chex® BCT™ is Streck’s blood collection tube for the preservation of whole-blood samples for immunophenotyping by flow cytometry. This direct-draw blood collection tube contains a patent-protected preservative that maintains the integrity of cellular CD markers for up to 7 days. Patient samples collected in Cyto-Chex BCT are stable at room temperature for convenient transport and storage. FDA cleared for the collection, transport, and storage of HIV-infected patient samples, Cyto-Chex BCT preserves the HIV CD panel of markers for up to 14 days at room temperature.


A1c-Cellular®

Streck’s A1c-Cellular® is the only A1c control available with intact red blood cells. This innovative, patent-protected control tests the entire HbA1c procedure, including lysing of red blood cells. Controlling with A1c-Cellular ensures that the entire system, instrument and reagents, is working properly and providing accurate patient results. A1c-Cellular is appropriate for immunoassay and ionic exchange HPLC methodologies and is assayed for the Bio-Rad® D-10, Ortho-Clinical Diagnostics VITROS® 5,1 FS, Arkray Menarini ADAMS™ A1c HA-8160, Beckman Coulter® Synchron CX®, Bio-Rad® Variant II™, Dade Behring® Dimension, Roche Cobas INTEGRA®, and the Tosoh G7 and A1c 2.2 Plus instruments.

 


Safety-coated vacuum tube for ESR testing

Introducing a new safety-coated ESR-Vacuum Tube for erythrocyte sedimentation rate determination on the ESR-Auto Plus® and ESR-100 analyzers and the ESR-10 Manual Rack. Container Technologies Laboratory, Inc., an independent packaging consultant, reports that Safety Coated ESR-Vacuum Tubes are 10 times more impact resistant than glass collection tubes, significantly reducing accidental breakage. The Mylar® coating contains glass and blood specimens in the event of breakage, reducing the risk of injury from jagged glass edges and potential exposure to blood-borne pathogens. Samples collected in Safety Coated ESR-Vacuum Tubes exhibit the same stability characteristics as those collected in conventional glass.


nRBC-Chex for ADVIA®

nRBC-Chex for ADVIA is the first nucleated red blood cell (nRBC) control designed to verify the accuracy and precision of the nRBC enumeration of the Siemens Healthcare Diagnostics, Inc. ADVIA 2120. The assay provides nRBC percent values as well as total WBC and RBC values. nRBC-Chex for Advia will allow the clinician to control instrument-reported nRBC values without manual verification of a stained patient smear. Packaged in plastic, cap-pierceable vials for use with open- or closed-mode systems, nRBC-Chex for ADVIA offers a closed-vial stability of 105 days and an open-vial stability of 14 days.
 


The fe500pro

The fe500pro is a fully automated platform that meets the sample processing requirements of hospitals, research institutes, and other clinical labs. It’s a reliable workhorsefor the whole range of sample-handling tasks that are necessary before analytical testing in core departments. Its flexibility and modularity, along with the smallest footprint and most functionality of any pre-analytical instruments, mean it can be fitted into any existing laboratory setup to enhance the sample flow. Its unique security features increase sample security to new levels. The fe500pro—navigating you toward security and efficiency.
 


ESP600

The ESP600 instrument offers the laboratory a new, powerful level of ELISA microplate processing with four probes and an independent gripper arm that delivers fast pipetting. In roughly the same footprint asa standard four-plate microplate system, the ESP600 analyzer can process in a single run what four-plate systems often take two runs to complete. Eliminating syringes and disposable tips saves the laboratory thousands of dollars a year in operating costs. Combined with The Binding Site’s extensive menu and open system support, the ESP600 offers the mid- to high-volume laboratory a fast, flexible, efficient, and cost-effective ELISA processor.
 


Thermo Scientific Point of Care Controls

Thermo Scientific’s Point-of-Care Controls for near-patient testing in hospitals and physician offices focus on urinalysis, hemoglobin, and occult blood testing. The urinalysis control is a ready-to-use, liquid control that can be stored at room temperature for 6 months and works with most major brands. The hemoglobin control is a liquid, whole-blood control with 2-year, closed-vial dating; 60-day, open-vial stability; and 30-day, room-temperature storage. The occult blood control is the only commercial external control available on the market featuring a 12-month room-temperature storage and a 2-year shelf life.   


NanoDrop™ 8000 spectrophotometer takes full-spectrum 
 

The Thermo Scientific NanoDrop 8000 spectrophotometer takes full-spectrum UV/Vis absorbance measurements of eight 1-µl samples, such as nucleic acid and protein, within one 20-second measurement cycle. Researchers can now perform critical QC checks that were either difficult or not feasible using single-sample spectrophotometers or plate readers. The new Sample Position Illuminator keeps track of the samples to be measured from a 96-well plate by lighting up the wells from underneath. This new feature helps reduce human error and improves ease of sampling.
 


Emerging Assays

Thermo Fisher Scientific—Clinical Diagnostics is pleased to introduce the Emerging Assays product line. Eliminate the flame and consolidate your workstations with the Infinity™ Lithium assay. Increase the sensitivity of results and eliminate hazardous shipping requirements with the Enzymatic Creatinine and the erCRP assays. When patients are in crisis provide the best turnaround time and results to emergency room physicians with the Infinity ACE and PGB assays. Need a better and faster way to analyze kidney stones? Try our Oxalate kit. Reagent applications are available for most chemistry analyzers; contact our Clinical Chemistry Technical Support Department at 1-800-528-0494, Option 2.
 


Fluoro-Max™ Fluorescent Particles

Thermo Scientific’s Seradyn Fluoro-Max Fluorescent particles are monodisperse particles prepared by unique and proprietary emulsion polymerization methods. Available in both carboxylate-modified and streptavidin-coated versions, Fluoro-Max Fluorescent particles are made by dyeing OptiLink Carboxylate-Modified particles with europium chelate and are available in standard 0.1-μM, 0.2-μM, and 0.3-μM diameters. They are dyed internally to prevent dye leaching and to assure maximum surface immunoreactivity. These particles are excellent for quantitative membrane-based rapid assays, heterogeneous assays, luminescent assays, research applications, phagocytosis studies, cell surface markers, and pore size determination.
 


ST AIA-PACK cTnI

The new ST AIA-PACK cTnI 3rd-Gen assay is designed for in vitro diagnostic use for the quantitative measurement of cardiac troponin I (cTnI) on TOSOH AIA system analyzers. Cardiac troponin I measurements are used as an aid in the diagnosis of acute myocardial infarction. *Pending FDA clearance.


AIA-PACK RBC FOLATE

The new AIA-PACK RBC FOLATE assay is designed for in vitro diagnostic use for the quantitative measurement of RBC folate in whole-blood samples on TOSOH AIA system analyzers. Although serum folate offers a reliable test, it fluctuates in serum based on dietary changes. RBC folate, however, does not become depleted as quickly as serum folate, and is much more concentrated in serum. RBC folate concentration correlates well with other indices of folate deficiency, such as bone-marrow cell morphology and hematological changes, making RBC folate concentration a reliable indicator of folate status. *Pending FDA clearance.

 


Tosoh HpLC ANALYZER-G8

The Automated Glycohemoglobin Analyzer HLC-723G8 is the next generation HbA1c monitoring system from Tosoh Bioscience. With a fast analysis time of 1.6 minutes and direct determination of SHbA1c with less than 2% CV, the G8 provides the high level of speed and reliability that labs have come to expect from Tosoh products. The extremely compact G8 is about 20 inches in width, depth, and height and weighs only 75 lbs. Automated maintenance, simple operation, and a host of time-saving features all combine to make the G8 analyzer a highly evolved and efficient solution for HPLC testing. *Pending FDA clearance.


Genesys™ Neonatal Hb Variant Screening Systems

Trinity Biotech introduces the Primus GeneSys Neonatal Hb Variant Screening System, the first on the market to offer a fully automated approach for newborn screening while providing positive detection of key hemoglobin variants. Our new 2-minute HPLC neonatal assay provides automated sample handling, sample preparation, sample reporting, confirmatory analysis, cleanup, and shutdown. The system also automatically runs an 8-minute confirmation on the same instrument for all positive results detecting S, C, D, E, O, and Bart’s variants, plus many more hemoglobin variants. The GeneSys Neonatal Hb Variant Assay is one of three assays available on the Primus ultra2 platform.


 
TRI-stat™ POC A1c Analyzer
   

Trinity Biotech introduces the new POC TRI-stat instrument and A1care™ reagent kit for interference-free HbA1c testing. Small and portable for office-to-office use, the analyzer’s features include boronate affinity technology, three tests in 10 minutes, <1 minute operator hands-on time, a small, 4-µL sample from finger stick or venous blood, ready-to-use reagents, factory calibration, complete automation after sample addition, and optional output of results to a printer or computer. The system is NGSP certified and FDA cleared. The TRI-stat instrument provides a fast, easy, convenient, on-the-spot way to improve patient care. Other diabetes-related tests are planned for the TRI-stat platform.

 


The Destiny MAX

Trinity Biotech announces a new generation in coagulation testing, the Destiny MAX coagulation analyzer. Ideal for large-volume laboratories, the Destiny MAX performs mechanical, optical, chromogenic, and immunoturbidimetric assays while using only two consumables. This high-throughput system offers 350 tests per hour, cap piercing, and the ability to link to laboratory automated systems. The Destiny MAX has integrated many of the features of the MDA analyzer, including sample verification using Trinity’s blue dye technology. Features include ¼ volume reagent and patient sample usage along with a calibration system for coagulation that is unique to Trinity Biotech. *Pending FDA clearance.


Captia™ Syphilis-IgM Capture

Trinity Biotech is pleased to introduce the CAPTIA Syphilis-IgM Capture kit. This is the only FDA-cleared test that specifically measures IgM to T.pallidum. The test is objective, quantitative, and can be fully automated. The test can be used as an aid in the diagnosis of congenital syphilis; to help differentiate a past infection from a current or recent infection; and to detect the early, predominantly IgM antibody response associated with primary syphilis. Trinity Biotech is now the only company to offer the full spectrum of syphilis testing—syphilis IgG, polyvalent syphilis IgG, and IgM CAPTIA syphilis IgM capture.


Vitamin D Plus Low

UTAK’s low-level Vitamin D serum control contains both 25-hydroxy vitamin D2 and D3 at 10 ng/mL. This unique lyophilized control is made from 100% human serum and has a 24-month shelf life with a reconstituted stability of 25 days. This product is sold in 5x5-mL quantities. Supplies are limited.
 


HPX® Halogen Lamps
 

Introducing a new category of highly stable, UVA-enhanced lamps to Welch Allyn Lighting’s HPX miniature halogen product family. The lamps are available in wattages ranging from 5W to 20W, and their output extends from the 300- to 400-nm UV range into the near IR while retaining full spectral output. Bright, small, and efficient, these highly stable sources exhibit 0.05% or less output variation. Our UVA-enhanced HPX lamps enable next-generation devices, such as low-cost, POC, and portable analytical equipment. To best meet each customer’s requirements, our engineering team customizes wattage, output, lamp life, spectral characteristics, reflectors, bases, and optic.
 


Vapro®2

Wescor is pleased to announce the new Vapro 2 vapor pressure osmometer with automatic thermocouple cleaning. This small, bench-top vapor pressure osmometer measures the osmolality of any body fluid. The vapor pressure method determines osmolality in natural equilibrium, precluding cryoscopic artifacts due to high viscosity, suspended particles, or other conditions that interfere with freezing point determinations. The Vapro 2 is easy to use, calibrate, and clean, and it is extremely stable and accurate. The osmometer only requires a 10-µL sample with a measurement range of 0–3,600 mmol/kg.


OnCOPro™ 

Introducing the new OnCOPro colloid osmometer, a small, bench-top colloid osmometer for measuring colloid osmotic pressure (COP) for prediction, onset, and degree of edema formation. The new OnCOPro osmometer only requires a 200-µL sample with a measurement range of 0–100 mmHg. The reference and sample chambers are self flushing, and the instrument has automatic zeroing and calibration functions. The OnCOPro surpasses all others by virtue of its ground-breaking, flow-through sample and reference chambers, making it extremely easy to use and a reliable and accurate partner in your lab.