American Association for Clinical Chemistry
Better health through laboratory medicine
New Products

Diasorin, Inc.


LIAISON® Rubella IgG

DiaSorin launched the LIAISON® Rubella IgG assay (PN 310460) on February 9, 2009, making the LIAISON® chemiluminescent platform the only fully-automated random access solution for consolidation of ToRCH testing on one platform. The LIAISON® Rubella IgG assay uses only 20µL of serum sample, while optimizing clinical laboratory efficiency and throughput by offering 35 minutes to the first result, throughput of 90 results/hour, and calibration stability of up to 4 weeks. Our exclusively designed Reagent Integrals house ready-to-use reagents is sufficient for up to 100 determinations and suitable for storage on-board the LIAISON® for up to 8 weeks.

Booth No. 1043  


LIAISON® HSV-1 and HSV-2

December 15, 2008, DiaSorin became the first and only manufacturer to offer fully-automated glycoprotein-G based type specific HSV assays. The LIAISON® HSV-1 and HSV-2 Type Specific IgG assays (PNs 310830/310620) show excellent sensitivity and specificity when compared with other commercially available type-specific HSV assays, in addition to improved ease of use and throughput with full automation and random access capability. The LIAISON® HSV assays optimize clinical laboratory efficiency with 35 minutes to the first result and throughput of 90 results/hour. Our exclusively designed Reagent Integrals contain ready to use reagents sufficient for 100 determinations with calibration and on-board storage stability of up to 4 weeks.

Booth No. 1043

Diazyme Laboratories


SMART Point-of-Care Testing System*

Diazyme’s new SMART point-of-care testing system provides a simple, rapid, and accurate platform for an ever growing number of general and special chemistry assays. The SMART requires minimal operator training and is easy to use and maintain. Calibration is by a lot-specific RFID card, which is included with each test kit for maximum convenience and accuracy. The Enzymatic Hemoglobin HbA1c assay is NGSP-certified and is not affected by hemoglobin variants such as hemoglobin S, C, and D. The system also provides accurate low-cost assays for homocystine and cystatin C. Additional assays are in development. *Pending FDA clearance.

Booth No. 2257 
 


Liquid Enzymatic Lithium

Diazyme’s new liquid-stable Enzymatic Lithium Assay provides improved reagent stability—2 month on-board stability and a dramatically reduced cost-per-test compared to current methods. The assay can be appliedto most common clinical chemistry analyzers with instrument specific packaging options, including Beckman-Synchron, Roche Hitachi, and Olympus AU Systems. The assay features excellent accuracy, precision, and offers an extended reportable range of 0.1–3.0 mmol/L lithium, reducing the need for retesting elevated patient samples. The method also demonstrates insignificant bias from indigenous ions and other interfering substances including hemoglobin, bilirubin, triglycerides, and ascorbic acid. Instrument parameters for most chemistry systems are available from Diazyme Laboratories on request.

Booth No. 2257


Liquid Enzymatic Plasma Myeloperoxidase (MPO) Assay*

MPO is emerging as a key cardiac inflammatory biomarker, and Diazyme’s new liquid Enzymatic MPO Assay is the first plasma MPO method that can be used on a wide variety of general clinical chemistry instrumentation. MPO activity is measured directly and the assay requires no special equipment or time-consuming off-line preparation steps thereby enabling true “stat” MPO testing capabilities. The assay measures only biologically active enzyme, which provides a unique clinical perspective of active inflammatory processes. The new method virtually eliminates concerns of interfering antibodies and cross-reacting proteins, providing improved test reliability and reduced interference. *Pending FDA clearance.

Booth No. 2257

Eurotrol, Inc.


pO2 AMR Validation Control

Hypoxic QC™ is the first pre-tonometered product of its kind to validate critically low (35mm Hg) and extra-low (15mm Hg) pO2 values. Hyperbaric QC™ is designed to validate the high (460 mmHg) and extra-high (710 mmHg) pO2 range. Together, these two products validate the full pO2 analytical measurement range of blood gas analyzers. Hypoxic QC features active hemoglobin buffering with 10-minute open ampule stability–making it well suited to perform method comparisons as well. The Hyperbaric QC is an aqueous formulation that validates high and ultra-high recovered values, making it ideal for cardiac cath labs and OR suites.

Booth No. 4005


GAS-ISE Hct QC

GAS-ISE HCT QC is the first all-in-one control product of its kind with pH, blood gases, electrolytes, metabolites, and hematocrit target values. Designed for i-STAT analyzers, the product eliminates the need to use two separate cartridges with each control check and cuts QC time in half. The product is available as a three-level QC, as well as a five-level AMR/linearity panel.

Booth No. 4005

Gems Sensors & Control


Fluidic System Engineering Design Services

 Engineered fluidic system designs from concept through product realization. Gems engineers have the experience and expertise to take your idea at any stage in its development cycle and design a simple module or a complex fluidic system. Services include: design documentation; verification; validation; project management; supply chain selection/certification; and design for manufacturability to reduce the overall product production cost. Our hands-on-experience and unique array of intelligent sensors provides medical OEMs and start-up companies with the resources needed to reduce development costs and speed time to market.

Booth No. 1840

Genzyme Diagnostics 


OSOM® ImmunoDip® Urinary Albumin Test

OSOM® ImmunoDip® Urinary Albumin Test is a rapid test for microalbuminuria. It aids in the early detection of kidney disease. The test device is simply placed in the urine sample for 3 minutes. Albumin >18 mg/L represents a positive result. Sensitivityis >99%, and specificity is 98%. CLIA-waived, room-temperature storage, and a shelf life of 18 months make this test convenient for both point-of-care and laboratories.

Booth No. 2845


Cystatin C Reagent

The Genzyme Cystatin C assay uses a colloidal gold methodology that is unique to the cystatin C marketplace and is intended for measuring cystain C in human serum, heparinized plasma, or EDTA plasma. The test uses a liquid-ready reagent and calibrator and is applicable to multiple chemistry platforms. It is easy-to-use with no additional preparation required.

 

Booth No. 2845

Grifols USA, LLC


Onko-Sure DR-70 ELISA Test

Recently, the AMDL Onko-SureTM DR-70® ELISA test received clearance from FDA as a colorectal cancer (CRC) monitoring test. The American Cancer Society states that CRC remains the second leading cause of cancer death in the U.S. despite monitoring. Onko-Sure is the first new cancer test to be approved by FDA for monitoring CRC since 1982 when carcino-embryonic antigen (CEA) was approved. In the early stages of CRC, 68–97% of biopsy positive patients are negative to CEA. The Onko-Sure test provides additional information for CEA-negative cancer patients. AMDL is an international biopharma company with operations in the U.S. and China. Grifols USA, LLC is the exclusive US distributor of Onko-Sure for the CRC indication.

Booth No. 655


Interlab G26 Agarose Gel Electrophoresis Analyzer

The Interlab G26 is the most compact and fully automated agarose gel electrophoresis analyzer available today. Interlab G26 offers a fast, secure range of high-clarity electrophoresis assays. Complete walk-away automation automates electrophoresis phases from sample applications to gel reading with no operator intervention. It features automated sample application with the ability to continuously load up to 8 gels for the same test or a range of assays. It is fast and easy, with minimal mouse clicks to start the analysis and initial 26 results within 38 minutes. The next gel is complete every 20 minutes. Data transfer to a PC is automated, providing easy data management as a result of innovative software. The unit has a compact, small footprint (34" x 20" x 21"), and it weighs 99 lb.

Booth No. 655

HYCOR, an AGILENT Technologies Division


Ultra-Sensitive EIA System

The new HYCOR Ultra-Sensitive EIA System is an automated, high-precision, high-throughput EIA platform with HYCOR’s full menu of allergens for accurate, cost-effective, and specific IgE allergy testing. The system meets all CLSI guidelines, is manufactured under QSR and ISO 13485, and is FDA cleared for quantitation of allergen-specific serum IgE. The outstanding low level measurement capabilities of the system allow early detection of low concentrations of allergen-specific IgE.

Booth No. 1149

IDEX Health & Science 


Rheodyne® TitanEZ Valves*

Rheodyne® TitanEZ™ valves are manifold-mountable, ceramic-on-ceramic, shear valves developed for the IVD market. One TitanEZ valve can replace many solenoid valves to effectively reduce OEM product cost and, in turn, reduce the total cost of ownership for the end user. Titan EZ valves offer the benefits of a ceramic valve at the price of a polymeric valve, as well as providing a reliable, low-cost alternatives to solenoid valves. Titan EZ valves are available in multiple configurations to meet the diverse needs of the IVD OEM market. Shown here is a TitanEZ valve attached to an Eastern Plastic’s manifold. *In development.

Booth No. 453

Immunodiagnostic Systems 


IDS-iSYS Automated Analyzer*

The IDS-iSYS Multi-Discipline Automated Analyzer is a closed, fully-automated, specialist’s immunoassay analyzer with the additional capacity to perform biochemistry andcoagulation tests. The system is intended for esoteric laboratories that have a high-volume immunoassay requirement and a need for reliable performance, fast turnaround time, and premier service. *Pending FDA clearance.

Booth No. 1643