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

 


Life Point. EMR

LifePoint.EMR is a suite of software interfaces, communications protocols, and applets that enable data exchange between electronic medical record (EMR) systems in physician offices and hospital/lab systems. Data is securely exchanged between our data center and each source system, then a queuing and data transformation processes transmits data to the appropriate destination(s). The suite comes with more than 50 pre-tested interfaces, monitoring tools, and agents that allow for expedited installations. Laboratory, radiology, pathology, microbiology, ER, CCD, and other results and orders are supported. HL7, XML, proprietary, PDF, and text formats can all be exchanged within the suite’s framework. LifePoint.EMR is a complete solution, requiring no VPN or third-party software to operate.
 


OneTouch® TGC® Advisor

Tight glycemic control creates extra work for hospital staff; therefore, products that facilitate its management are needed. That’s why LifeScan, Inc., is proud to present this new software program that measures and manages the information necessary for tight glycemic control programs. The OneTouch TGC Advisor, an upgrade for the OneTouch® DataLink® Data Management System, is configurable by location and reportable by patient. It generates real-time patient graphs and trend reports that can be distributed via e-mail. It also helps users assess protocol compliance and patient outcomes. The OneTouch TGC Advisor is a key component of LifeScan, Inc.’s Integrated IntelligenceSM solutions for improved clinical decision making.

 


 
OneTouch® DataLink® Wireless V2
  

With this product, LifeScan, Inc., brings a new level of efficiency to the POC environment. Now, healthcare providers can enjoy flexible, secure wireless connectivity between OneTouch® Flexx™ Meters and the OneTouch® DataLink® Data Management System. The OneTouch DataLink Wireless V2 improves workflow and the data transfer process, with meter data reportable in near real time for enhanced clinical decisions. The OneTouch DataLink Wireless V2 is a key product component of LifeScan, Inc.’s Integrated IntelligenceSM solutions, providing healthcare institutions with the products and technology they need to advance care across the continuum.


StatusFirst® Drugs of Abuse 10 Panel

LifeSign introduces the StatusFirst Drugs of Abuse 10 panel test, a rapid, POC assay that is instrument read. A qualitative immunoassay for the detection of drugs-of-abuse in urine, the StatusFirst DOA 10 panel features a simple procedure: dispense two drops of urine into a StatusFirst DOA 10 device and then read the results in the DXpress® Reader in 5 minutes. The DXpress Reader eliminates operator subjectivity and provides a hard copy printout while delivering accurate results. The StatusFirst DOA 10 Panel features the following drug combination: MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP. A five-panel test is also available.

 


STATUS-COLON ASSURE

LifeSign introduces the CLIA-waived STATUS-COLON ASSURE test, a rapid POC assay. The STATUS-COLON ASSURE is a two-tier collection and testing system combining the traditional fecal occult blood detection (guaiac) method with immunochemical testing for the detection and confirmation of human hemoglobin on one test card. The iFOBT portion of the test has a sensitivity of 50 µg Hgb/g feces for a higher detection rate of colon disease. The combo test card can be stored up to 30 days at room temperature without affecting the results.


Horizon Anatomic Pathology™

McKesson’s Horizon Anatomic Pathology (HAP) application is the new, next-generation application developed by McKesson from the ground up for pathologists, histologists, and cytologists. Using an expert task-based workflow engine, it drastically improves efficiency, decreases turnaround time, and enhances communication among pathology areas. Incorporating industry leading technologies like barcode patient selection and embedded dictation, HAP significantly improves patient safety. The Virtual Slide Tray™ serves as the pathologist’s portal to receive and perform work from a single screen, including correlations, additional stains and recut orders, dictation, consultations, access to clinical pathology results, and digital images. HAP is integrated with McKesson’s Horizon Lab™.
 


StaRRsed Inversa 24M
 

The newly developed ESR analyzer performs blood sedimentation in accordance with the globally accepted Westergren method. A built-in barcode reader, printer, credit card charging system, QC program, and LIS connectivity make the StaRRsed Inversa 24M analyzer the ideal instrument for labs doing up to 150 ESR’s a day. It works with standard EDTA blood using an automated accurate dilution with citrate solution, so no special ESR tubes are needed. No disposables are required either because the StaRRsed Inversa 24M automatically cleans pipettes for reuse. The system performs 24 ESRs in 30 minutes, unattended, saving time and money.
 


SQA-V Gold Automated  Semen Analyzer

The SQA-V Gold analyzer is a high-performance sperm analysis instrument used to test male fertility. It provides a precise and accurate 75-second automated semen analysis and delivers 16 clinical parameters, including count, motility (A+B+C), morphology, velocity, and functional sperm. Updated features include: full dynamic range; autotransfer to the included data manager; user-friendly interface; and an improved visualization system..
 


Bottle Top Dispenser: MICROLIT

During the last 17 years, Microlit has emerged as a strong R&D-based and ISO- certified organization. A comprehensive range of CE-marked, liquid handling products include: Manual Micropipette, Electronic Micropipette, Electronic Pipette Filler, Micropipette stand and tips. Introduction of the new Microlit Bottle Top Dispenser at AACC completes the liquid-handling range of micropipette products. These general purpose, fully autoclavable bottle top dispensers are suitable for a wide range of routine lab dispensing. CE certified and conforming to ISO 8655 standards, each dispenser undergoes strict QC and has an excellent performance-to-price ratio.
 


Friend™ Cardiac Panel:heArt Square

This new-generation, FREND LOC-based immunoassay analyzer was developed with a new philosophy and technology. Sample volume is just 10 µL with a 5-minute time to result. This product is a total solution for labs and represents one of the leading near-patient testing instruments. Our first combination panel will be very valuable for ACS and AMI patients (CK-MB, troponin I, and myoglobin). Research and development will be continued for NT-pro BNP, D-dimer, DOA, and others.

Our first combination panel will be very valuable for ACS and AMI patients. The FREND Cardiac Panel includes CK-MB, troponin I, and myoglobin. The panels runs on the new generation, FREND LOC-based immunoassay analyzer. Developed with a new philosophy and technology, the analyzer uses just a10-µl sample volume, and the time to result is 5 minutes. This product is a total solution for near-patient testing. Research and development will be continued for NT-pro BNP, D-dimer, DOA and others.
 


StatStrip™ Glucose and StatSensor™ Creatinine

Nova StatStrip™ Glucose and StatSensor™ Creatinine monitors are two new handheld, whole-blood meters for POCT. StatStrip Glucose test strips feature new Multi-Well™measuring technology that creates a new class of analytical performance comparable to central laboratory testing. The StatStrip Glucose monitor measures and eliminates interferences from hematocrit, maltose, oxygen, acetaminophen, ascorbic acid, and uric acid, while the StatSensor monitor measures creatinine in whole blood in just 30 seconds and calculates eGFR by MDRD or Cockroft-Gault equations. The StatSensor Creatinine monitor’s small 1.2-µL sample volume allows easy and virtually painless sample acquisition from a finger prick.
 


NuAire’s SpinGard

NuAire’s SpinGard Large Capacity Tabletop Centrifuges offer faster speeds for optimum separation. The SpinGard allows instant rotor exchange in just a matter of seconds. The SpinGard centrifuges have automatic recognition of all the rotors and calculate the rotational speed. A duel-door lock and imbalance detector enhances the safety on each unit. All SpinGard units have a large LCD display for all the information, from diagnostic messages to the rotor library and running conditions.
 


Olympus AU3000i® Luteinizing Hormone Assay

The 28-minute, two-step, paramagnetic particle Olympus AU3000i LH assay determines quantitative concentrations of luteinizing hormone using 25 µL of human serum or lithium-hepari plasma. The measuring range is approximately 0.20–180 mIU/mL, and the expected working imprecision is ≤ 5% (total CV). Reagents are ready to use. Onboard reagent and open control vial stability are 28 days. Calibration frequency is 14 days.


Olympus AU3000i® Follicle Stimulating Hormone Assay
 

The 28-minute, two-step, paramagnetic particle Olympus AU3000i FSH assay determines quantitative concentrations of follicle stimulating hormone using 25 µL of human serum or lithium-heparin plasma. The measuring range is approximately 0.20–180 mIU/mL and the expected working imprecision is ≤ 5% (total CV). Reagents are ready to use. Onboard reagent, open control vial stability, and calibration frequency are all 28 days.

 


Olympus AU3000i® TSH Assay achieves 4th-Generation Functional Sensitivity

The 28-minute, two-step, paramagnetic particle Olympus AU3000i TSH assay quantifies concentrations of TSH using 100 µL of human serum, lithium-heparin plasma, or EDTA plasma. The measuring range is approximately 0.001–130 μIU/mL. Achieving 4th-generation functional sensitivity, the calculated functional sensitivity on an Olympus AU3000i system is 0.0013 mIU/L. Reagents are ready to use. Onboard reagent stability, open control vial stability, and calibration frequency are all 28 days.

 


Olympus AU3000i® Progesterone Assay

The 28-minute, competitive, paramagnetic particle Olympus AU3000i Progesterone assay determines quantitative concentrations of progesterone using 10 µL of human serum or lithium-heparin plasma. The measuring range is approximately 0.1–55 ng/mL, and the expected working imprecision is ≤ 10% (total CV). All reagents are ready to use. Onboard reagent stability, open control vial stability, and calibration frequency are all 28 days.

 


Olympus AU3000i® Thyroid Panel

The Olympus TSH assay has a measurable range of 0.001–130 mIU/mL and a func-tional sensitivity of 0.0013 mIU/mL. The T-uptake assay measures the saturation of thyroid hormone binding capacities in a patient specimen. When used with an Olympus Total T4 determination, the FTI can be calculated. Reagents are ready to use with 28-day stability for onboard. The calibration frequency is 28 days.


Olympus AU3000i® Prolactin Assay

The 28-minute, two-step, paramagnetic particle Olympus AU3000i Prolactin assay determines quantitative concentrations of prolactin using 50 µL of human serum or lithium-heparin plasma. The measuring range is approximately 0.05–300 µg/L, and the expected working imprecision is ≤ 7% (total CV). All reagents are ready to use. Onboard reagent stability, open control vial stability, and calibration frequency are all 28 days.

 


Olympus AU3000i® T-Uptake Assay

The 28-minute, one-step competitive, paramagnetic particle Olympus AU3000i T-Uptake assay quantifies the thyroxine binding capacity of serum or lithium-heparin plasma. The sample volume requirement is 15 μL. The Olympus T-Uptake results should be used with an Olympus Total T4 determination to calculate the FTI. Reagents are ready-to-use. Onboard reagent, open control vial stability, and calibration frequency are all 28 days.


Olympus AU3000i® Total ß-hCG Assay*

The 28-minute, two-step, paramagnetic particle Olympus AU3000i Total ß-hCG assay determines quantitative concentrations of total ß-hCG using 50 µL of human serum or lithium-heparin plasma. The measuring range is approximately 0.05–1000 mIU/L and the expected working imprecision is ≤ 6% (total CV). Reagents are ready to use. Onboard reagent stability, open control vial stability, and calibration frequency are all 28 days. *Pending FDA clearance.