American Association for Clinical Chemistry
Better health through laboratory medicine
July 2007 Clinical Laboratory News: New Product Review

   
July 2007: Volume 33, Number 7

 

ProMag™ Highly Uniform Polymer-based Magnetic Spheres

The highly uniform, 3-µm ProMag polymer-based magnetic spheres feature a hydrophilic surface for low nonspecific binding in protein-based systems and superior handling without the use of surfactant. These high-binding beads are suitable for use across a range of research and diagnostic applications: from laboratory-scale work to more stringent requirements of high-throughput applications. Get noticeably decreased separation times, without breaking the bank.

 

New Development Service for ELISA Manufacturers

We now offer a cost-effective, custom-built development program to convert your ELISA to a lateral flow assay. This service allows manufacturers to access the growing and lucrative POC market, ensure market coverage both the lab and POC sector, maximize return on your current analyte, and find diversification in a highly competitive market. We are highly experienced in lateral flow test development and have a number of case studies featuring successful ELISA to lateral flow conversions that maintain high levels of sensitivity and specificity. For a practical demonstration on how rapidly and cost effectively we can help you meet your rapid test development goals, stop by our booth.

 


FACSCanto™ II Flow Cytometer

The new FACSCanto II system is the only FDA-cleared flow cytometer on the market with optional 8-color capability. It delivers industry-leading data quality on an easy-to-operate platform. With the FACSCanto II system's enhanced detection sensitivity, high speed, and automated sample handling, your laboratory is well positioned for the superior performance you have been looking for. Sign up for a demo of this high-performance flow cytometry system online at www. bdbiosciences.com/systemdemo.

 


UniCel® DxI 600 Analyzer

The UniCel DxI 600 analyzer is designed to bring exceptional productivity, a broad menu, and ease-of-use to today's mid-volume laboratories. Bar-coded, liquid, ready-to-use reagents can be loaded on the system quickly and easily. The system holds 50 self-sealing reagent packs, and operators can load all reagents and consumables ‘on-the-fly' without using the console computer, thereby minimizing manual intervention. The UniCel DxI 600, with a maximum throughput of 200 tests per hour and 3 hours of walk-away operation, uses the same chemiluminescent technology, the same reagent packs, and assay protocols comparable to the other analyzers in the Access® family—Access 2 and UniCel DxI 800.

 

Access® Inhibin A Assay

The Access Inhibin A assay is the first automated assay for the quantitative determination of dimeric inhibin A levels in human serum and plasma. The assay is used as an aid in the diagnosis and monitoring of various reproductive hormonal disorders. The assay delivers a time-to-first result in approximately 56 minutes and offers 28-day calibration and open-pack stability. The liquid, ready-to-use reagent features an analytical sensitivity of <1 pg/mL and total imprecision of =8% CV at inhibin A concentrations >30 pg/mL.

 

AutoMate™ 800 Sample Processor

When you need to improve lab efficiency, turn to the AutoMate 800 sample processor for an automation system that fits your unique requirements. The AutoMate 800 system has everything you need to streamline pre- and post-analytical processes and position your lab for optimal performance and labor usage. Features include: single point of entry; advanced, automated sample loading and sorting; fully integrated centrifugation for faster test turnaround time with less variability; through-the-label sample volume detection; decapper module for maximum efficiency and safety; intelligent aliquotting and tube labeling to ensure faster, more accurate secondary tube preparation; and intuitive software for ease of use.

 

ACLTM TOP CTS System

The ACL TOP CTS (Closed-Tube Sampling) instrument is a fully automated, user friendly system that helps high-volume labs maximize labor resources and improve patient care. The CTS feature eliminates the need to decap and recap, helping to increase productivity and improve operator safety. This state-of-the-art system provides clotting, chromogenic, and immunoturbidimetric testing capabilities with a complete menu of routine and specialty assays. Powerful and intuitive, the ACL TOP CTS system offers 24-hour, 7-day continuous operation without interruption to workflow, allowing your lab to increase testing efficiency and reduce turnaround time.

 

Automated Nucleic Acid Extraction Instrument

Introducing the UniCel® NsP 10, a small-scale automated nucleic acid sample preparation platform designed to streamline laborious extraction procedures in clinical laboratories. Extractions from one use, and quick solution for laboratories in need of nucleic acid extraction automation. The UniCel NsP 10 system will accept many specimen types and uses a variety of Agencourt® SPRI® chemistries in convenient, ready-to-use, prepackaged cartridges.

 

eLINE® Electronic Dispenser

The eLINE electronic dispenser provides all of the ergonomic benefits inherent in the state-of-the-art eLINE electronic line of pipettors. In addition to electronic tip ejection, a symmetrical, balanced, and lightweight design makes operator handling convenient and stress free. A rechargeable battery provides hours of uninterrupted, reliable power, and it is recharged directly by adapter, or alternatively, with the single- or four-position charging stands compatible with eLINE electronic pipettors. The eLINE dis-penser tip guide feature assists operators in the tip selection process based on volume and aliquots to be dispensed. The eLINE dis-penser operates with proprietary syringe tips.

 


BioPlex™ EBV IgG and EBV IgM Kits

Announcing the launch of the EBV IgG and EBV IgM kits for the BioPlex 2200 system. The BioPlex EBV IgG kit contains assays for VCA, NA-1, and EA-D, and the EBV IgM kit contains assays for VCA and heterophile antibody. The total EBV test throughput is in excess of 190 results per hour, making it the highest throughput EBV test system on the market. In addition, the heterophile antibody assay in the BioPlex EBV IgM kit represents the first time this test has been made available on a fully automated, random access system.

 

TOX/See™ Rapid Urine Drug Screen Instrument

The TOX/See instrument is a one-step, handheld, point-of-care device for the qualitative detection of 14 of the most commonly abused drugs or their metabolites in human urine. New tests for oxycodone, buprenorphine, and propoxyphene have been added to a test menu of 11 other drugs, which includes amphetamines, methamphetamine, MDMA, opiates, cocaine, PCP, THC, benzodiazepines, barbiturates, methadone, and TCA. With the ability to simultaneously detect 10 drugs in 5 minutes, the product is well suited for the needs of emergency departments. Test results can be read for up to 1 hour. The TOX/See device also features integrated test controls, easy-to-read results, and an 18-month shelf life.

 

AmpliTrol™ HPV Quality Control

The AmpliTrol HPV control is intended for use as an un-assayed, third-party quality control with in vitro diagnostic assay procedures for the detection of high-risk human papillomavirus (HPV) nucleic acid in cervical specimens with the Digene Hybrid Capture® 2 high-risk HPV DNA assay test system. Stored at 2–8°C, AmpliTrol HPV controls are liquid stable and can be used for 60 days after opening.

 

AmpliTrol™ III Quality Control

Announcing the addition of the AmpliTrol III quality control to a comprehensive line of liquid- stable, multi-analyte, unassayed, third-party quality controls. This product is designed for use with qualitative in vitro diagnostic procedures for the detection of human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV), and hepatitis C virus (HCV) nucleic acids in serum or plasma from donations of human blood and blood components. AmpliTrol III quality controls may be tested in the same manner as patient samples, including preparation, amplification, and detection procedures.

 

VIROTROL® I Quality Control

The VIROTROL I quality control is a multi-analyte, un-assayed, third-party quality control intended for use with in vitro assay procedures for determination of antibodies to human immunodeficiency virus type 1 (HIV-1), human T-lymphotropic virus type I (HTLV-I), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), hepatitis B core antigen (HBc), and cytomegalovirus (CMV). VIROTROL I quality controls are a liquid-stable product when stored at 2–8°C and should be sampled in the same manner as a patient specimen.

 

VIROTROL® Lyme Quality Control

The VIROTROL Lyme quality control is a reactive, un-assayed, third-party quality control for use with in vitro enzyme immunoassay procedures for determination of immunoglobulin G (IgG) antibodies to Borrelia burgdorferi. It is supplied as a ready-to-use, liquid-stable control that can be sampled in the same manner as a patient specimen. VIROTROL Lyme quality controls have a 2-year shelf life and a 60-day open-vial stability at 2–8°C.

 

VIROTROL® MuMZ™ Quality Control

The VIROTROL MuMZ quality control is intended for use with in vitro diagnostic enzyme immunoassay procedures for determination of immunoglobulin G (IgG) antibodies to mumps, measles (Rubeola), and IgG antibodies to varicella-zoster virus (VZV). The VIROTROL MuMZ quality control is a liquid-stable, multi-analyte, un-assayed, third-party quality control that is sampled in the same manner as a patient specimen. The controls should be stored in the refrigerator at 2–8°C. Their open-vial stability is 60 days.

 

in2it™ POC Analyzer

Introducing the in2it A1c point of care analyzer. This fully automated system is designed for simplicity, convenience, and speed in near-patient testing, providing results while the patient waits. The in2it assay requires only 10µL of capillary or venous blood and sues boronate affinity chromatography for results that are free from hemoglobin variant interference and traceable to the worldwide DCCT reference. The in2it analyzer is FDA cleared for prescription home use, CLIA waived, and qualifies for CPT code 83037, offering the maximum U.S. reimbursement limit of $21.06. The analyzer supports multi-language screen displays and offers computer connectivity for complete data management.

 

PR3100TSC Microplate Reader

The PR3100TSC instrument is an intelligently designed, compact, computer-driven microplate reader that measures the absorbance of specimens in 96-well plates. This reader is configured with an on-board, fully functional computer that allows the user to manage the instrument operation and data reduction. Included in the configuration are five pre-installed filters (405, 450, 492, 550, 620nm) that work directly with the reader. The broad colored touch screen, together with a wizard interface, offers comprehensive data reduction with a streamlined operation for all assays.

 

BioPlex™ 2200 Syphilis IgG Kit

Announcing the launch of the BioPlex 2200 Syphilis IgG kit, further expanding the infectious disease menu on the system. The BioPlex Syphilis IgG kit is the only Syphilis IgG-specific test available on a fully automated, random access platform and shows excellent clinical sensitivity and specificity when compared to traditional testing methods.

 

Medical Decision Support Software for BioPlex™ 2200

The new Medical Decision Support Software (MDSS) is designed for use with the BioPlex 2200 ANA Screen on the BioPlex 2200 System. This interpretive algorithm-based software is the first product of its kind to be FDA cleared for the purpose of correlating patient antibody results with specific autoimmune diseases. Using the BioPlex 2200 ANA Screen with MDSS, autoimmune laboratories will be able to provide physicians with valuable information on possible disease associations for patient antibody profiles—information that has never before been available through a clinical diagnostic system.

 

Complete Hepatitis Product Line

Announcing the launch of the new microplate EIA Hepatitis line (Hepatitis A and B): MONOLISA Anti-HBs™, MONOLISA Anti-HBc™, MONOLISA Anti-HBc IgM™, MONOLISA Anti-HAV™, and MONOLISA Anti-HAV IgM™. These are qualitative assays with common reagents, standardized procedures, and colored reagents for monitoring procedural steps. MONOLISA Anti-HBs is also quantitative when used with the calibrator kit. All assays are for manual and automated use. These five new EIA assays are part of a comprehensive hepatitis line expanding the current infectious disease menu of HBsAg, HIV-1, and HIV-2 assays.

 

MRSASelect™ Medium

Announcing the launch of a new chromogenic medium for the screening of MRSA (Methicillin Resistant Staphylococcus aureus) within 18–24 hours. The MRSASelect medium is a selective and differential chromogenic medium for the qualitative detection of MRSA. The test can be performed on nasal specimens from patients and healthcare workers to screen for MRSA colonization. MRSA will appear as pink colonies and non-MRSA organisms are inhibited or appear as white or colorless colonies. The MRSASelect medium does not require incubation beyond 18–24 hours, at which time positive or negative results can be reported.

 

VARIANT™ II TURBO Link System*

Announcing a new automated hematology and HbA1c testing solution that significantly improves laboratory workflow. Bio-Rad's VARIANT II TURBO Link integrates HbA1c testing into the HST-N hematology automation platform. Benefits include efficient sample handling through workstation consolidation; quality patient care by exposing potential variant hemoglobins that may interfere with other methods; and turnaround time improvements through automating data and sample decisions through the use of MOLIS WAM software. Improve your laboratory's performance by investing in automated Lavender Top Management™. *Pending FDA clearance.

 


Ultraflex™ III Novel Next-Generation TOF/TOF MS

The new ultraflex III instrument is the most advanced MALDI-TOF/TOF mass spectrometer yet for cutting-edge expression analysis and clinical proteomics, plus a broad range of other large molecule analyses. With unique smartbeam technology, the ultra-sensitive ultraflex III triples acquisition speed for advanced LC-MALDI workflow. Innovative features provide top TOF/TOF sensitivity and speed in LC-MALDI and MALDI molecular imaging where absorbing tissue areas are scanned with a tiny laser focus and adjustable repetition rates for maximum sensitivity. All-purpose WARP-LC™ workflow software supports intelligent, results-dependent LC-MALDI acquisition, protein sequence validation, PTM screening, and accurate, quantitative proteomics for all label chemistries.

 


Type 7616 Micro-Dosing Pump

The Type 7616 unit is a self-priming diaphragm pump with active inlet and outlet valves, offering medical product manufacturers precise dosing capability from 0.5 µL–6 µL per stroke. This bi-directional and low dead-volume unit offers a dosage deviation < ±1% per stroke. Additionally, the Type 7616 pump is more compact and less costly than most syringe and peristaltic pumps. Delivered volume with the Type 7616 unit is set via cycle rate and stroke adjustment. Wetted parts manufactured of highly resistant PEEK (body) and Simriz® (perfluoroelastomer seals) allow the unit to easily accommodate aggressive media.

 

Once Step Helicobacter pylori Antigen Stool Test

The new helicoCARE direct rapid test directly detects H.pylori antigen in stool samples. The test shows a sensitivity of 99% and a specificity of 95%, with an overall test time of 10 minutes. The helicoCARE direct is suitable for rapid POC H.pylori detection. It is CE marked and a 510(k) application has been submitted to the FDA. The complete kit includes sampling vials, test cassettes, and instructions for both patients and physicians.

 


QuantiFERON®-TB Gold Test

The QuantiFERON-TB Gold test is the new breakthrough blood test for tuberculosis that is set to revolutionize hospital and public health TB programs. More accurate, reliable, and convenient than the tuberculin skin test, the QuantiFERON-TB Gold test offers the ability to detect tuberculosis infection more specifically than previously possible, providing significant medical and economic benefits. The new test offers several important advantages over the 100-year-old skin test, including the fact that it is completely unaffected by an individual's BCG vaccination status and only requires one visit to perform. The added convenience of our In-tube format (currently under review by the FDA) means that QFT can be performed on anyone, anywhere.

 


Dual Path Platform (DPP™) Technology

The patented Dual Path Platform (DPP) Technology (US Patent #7,189,522) was developed as a platform for next generation, rapid diagnostic testing. This technology circumvents existing IP in the POC sector and offers a novel, low-cost, rapid technology as an alternative to established single-path, lateral-flow formats. Advantages of DPP technology include increased analytical and clinical sensitivity, multiplexing capabilities, and quantifiable results. The technology is available for application in diverse global diagnostic markets for human and veterinary assays, food safety, bioterrorism, environmental testing, and more. The company is seeking license opportunities outside of its core business focus.

 

Chemtrue® Rapid Diagnosis Intelligent Test Reader

The Chemtrue rapid diagnosis intelligent test reader is a new immunodiagnostic instrument mainly composed of a specialty optical fiber probe, monolithic processor, and IC card. It uses the principle of the reflected light intensity method to carry out semi-quantitative analysis for gold standard test bar (card). The lightweight instrument uses small volumes and features high sensitivity, rapid measurement, and simple operation.