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

   
July 2007: Volume 33, Number 7


CBC-LINE Ultra Low Reportable Range Kits

CBC-LINE Ultra Low Reportable Range and Ultra Low Plus RBC Reportable Range Kits offer a reliable method to establish a hematology analyzer's performance and reportable range at the very low end of the linear range for white blood cell, platelet, and red blood cell determinations. Linearity combined with independently verified and documented calibration is used to establish the range of the lowest patient values that can be accurately reported. Each multilevel kit contains gravimetrically accurate linear dilutions of cell concentrates. The dilutions are packaged in 3-mL pierceable tubes. An extensive Instrument Evaluation Report of the results is included at no extra charge with each kit.

 

CBC-5D Plus Retics Hematology Control

The CBC-5D Plus Retics hematology control is a tri-level, whole-blood control containing reticulocytes. It is designed specifically for Beckman Coulter™ hematology analyzers. Assay disks are provided for assay value uploading, and the vial labels are bar coded to allow the control sample values to load into the correct control file. The CBC-5D Plus Retics control is packaged in pierceable, screw cap 5-mL tubes and offers 14-day, open-vial and 105-day, closed-vial stability. A companion calibrator product, the CBC-CAL PLUS instrument, is available. The CBC-Monitor Online Quality Control Program is available to all CBC-5D Plus Retic control customers.


Cardiac Biochip for Early MI Diagnosis

With dedicated analyzers, biochip array technology enables the simultaneous measurement of multiple markers in a patient sample through specific capture antibodies fixed onto discrete test regions.The fully-automated, FDA-cleared Evidence® and the semi-automated Evidence Investigator™ integrated analyzers perform simultaneous quantitative detection of a wide range of protein analytes in a multi-analyte format. The cardiac biochip array measures carbonic anhydrase III, creatine kinase MB, glycogen phosphorylase BB, fatty acid binding protein, myoglobin (Mb), and troponin I (cTn I). Its diagnostic value for MI diagnosis has been tested in clinical settings. At 3–6 hours, the multimarkers outperformed troponin by 20% with a 90% diagnostic accuracy.


Xsera™ Rapid HIV-1/2 Antibody Controls

Introducing Xsera Rapid HIV-1/2 Antibody Controls for use with FDA-cleared, rapid HIV test kits. Xsera Rapid HIV-1/2 Antibody Controls are heat-inactivated, human plasma solutions, requiring no reconstitution. They feature a 2-year shelf life when stored at 2–8°C and may be stored at room temperature, up to 30°C, for 60 days after opening. The controls are provided in vials containing 1 mL of solution. Each kit contains one vial each of HIV-1 antibody-positive, HIV-2 antibody-positive, and HIV antibody-negative controls.


cobas® c 111 Clinical Chemistry Analyzer

The cobas c 111 analyzer is an automated system designed and manufactured specifically for small workload laboratories. The analyzer can perform up to 65 photometric tests per hour and 180 electrolyte tests per hour. With key components such as optics, reagents, ISEs, and calibrators taken from larger cobas Integra® and cobas blood gas systems, the cobas c 111 analyzer joins a family of analyzers designed to deliver consistent results from the smallest to the largest system. COBAS and COBAS INTEGRA are trademarks of Roche.

 

Next-Generation Analyzer

Announcing the launch of the MODULAR PRE-ANALYTICS EVO system. This system permits a lab to automate its sample preparation process, such as centrifugation, decapping, aliquotting, and barcode labeling, all enhancing the efficiency and productivity of the laboratory. This new system provides highly reliable pre-analytical processing while now allowing for the connection to second-generation, integrated analytics, the cobas® 6000 analyzer series. Automated pre-analytics, integrated chemistry and immunochemistry analytics, and middleware solutions form the foundation of the Single Solution.

 

The Roche D-Dimer Assay

Introducing the FDA-cleared Roche D-Dimer assay for the exclusion of DVT and PE when used in conjunction with a non-high, clinical probability assessment. The evidence for exclusion is supported by prospective management studies showing sensitivities and NPVs of 99–100%. Convenient and accurate testing using the Roche D-Dimer assay provides laboratories with results within 10–15 minutes. The Roche D-Dimer assay is easily integrated into the routine chemistry workflow with the choice of lithium heparin or citrated plasma sample types. Low CV's near cutoff, combined with a low detection limit, leads to more reliable and actionable results for physicians.

 

COBAS® AmpliPrep®/COBAS TaqMan® HCV Test

Introducing a new hepatitis C virus (HCV) monitor test for research use only (RUO) on the COBAS AmpliPrep / COBAS Taqman System. The COBAS AmpliPrep/COBAS Taqman HCV test is a nucleic acid amplification test for the quantitation of HCV RNA in human serum or plasma. Sample preparation is automated using the COBAS AmpliPrep instrument with amplification and detection automated using the COBAS TaqMan analyzer.

 

Elecsys Anti-HBs and HBsAg Assays

Introducing the Elecsys antibody to hepatitis B surface antigen (anti-HBs) and hepatitis B surface antigen (HBsAg) assays for use on the MODULAR ANALYTICS E170 analyzer. Electrochemiluminescence (ECL) technology delivers excellent analytical sensitivity and specificity on HBsAg and anti-HBs for the Elecsys 2010 and MODULAR ANALYTICS E170 analyzers. Standardization of 18-minute tests on the MODULAR ANALYTICS systems improves analyzer efficiency for optimal workflow of 170 tests per hour.

 

Mycophenolic Acid Assay

Introducing the first FDA-cleared mycophenolic acid assay for use on the COBAS Integra® and cobas c 501 analyzers. This fully automated assay measures total MPA in serum or plasma using IMPDH enzyme resulting in excellent specificity (cross reactivity to MPAG <0.1% and AcMPAg <7%), sensitivity (0.4 µg/mL), and precision (total imprecision CV<5%). Proven performance, with accuracy correlated to validated HPLC/LCMS methods, leads to accurate and reliable patient results. The 100-test reagent, with a 12-week, on-board stability and 5-week calibration frequency, offers a 20-minute, cost effective, and convenient method for measuring total MPA.

 

COBAS® AmpliPrep® Total Nucleic Acid Isolation (TNAI) Kit

From a global leader in clinical diagnostics comes another proven technology, the COBAS AmpliPrep Total Nucleic Acid Isolation kit. With all reagents, disposables, and software designed to work together to optimize performance, the kit offers automated sample preparation on an easy-to-use instrument. To eliminate contamination, the kit offers dedicated disposables and transport of samples through closed tubes.

 

Sera-Mag® SpeedBeads™ Magnetic Beads

Sera-Mag SpeedBeads particles are the newest entry in the Sera-Mag line of magnetic beads. These beads respond twice as fast to a magnetic field as our original Sera-Mag particles and are available in carboxylate-modified and streptavidin-coated versions. They are especially useful in clinical immunoassays where speed of response is important or for isolation from viscous solutions in molecular biology applications. The entire line of Sera-Mag encapsulated magnetic particles exhibit high-binding capacity, excellent stability, low nonspecific binding, exquisite sensitivity, and very slow settling rates. The new SpeedBeads will create improved immunoassay and molecular biology sample prep reagents.


Recapper RC 1200

The Recapper RC 1200 instrument is a bench-top or stand-alone unit that safely and rapidly recaps up to 1,200 screw cap or evacuated tubes per hour, reducing the risk of repetitive motion injuries and accidental exposures. The Recapper unit places a universal, anti-evaporation cap that accommodates tube diameters from 13–16 mm onto open tubes for storage. The RC 1200 system can be adapted to accommodate most linear analyzer racks, eliminating additional transfer of opened tubes, and multiple tube sizes and styles may be processed simultaneously with no prior sorting. Archiving caps are available in convenient bulk packaging. Minimal routine maintenance is required.


CAPILLARYS™ Hemoglobin Assay

By separating, detecting, and quantifying normal and variant hemoglobins, the CAPILLARYS Hemoglobin assay is designed to aid in the diagnosis of thalassemias and hemoglobinopathies. This assay has been adapted to the CAPILLARYS 2 capillary electrophoresis (CE) system in order to provide complete automation, high throughput of 34 per hour, and positive sample ID. Presumptive hemoglobin ID is facilitated by an onboard library, and results are presented with no extraneous peaks. CE technology provides a HR separation similar to IEF testing with accurate HbA2 quantitation in the presence of Hbs E and S, and enhanced detection of Hbs H, Bart's and Delta A2.


HIV-1 Seroconversion Panels*

Introducing the new BBI HIV-1 Seroconversion Panels for use in designing and developing assay formats, fine-tuning automation requirements, and evaluating or assessing assay performance and sensitivity. Each panel includes a set of serial bleeds from an individual plasma donor prior to and following the development of HIV markers. Panels are characterized for HIV-1 RNA, HIV-1 antigen, and anti-HIV, as these markers evolve from negative to positive, and are provided with a comprehensive data sheet containing test results from a wide range of commercially available test kits. *For research use only. Not for use in diagnostic procedures.


Cyto-Chex Blood Collection Tube

The Cyto-Chex Blood Collection Tube (BCT) is a vacuum-draw tube intended for whole-blood sample collection, preservation, and transport. The Cyto-Chex BCT is designed to preserve cellular morphology and cell-surface epitopes allowing for the characterization and enumeration of unique cell types, including rare or fragile cells. Recent studies demonstrate that tumor-specific antigens are preserved for up to 5 days in the Cyto-Chex BCT, but show degradation at 24 hours in a standard EDTA tube. The Cyto-Chex 10-mL BCT is the only product available for preservation of direct blood draws without significant dilution of the sample.

 

Cell-Chex Auto Body-Fluid Control

The Cell-Chex Auto control is the first body-fluid control for automated body-fluid analysis for use on the Abbott CELL-DYN 3200, CELL-DYN 4000, and CELL-DYN Sapphire, the Coulter LH750, and the Sysmex XE-2100 instruments. The Cell-Chex Auto control verifies the accuracy of the lower RBC and WBC linearity limits of the instruments' reportable range. All three levels of Cell-Chex Auto controls are lower than the low-abnormal level of daily hematology controls and calibration material. Cell-Chex Auto controls are available in 3-mL plastic, cap-pierceable vials. Each level is packaged separately and offers a closed-vial stability of 75 days and an open-vial stability of 30 days.

 

nRBC-Chex Control
 

The nRBC-Chex control for LH is the only nucleated, red blood cell control designed to evaluate the accuracy and precision of the Coulter LH 750/LH 755 hematology analyzer in its enumeration of the nRBC parameter. The assay provides nRBC percent values, as well as total WBC and RBC values. The nRBC-Chex control for LH 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 controls for LH offer closed-vial stability of 75 days and open-vial stability of 14 days.

 

Safety-Coated ESR-Vacuum Tube

 The new safety-coated ESR-Vacuum Tube for erythrocyte sedimentation rate determination is designed for use on the ESR-Auto Plus™ and ESR-100™ analyzers and the ESR-10 Manual Rack. 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, preserving patient samples for up to 72 hours when transported and stored at 2–10°C prior to analysis.


Synermed® IR500-II™ Biochemistry Analyzer

The Synermed IR500-II Biochemistry Analyzer performs 300 tests per hour on typical biochemistry profiles. The addition of the optional Integral-ISE-Unit can bring testing rates to 500 tests per hour, and Windows®-based software provides simplified test or profile selection for scheduling workloads. The IR500-II analyzer is designed to optimally use near-infrared chemistry methods in order to minimize interference from lipemia, hemolysis and icterus.


UF-1000i™ Fully Automated Urine Particle Analyzer*

The UF-1000i Fully Automated Urine Particle Analyzer utilizes fluorescent flow cytometry for accurate counts of urine particles. The analyzer classifies and enumerates RBC, WBC, EC, hyaline casts, and bacteria. It also classifies small round cells, path casts, crystals, yeast, sperm, and mucus and flaggs them at user-defined thresholds. Capable of processing up to 100 tests per hour, the UF-1000i uses intuitive software and a long-life, semi-conductor laser. Its streamlined design has a 30% smaller footprint than previous UF-series analyzers. The UF-1000i uses sophisticated reagents and two analysis channels, allowing for enhancement in the identification of urine particles with little tech intervention. *Pending FDA clearance.

 

Diesse™ VES-Matic Cube 200 Erythrocyte Sediment Analyzer

The concept of Lavender Top Management™ has been enhanced with the addition of the Diesse VES-Matic Cube 200 analyzer. This fullyautomated, random-access ESR analyzer can process up to 200 tests per hour. The VES-Matic Cube 200 analyzer tests primary tubes and is compatible with the sample racks from the Sysmex automated hematology line, as well as with other cell counting systems. This system utilizes an innovative new technology that improves ESR turnaround time by 60% with no consumption of sample. Patient results are normalized to the industry-standard Westegren method. The VES-Matic Cube 200 system is expected to launch in the third quarter of 2007.


FARRZYME™ anti-dsDNA Assay

The FARRZYME anti-dsDNA assay is the first dsDNA assay for in vitro diagnostic use cleared by the FDA for the quantitative measurement of specific high-avidity IgG autoantibodies against dsDNA. Studies have shown that high-avidity, IgG- specific, anti-dsDNA autoantibodies have a high correlation to SLE and lupus nephritis, as well as a relationship with disease progression. The FARRZYME assay is non-isotopic and is available in a convenient break-apart well format and is fully automatable.


QMS® Lamotrigine Immunoassay

Announcing the development of the QMS Lamotrigine Immunoassay for the quantitative determination of lamotrigine levels in human serum or plasma. This immunoassay is an aid in management of patients treated with lamotrigine anticonvulsant drug therapy. The QMS Lamotrigine assay is based on particle-enhanced turbidimetric principles and can be used on a variety of automated clinical analyzers. The regents, calibrators, and controls are liquid stable and easy to use. This immunoassay provides clinical laboratories with a simple, rapid, and precise lamotrigine serum level measurement.

 

QMS® Topiramate Immunoassay*

Announcing the development of the QMS Topiramate Immunoassay for the quantitative determination of topiramate levels in human serum or plasma. This immunoassay is an aid in management of patients treated with topiramate anticonvulsant drug therapy. The QMS Topiramate assay is based on particle-enhanced turbidimetric principles and can be used on a variety of automated clinical analyzers. The regents, calibrators, and controls are liquid stable and easy to use. This immunoassay provides clinical laboratories with a simple, rapid, and precise topiramate serum level measurement. *Pending 510(k) clearance.

 

QMS® Zonisamide Immunoassay

The new QMS Zonisamide Immunoassay for the quantitative determination of zonisamide levels in human serum or plasma is an aid in management of patients treated with zonisamide anticonvulsant drug therapy. The QMS Zonisamide assay is based on particle-enhanced turbidimetric principles and can be used on a variety of automated clinical analyzers. The regents, calibrators, and controls are liquid stable and easy to use. This immunoassay provides clinical laboratories with a simple, rapid, and precise zonisamide serum level measurement.

 

Reagent Microspheres

Designed to help improve your lateral flow test development, Thermo Fisher Scientific Reagent Microspheres have a new surface chemistry to offer in addition to the existing surfaces and colors already available. New amine-modified microspheres are now available in the Reagent Microsphere product line.


Glycohemoglobin Analyzer*

The G8 analyzer is the newest, state-of-the-art HPLC instrument. With demonstrated superior chromatographic resolution, the G8 analyzer retains the hallmarks of earlier models. Enhancements to the G8 model maintain the accuracy and precision required for HbA1c testing. The analyzer offers a help menu and reminder pop-up screens for ease of operation. Historically, our HPLC Analyzers have proven to have the lowest CV's of any available glycohemoglobin method. *Pending FDA clearance.

 

AIA-Intact PTH*

Introducing a new analyte to the AIA-Menu—AIA Intact PTH. The AIA-Intact PTH analyte will be available as a short-time assay with an incubation time of 10 minutes. The AIA-Intact PTH assay has the same dry reagent format as other AIA assays and can be used on all the AIA platforms. Combined with the small and compact AIA-360, the AIA-Intact PTH assay can be used as a STAT assay. The high throughput of the 600 II and 1800 systems can be used in a central laboratory for routine testing. * Pending FDA clearance.


TrepSure Syphilis Test

Announcing the introduction of the TrepSure syphilis test to the current line of infectious disease test kits. As a polyvalent assay, the TrepSure test detects both IgG and IgM, identifying syphilis at any stage due to its high specificity and sensitivity, both at 99.9%. A cocktail of recombinant antigens allows improved detection of syphilis with no false positives while robust “black and white” results allow increased reporting accuracy, alleviating “gray” results. Fully automated for greater throughput, the TrepSure assay includes bar-code reading for positive patient ID and LIS interface to download work lists and upload results.

 

CAPTIA Quantitative Qualitative Autoimmune Line

Announcing the introduction of a new family of innovative ELISA tests for diagnosis of autoimmune disease. With the option of either quantitative or qualitative interpretation, the CAPTIA kits include the new SACS (sample and assay check system) that cause a color change when sample is added. All kit liquids are color coded, and reagents are color coded with different caps. The kits share the same protocol, predilution ratio, and buffer, while also sharing the same calibrator range and cut-off value, except screening. Kits feature ready-to-use reagents and XS wash buffer that is more resistant to bacterial contamination often seen in automation.

 

TrinBlot™ Automated Western Blot Testing System

Introducing the TrinBlot System for automated Western Blot testing. Comprised of a processor and scanner, the system automates Western Blot testing for a significant reduction of technologist hands-on time. The processor automates the MarBlot™ Lyme tests using a tray that performs multiple assays simultaneously. Once processed, the scanner uses 3D scanning technology to digitalize test strips from the processor reaction tray to the main system. Interpretive software detects strip bands, precisely linking them to reference strips for results. Taken together, the TrinBlot processor and scanner provide a solution for digitalization, evaluation, and archiving of Western Blot products.

 

Destiny MAX Coagulation Analyzer

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


Custom Systems for Automated Chemistry

We offer a custom service for designing and building automated chemistry systems, such as proving an automated laboratory or polymorph screening. Current projects have full process flexibility and allow large numbers of experiments to run unattended. Systems automate process steps—liquid/solid additions, heating/cooling, agitation, sampling, and analysis—including novel non-invasive detection and analysis methods developed by our company. Where possible, existing instrumentation and labware are used to reduce development costs and simplify implementation. We have 20 years of experience in supplying automation systems ranging from benchtop to factoryscale.


Vitamin D Serum Control

The measurement of 25-hydroxy-vitamin D (25-OH-D), the main circulating metabolite of vitamin D stored in the human body, is useful for assessing vitamin D status in patients. The new Bi-Level Vitamin D Control is the perfect control for those users whose main goal is the accurate quantitation of both 25-OH-D2 and D3. Level 1 contains 25-OH-D2 and D3 at 30 ng/mL, while Level 2 contains 25-OH-D2 and D3 at 73 ng/mL. This lyophilized control has a 24-month shelf life with a reconstituted stability of 25 days. Each level is packaged in 5x5-mL quantities.


SCOUT DS Screening Device

The SCOUT DS instrument is a non-invasive screening device for type 2 diabetes and pre-diabetes. The SCOUT DS instrument provides results in approximately 60 seconds, and patients do not have to fast. In pre-market clinical trials, the instrument has demonstrated significantly better sensitivity than both fasting plasma glucose and HbA1c for diabetes and pre-diabetes detection. The SCOUT DS instrument measures advanced glycation endproducts (AGE's), a well-studied biomarker of diabetes complications.


PAPQUICK® Polychromatic Cytology Stain System

Announcing a major improvement on cytology staining—the PAPQUICK cytology stain system  With only three reagents, the PAPQUICK system allows all kinds of fixations, facilitating sample reading and interpretation. The system offers fewer steps, less reagents, in less time, plus any kind of fixation, even air drying. The PAPQUICK system reduces the number of steps by half and offers 90-second fixation in air-dried material and 4 minutes in wet material. The system also features great sharpness and cytoplasmic transparency with high definition of nuclear components.

 

HistoSonda®

HistoSonda probes are designed for in situ hybridization for detection of gene expression. HistoSonda probes are 200 to 700 nucleotides long, single-stranded, stable DNA fragments with high specificity and very high target detection. The probes are suitable for paraffin tissues, even archival samples, and are easy to include in routine IHC without using formamide, increasing target detection. A short protocol offers results in 3 hours, with 1-hour hybridization. They can be used for multiple myeloma and lymphoma diagnosis and classification, as well as for hepatocarcinoma and diseritropoïesis. Available HistoSondas probes include: kappa, lambda, EBER, serum albumin, the nowhere-else-available alpha, delta, epsilon, gamma, and mu heavy chains probes.