Laboratory Data Management System
For small hospitals and physician office laboratories
AP-Visions LLC, Marco Island, Fla, introduces xLAB, a cost-effective solution for laboratory data management needs in small hospitals and physician office laboratories. The software supports a user-definable, single-screen order entry in a rules-based environment. It also provides full QC management with Levey Jennings graphs and Westgard rules. The xLAB software release is EMR-ready and includes support for multiinstrument interfacing along with interpretive reporting and reflex testing.
(714) 306-0996; www.ap-visions.com
High-Speed Live Microscopy Camera
Adapts to any microscope
SPOT Imaging Solutions, Sterling Heights, Mich, introduces the high-speed SPOT Insight Gigabit Camera, with 4-megapixel resolution and a large field of view that can be used in live microscopy presentations. The camera uses a Kodak 21.4-mm scientific CCD sensor. Fixed images can be captured in all common formats. Low-noise circuitry enables 14-frames-per-second live imaging, and the camera adapts to any microscope. The software interface controls the camera on PCs or Macs, providing a smooth live view of the microscope slides, even during zooming and focusing. Users can add measurements and annotate images live, increasing interactivity and engagement with the material.
SPOT Imaging Solutions
(586) 731-6000; www.spotimaging.com
Tissue Embedding Center
Four-line digital display
The Tanner TN1500 tissue embedding center from Tanner Scientific, Durham, NC, was designed from the ground up based on feedback from histologists. A four-line digital display allows for easier programming—all surface temperatures can be viewed and adjusted without the need to scroll. A fully adjustable cryo plate can be placed on the right or left side of the unit. A heated area in the front of the unit sits back to avoid arm burns. An adjustable-intensity bright LED light on a flexible tube can be placed according to the user’s preferences. The 2.6-gallon tank capacity holds about three full bags of paraffin.
(919) 309-0188; www.tannerscientific.com
The Alliance/OHAUS Pioneer Series analytical balance from OHAUS Corp, Parsippany, NJ, provides 1.0-mg repeatability and has selectable environmental settings to compensate for vibrations and other disturbances and adjust for slow-filling applications. To avoid sample contamination, the draftshield features removable glass panels and sliding doors that are easy to clean, while an up-front level indicator lets users quickly assure the balance is level prior to each use. Featuring a software reset menu, a combination of software and mechanical switch-lock menus, including calibration, the balance has user-selectable span calibration points, communications settings, and printing options.
(800) 672-7722; www.ohaus.com
Spacious UV Viewing Cabinet
Used for gel analysis
The CL-150 series of UV workstations from Spectroline, Westbury, NY, enables lab technicians to view, analyze, and photograph fluorescent samples with both epi-illumination and transillumination light sources. A removable bottom panel allows either unit to be placed directly over the transilluminator. The 25-watt white light bulb in the cabinet provides visible illumination for easy sample preparation. The spacious CL-150 cabinet is able to accommodate large electrophoresis gels and up to four 8-inch x 8-inch (20 cm x 20 cm) TLC plates. Felt curtains allow easy access to the cabinet interior while blocking out external light. The housing dimensions are 17.5 inches x 20.25 inches x 9.75 inches. Both cabinets are made out of rugged aluminum with a chemical-resistant polyurethene coating.
(800) 274-8888; www.spectroline.com
Makes frequently performed measurements easier
Sartorius, Bohemia, NY, has made its laboratory balance, Cubis, more user-friendly. Sartorius Q-Apps can now be installed on any Cubis balance to guide users quickly and easily in performing any weighing application. The new Q-Apps are available for weighing applications that are frequently performed, such as determination of the minimum sample weight according to the USP, differential weighing, formula or recipe management, average weight control, application-specific calibration, or easy pipette calibration. Once downloaded, they can be selected from the balance’s task list. Each application will guide the user step by step through the weighing process selected. Q-Apps ensure 100% compliance with SOPs (standard operating procedures) that specify workflow instructions and analytical methods, eliminating the need for additional checking of weighing results.
(800) 368-7178; www.sartorius.com/cubisindividual
FFPE DNA Extraction Kit
Uses purely mechanical processing
Covaris Inc, Woburn, Mass, introduces the single-tube FFPE DNA extraction kit. The kit provides an optimized reagent and protocol for high-yield DNA extraction from formalin-fixed, paraffin embedded (FFPE) tissue samples. Adaptive focused acoustic (AFA) technology is used to emulsify and separate the paraffin, while simultaneously rehydrating the tissue sample in an aqueous solution within a few minutes. Covaris Focused-Ultrasonicators enable the purely mechanical processing of the samples, eliminating the need for organic solvents. Large-molecular-weight DNA is efficiently extracted from FFPE samples with greater yield when compared to organic extraction with some other commercially available kits. The AFA-based kit brings standardization to a previously uncontrolled preanalytical preparatory step.
(781) 932-3959; www.covarisinc.com
Alpha-Tec Systems 5% Oxalic Acid
Reduces bacterial overgrowth
Used in conjunction with the Alpha-Tec Systems’ NAC-PAC line of digestion/decontamination, buffering, and resuspension reagents, 5% Oxalic Acid from Alpha-Tec Systems, Vancouver, Wash, optimizes decontamination conditions of specimens with P. aeruginosa. Pseudomonas aeruginosa is present in the respiratory tracks of approximately 80% of patients with cystic fibrosis, and isolates can survive the most commonly used sputum decontamination method [NALC with NaOH]. Studies have shown that combining the NALC-NaOH decontamination method with the oxalic acid treatment greatly reduced bacterial overgrowth and improved recovery of mycobacteria. The product is ready for use and can be easily incorporated into routine clinical testing.
(360) 260-2779; www.alphatecsystems.com
Direct-Draw Blood Collection Tube
Available in multiple configurations
Cyto-Chex BCT from Streck, Omaha, Neb, is a direct-draw blood collection tube for the preservation of whole-blood samples for immunophenotyping by flow cytometry. The preservative contained in the tube maintains the integrity of the white blood cell cluster of differentiation (CD) markers for up to 7 days at room temperature, allowing for convenient transport and storage. The new 2.0-mL draw tube is packaged in six- and 100-tube configurations. Cyto-Chex BCT is also offered in a standard 5.0-mL draw tube, packaged in six-, 25-, and 100-tube sets.
(800) 228-6090; www.streck.com
New Reference Resource for Soft Tissue Pathology Identification
Captures key morphologic patterns
A new medical reference book, Practical Soft Tissue Pathology: A Diagnostic Approach, published by WB Saunders, an imprint of Elsevier, Philadelphia, captures key morphologic patterns for a comprehensive range of common and rare soft-tissue conditions and assists in the interpretation of complex diagnostic puzzles. Authored by Jason L. Hornick, MD, PhD, assistant professor of pathology, Harvard Medical School, consultant in gastrointestinal pathology, Children’s Hospital, Boston, this addition to the Volume in the Pattern Recognition Series is extensively illustrated in full color throughout. Access to the entire 592-page text and image bank on Expert Consult online adds time-saving convenience.
(800) 545-2522; www.elsevier.com
Trio of assays for Z drug detection
Use urine and blood specimens
Randox Toxicology, Kearneysville, WVa, introduces three new ELISA testing kits for the detection of sedative drugs Zopiclone, Zaleplon, and Zolpidem. The kits detect Z drugs in urine and blood specimens. The Zolpidem ELISA offers a limit of detection (LOD) of 0.4 ng/mL in urine and 0.52 ng/mL in blood. The Zopiclone and Zaleplon ELISA kits are the first immunoassays available for the rapid detection of these drugs, the company says, noting that prior to their release, the only way to detect Zopiclone and Zaleplon was with timely chromatographic analysis.
(866) 472-6369; www.randoxtoxicology.com
New Seroconversion Panels
Provides patient samples for Hepatitis B, HIV
SeraCare Life Sciences, Milford, Mass, introduces three new seroconversion panels that provide difficult-to-find patient samples for Hepatitis B and HIV. The company’s newest offerings expand its line of seroconversion panels focusing on infectious disease. Each panel represents a single donor and demonstrates how that donor’s blood converts in the presence of the disease during the sample collection period, presenting a unique challenge to the assay. Each product’s data sheet provides a graphical depiction of the donor’s seroconversion, along with comparative data that enables customers to review their test results against the results of other industry assays.
SeraCare Life Sciences
(800) 676-1881; www.seracare.com
Specimen Preparation Reagent System
Reduces need to reprocess samples
Alpha-Tec Systems, Vancouver, Wash, offers NAC-PAC EA3, a complete specimen preparation reagent system to properly digest, buffer, and resuspend patient samples for lab analysis for the presence of Mycobacterium spp. Reagents found in this system improve the efficiency of AFB diagnostics and reduce the need to reprocess samples, by controlling pH throughout the entire specimen-preparation procedure with an integrated pH indicator to ensure a neutral patient sample is achieved. The system reduces cross-contamination and improves sensitivity and specificity of downstream diagnostic instruments while keeping costs and complexity low.
(360) 260-2779; www.alphatecsystems.com
Hemoglobin A1c Assay
Improved accuracy and precision
Beckman Coulter, Brea, Calif, has received FDA clearance for a new Hemoglobin A1c assay (HbA1c) with improved performance for standard use on the company’s UniCel DxC Systems. The HbA1c reagent has been designed and developed to improve accuracy and precision. It is standardized and holds a certificate from the National Glycohemoglobin Standardization Program. Features include ready-to-use liquid reagents for A1c and total hemoglobin; five-level calibrator set; no cross-reactivity with HbA1a, HbA1b, acetylated hemoglobin, carbamylated hemoglobin, and glycated albumin; and no significant interference from hemoglobin variants HbS, HbC, HbD, HbE, or HbF.
Beckman Coulter Inc
(800) 526-3821; www.beckmancoulter.com
Helps detect birth defects
The ARCHITECT AFP test from Abbott, Abbott Park, Ill, which might help detect serious birth defects and the progression of testicular cancer, has received FDA approval. Biomarkers, such as alpha-fetoprotein (AFP), are substances in the body that physicians can measure to identify the progress of diseases or conditions and to evaluate the effectiveness of treatments. The new assay runs on Abbott’s automated ARCHITECT i2000, i2000SR, ci8200, and ci16200 analyzers (instrument pictured, right). Test results, when used in conjunction with ultrasonography or amniography, are a safe and effective aid in the detection of fetal open NTD.
(847) 937-6100; www.abbott.com
Aspirin Effect Diagnostic Test
Measures aspirin therapy’s effect in cardiovascular disease
Atherotech Diagnostics Lab, Birmingham, Ala, expands its heart disease risk assessment with the AspirinWorks Test to complement its menu of cardiovascular disease risk assessment tests. More than one million Americans experience new or recurrent heart attacks each year. These at-risk individuals are candidates for aspirin therapy and should be tested for the presence or absence of the therapy’s effect. This test is used to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine, which aids a physician in the determination of aspirin effect. The test maximizes the value of the company’s proprietary VAP Lipid Panel and accompanying line of cardiometabolic disease diagnostics and management tests.
Atherotech Diagnostics Lab
(800) 719-9807; www.Atherotech.com
Urine-Based HPV-HR Assay
Test is noninvasive
Trovagene Inc, San Diego, introduces its urine-based HPV-HR (high-risk) assay, a molecular human papillomavirus (HPV) test. The noninvasive test is designed to identify the presence or absence of 15 known, high-risk HPV strains using proprietary DNA sequences. The Trovagene HPV-HR DNA test may improve the adoption and acceptance rate of HPV testing. For women who wish to avoid repeated physical exams, but still need monitoring for their HPV status, a urine-based HPV-HR DNA test can facilitate more comprehensive patient monitoring.
(888) 391-7992; www.trovagene.com/HPV
p40 Mouse Monoclonal Antibody
Applications in cases where p63 is often used
Biocare Medical, Concord, Calif, introduces a highly specific p40 mouse monoclonal antibody (IVD). Mouse monoclonal anti-p40 [BC28] demonstrated similar sensitivity and specificity as the rabbit polyclonal p40, staining 97% of cases of lung squamous cell carcinoma (SqCC) and 0% cases of lung adenocarcinoma (ADC) in an in-house study. The mouse monoclonal antibody has significantly less background and does not stain macrophages. p40 may have applications in cases where p63 has traditionally been used as an IHC marker.
(800) 799-9499; www.biocare.net
C. difficile Assay
Three-step sample-preparation process
Quidel Corp, San Diego, and Life Technologies Corp, Carlsbad, Calif, have received FDA 510(k) clearance to market the Quidel Molecular Direct C. difficile Assay with Life Technologies’ QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments. The Quidel assay kit includes an extraction-free, three-step sample-preparation process that requires no heat step, no timed step, and no centrifugation. This direct-to-amplification procedure allows the assay to generate a result in less than 70 minutes. This is Quidel’s first assay with a streamlined stool-processing procedure.
(858) 552-1100; www.quidel.com
RSV + hMPV assay
Can be batched alongside other Quidel assays
Quidel Corp, San Diego, offers the Quidel Molecular RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). The assay distinguishes between RSV and hMPV, two different viruses that cause respiratory infections with very similar symptoms. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing molecular testing infrastructure, such as Life Technologies’ Applied Biosystem 7500 Fast DX thermocycler. These reagents provide features that include simple transport and refrigerated storage (no freezer required), convenient workflow, and a short time to result. Because they share a common extraction protocol, the RSV + hMPV assay can be batched alongside other Quidel Molecular assays, such as the Influenza A+B PCR assay, in the same multiwell panel for customized multiplexing capability.
(858) 552-1100; www.quidel.com
Strep A and B Tests
Recategorized as moderate complexity
The illumigene Group A Streptococcus and illumigene Group B Streptococcus tests from Meridian Bioscience Inc, Cincinnati, have been recategorized by the FDA as Moderate Complexity under the Clinical Laboratory Improvement Amendments (CLIA). Moderately complex tests are assays that are considered to be simple and easy to use. Illumigene Group A Streptococcus is a qualitative molecular test for the detection of Group A Strep pharyngitis. Clinical studies have shown that illumigene Group A Streptococcus increased detection of positives by 53% over traditional culture in symptomatic patients. Illumigene Group B Streptococcus fully complies with the guidelines from the Centers for Disease Control and Prevention for the detection of GBS, and clinical studies have shown that broth enrichment, followed by testing with illumigene Group B Streptococcus, increased detection of true positives by 29% over traditional culture, thus allowing for appropriate treatment of mother at time of delivery and ensuring the best outcome for baby.
Meridian Bioscience Inc
(800) 543-1980; www.meridianbioscience.com
Eye Disease Genetic Test
Features 100% accuracy
Avellino Lab USA, Menlo Park, Calif, introduces the Avellino-GENE Detection System (AGDS) genetic test for Avellino Corneal Dystrophy (ACD), a disease that develops slowly in the eye, causing cloudiness at the center of the corneas that could lead to impaired vision or blindness. Carriers of ACD are at an extreme risk for experiencing eventual blindness should they undergo vision correction surgery, such as LASIK, LASEK, or PRK. While there is no treatment for ACD, Avellino’s test is able to detect the presence of the ACD gene mutation. A rare genetic mutation, ACD is found in an estimated one out of every 870 individuals, according to published research. The noninvasive AGDS test involves a mouth swab. The sample is sent to Avellino Lab USA, and, within 24 to 48 hours, the results are provided to the ophthalmologist, with 100% accuracy.
Avellino Lab USA
(650) 396-3741; www.avellinolab.com/us
Assayed Linearity Control Kit
Now assayed for UniCel HxH 800
CVA from Streck, Omaha, Neb, an assayed linearity control kit used to determine the patient-reportable range of three-part and five-part hematology instruments, is now assayed for the Beckman Coulter UniCel DxH 800, beginning with lot 3070. CVA establishes an instrument’s reportable range and verifies linearity, testing the extreme upper and lower limits of an instrument, assuring patient results are valid. Each kit has customized ranges appropriate for each instrument model and provides instrument-specific assay values for the white blood cell (WBC), platelet (PLT), red blood cell, and hemoglobin parameters. WBC and PLT parameters have extended ranges, providing values up to 410,000 and 3.5 million for instruments with extended linearities. CVA has open-vial stability of 5 days and closed-vial stability of 120 days.
(800) 228-6090; www.streck.com