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Product Releases



August 14--Complete Benchtop Lab Package from Carolina Chemistries

August 14, 2008--Carolina Chemistries (CLC) now offers a complete bench top laboratory package, perfect for any clinical laboratory. The package includes the BioLis 24i chemistry analyzer, the BC 3200 hematology analyzer and the Tosoh Immunoassay analyzer. CLC's chemistry analyzer, the BioLis 24i, offers a 100-plus test menu with a throughput of 400 tests/hour. The BioLis 24i uses barcoded and liquid ready-to-use reagents. The general chemistries cover all Comprehensive Metabolic, Basic, Hepatic, Renal, Anemia and Lipid Panel tests. Without any sample pretreatment, direct HbA1c and direct TIBC can also be performed on this instrument. Additionally, the BioLis 24i has permanent cuvettes and comes with a water system that eliminates shipping costs and storage space for cubes of water.

The BC-3200 Hematology Analyzer is known for its closed tube sampling technology. Tosoh's Immunoassay systems use a Unit Dose Test Cup reagent technology, which does not require on-board refrigeration, pre-mixing, and pre-measuring. This instrument also gives the lab fast and accurate results. CLC's complete lab is ideal for physician's office and small hospitals labs, as well as serving as back-ups for larger analyzers. 

www.carolinachemistries.com



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August 12--The Binding Site Offers Cystatin C Assay

August 12, 2008--The Binding Site (Birmingham, UK) announces FDA clearance of its Cystatin C assay for use on the Roche Modular Analytics instrument. This rapid and fully automated assay is an accurate marker of glomerular filtration rate. Cystatin C levels are independent of age, gender, muscle mass or inflammatory processes and are reliable for monitoring renal function. This kit uses a latex enhanced reagent for high specificity and sensitivity and excellent assay precision. The complete kit, including a human serum calibrator set, is provided in a ready-to-use format. 

www.thebindingsite.com



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August 11--Rees Scientific Introduces the Next Generation of Wireless Temperature Monitoring

August 11, 2008--The next generation of Rees Scientific's Wireless Environmental Monitoring provides data reliability, robust security, wireless flexibility and the expertise and support of the industry's premier provider of Environmental Monitoring Solutions. Key features include 2.4 GHz True Direct Sequence Spread Spectrum (DSSS) transmissions, Data Buffering at the transmitter level, ZigBeeTM Technology, Low Battery Alarm, and Reliable Two-way Communication with Self-healing Mesh Networks. V.2 Wireless is compatible with existing sensors and Rees Hardware.

Coupled with CentronSQL, our most powerful Environmental Monitoring System to date, Rees Scientific offers centralized Alarm Notification and Data Collection, Joint Commission, GxP, FDA 21CFR11 and USP <797> Compliance. Meet today's toughest regulatory standards with Advanced and Custom reports utilizing Crystal Reports, independent logging rates, graphical input status reports and scalable maps. Alarm notification via local sonic, relay, text messaging, telephone and e-mail notification combined with Web access ensures that the right people are notified and respond quickly wherever they are. 

A single system can monitor numerous departments within your facility whether they are on a different floor, in a different building or even in a different town. Each input can be assigned to a specific department and viewed only by the authorized users. This allows each department to handle its own alarms, generate its own reports, and use its own SOPs.

www.reesscientific.com



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August 11--Inverness Medical New Rapid HIV Diagnostic Test

August 11, 2008--Inverness Medical Innovations Inc. announces the introduction of its new fourth generation rapid HIV diagnostic test, the Determine HIV-1/2 Ag/Ab Combo. The test will be introduced to the developing world during the third quarter, and in certain other markets during 2009.

What differentiates this test is that it is capable of detecting HIV infections earlier than HIV antibody only tests. The Determine HIV-1/2 Ag/Ab Combo is the first rapid diagnostic which enables simultaneous detection of HIV p24 antigen (Ag) and antibodies (Ab) for HIV-1 and HIV-2 in human serum, plasma or whole blood.

The p24 antigen is present during the first few weeks of HIV infection and can be identified before HIV antibodies are produced, making it an ideal marker to aid in early HIV detection. By targeting p24 antigen as well as the HIV antibody response, Determine HIV-1/2 Ag/Ab Combo improves the ability to detect and diagnose acute (early) HIV infection.

Identifying acute HIV infection is a matter of global health concern. It is estimated that a significant number of newly acquired HIV infections are transmitted by those acutely infected, most unaware of their HIV status.

The Determine HIV-1/2 Ag/Ab Combo is a rapid, point-of-care lateral flow test which provides clear visual results in 20-minutes. The simple to use format enables HIV testing to be conducted in a broad range of clinical settings, from the physician's office to the most remote environments of the developing world.

www.invernessmedical.com



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August 11--EXAKT Technologies Launches New eStore

August 11, 2008--EXAKT Technologies Inc. announces the launch of its new online store. The new eStore will offer the most popular specimen packaging configurations and allow the customer to purchase a wide variety of standard packages 24/7. EXAKT-PAK® packaging contains all the components required to meet both USDOT and IATA regulations for a given specimen category. The most popular Biological Substances Category B and Exempt Human and Animal Specimens packages have been made available online.  Standard packaging is available online for shipping vials, tubes, Petrie dishes, jars and cryovials. 

"Many of our existing customers wanted the ability to place orders electronically," states Linda Durbin, president, EXAKT Technologies. "We also wanted the new customer to be able to look at specific products and order online. If a customer does not see exactly what they need in our eStore, we encourage them to call and talk with us about custom assembling exactly what they need."

www.exaktpak.com



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August 5--Monogram Biosciences Launches Resistance Assay for HIV Integrase Inhibitors

August 5, 2008--Monogram Biosciences Inc. announce the launch of its PhenoSense® Integrase assay, built on Monogram's proprietary technology platform, PhenoSense. The assay directly measures the susceptibility of HIV to a new and potent class of integrase inhibitor drugs that blocks viral replication by preventing viral genes from integrating into the DNA of newly infected cells. Together with PhenoSense GT®, PhenoSense Integrase provides the most complete picture of resistance to antiretroviral therapies.

PhenoSense Integrase along with other Monogram assays were used to support the clinical trials of the first commercially-available integrase inhibitor, Merck's Isentress™ (raltegravir), which received U.S. Food and Drug Administration (FDA) approval in October 2007. In Merck's phase III BENCHMRK trials, Monogram's PhenoSenseGT was used to select optimized drug regimens in the placebo and Isentress-containing treatment arms while PhenoSense Integrase was used to identify and characterize Isentress resistant viruses in treatment failures. The company is also actively involved in the clinical evaluation of Gilead's integrase inhibitor candidate, elvitegravir, currently in Phase III studies. In addition to drug resistance, PhenoSense Integrase also measures reductions in viral replication capacity associated with integrase inhibitor resistance that may help characterize viral fitness.

The performance of the PhenoSense Integrase assay is validated in compliance with regulations specified by the Clinical Laboratories Improvement Amendments (CLIA) and is performed in Monogram's Clinical Reference Laboratory, which is accredited by the College of American Pathologists (CAP).

www.monogrambio.com



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August 4--Tharo Systems Offers New 4" and 6" Wide Label Printers

August 4, 2008--The new Tharo Systems H-400/H-600 Series thermal transfer product identification and bar code label printers, available in 203 or 300 DPI, feature a durable all metal construction with a cast aluminum center wall for added strength. The large media window allows for easy viewing and monitoring of supplies. Standard features include a high-speed USB 2.0 interface for fast data transfer and a real-time clock for time and date stamping of labels. The standard Stripper Sensor on the H-400 Series can be used for either strip-and-peel or tear-off applications. Along with all of these standard features, the Tharo H-Series printers also ship with a free version of Tharo Systems' EASYLABEL® Start software for custom designing and printing labels. Options include: Cutter, Internal Rewind, Ethernet Adapter and Applicator Interface.

No PC is necessary -- download your label formats to the Printer's Flash Memory, unplug the printer from the PC, plug in a standard PC keyboard, take the printer to another location and start printing.

www.tharo.com/h400.php



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August 4--Seegene's New Rapid Sepsis Test Analyzes 68 Indicators for Sepsis

August 4, 2008--Seegene's Seeplex® Sepsis multi-pathogen screening test brings a novel and fast-acting diagnostic technique for hospitals to simultaneously verify a complex range of targets that indicate sepsis, the leading cause of death in non-coronary intensive care units worldwide.

This disease leaves a muddy footprint providing no clear track back to the initial indications, which may have been Gram-positive bacteria, Gram-negative bacteria or one of eight fungi.

The medical problem is determining the correct treatment during the first days of the disease. Currently physicians and clinicians need to choose among several tests with little confidence the results will definitely identify that a patient does or does not have the disease. Alternatively, a multiple-phase blood culture test covering a range of specific targets can be ordered, though it is an expensive process requiring time against a disease that quickly takes hold and rapidly deteriorates a patient's condition.

The Seeplex Sepsis Test is a single lab test that quickly determines the levels of suspected targets in a patient's blood sample to better inform the diagnosis and create an opportunity for quickly applying an appropriate treatment to head off the disease.

In a recent clinical study in Korea, the Seeplex testing approach demonstrated higher sensitivity than the blood culture test methodology. Out of 370 hospital patients suspected of having sepsis, 53 patients tested positive using the Seeplex Sepsis Test while 32 patients tested positive using the blood culture method.

Of additional significance to those on the front lines of disease control was the fact that the Seeplex Test identified those higher rates of infection on the same day that blood samples were taken. This is in contrast to blood culture which took 3-4 days to return test results.

The Seeplex Sepsis Test simultaneously screens for 64 sepsis-causing pathogens: 48 Gram (+) bacteria, 10 Gram (-) bacteria, and 6 fungi.

Additionally, four drug resistant genes (vanA, vanB, mecA, and blaSHV) can also be discriminated. The Seeplex Sepsis Test requires only 0.4 ml of patient's whole blood and provides test results in five hours.

The cost of the test is significantly lower than any other methods in the market. Not only will it help improve patient management in terms of expenses and time but also reduce unnecessary use of antibiotics, resulting in appropriate treatment to head off sepsis at the earliest possible stage of disease development.

Seeplex Sepsis Test is not for diagnostic procedures in the USA and will not be available in the USA pending regulatory approval.

The novel technique behind the new test technique is Seegene's proprietary DPO(TM) (dual priming oligonucleotide) primer system that amplifies DNA sequence using established polymerase chain reaction (PCR) but more rapidly screens for targeted bacteria generating consistently high PCR specificity while preserving a sensitivity as high as that of single PCR.

www.seegene.com



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August 4--ARTEL Launches Pipette Quality Management System

August 4, 2008--ARTEL launches its Pipette Quality Management System to help laboratories easily transition to a robust, in-house pipette calibration process for greater control over data quality. As part of the Pipette Quality Management System, ARTEL will install and validate the ARTEL PCS® Pipette Calibration System to seamlessly and rapidly integrate it into existing laboratory operations. ARTEL will also train laboratory staff on using the PCS and its pipette quality management software to ensure optimal execution of liquid handling quality assurance programs.

Currently, personnel shortages and a scarcity of resources are plaguing clinical, pharmaceutical, and other life science laboratories.  These challenges are driving the growing demand for easy-to-use laboratory technologies and an increased reliance on vendor services and training, leading to the introduction of ARTEL's Pipette Quality Management System.

ARTEL will install the PCS in customer facilities to speed time to use and streamline the transition process. The PCS is a rapid, user-friendly instrument that automatically measures and documents the accuracy and precision of volumes dispensed from single-channel pipettes. Portable and robust, the PCS can be used on the bench and calibrates pipettes in minutes, providing laboratories the flexibility and convenience of an internal calibration method.  

Post-installation, ARTEL will validate the PCS to ensure that the instrument's performance meets specific laboratory needs and regulatory guidelines. ARTEL's validation services also include consultation on development of standard operating procedures. 

The Pipette Quality Management System includes laboratory staff training.   ARTEL liquid handling experts will guide laboratory personnel on optimal use of the PCS and setting up and using its Pipette TrackerTM software.  This software allows users to efficiently manage the pipette calibration process by flagging pipettes that are due for calibration and identifying performance trending over time.   The ARTEL Pipette Tracker software directly acquires pipette calibration data from the PCS and automatically compares calibration results to user-set tolerances for immediate pass/fail analysis. The software maintains the data to ensure regulatory compliance and supports barcode and calibration label scanning and printing to streamline operations.

www.artel-usa.com



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August 1--Streck Launches Web Site Featuring Blood Collection Tube Line

August 1, 2008--Streck Inc., an independent developer and manufacturer of hematology and flow cytometry products for the clinical laboratory, announces a new Web site featuring its line of innovative blood collection tubes.

StreckInnovations.com features Streck's Cyto-Chex®BCT™, Rare-Cell™BCT and Cell-Free DNA™BCT. The theme of the Web site is "Technology in a Tube."

Cyto-Chex BCT is Streck's blood collection tube for the preservation of whole blood samples for immunophenotyping by flow cytometry. This direct-draw blood collection tube contains a patent-protected preservative that maintains the integrity of cellular CD markers for up to seven days. Patient samples collected in Cyto-Chex BCT are stable at room temperature for convenient transport and storage. FDA-cleared for the collection, transport and storage of HIV-infected patient samples, Cyto-Chex BCT preserves the HIV CD panel of markers for up to 14 days at room temperature. 

Rare-Cell BCT is Streck's blood collection tube for the preservation of rare and fragile cell types, including circulating tumor cells, circulating epithelial cells, circulating endothelial cells and fetal cells circulating in maternal blood. Rare-Cell BCT allows for the detection, enumeration and characterization of these rare cells. The direct-draw blood collection tube contains a patent-protected preservative that preserves antigen expression and cell morphology for up to three days at room temperature. Rare-Cell BCT is for research use only and has not been cleared for diagnostic procedures.

Cell-Free DNA BCT is Streck's blood collection tube for the preservation of cell-free DNA circulating in plasma which is amplifiable and suited for a wide range of downstream research applications such as PCR, Southern Blot, SNP (single nucleotide polymorphisms) analysis and Pharmacogenomic studies. Studies indicate that analysis of cell-free DNA may allow a non-invasive method of prenatal screening and diagnosis through fetal genotyping. The patented preservative in Cell-Free DNA BCT prevents the release of contaminating genomic DNA into the sample, providing research scientists a 14-day window for sample preparation at room temperature. This unique product is for research use only and is not for use in diagnostic procedures.



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August 1--Mindray Unveils New Analyzers and Reagents at AACC

August 1, 2008--Mindray Medical International Limited, a developer, manufacturer and marketer of medical devices worldwide, highlighted all of its marketed in vitro diagnostic products and unveiled three new units and reagents at the 2008 Annual American Association for Clinical Chemistry (AACC) conference.

Mindray displayed its entire line of in vitro diagnostic products at the conference, along with three demo units: the BC-5300 and BC-5380, both of which are hematology analyzers, the BA-88A, a semi-automatic biochemistry analyzer, and the first five reagents for the biochemistry analyzer. All products are expected to enter the international market in the second half of 2008.

www.mindray.com



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July 29--Cepheid Introduces GeneXpert Infinity-48 System at 2008 AACC Meeting

July 29, 2008--Cepheid introduced its GeneXpert® Infinity-48 high-throughput system at the 2008 American Association for Clinical Chemistry Annual Meeting in Washington, D.C. The newest addition to Cepheid's GeneXpert family of molecular diagnostic testing systems delivers the world's first and only fully-automated random access system designed for management of the entire molecular testing workflow. After a sample is loaded into a GeneXpert cartridge, the Infinity-48 System does the rest--sample in, answer out. The Infinity-48 manages the sample data, cartridge loading and unloading and reporting of test results.

"Cepheid's GeneXpert Infinity-48 System represents the pinnacle of molecular diagnostics automation today," says Cepheid CEO John Bishop. "With an expanding pipeline of on-demand tests in the Infectious Disease, Oncology, and Genetic Disease markets, the Infinity Series of Systems is positioned to become the platform of choice for high-throughput laboratories."

Cepheid's GeneXpert Infinity-48 System uses robotic cartridge handling, managed by Cepheid's XpertiseTM software package and full touch screen driven menu, to run up to 1,300 different molecular tests during any 24-hour period, depending upon test selection. With each of the system's 48 testing modules managed as an independent testing site, the Infinity-48 System can start test runs anytime samples are collected--24 hours a day, 365 days a year. Delivering true walk away ease-of-use, the Infinity-48 System is positioned to improve workflow while further accelerating time-to-result, enabling healthcare providers to make more informed patient management and treatment decisions.

The Infinity-48 System can be configured with 16, 24, 32, 40 or 48 modules. To handle the current, and future, testing needs of any organization the system can be upgraded with additional modules in blocks of eight.

Cepheid's Xpertise software integrates with Laboratory Information System (LIS) and Hospital Information System (HIS) networks to provide communication for all incoming and outgoing test orders and results.

ank



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July 25--American Diagnostica Acquires vWF Manufacturing Rights

July 25, 2008--American Diagnostica Inc. announces it has acquired the manufacturing rights to the Axis-Shield von Willebrand Factor (vWF) Activity Kit from Axis-Shield Diagnostics Limited, Dundee, Scotland. This assay uses a novel vWF antibody and allows the rapid determination of vWF activity. vWF, an important protein in the coagulation cascade, serves as a carrier that stabilizes factor VIII and acts as an adhesion protein in clotting. von Willebrand's Disease (vWD) is considered to be the most common bleeding disorder, with an incidence of 1 in 100 persons, caused by defects in, or reduced levels of, vWF.

www.americandiagnostica.com



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