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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.
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
"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
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
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
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
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
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.
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
"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.
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