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2008 NEw Pr o d u c t rEv i Ew special section Advertisement eliminating the use of transfer lines and consequently improving accuracy and precision. At 8 mm in diameter and weighing only 26 g, probes have 9-mm centers with each syringe drive operating independently. With its patented technology, small footprint, use of serial communications, and easy serviceability, the Parker Smart Syringe Probe helps optimize instrument design. Parker Hannifin/ Pneutronics Division Circle No. 489 in the Reader Service Card CVDefine Assay CVDefine is a unique new marker for early detection of harmful lesions caused by immunological response and inflammation in the artery wall. CVDefine measures antibodies against phosphorylcholine (PC), one of the major epitopes on oxLDL. These antibodies are common from an early age and have an important role in development of cardiovascular disease. Low IgM anti-PC Ievels indicate an increased risk for cardiovascular disease, while high anti-PC levels predict a favorable outcome in atherosclerosis development in hypertensive patients. CVDefine provides an easy-to-use standard ELISA procedure for quantitative analysis of PC antibodies in human serum and plasma. Athera Biotechnologies Circle No. 490 in the Reader Service Card BS-400 Chemistry Analyzer The new BS-400 fully-automatic clinical chemistry analyzer extends the excellent reputation of the BS series family renowned for high performance. The BS-400 is a truly random access and open system for routine and special chemistries, including specific proteins and electrolytes. It provides a flexible work platform for end users with reliable product quality. With throughput of constant 400 chemistry tests per hour, the BS-400 is an ideal workstation as a main system, back-up system, or for specialties. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Circle No. 491 in the Reader Service Card Liquid Stable Homocysteine Reagent The Liquid Stable(LS) 2-Part Homocysteine reagent is intended for in vitro quantitative determination of total homocysteine in plasma and serum (EDTA , Li-Hep, serum, and SST). The versatile assay employs two ready-to-use reagents and two calibrators and is standardized to the NIST SRM 1955 Homocysteine Reference Material. A key feature of the assay is the onboard reagent stability for 30 days that ensures a typical calibration stability of 14 days. The LS 2-Part assay demonstrates excellent correlation with both other immunoassays and HPLC methods. The test has a high throughput of up to 750 tests/hr and clinical protocols are available for many of the commonly used clinical chemistry analyzers. Axis-Shield Circle No. 492 in the Reader Service Card Evaluation Validation Software for Clinical Lab Instruments EP Evaluator, Release 8 is the industryleading product line of software programs to evaluate clinical lab methods. Flexible design provides the features needed by small, medium, and large labs to meet all CLIA ‘88 and CAP requirements for validating and evaluating methods. The program also includes three lab management modules: Inventory Management, Cost per Test, and Incident Tracking to monitor patient safety events. David G. Rhoads Associates, Inc. Circle No. 493 in the Reader Service Card ACU-CAP Vial Closure The new ACU-CAP vial closure provides convenient and precise reconstitution of lyophilized materials, eliminating the need for manual pipetting. The single-use device makes the reconstitution of reagents, calibrators, and QC materials significantly more convenient for labs and POCT locations and eliminates the imprecision and pre-analytical error associated with manual pipetting. Eurotrol, Inc. Circle No. 494 in the Reader Service Card Combination QC for i-STAT Analyzers GAS-ISE-HCT QC is the first all-in-one control product of its kind with pH, blood gases, electrolytes, metabolites, and hematocrit target values. Designed for i-STAT analyzers, the product eliminates the need to use two separate cartridges with each control check and cuts QC time in half. The product is available as a three-level QC, as well as a 5-level AMR/linearity panel. Eurotrol, Inc. Circle No. 495 in the Reader Service Card Po2 AMR Validation Control Hypoxic QC is the first pre-tonometered product of its kind to validate critically low (35mmHg) and extra-low (15mmHg) Po2 values. Hyperbaric QC is designed to validate the high (460mmHg) and extrahigh (710mmHg) Po2 range. Together, these two products validate the full Po2 analytical measurement range (AMR) of blood gas analyzers. Hypoxic QC features active hemoglobin buffering with 10-minute open ampule stability, making it well suited to perform method comparisons as well. The Hyperbaric QC is an aqueous formulation that validates high and ultra high recovered values—ideal for cardiac catheterization labs and OR suites. Eurotrol, Inc. Circle No. 496 in the Reader Service Card Hemosure® Immunological Fecal Occult Blood Test The Hemosure Fecal Occult Blood Test (IFOBT) is the most advanced screening method for colorectal cancer available today. The technology has eliminated the need for patient dietary and medication restrictions prior to testing and it has significantly increased the chance of early detection of this very curable disease. Easily performed in clinics, doctors’ offices, hospitals, and labs. The Hemosure iFOB is FDA approved and CLIA waived. Hemosure Inc. Circle No. 497 in the Reader Service Card Combiscan/Combiscreen Urinalysis Screening System The superior urinalysis screening products from Analyticon, a leading company selling around the world, are now available in the U.S. CombiScan® readers and CombiScreen® strips, using advanced German product engineering, offer superior performance plus fast and cost-effective results. A choice of two CombiScan readers deliver automated high throughput that can link directly to patient and hospital databases. Importantly, CombiScreen strips cost 25% less than competing products from the major manufacturers. The overall system is an ideal entry-level, complete solution for laboratories looking for superior performance at affordable prices. Analyticon Biotechnologies, Inc. Circle No. 498 in the Reader Service Card Lyophilized Reagent Delivery Systems* The ReActivator reagent delivery system incorporates manufacturers’ reagents in a lyophilized state (LyoSpheres) and liquid diluents together inside of an easy-to-use disposable unit-of-use rehydrating and mixing dispenser. ReActivator provides your customers with pre-measured, convenient, precise, and contaminate-free, stable reagents. BIOLYPH has developed and designed 12 different models of ReActivator to meet a wide variety of needs. BIOLYPH will also customize a ReActivator model to meet your specific requirements. *Patent pending. BIOLYPH LLC. Circle No. 499 in the Reader Service Card CliniCal laboratory news JuLy 2008 43
long-awaited cdc draft report on the status of lab medicine published after months of anticipation, a draft of Laboratory Medicine: A National Status Report is available for viewing. CDC accepted comments on the draft until June 23 and will consider them for inclusion in the final draft, expected to be posted by the end of July. The report is one part of a three-task project shepherded by the CDC to enhance the practice of laboratory medicine by identifying ways to improve laboratory testing and services. The other related tasks and accompanying reports involved developing a process to define, identify, categorize, and evaluate best practices and policies in laboratory medicine and the settings in which they apply; and evaluating the effectiveness of U.S. proficiency testing programs to meet quality improvement, educational, and regulatory goals for clinical laboratories (see CLN, June 2008). Written by The Lewin Group, under subcontract to Battelle Memorial Institute, the report examines key factors affecting laboratory medicine. It includes a detailed profile of the laboratory medicine sector and discusses such topics as current standards for laboratory testing and services, regulatory oversight including CLIA, impact of accreditation, reimbursement policies, performance measurement, quality improvement, evidence-based decision making, and trends affecting the field. According to the report, laboratory services account for only 2.3% of total U.S. reguLatory 44 CliniCal laboratory news JuLy 2008 p r o f i L e s p r o f i L e s healthcare expenditures and 2% of Medicare expenditures, but they play a significant role in informing healthcare decisions and spending. Appropriate use of laboratory testing is essential for achieving safe, effective, and efficient patient care. To read the draft report, go to www.futurelabmedicine.org. aacc calls on laboratorians to support The national children’s study Children’s Health Act of 2000 au- T he thorized the National Institute of Child Health and Human Development, as well as the National Institute of Environmental Health Sciences, the CDC, and the U.S. Environmental Protection Agency, to conduct the National Children’s Study (NCS). This initiative will examine environmental influences on the health and development of over 100,000 children through infancy, childhood, and early adulthood. But this study is contingent on Congress’s providing the $192.5 million needed to keep the National Children’s Study moving forward. Unfortunately, the budget proposal President Bush submitted to Congress for FY 2009 did not provide funding for the study. AACC has endorsed the study, and the Pediatric Reference Range Committee (PRRC) is working with the scientists leading the study, advising them on laboratoryrelated issues such as how to collect and store samples and how to analyze them. The PRRC hopes to use the data gathered from the study to develop pediatric reference ranges. The PRRC also is planning to conduct a series of adjunct studies, in conjunction with the NIH initiative, to consider key analytes not taken up by NCS. AACC urges all laboratorians to contact their legislators via AACC’s online advocacy center on the AACC Web site, www.aacc. org/gov/gov_affairs/pages/capwiz.aspx, to encourage them to support this important study. national Quality forum endorses consensus standards The National Quality Forum (NQF) has endorsed 48 voluntary consensus standards focused on measuring the performance of acute care hospitals. NQF anticipates that these measures will facilitate broad-based quality improvement within hospitals and will help track progress toward improved patient safety. Six of the measures target venous thromboembolism (VTE), a leading cause of illness and death in the U.S. One of these measures involves laboratory assessment of VTE patients with anticoagulation overlap therapy, and another focuses on unfractionated heparin dosages/platelet count monitoring. NQF has categorized other measures as Length of Stay/Readmission, Adult Patient Safety, Pediatric Patient Safety, Pediatrics, and Surgery and Anesthesia. To view the entire list of measures, go to www.qualityforum.org/news/releases/051508-endorsed-measures.asp. rWjf commits $300 million To Tackle disparities The Robert Wood Johnson Foundation (RWJF) recently announced a 3-year, $300 million initiative intended to narrow healthcare disparities across lines of race and geography. Officials said it would be the largest effort to improve healthcare quality ever undertaken by a charity in the U.S. The initiative, focusing on communities in 14 geographic areas that together account for 11% of the population, will bring together practices, hospitals, health plans, and patients to work on ways to improve the quality of care across different settings. The RWJF also released new research— conducted by the Dartmouth Atlas Project at the Dartmouth Institute for Health Policy and Clinical Practice—that analyzes Medicare claims to illustrate variations in healthcare quality nationwide. One finding of the new study was that an estimated one in seven patients with diabetes does not get crucial blood tests, such as HbA1c. About 85% of white patients with diabetes received these tests, compared with 79% of African Americans. In Alaska, 71% of patients with diabetes received blood sugar control tests every year, compared with the national average of 91%. To access more information about the initiative, go to www.rwjf.org. federal Grants for school drug Testing The White House Office of National Drug Control Policy and the U.S. Dept. of Education awarded federal grants for school-based random student drug testing totaling $5.8 million to 50 educational entities in 20 states. It is the fifth such grant award announcement since 2003. States in which the grants were awarded are: Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Nevada, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas, Utah, and Washington. Grant amounts range from $38,860, given to Currituck County Schools in North Carolina, to $228,569, given to Premier Integrity Solutions, a drug and alcohol testing company headquartered in Russell Springs, Kentucky. More than $40 million in federal grants have gone to an estimated 140 education and health entities since 2003 to develop, implement, or expand random student drug testing. The U.S. Supreme Court upheld the constitutionality of school-based random student drug testing in 1995 and 2002. next month in CLN cdc’s status of lab medicine report
Page 1 and 2: news brief IVD Market Growth Looks
Page 3 and 4: Clinical Laboratory News ediTorial
Page 5 and 6: GINA Opens Door for Research Partic
Page 7 and 8: CLN’s Lab 2008: improviNg heaLthC
Page 9 and 10: abnormal lipoproteins. Using the NH
Page 11 and 12: among healthcare workers is whether
Page 13: Quality Gaps in Communicating Labor
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