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special section Advertisement (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma. It is intended for use as an aid in the diagnosis of HIV-1/HIV-2 infection in subjects age ≥2 and pregnant women, including acute/ primary HIV-1 infection. The test does not distinguish between HIV-1 p24 antigen, HIV-1 antibody, or HIV-2 antibody and is not intended for blood screening. Results should be interpreted with the patient’s presentation, history, and laboratory results. *For in vitro diagnostic use only in the U.S.; for sale by or on order of physician or to clinical laboratory only. Abbott Diagnostics www.abbottdiagnostics.com Booth No. 2531 StrongStep® Candida albicans /Trichomonas vaginalis Antigen Combo Rapid Test* Vaginitis is one of the principal reasons women see an obstetrician or gynecologist. Candidiasis and trichomoniasis are responsible for most cases of infectious vaginitis, but they need different treatment. StrongStep Candida albicans/Trichomonas vaginalis Antigen Combo Rapid Test is an immunochromatographic assay for qualitative presumptive detection of these two pathogens from vaginal swabs. Samples can be self-collected by patients. In addition, compared with wet mount and culture, the results from this antigen test are less influenced by vaginal local drug treatment before the patient’s clinic visit. The test offers a simple testing procedure and fast results at the time of patients’ clinic visit. *Pending FDA clearance. Available for sale outside the U.S. Nanjing Liming Bio-products Co., Ltd. www.limingbio.com Booth No. 117 StrongStep® N. gonorrhoeae/C. trachomatis Antigen Combo Rapid Test * N. gonorrhoeae and C. trachomatis are closely related, and patients are often co-infected with the two pathogens. Patients should therefore be tested for gonorrhea and chlamydia simultaneously. StrongStep N. gonorrhoeae/C. trachomatis Antigen Combo Rapid Test is an immunochromatographic assay for qualitative presumptive detection of N. gonorrhoeae and C. trachomatis in female cervical-swab and male urethral-swab specimens. Unlike culture, the results from this antigen test are seldom influenced by patient’s self drug treatment before a clinic visit. The test offers convenience for clinicians and provides patients with rapid results at the time of their clinic visit, thereby allowing early treatment and preventing further com- 24 CliniCal laboratory news July 2011 2 0 11 N E w P r o d U c T s r E v I E w plications. *Pending FDA clearance. Available for sale outside the U.S. Nanjing Liming Bio-products Co., Ltd. www.limingbio.com Booth No. 117 StrongStep® HSV 1/2 Antigen Rapid Test* Diagnosing herpes by visual examination of a lesion does not give an accurate diagnosis because many other infections or irritations can look just like herpes. Testing for the virus directly from the skin is useful if genital symptoms are present during the patient’s clinic visit. StrongStep HSV 1/2 Antigen Rapid Test is an immunochromatographic assay for qualitative presumptive detection of HSV 1&2 antigens in mucocutaneous specimens. The test is intended for confirmation of HSV symptomatic infection but also differentiates other genital ulcer diseases with herpes easily and quickly. Because the test detects antigen, it yields much higher sensitivity and specificity than antibody tests. Compared to PCR or culture, the test offers wider feasibility. *Pending FDA clearance. Available for sale outside the U.S. Nanjing Liming Bio-products Co., Ltd. www.limingbio.com Booth No. 117 Aquaporin-4 Antibody ELISA Test kit* KRONUS, a leading provider of specialized autoimmune diagnostic test kits, is pleased to announce the availability of a new ELISA test kit for measuring antibodies to aquaporin-4 (AQP-4Ab). Aquaporin-4 is the most abun- dant water channel protein in the central nervous system and is expressed extensively within the brain and spinal cord regions. This new ELISA allows for accurate and specific determination of autoantibodies to AQP-4. *For research use only. KRONUS, Inc. www.kronus.com Booth No. 1622 Voltage-Gated Potassium Channel Antibody RIA Test kit* KRONUS, a leading provider of specialized autoimmune diagnostic test kits, is pleased to announce the availability of a new RIA test kit for measuring antibodies to the voltagegated potassium channel (VGKC–Kv1.1, 1.2 and 1.6). This new RIA allows for accurate and specific determination of VGKCAb. Measurement of antibodies to voltage-gated potassium channels (VGKC) may be useful in select indications.*For research use only. KRONUS, Inc. www.kronus.com Booth No. 1622 CLC 720 Chemistry Analyzer* Carolina Liquid Chemistries’ CLC 720 is a discrete, random-access, fully automated, floor-model chemistry analyzer. The CLC 720 is capable of running up to 100 different tests from CMPs, DAUs, and lipids to specialty tests such as cystatin C and 1,5 AG (GlycoMark®). The CLC 720 can run 560 tests/hour with ISE. It is an excellent fit for hospital, start-up, and small reference laboratories, as well as satellite laboratories, large reference laboratories, or large physician clinics. *Pending FDA clearance. Carolina Liquid Chemistries Corp. www.carolinachemistries.com Booth No. 4121 Four-Level Methotrexate Controls* UTAK’s Four-Level Methotrexate Controls are manufactured in 100% human serum with no added preservatives to eliminate matrix effects and improve precision. The four methotrexate concentrations are 0.05, 0.075, 0.5, and 0.75 µmol/L. These lyophilized controls have a 30- month shelf life, 25 days of reconstituted stability, and are packaged in a 5 x 5-mL volume size.*Available for sale outside the U.S. UTAK Laboratories, Inc. www.utak.com Booth No. 1761 Bi-Level Antifungal Controls * UTAK’s Bi-Level Antifungal Controls are manufactured in 100% human serum with no added preservatives to eliminate matrix effects and improve precision. The analyte panel of antifungals includes Fluconazole, 5-Flucytosine, Itraconazole, Hydroxy-Itra- conazole, Posaconazole, and Voriconazole at clinically relevant concentration levels. These lyophilized controls have a 30-month shelf life, 25 days of reconstituted stability, and are packaged in a 5 x 5-mL volume size. *Available for sale outside the U.S. UTAK Laboratories, Inc. www.utak.com Booth No. 1761 MALDI Biotyper* Bruker’s MALDI Biotyper identifies microorganisms using MALDI-TOF mass spectrometry by measuring the unique, characteristic molecular fingerprint of the proteins that are found in all microorganisms. The resulting patterns of these proteins are used to reliably and accurately identify a broad range of microorganism down to the species level. The MALDI Biotyper is very accurate, highly reproducible, extremely costeffective, fast, and easy-to-use. It is especially designed to meet the demands of the microbiology laboratory. This new technology has changed and modernized the way microbial identification is done in clinical laboratories around the world. *For research use only. Pending FDA clearance. Available for sale outside the U.S. Bruker Daltonics www.bdal.com Booth No. 3853 T Module System* The T Module System is a revolutionary multi-parameter instrument based on latex technology that simultaneously performs tests such as CRP, ASO, RF, and Hb1Ac in a few minutes. The modular configuration allows laboratories to run the instrument with a customized panel of tests according to the needs of each laboratory. The instrument analyzes the kinetic reaction and recognizes the prozona effect, recovering the sample with appropriate dilution. The calibration curves of each reagent kit are recorded into a volumetric card that enables the analysis. *In development. Alifax SpA www.alifax.com Booth No. 4031 ACQuITY® Online SPE System* Waters introduces the ACQUITY Online SPE System for general laboratory use. The ACQUITY Online SPE System couples powerful and enabling UPLC® Technology with automated, online, solid-phase extraction to streamline workflows and improve analytical performance for LC-MS/MS-based assays. This fully integrated system solution is designed to improve the flexibility of LC-MS/ MS testing by allowing multiple assays to
2 0 11 N E w P r o d U c T s r E v I E w special section Advertisement be performed on a single platform. Singleuse cartridges are used to perform each and every extraction on the system, reducing the risks of analyte carryover and accumulation of matrix components that can compromise analytical performance. *For research use only. Waters Corporation www.waters.com/clinical Booth No. 3136 The NGAL Test* The NGAL Test, a particle-enhanced turbidimetric assay for the quantitative determination of NGAL in human urine or plasma, is designed for routine diagnostic use on chemistry analyzers from numerous manufactures, such as Roche, Abbott, Siemens, and Beckman Coulter. NGAL is a novel biomarker for diagnosing acute kidney injury (AKI). The test effectively gives almost any laboratory immediate access to a fast and easy method to measure NGAL. This test is intended for in vitro diagnostic use in select countries only. Check for availability in your country on our website. *For research use only. BioPorto Diagnostics A/S www.bioporto.com Booth No. 2809 hema-screen SPECIFIC* hema-screen SPECIFIC is an immunochemical, fecal, occult-blood test specific for human hemoglobin. hema-screen SPECIF- IC’s distinguishing feature is our patented DEVEL-A-TAB collection slide, allowing two specimens to be tested at the same time. The new enhanced version of hema-screen SPECIFIC contains an additional 10 collection system/mailing envelopes. This feature allows doctors or labs to hand out additional collection system/mailing envelopes to compensate for non-compliance. Look for our new packaging. *In development. Immunostics Inc. www.immunostics.com Booth No. 1556 ABO & RhD Blood Grouping kit* INTEC ABO & RhD Blood Grouping Kit uses unique visual testing technology to detect ABO and RhD blood groups based on the immune response principle of antigens and antibodies. The kit is suitable for on-site blood collection, medical laboratory testing, and urgent pre-transfusion testing. With rapid accurate results and good performance in specificity and stability, the kit can be stored at 2–30ºC for 2 years. The kit offers detection of ABO and RhD blood groups simultaneously in one test without any additional equipment. This product has international patent: No.: PCT/CN2009/000322. *Pending FDA clearance. InTec PRODUCTS, Inc. www.intecasi.com Booth No. 741 BS-800 Modular System* BS-800 Modular System, an innovative clinical chemistry diagnostic system manufactured by Mindray Corporation, incorporates Mindray’s suggested reagents, calibrators, and controls. It can be adapted to customers’ needs by integrating one to four modular units with various throughputs, ranging from 1,200–4,800 tests/hour. The systems uses only 100 µL of reagent, takes up to 860 The scientific proof of a technology breakthrough is not established by a single study. The technology must be evaluated and the study results duplicated in numerous settings to be considered scientifically valid. In the last two years, 50 published studies by leading diabetes hospitals throughout the world validate that Nova’s StatStrip glucose sensor technology dramatically improves accuracy by reducing hematocrit and other interferences. These studies have been conducted at some of the most prestigious diabetes centers in the world including the Mayo Clinic, John Hopkins University School of Medicine, University of California Davis Center for Point of Care Technology, University of Toronto Sunnybrook Health Sciences Center, Addenbrooke’s Hospital Cambridge University Hospitals, UK, WEQAS and University Hospital, Cardiff, Wales, Isala Klinieken, Netherlands. Some conclusions: www.statstrip.com samples, has 2–8ºC reagent cooling, reagent bubble detection, and user-friendly operating software. The system allows labs to focus on cost-effectiveness, result accuracy, operator safety, and technology advancement. BS-800 Modular System provides a brand new experience in laboratory practice and lets labs Scientific Papers Validate Nova’s Technology Breakthrough In Glucose Sensor Accuracy Nova Multi-Well Glucose StatStrip ® Technology Publications and Presentations Copies of this booklet are available by contacting Nova Biomedical Tel: 781-894-0800 www.novabiomedical.com “Here we further demonstrate for the first time that anemia is the primary cause of glucometer error in hemodynamically stable adult ICU patients and that eliminating hematocrit error decreases the frequency of hypoglycemia.” Pidcoke M et al. Crit Care Med 2010 “The new generation StatStrip glucose meter, which has been designed to compensate for hematocrit and chemical interferences, reduces the likelihood of erroneous results arising from interference factors that influence current conventional glucose meters.” Bewley B et al. Point of Care 2009 “The StatStrip system was not susceptible to hematocrit, ascorbate or maltose interferences, either alone or in combination with one another. The other strip meter systems tested were significantly influenced by these interferences.” Lyon ME. AACC, Annual Meeting 2008 “With the exception of the Nova StatStrip, all meters were affected by variable hematocrit.” Mohn B. NZJ Med Lab Sci 2010 United States GLU Canada (Cont’d) Asia Europe Europe Cont’d The Nova StatStrip ® Blood Glucose Meter Evaluation: Hematocrit Dependency, Method Comparison, Interfering Substances and Neonatal Samples Clinical Evaluation of a Point of Care Device for Creatinine measurements in the Followup of Kidney Transplant Patients Validation of two Point-of-Care Testing devices for fetal lactate assessment during labour Evaluation of the Nova Biomedical StatStrip ® Glucose Meter Assessment of the Performance of Handheld POC Sensors for Measuring 3-Hydroxybutyrate Four Step Validation Procedure for Evaluating POCT Meters Comparison of Four Hospital Based Glucose Meter Technologies for Accuracy, Precision and Interferences Encountered in Hospitalized Patients An Evaluation of the Analytical Specificity and Clinical Application of a New Generation Hospital Based Glucose Meter in a Dialysis Setting Improved POC Meter Accuracy for Monitoring and Managing Glucose Levels in Dialysis Patients Nova StatStrip ® Evaluation of a Point-Of-Care (POC) Glucose Meter Suitable for Use in Complex Tertiary Care Facilities Performance of a StatStrip : Could This Device be used to Effectively Implement Tight Glycemic Control and Triage Blood Glucose and Insulin Management in Critical Illness An Evaluation of the Analytical Performance of a New Generation Hospital Based Glucose Meter in a Neonatal Care Unit Reliability of Glucose Meters in Hospitals in Austria Performance of the Nova StatStrip Care Glucose Meter in a Neonatal Intensive Care Unit Multi-site Evaluation of Point of Care Glucose Meters in a Neonatal Intensive Care Unit A Multi-Site Analytical Assessment of a New Hospital POC Glucose Meter for Accuracy, Precision, Correlation, and Interferences Encountered in Hospitalized Patients ® Meter Comparison of Accuracy of a Glucometer and a Blood Gas Analyzer in an Adult ICU Comparison of Accuracy of Three POC Glucometers in an Adult ICU Performance Of The Statstrip Glucose Meter In Inpatient Management Of Diabetes Mellitus Testování Glukometrů a Jejich Porvnání Evaluation d’un Nouveau Lecteur de Glycémie Intégrant une Correction Automatique de l’Hématocrite Galatose Interference on POCT Glucose Analysis Interference of Hematocrit and Maltose Plasma Concentrations on the Accuracy of Different Blood Glucose Measuring Systems Das Blutzuckermessystem StatStrip ® ist nicht empfindlich für Interferenzen durch Hämatokrit oder andere bekannte Störsubstanzen Genauigkeit des Blutzuckermess-systems StatStrip ® Comparison Evaluation of Three Point-of-Care Glucose Meters with Neonatal Patient Samples Exhibiting Varied Hematocrit and Triglyceride Concentrations Comparative Testing for Better Glycemic Control Accuracy and Reliability of the Nova StatStrip® Glucose Meter for Real-Time Blood Glucose Determinations during Glucose Clamp Studies Evaluation of the Impact of Hematocrit and Other Interference on the Accuracy of Hospital-Based Glucose Meters Use of Samples from Indwelling Venous Catheters for Glucose Meter Testing Comparison of Four Hospital Based Glucose Meter Technogies Accuracy, Precision, and Interference Encountered in Critically Ill Patient Evaluation of a New POCT Bedside Glucose Meter and Strip with Hematocrit and Interference Corrections Evaluations of Nova StatStrip im Vergleich zu anderen Messsystems und zu einer Standard- Labormethode Analytical Performance of an Interference- Resistant Glucose Meter Suitability Assessment of a New Bedside Interference Free Glucose System for Use in Critical Care ® Blood Glucose Monitoring System in Neonates Evaluation and Implementation of the Nova StatStrip® Bedside Glucose Monitor for Patients Undergoing Cardiopmonary Bu-pass Graft Surgery (CABG) Development and Use of a Methodology for the Evaluation and Implementation of POCT Devices RGH’s Method for Evaluation and Implementation of Data-managed Bedside Glucose (POCTG) Monitoring Evaluation of Point of Care Bedside Glucose Monitors for Use in a Specialty and Transplant Hospital Hematocrit Effect Outweighs Other Sources of Glucometer Error in Critical Care Assessing the Performance of Handheld Glucose Testing for Critical Care Evaluation of a Glucose Meter with Negligible Hematocrit or Chemical Interference Predicted Discrepancies Between Direct Reading Whole Blood Biosensors and Central Lab Plasma Methods: Predicting and Avoiding Medical Error Estimates of Total Analytical Error in Consumer and Hospital Glucose Meters Contibuted by Hematocrit, Maltose and Ascorbate Interference Studies with Two Hospital-Grade and Two Home-Grade Glucose Meters see us at the 2011 clin lab expo, booth no. 2923 Canada Multi-National Sites 200 Prospect Street Waltham, MA 02454-9141 U.S.A. TEL: (781) 894-0800 (800) 458-5813 www.novabiomedical.com ® Point of No. 169 Rev. 1/20/11 CliniCal laboratory news July 2011 25
Page 1 and 2: news brief Forecast: robust Market
Page 3 and 4: Most Adults Check Online for Health
Page 5 and 6: visitors and the hundreds of thousa
Page 7 and 8: Bio-Rad Laboratories HEMOGLOBIN TES
Page 9 and 10: IGF-I Automated Assay Now Available
Page 11 and 12: care. Unfortunately, most laborator
Page 13 and 14: The point of our demonstration is a
Page 15 and 16: checklist for structured handoffs a
Page 17 and 18: Being Prepared Hickson urges labora
Page 19 and 20: See what we see. At Phadia, we see
Page 21 and 22: itC ...............................
Page 23: See us at the 2011 Clin Lab Expo, B
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Page 43 and 44: Expand Your Expertise. Validate You
Page 45 and 46: iNdustry p r o f i L e s p r o f i
Page 47 and 48: news from the fda Pcr-based hepatit

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