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hba1c alone not a reliable diagnostic Tool in obese adolescents new research by Yale University investigators indicates that a hemoglobin A1c (HbA1c) level of 6.5% underestimates the prevalence of prediabetes and diabetes in obese adolescents (Diabetes Care 2011;34:1306–11). The results suggest that HbA1c alone is a poor diagnostic tool in this population, according to the authors. The researchers investigated the utility of HbA1c in obese adolescents because clinical guidelines recently endorsed HbA1c to diagnose diabetes and identify patients at risk for developing diabetes did not include studies involving adolescent populations. Studies evaluated to make those recommendations all involved adults, and little is known about the use of HbA1c in children and adolescents. The study involved 1,156 obese adolescents with a mean age of 13.3 years who were not taking medications that might affect glucose metabolism and who were not already known to have type 2 diabetes. All subjects had baseline oral glucose tolerance tests (OGTT) and HbA1c testing, and a subgroup of 218 subjects had repeated testing after a mean of 1.68 years. At baseline, 77% of subjects had normal glucose tolerance with HbA1c levels 6.5%. However, 27% of subjects considered to have normal glucose tolerance based on HbA1c results were classified as being prediabetic based on OGTT. Among subjects diagNostiC 46 CliniCal laboratory news July 2011 p r o f i L e s p r o f i L e s placed in the at-risk group by HbA1c results, 53% were considered to have normal glucose tolerance and 47% prediabetes or diabetes based on OGTT. Finally, 12.5% of subjects considered to have diabetes based on HbA1c results were designated as having normal glucose tolerance and 24% to have prediabetes by OGTT. Based on these findings, the researchers called for further investigation about the role of HbA1c levels in diagnosing prediabetes and diabetes in adolescents and children. ovarian cancer screening does not reduce cancer-related mortality findings from the landmark Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial indicate that for women in a general population, annual screening with CA-125 biomarker testing and transvaginal ultrasound compared with usual care did not reduce ovarian cancer mortality (JAMA 2011;305:2295–2303). At the same time, this testing algorithm increased invasive medical procedures and associated harms. The ovarian cancer arm of PLCO involved 78,216 women age 55–74 years at enrollment, 39,105 of whom underwent annual screening, and 39,111 of whom received usual care. Those in the intervention arm had CA-125 testing for 6 years and transvaginal ultrasound for 4 years, with a median follow-up of 12.4 years. The investigators found 212 and 176 ovarian cancer cases in the intervention arm and usual care arms, respectively. There were 118 ovarian cancer-related StatisPro software makes method evaluation easy, and it’s simple to see why. ■ Easy-to-follow step-by-step instructions ■ Easy-to-read tables and graphs ■ Faithful implementation of the latest CLSI method evaluation guidelines StatisPro promotes best laboratory practices by following CLSI documents referenced by The Joint Commission and College of American Pathologists (CAP). Visit CLSI Booth 2139 at the AACC and ASCLS Clinical Lab Expo. deaths in the intervention arm, compared with 100 in the usual care group or 3.1/10,000 person-years versus 2.6/10,000 person-years, respectively. The difference in survival between the intervention and usual care groups was not statistically significant, and no stage shift was observed, meaning that over the course of the study among intervention arm subjects in comparison to normal care subjects, there was not a decline in cases first diagnosed in later stages of the disease. In addition, there was an approximate 5% false-positive rate for each screening round. Although this rate is comparable to or even lower than false-positive rates for mammography screening, the researchers noted that “the nature of the diagnostic follow-up, which often included invasive procedures, was a serious concern.” They concluded that “even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality.” different centrifugation conditions Produce similar results an analysis of centrifugation conditions on clinical chemistry and immunology results found that three different conditions delivered identical test results (BMC Clinical Pathology 2011 doi:10.1186/1472– 6890-11-6). The results are significant because they suggest that laboratories may be able to reduce centrifugation times and consequently lower their overall turnaround times. The researchers conducted the investigation because although pre-analytical centrifugation occurs countless times every day in laboratories around the world, the influence of the process on lab results has only rarely and recently been investigated. World Health Organization (WHO) guidelines issued in 2002 recommended a centrifugation time of at least 10 minutes The Gold Standard in implementing CLSI standards Verify precision, linearity, bias Perform method comparisons Verify or transfer reference intervals Establish LOD/LOQ Ensure accurate results Demonstrate compliance Save time Visit www.StatisPro.org to find out more and order a free 30-day trial. for serum and 15 minutes for plasma with a relative centrifugation force (RCF) of 2,000–3,000g. The study involved 74 tests on six samples from 44 consecutively admitted patients, for a total of 444 results per patient. The investigators compared three centrifugation conditions, including 15 minutes at 2,180g RCF, 10 minutes at 2,180g RCF, and 7 minutes at 1,870 g RCF, all at 15°C and with a deceleration time of 32 seconds. Two different plasma separators were used for each centrifugation condition. The researchers found “identical” results in all parameters. They conducted Deming fit, alpha error, and beta error analyses, and found that only 3.6% of statistical test results fell outside the p
news from the fda Pcr-based hepatitis c Test Gets nod abbott has received FDA approval to market its RealTime PCR (polymerase chain reaction) test for measuring hepatitis C (HCV) viral load. The Abbott RealTime HCV assay is designed to be used as an aid in managing HCV-infected patients undergoing antiviral therapy, and helps physicians predict sustained and non-sustained virological response to HCV therapy. Test to monitor lung cancer cleared fujirebio Diagnostics has received FDA clearance to market the first biomarker assay to aid in the management of patients with lung cancer. The CYFRA 21-1 EIA test monitors disease progression during the course of disease and treatment of lung cancer patients. Q fever mdx Test cleared fDA has cleared the first nucleic acid amplification test for the diagnosis of Q fever infection in military personnel serving overseas. The test was developed by Idaho Technology and funded by the SamPLE PrEParaTiON daTabaSE Chemical Biological Medical System Joint Project Management Office within the U.S. Department of Defense. The test identifies and detects the bacteria that cause Q fever, Coxiella burnetii, within 4 hours. clearance for biomérieux’s mrsa Test bioMérieux has received FDA clearance to market its automated molecular test for methicillin-resistant Staphylococcus aureus. The NucliSens EasyQ MRSA test detects seven MRSA types, covering the most prevalent strains. siemens Gets clearance for heroin use screening Test siemens Healthcare Diagnostics has received FDA clearance for its newest drugs-of-abuse test, the Emit® II Plus 6-Acetylmorphine assay. The test allows labs to selectively test for heroin use. The Emit II Plus 6-Acetylmorphine assay differentiates heroin from other opioids with no cross-reactivity to structurally related substances and is part of Siemens’ Syva® Emit drugs-of-abuse testing assay menu. Clinical Analytes in plasma, whole blood, and urine now available at biotage.com/applications Just Released! Extraction of Sub-Nanogram Levels of Catecholamines from Human Plasma Using EVOLUTE ® WCX EVOLUTE WCX Benefits • High selectivity with multi-step wash provides ultra-clean extracts • Fast, simple, methodology compatible with both manual and automated platforms • Removes proteins, salts, non-ionizable interferences and phospholipids • Minimal ion suppression for Mass spec • Excellent flow characteristics • High analyte recoveries To see more sample prep applications, visit biotage.com/applications Total Ion Chromatogram for sub-nanogram levels of epinephrine (100 pg/mL) and dopamine (200 pg/mL) and norepinephrine (1000 pg/mL) extracted from spiked plasma with EVOLUTE WCX. * plasma artefact peaks observed at the LLOD. index To adverTisers Please visit these websites to learn more about the products in this issue. arK diagnostics ............................................. 6 www.ark-tdm.com bio-rad laboratories ........................................ 7 www.bio-rad.com/diagnostics biotage ...................................................... 47 www.biotage.com clinical and laboratory standards institute .................. 46 www.statispro.org diazyme ..................................................... 48 www.diazyme.com Greiner bio-one vacuette na ................................ 13 http://us.gbo.com ids ltd. ...................................................... 9 www.idsplc.com/en-us/home/ Kamiya biomedical company .......................... 6, 12, 45 www.kamiyabiomedical.com Kronus ....................................................... 29 www.kronus.com medicon Gmbh .............................................. 44 www.optima-packaging-group.de nova biomedical ............................................. 25 www.statstrip.com Phadia us inc. ............................................... 19 www.phadia.us randox laboratories ........................................ 5 www.randox.com roche diagnostics corp. ..................................... 2 www.roche.com sarstedt inc. ................................................. 27 www.sarstedt.com sysmex corporation ......................................... 23 www.sysmex.com/us Wako diagnostics ......................................... 8, 33 www.wakodiagnostics.com oem biosPacific ................................................... 39 www.biospacific.com cis-bio us ................................................... 35 www.cisbio.com fluid metering inc. ........................................... 37 www.fmipump.com utak laboratories ........................................... 31 www.utaK.com Wheaton industries .......................................... 41 www.wheaton.com CliniCal laboratory news July 2011 47
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 and 24: See us at the 2011 Clin Lab Expo, B
Page 25 and 26: 2 0 11 N E w P r o d U c T s r E v
Page 43 and 44: Expand Your Expertise. Validate You
Page 45: iNdustry p r o f i L e s p r o f i

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