Download the entire issue - American Association for Clinical ...

More documents

Recommendations

Info

More Data Needed for Protocol Change chest Pain Protocol, continued from page 1 chest pain patients to get the risk as low as possible,” Than explained. “Given that only 20 to 25 percent have acute myocardial infarction, that’s a lot of people being investigated. That, paired with the fact that hospitals have an immense problem with overcrowding, is one of the challenges of the healthcare system for the next decade, if not longer.” He is director of emergency medicine research at Christchurch Hospital in Christchurch, New Zealand. The Details of ASPECT Than and his colleagues at 14 emergency departments in nine countries in the Asia- Pacific region launched the Asia-Pacific Evaluation of Chest Pain Trial (ASPECT) to assess whether a pre-defined protocol could identify patients presenting to the emergency department with chest pain who would be at low risk of harm if they were discharged early. The protocol’s POC panel consisted of cardiac troponin I (cTn), creatine kinase MB (CK-MB), and myoglobin. Researchers combined biomarker results with the Thrombolysis in Myocardial Infarction (TIMI) risk score and electrocardiograph (ECG) to establish patient risk. ASPECT involved 3,582 consecutive adult patients who reported at least 5 minutes of chest pain suggestive of ACS. Patients received normal care, and attending physicians had access to central lab cTn results but were blinded to TIMI score and results from the POC panel, samples for which were drawn at admission and after 2-hours. The researchers combined the ASPECT protocol with medical records and telephone followup to determine the study’s primary endpoint, major adverse cardiac events within 30 days after initial presentation. The POC panel results were considered positive when cTn was ≥0.05µg/L, CK MB was ≥4.3 µg/L or had an increase ≥1.6 µg/L within 2 hours, or myoglobin was ≥108 µg/L or increased ≥25% within 2 hours. Patients were deemed low risk if they had a TIMI score of 0, no new ischemic changes on ECG, and normal results from the POC biomarker panel, at both admission and 2-hours. The researchers found that 9.8% Assays for the Next Generation TM TM TM TM TM Levetiracetam Topiramate Zonisamide Lamotrigine Gabapentin 1190 Bordeaux Drive, Sunnyvale, CA 94089 877.869.2320 6 CliniCal laboratory news July 2011 of patients were at low risk and would have been eligible for early discharge. Following release from the hospital, a major cardiac event occurred in three (0.9%) low-risk patients, giving the protocol a sensitivity of 99.3%, specificity of 11%, and negative predictive value of 99.1%. Practice Changes Desired but Difficult Observers agreed that a system which would lead to as many as 10% of suspected ACS patients being discharged quickly and safely would have considerable merit. “There’s overcrowding in emergency departments in the U.S. and world wide, so even a nine or 10 percent discharge rate that wasn’t there before would make a big difference in work flow,” said Alan Wu, PhD, director of clinical chemistry and toxicology at the University of California- San Francisco. However, Wu was not alone in cautioning that as intriguing as the ASPECT results may be, a 2-hour assessment protocol is unlikely to be adopted in practice anytime soon. “It’s not a simple thing to change protocols. No single study would be the driving force to elicit such a change, but this will contribute to it,” he said. “Every institution would have to look at its own resources, needs, and turnaround times, and determine if it would be comfortable with a twohour rule-out. A lot of hospitals in the U.S. will not be ready to adopt this today, especially where the medicolegal aspects are so different and we don’t have the luxury of missing an MI.” Hospitals worldwide adhere to guidelines on the universal definition of MI issued in 2007 by the European Society of Cardiology, American College of Cardiology Foundation, American Heart Association, and World Heart Foundation. These guidelines call for a cTn measurement exceeding the 99th percentile of a normal reference population with a coefficient of variation ≤10% as an element of diagnosing MI, along with at least one additional criterion: symptoms or ECG changes indicative of ischemia; development of pathological Q waves in the ECG; or imaging evidence of new loss of viable myocardium or regional wall motion abnormality. The guidelines ARK’s homogeneous enzyme immunoassays measure newer anticonvulsants in serum or plasma. The liquid, stable, ready-to-use formulation delivers convenience for routine use. ARK produces assays of choice—high-quality, rapid, and reliable—for precise results on automated clinical chemistry analyzers. Call or email today. see us at the 2011 clin lab expo, booth no. 3753 customersupport@ark-tdm.com www.ark-tdm.com also note the importance of rising and/or falling cTn values in discerning MI. Measurements should be taken at the time of first assessment and 6–9 hours later to detect any pattern. CK-MB by mass assay is an acceptable alternative when cTn values are not available, according to the guidelines. Cutting Down Assessment Times Healthcare systems have adopted various strategies to adhere to the universal definition of MI while not keeping chest pain patients in emergency department beds per se. For example, many have chest pain or observation units where they transfer suspected ACS patients for continued work up. However, depending on how the units are staffed and where they’re located, they may still demand attention and resources from the emergency department for 6–8 hours, and in some instances, up to 12 hours. Widespread adoption of the universal definition of MI and use of strategies like observation units reflect how far the fields of emergency medicine and cardiology have come over the past three decades in discerning MI from other sources of chest pain and moving towards shorter, more efficient assessment processes, according to Ezra Amsterdam, MD, associate chief of cardiovascular medicine at UC Davis Medical Center in Sacramento, Calif. “There’s been an evolution over the past 30 years. K-ASSAY ® We’ve gone from admitting every adult patient with chest pain, and putting them through these rule-out procedures with serial cardiac enzymes and ECGs over several days until you finally decided it was OK to discharge the patient. That’s accelerated into protocols where a majority of patients are not admitted, and it’s done safely,” he explained. “So the ASPECT protocol is not new per se. What’s new is their systematic approach to a two-hour assessment.” An Objective Method Such a systematic approach to identifying patients at low risk has been a missing ingredient in emergency medicine, according to W. Frank Peacock, MD, vice chair of emergency medicine at the Cleveland Clinic Foundation. “Chest pain is the emergency department’s first or second most common presentation. The likelihood of an emergency doctor having a bad outcome in patients with chest pain occurs in the first five years of practice, so that tells you it’s really subjective,” he said. “What Martin did was to validate an accelerated diagnostic protocol with completely objective measures. There’s nothing subjective about it, and that’s the advantage.” Peacock helped analyze data and write the ASPECT report, but no Cleveland Clinic patients were part of the study. See chest Pain Protocol, continued on page 8 The Assay You Can Trust... Immunoassay Reagents for Chemistry Analyzers • Ferritin Our ferritin reagent offers the best performance with the lowest cost per test on the market !! � Widest measuring range (2 - 1,000 ng/mL) � Less interference from rheumatoid factors � Less high-dose hook effect � Serum or plasma samples � Compatible with any blood collection tube Other Nutritional Assessment Reagents: • Prealbumin • Transferrin � Adaptable to most chemistry analyzers including: Abbott Aeroset Abbott Architect ® c8000 Alfa Wassermann ACE ® Alfa Wassermann Alera ® Beckman Synchron CX ® / DX ® Beckman Synchron LX ® Beckman / Olympus AU series Horiba ABX Pentra 400 Mindray BS-200 For in vitro diagnostic use. KAMIYA BIOMEDICAL COMPANY 12779 Gateway Drive, Seattle, WA 98168 800-526-4925 206-575-8068 FAX: 206-575-8094 www.kamiyabiomedical.com � � Roche Cobas c501 / 6000 Roche Cobas Mira ® / Fara ® Roche / Hitachi 700 & 900 series Siemens / Bayer Advia ® 1650 / 2400 Siemens / Bayer Dimension ® Siemens / Bayer Opera ® Stanbio Sirrus ® / Prestige 24i Vital Diagnostics Envoy 500 Others . . . see us at the 2011 clin lab expo, booth no. 2220 Ferritin CLN 08-2010A.indd 1 6/29/2010 5:24:42 PM
Bio-Rad Laboratories HEMOGLOBIN TESTING Bio-Rad A1c See the Difference Bio-Rad HPLC Lets You See the Whole Picture Don’t settle for less – get the full patient picture. With Bio-Rad A1c, see potential interfering substances, including hemoglobin variants, with your HbA1c results. Accomplish more in fewer steps with the D-10 System’s simple operation, easy switching between HbA1c and β-thalassemia assays and expandability with a rack loader for higher volumes. Bio-Rad HPLC gives more information so physicians can provide the best quality diabetes and hematology care. See the difference so you can be the difference in patient care. Bio-Rad A1c • Be the difference For more information, contact your local Bio-Rad office 1-800-2BIO-RAD diabetes.bio-rad.com See us at the 2011 Clin Lab Expo, Booth No. 1631
Page 1 and 2: news brief Forecast: robust Market
Page 3 and 4: Most Adults Check Online for Health
Page 5: visitors and the hundreds of thousa
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 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

Download the entire issue - American Association for Clinical ...

Create successful ePaper yourself

Delete template?

Save as template?