oCtoBeR 2010 - American Association for Clinical Chemistry

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detecting il-2 and ifn-γ discriminates between active and latent Tb infection new research indicates that detecting interleukin-2 (IL-2) in addition to interferon-γ (IFN-γ) discriminates active from latent Mycobacterium tuberculosis infection (Clin Microbiol Infect 2010;16:1282-1284). The research builds diagNostiC 22 CliniCal laboratory news oCtoBeR 2010 p r o f i L e s p r o f i L e s on recent studies demonstrating the utility of assays that measure IFN-γ release in blood cells stimulated with M. tuberculosis antigens, according to the authors. IFN-γ release assays accurately diagnose tuberculosis (TB) infection, but do discriminate active from latent TB. The researchers stimulated whole blood with M. tuberculosis-specific antigens and used the QuantiFERON-TB Gold In Tube test to measure IFN-γ release and a commercially available ELISA assay to measure IL-2 release after 18 and 72 hours of incubation. The specimens came from patients hospitalized in an infectious diseases unit and from control subjects without known exposure to TB. Participants also underwent tuberculin skin testing (TST); those with positive test results and positive M. tuberculosis culture from sputum were considered to have active TB. Latent infection was defined as positive tests in exposed individuals with no signs of active disease. The investigators found that subjects with either latent or active TB had significantly higher levels of IFN-γ than controls. However, IFN-γ levels between individuals If you want to be known as an expert, you have to become an expert. AACC’s online certificate program is the way. ““ • Clinical Laboratory Leadership and Management • Laboratory Support for Diabetes Testing • Point-of-Care Specialist • Basic Principles and Architecture of Laboratory Information Systems • Fundamentals of Molecular Pathology • Statistical Methods for Clinical Laboratorians • Using Tandem Mass Spectrometry in the Clinical Laboratory To learn more and enroll, visit aacc.org and click on “Events,” then “Online Education.” 7 Online Learning Certificate Programs from CLN_online_cert_jnr_isl_ad_7x10.indd 1 7/16/10 12:44:07 PM with latent or active TB were not significantly different at 18 or 72 hours after incubation. In contrast, after 72 hours’ incubation, IL-2 levels were significantly higher in patients with latent TB infection than either active TB or healthy controls. The area under the receiver operator characteristic curve was 0.99, and a threshold of 2.0 U/ mL yielded a sensitivity of 90% and specificity of 97.5%. The authors speculate that the increased levels of IL-2 observed in latent TB infection likely reflect more IL-2 secreting and IL-2/IFN-γ-secreting central memory Tcells along with fewer IFN-γ-secreting effector memory T-cells in individuals with latent as opposed to active TB. bnp levels do not predict intracranial hemorrhage in pediatric Trauma patients researchers at Children’s Hospital Los Angeles found that B-type natriuretic peptide (BNP) levels measured during an emergency visit do not predict intracranial hemorrhage (ICH) in pediatric trauma patients (J Trauma 2010;68:1401–5). They conducted the study to determine whether BNP might help identify children most in need of computed tomography (CT) scans. Emerging evidence indicates there is a significantly increased risk of cancer among pediatric patients who have CTs, and protocols to deploy CT more selectively have been implemented. At the same time, emerging evidence suggests that BNP levels are elevated in adults with head injuries. Since BNP tests are readily available and can be performed quickly, the researchers hypothesized that this analyte might predict ICH and help guide physicians in determining whether a CT would be needed. They enrolled 100 consecutive pediatric patients presenting at the emergency department who were classified as Level I trauma status with the most critical injuries and physiologic parameters. However, of 95 patients who remained in the study for analysis, they did not find a relationship between BNP levels and the presence of various trauma injury measurements such as injury severity score, Glasgow coma scale, or loss of consciousness. In fact, BNP levels for 57.9% of patients were below the assay’s lower limit of detection, and mean BNP levels among patients in the positive ICH group were slightly less than those who were negative for ICH. While the researchers conclude that based on their study, BNP levels are not clinically relevant to predict CTs with positive results for ICH, they underscored that specimens drawn for the study were taken only upon arrival at the emergency department. However, evidence in adults indicates that BNP levels in aneurysm and subarachnoid hemorrhage did not rise significantly until hours or days later. The authors suggest that further investigation of pediatric BNP levels outside the emergency setting is warranted. visit aacc.org
news from the fda fda approves first automated molecular Test for hbv abbott has received FDA approval to market an assay for measuring viral load, the amount of hepatitis B virus (HBV) in a patient’s blood. The Abbott RealTime HBV assay is the first and only FDAapproved test capable of automating HBV viral load testing from sample extraction to final results. The test provides sensitive measurement of HBV in human plasma or serum from individuals chronically infected with HBV and is designed for use as an aid in the management of patients with chronic HBV infection undergoing antiviral therapy. bd gets moderate complexity status for group b strep assay becton Dickinson has received moderate complexity status from the FDA for its BD MAX GBS Assay for Group B Streptococcus (GBS) on the BD MAX System. With the new test status, the BD MAX GBS Assay will be available as a cost-effective molecular test for a wider range of laboratories performing GBS screening. fda clears new Test system to detect Torch infections ZEUS Scientific has announced clearance of its AtheNA Multi-Lyte ToRCH IgG Plus Test System. This new test system is designed for the qualitative detection of specific human IgG class antibodies to Toxoplasma gondii, rubella, cytomegalovirus (CMV), and HSV 1 and 2 (type specific) in human sera (TORCH). According to the company, the assay’s results are meant to be used as an aid in assessing the serological status of individuals, including pregnant women. Serological testing for infection by TORCH organisms in fetuses and newborns can aid in identifying individuals who are at significant risk of adverse outcomes. arrayit seeking pma for ovarian cancer Test arrayit, a microarray firm, announced that it will be seeking pre-market approval from FDA for its OvaDx ovarian cancer test. According to the firm, the test is based on Arrayit’s proprietary microarray platform that detects close to 100 protein biomarkers in serum. The company claims that the OvaDx test can identify ovarian cancer 5 years before there are any signs or symptoms. fda clears radiometer’s new abl90 fleX poc analyzer radiometer has received FDA clearance for its ABL90 FLEX analyzer. The new cassette-based analyzer is the latest addition to the company’s blood gas line, offering speed and high-throughput in a compact instrument. The ABL90 FLEX analyzer delivers results on 16 parameters in 35 seconds from 65 µL of whole blood. c A ll FOr A b S trA ctS Deadline: January 31, 2011 43rd Annual Emerging Technologies for 21st Century Clinical Diagnostics April 14 & 15, 2011 baltimore, Md. Abstracts on all areas of pre-commercial technology for clinical diagnostics are welcome! $500 Outstanding Poster Award The Oak Ridge Conference is the American Association for Clinical Chemistry’s annual forum for emerging clinical diagnostic technologies. With presentations focusing on novel technologies and systems, the meeting brings together thought leaders from industry, academia, and clinical laboratories. The conference focuses exclusively on pre-commercial technologies, and session topics are updated each year to reflect diagnostic trends. Now in its 43rd year, the Oak Ridge Conference is firmly established as the premier forum for next generation clinical diagnostics developers. Last year, the conference attracted more than 80 abstracts. You can be a part of this highly regarded conference by submitting an abstract for the poster session. The conference committee will select abstracts for brief oral presentations. Sessions l New Sequencing Technologies for Clinical Diagnostics l Innovative Technologies for Infectious Disease Diagnostics l New Technologies for Quantitative Pathway Mapping in Tissues l Novel Nanotechnology Approaches for Diagnostics For more information and to submit an abstract, go to: www.aacc.org/events/ American Association for Clinical Chemistry, Inc. 1850 K Street, NW, Suite 625, Washington, DC 20006 Attendees rate this the best poster session for emerging diagnostic technologies. indeX To adverTisers Please visit these websites to learn more about the products in this issue. bio-rad laboratories ........................................ 5 www.bio-rad.com/diagnostics fujirebio diagnostics ........................................ 24 www.taketherightpath.com Kamiya biomedical company .......................... 7, 18, 23 www.kamiyabiomedical.com Kronus ....................................................... 20 www.kronus.com midland bioproducts corp. .................................. 6 www.midlandbio.com ortho-clinical diagnostics ............................. 2, 11, 19 www.orthoclinical.com Wako diagnostics ........................................... 17 www.wakodiagnostics.com K-ASSAY ® 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 . . . CliniCal laboratory news oCtoBeR 2010 23 Ferritin CLN 08-2010A.indd 1 6/29/2010 5:24:42 PM
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