PCL ALVERNO INSTALLING NEW ANALYZERS AND AUTOMATION

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1 October 2014 Dear Healthcare Provider, The information contained in the packet may be very important to your practice. Below is a quick summary of the items that are included in this mailing. Please take a moment to read this and review the enclosed material for detailed information. TEST BULLETIN PCL ALVERNO INSTALLING NEW ANALYZERS AND AUTOMATION PCL Alverno will move its chemistry and immunochemistry testing to new and improved high capacity and efficient platforms. This transition is scheduled for October 28, For additional information on what changes will occur, please see pages 2-3. TEST UPDATES PCL Alverno, in an effort to reduce turnaround times, is bringing testing for HLA-B27 and caffeine in-house beginning November 15, For details, please see pages 4-5. NEW WEBSITE COMING SOON! PCL Alverno will launch its new website in November. We are excited to bring you the new PCL Blog, which will bring you the information contained within this mailer electronically. Having an electronic communication mechanism will allow us to share breaking news and important laboratory information with you as it happens. We will have a contest with prizes if you join our blog! We will have more information in next month s mailer and your account executive will have details in the near future as well. HAVE YOUR DEMOGRAPHICS CHANGED? If your phone or fax numbers changed, or if there are changes in your office hours, building access hours or days of operations, we need to know! Please take a minute to call our client services department at and tell our staff about the changes. This ensures that we continue to provide you with timely, high-quality testing and service. HAVE QUESTIONS? Your account executives are ready to answer your questions and help you in any way. If you do not know your account executive, call Donna at , extension Dalia Alcantar Northwest Indiana Kevin Bailey Chicago Carolyn Cantele Chicago, Northwest Illinois Michelle Miller Indianapolis Paulette Paquette Central Illinois Page 1

2 Test Summary PCL ALVERNO NEW CLINICAL CHEMISTRY ANALYZERS PCL Alverno is pleased to announce that chemistry and immunoassay testing will be moving to new and improved high capacity and efficient platforms. The transition is scheduled to be completed by October 28, Test reports will reflect the new reference ranges once the new system is live, and they will also be available as usual in the collection manual on our website. Potential for changes to the test menu in your ordering system exists but should be minimal. AU platforms will perform routine chemistry tests such as CMP, BMP and Lipid panels. DXI platforms will perform immunoassay tests like thyroid hormones, prostate specific antigen and testosterone. PCL Alverno will also have liquid chromatography mass spectrometry capabilities. TEST METHODOLOGY UPDATES A few assays will have methodology changes and include Troponin, NT-ProBNP and the immunosuppressant drugs Tacrolimus and Cyclosporin A. METHODOLOGY CHANGES ASSAY CURRENT METHOD NEW METHOD Troponin Troponin T Troponin I BNP NT-ProBNP BNP Tacrolimus Enzyme Immunoassay LC/MS/MS Cyclosporine Enzyme Immunoassay LC/MS/MS Page 2

3 UNIT REPORTING UPDATE The table below highlights assays that will have a unit change. UNIT CHANGES TEST CURRENT UNIT UPDATED UNIT CRP mg/dl mg/l Beta-2-Microglobulin mg/l mg/dl Magnesium Urine meq/24 hr mg/24 hr Alcohol g/dl mg/dl Ceruloplasma mg/dl mg/l T3 ng/dl ng/ml T Uptake TBI % Testosterone ng/dl ng/ml REFERENCE RANGE UPDATE Changing methodologies or assay platforms often results in reference range changes. In each case, the test report will clearly state a new reference range is in effect. In most cases the change will be very slight, not affecting the medical decision points. PCL Alverno conducts reference range validation studies before reporting. For analytes that are very rare or in cases where specimen type prohibits collection in healthy individuals, as in CSF, published literature and manufacturers studies are adopted. Where a significant reference range change occurs, a baseline adjustment may be required for physicians that are monitoring patient therapy. The table below lists assays that will have the most significant changes in reference ranges with the conversion to the new analyzers. SIGNIFICANT REFERENCE RANGE CHANGES TESTS IMPACTED Alcohol CRP Testosterone Alpha-1-Antitrypsin Folate Thyroglobulin Antibody Beta-2-Microglobulin Magnesium Urine Thyroperoxidase Antibody (TPO) C3 Sex Hormone Binding Globulin UIBC C4 T Uptake Uric Acid Urine Ceruloplasma T3 Urine Protein Page 3

4 HLA-B27 Available November 15, 2014 Test Summary CLINICAL USE Testing for the presence of histocompatibility antigen HLA-B27 assists in the diagnosis of ankylosing spondylitis, juvenile rheumatoid arthritis and Reiter syndrome. CLINICAL BACKGROUND HLA-B27 is a blood test to look for a protein that is found on the surface of white blood cells. The protein is called human leukocyte antigen B27 (HLA-B27). A positive test means HLA-B27 is present. It suggests a greater-than-average risk for developing or having certain autoimmune disorders, such as ankylosing spondylitis. 90% of ankylosing spondylitis sufferers express the HLA-B27 antigen, versus 7% in the normal population. In ophthalmology, associations are strongest in diseases of the uvea. Of patients with uveitis, 19-88% have the HLA-B27 phenotype. The HLA-B27 phenotype has also been associated with psoriatic arthritis, inflammatory bowel disease, juvenile rheumatoid arthritis and reactive arthritis (Reiter syndrome). The HLA-B27 test is not diagnostic, but the results add information, increasing or decreasing the likelihood that the person being evaluated has the suspected autoimmune disorder. SPECIMEN REQUIREMENTS Specimen: 1mL EDTA (lavender top) Whole Blood Minimum volume accepted 0.5 ml Stability: 72 hours at room temperature CAUSE FOR REJECTION Frozen specimen METHOD Flow Cytometry REFERENCE RANGE Negative TURNAROUND TIME Testing is batched Monday through Saturday CPT CODE* *CPT codes provided are for informational purposes only. Questions regarding coding should be directed to the payor. Page 4

5 CAFFEINE Available November 15, 2014 Test Summary CLINICAL USE Serum quantitative caffeine analysis is intended for the monitoring of caffeine therapy, especially in cases of neonatal apnea. CLINICAL BACKGROUND Methylxanthines, particularly theophylline and caffeine, are used to control and prevent neonatal apnea. Methylxanthines are competitive inhibitors of adenosine receptors, which are an inhibitory neuromodulator of respiratory drive. Blockage of these receptors results in increased ventilator responsiveness. Apnea, most frequently seen in premature infants, is a significant contributor to the morbidity of low birth weight infants. Apnea occurs in approximately 25% of infants weighing less than 2,500 grams at birth and in 85% of infants weighing less than 1,000 grams. Infants on theophylline therapy have significant levels of caffeine in the blood because they metabolize theophylline to caffeine. Caffeine is a pharmacologically active metabolite of theophylline. Caffeine in premature infants has a long half-life and is therefore easily accumulated. SPECIMEN REQUIREMENTS Specimen: Serum only Stability: 2-8 C for 7 days CAUSE FOR REJECTION Plasma specimen or sent room temperature METHOD EIA REFERENCE RANGE Therapeutic 5-20 ug/ml (neonates) Toxic >40 ug/ml CPT CODE* *CPT codes provided are for informational purposes only. Questions regarding coding should be directed to the payor. Page 5

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