May Immunohistochemistry. Immunology. Microbiology. Referral Testing. ROS1 screening

Transcription

1 May 2017 Immunohistochemistry ROS1 screening Immunology Immunofluorescence (IFA) assay platform change ANCA (Anti-Neutrophil Cytoplasmic Ab) Panel for Vasculitis Anti-Mitochondrial Antibody Anti-Native DNA Anti-Nuclear Antibody Screen Anti-Smooth Muscle Antibody Helicobacter pylori IgA assay obsolete Lead, blood testing changes Myeloperoxidase Antibodies assay brought in-house Proteinase 3 Antibodies, IgG assay brought in-house Microbiology Influenza and RSV testing update Referral Testing Alcohol Biomarker, Quant orderable with unique test code Antidepressant drug screen, urine quant assay available Bupropion (Wellbutrin) specimen requirement change Lead, venous blood; new orderable test available

2 IMMUNOHISTOCHEMISTRY ROS1 screening methodology change Allina Health Laboratory has transitioned to Immunohistochemistry (IHC) as the methodology for screening for c-ros oncogene 1 (ROS1) mutation status. All ROS1 IHC positive cases will be reflexed to confirmatory ROS1 FISH testing at additional charge. True ROS1 gene rearrangement frequency in lung adenocarcinomas is estimated to be 2%. By switching to ROS1 IHC, we will be able to provide a faster turn-around time and a less expensive screening test for your patients. ROS1 IHC is a highly sensitive test, but has lower specificity. We anticipate the ROS1 IHC false positive (reflex rate) to be approximately 25% which means that you will have a result for approximately 75% of your patients within 1-2 business days. IMMUNOLOGY Immunofluorescence (IFA) assay platform change The Allina Health Immunology laboratory has transitioned to the INOVA QUANTA-Lyser platform for testing of the Immunofluorescence (IFA) Immunology assays. As per best practice guidelines of the American College of Rheumatology, the test methodology will continue to be Immunofluorescence Antibody (IFA), however, additional patterns and titers will be reported for these tests, as outlined below. All positive ANA, p-anca and c-anca will automatically reflex to a titer and positive or atypical p-anca or c-anca will reflex to MPO and PR3. This additional testing incurs an additional charge, as has been levied previously on positive specimens referred to titers. The new platform will contain an automated digital IFA microscope for the detection of autoantibodies which will aid in the standardization of pattern recognition and titering of results. There will be no changes in specimen requirements, CPT code or pricing associated with this transition. Details regarding the changes to each of the five affected assays are included on the following pages. 2

3 ANCA (Anti-Neutrophil Cytoplasmic Ab) Panel for Vasculitis Test # 528 Titers performed on c-anca only at 1:40, 80 and160 Positive c-anca and p-anca will reflex to MPO and PR3 Previous Titers performed for positive c-anca and p-anca at the following dilutions: 1:40, 80, 160, 320, 640, 1280 To rule out interference, ANA will be performed at 1:20 on any atypical p-anca. Note that ANA at this titer is utilized in the laboratory for interpretation only. It is not a reportable ANA result and should not be interpreted as a positive ANA for the diagnosis of lupus or other auto-immune disease. Positive or atypical c-anca and p-anca will reflex to MPO and PR3. NEW Anti-Mitochondrial Antibody Test # 652 Titers performed: 1:40, 80 and 160 Previous Titers performed: 1:40, 80, 160, 320 and 640 NEW Anti-Native DNA Test # 605 Screening performed at 1:10 dilution Titers performed: 1:40 and 160 Previous Screening performed at 1:10 dilution Titers performed: 1:20, 40, 80, 160, 320 and 640 NEW 3

4 Anti-Nuclear Antibody Screen Test #12467 Current Screening performed at 1:80 dilution Patterns reported: Homogenous Speckled Nucleolar Spindle Centromere Titers performed: 1:160, 640 and 2560 NEW Screening performed at 1:80 dilution Patterns reported: Homogenous Speckled Nucleolar Spindle Centromere Nuclear Dots DFS (Dense Fine Speckled) Comment: if cytoplasmic staining is present Titer performed: 1:160, 320, 640, 1280, 2560 and 5120 Anti-Smooth Muscle Antibody Test #715 Current Titers performed: 1:40, 80 and 160 NEW Titers performed: 1:40, 80, 160, 320 and 640 Helicobacter pylori IgA assay (343) obsolete Due to lack of clinical utility, effective June 6, the H. pylori IgA antibody testing assay will be made obsolete. H. pylori IgG antibody testing will still be available. The preferred non-invasive methods for evaluating for Helicobacter pylori infection are: Helicobacter pylori Breath Test (7188) Helicobacter pylori Ag, stool (4767) Since H. pylori antibodies persist for years after a resolved infection, a positive antibody test is not an indication to treat. Current guidelines for the noninvasive evaluation of H. pylori infection recommend only tests that detect active infection; the urea breath test or the stool antigen test.* 4

5 When H. pylori antibody testing is performed, the only test with established clinical value is the IgG test. Ken Batts, MD, a specialist in GI pathology, notes that H. pylori IgG antibody testing can be useful as an adjunctive marker for helicobacter. A negative H. pylori IgG serology essentially excludes helicobacter; a positive result needs additional stool, breath or biopsy examination to determine if ongoing infection is present. There is no remaining clinical utility for IgA antibody testing due to lack of specificity, as confirmed by a retrospective analysis of internal data: H. pylori IgA and IgG antibody test performance in 97 patients who had concurrent biopsy, breath, or stool testing. (internal data Oct April 2017.) *See Mayo Clinic Communique: Helicobacter pylori infection: Serologic testing not recommended. IgA Ab Helicobacter IgG Ab pylori (will be (will remain Serology discontinued as available) of 6/6/17) Sensitivity 43% 83% Specificity 21% 84% PPV 5% 40% NPV 78% 98% Lead, blood testing changes Due to a CDC advisory released on 5/17/17 regarding blood lead testing on venous specimens, Allina Health Laboratory is implementing immediate changes to our Lead, blood assay. Effective immediately, the name of our in-house blood lead test has been changed to Lead, capillary, and testing will be performed ONLY on CAPILLARY specimens collected by finger stick or heel puncture into a lavender Microtainer tube. Venous specimens must be collected in a navy EDTA Lead free tube, ordered as a Lead, venous blood (12345/LABG12345) will be sent to Mayo Medical Laboratories (MML) for testing. The methodology used by MML is not affected by the CDC advisory. Existing venous specimens already collected in a lavender tube can still be tested at MML; going forward, specimens must be collected in the navy blue topped EDTA tube. Additional details are provided below. A retesting plan will follow this communication. SPECIMEN COLLECTION Capillary: No change; The blood from the finger stick or heel puncture site must be placed directly into a lavender Microtainer. Venous: Venous specimens must now be collected in a Navy blue EDTA lead-free collection tube and will be routed to MML for testing. Navy blue EDTA lead-free tubes can be obtained 5

6 using your standard supply catalog ordering process; these tubes are in the Blood Collection Specialty Tubes category. We have taken steps to increase our inventory of these tubes. In rare instances where venipuncture is performed on infant for other testing and only a small amount of blood is available, blood for lead testing can be placed in a separate lavender microtainer. You MUST handwrite VENOUS on the specimen label for the sample to be forwarded to MML. This is very important to insure accuracy of patient test results. TEST ORDER Use the Lead test (147) order for capillary specimens only. If a venous specimen is collected, and the 147/ has been inadvertently ordered, the collecting site must change the order to a Lead, Venous blood (912345LAB12345). Myeloperoxidase Antibodies assay brought in-house On May 16th, Allina Health Laboratory began performing the Myeloperoxidase Antibodies assay (1254/LAB1254) in house at our Central Laboratory using Chemiluminescence. Bringing this assay in house will aid in the timely diagnosis of immune-mediated vasculitis. The assay was previously referred to Mayo Medical Laboratories (MML) and performed by Multiplex Flow Immunoassay (Bead Technology). Along with the methodology change, reference ranges and units of measure were changed. Note that the numerical values of results are not comparable between the two methodologies, however, method comparison studies have shown excellent qualitative comparison between MML and our Central Laboratory. A comparison of the current and new reference ranges follows: Previous Ref Range NEW Ref Range Myeloperoxidase Aby (MPO) <0.4 U (negative) <20 CU (negative) U (equivocal) 20 CU (positive) 1.0 U (positive) Note: Units of measure of the Inova Bioflash chemiluminescent assays are in CU or chemiluminescent units. These units are not interchangeable with units reported for the previous assay performed by MML. Specimen Information There were no changes in specimen requirements associated with this transition. CPT and price There were no changes to either CPT codes or pricing for this assay. 6

7 Proteinase 3 Antibodies, IgG assay brought in-house On May 16th, Allina Health Laboratory began performing the Proteinase 3 Antibodies, IgG assay (12685/LAB12685) in house at our Central Laboratory by Chemiluminescence. Bringing this assay in house will aid in the timely diagnosis of immune-mediated vasculitis. The assay was previously referred to Mayo Medical Laboratories (MML) and performed by Multiplex Flow Immunoassay (Bead Technology). Along with the methodology change, reference ranges and units of measure also be changed. Note that the numerical values of results are not comparable between the two methodologies, however, method comparison studies have shown excellent qualitative comparison between MML and our Central Laboratory. A comparison of the previous and new reference ranges follows: Previous Ref Range NEW Ref Range Anti-Proteinase 3 (PR3) <0.4 U (negative) <20 CU (negative) U (equivocal) 20 CU (positive) > or =1.0 U (positive) Note: Units of measure of the Inova Bioflash chemiluminescent assays are in CU or chemiluminescent units. These units are not interchangeable with units reported for the previous assay performed by MML. Specimen Information There were no changes in specimen requirements associated with this transition. CPT and price There were no changes to either CPT codes or pricing for this assay. 7

8 MICROBIOLOGY Influenza and RSV testing update Flu season is over and the prevalence of both influenza and RSV is very low. Effective June 1 st, Rapid Influenza and RSV testing will be suspended until fall, as the accuracy during the off-season is very poor. If a sporadic case of influenza or RSV is suspected, the following tests may be ordered: References: Test Name Test Code Detects Turnaround time Influenza A/B/H1N1 Molecular Detection, PCR 8810 Influenza Virus Type A,Type B and Respiratory Syncytial Virus (RSV), Molecular Detection, PCR MML: FLUNP Influenza A, B, and H1N1 RSV, Influenza A & Influenza B Same day 1-2 days REFERRAL TESTING Alcohol Biomarker, Quant orderable with unique test code Beginning June 6, 2017, the Alcohol Biomarker, Quant assay, referred to MedTox Scientific, will be orderable with a unique ordering code. Results will be interfaced, and no longer resulted as See separate report. Test Name: Test Number: NEW Test number: Collect: Container: Transport/Stability: Alternate Names: Performing Lab: Days Set Up: Expected TAT: Method: CPT Codes: Alcohol Biomarker, Quant ml Random urine, no preservative Non-Sterile Screw Cap Urine Container Refrigerated, Ambient - 3 days, Frozen (OK) ABURQT, EtG, ETG, EtS, ETS, LAB8467 MedTox Scientific (868); R-MX Varies 5-6 days Liquid Chromatography with Tandem Mass Spectrometry (LC/MS/MS) G0480 8

9 Antidepressant drug screen, urine quant assay available Effective June 6th, 2017, Allina Health Laboratory will offer a new Antidepressant drug screen, urine quant, referred to MedTox Scientific. This new assay screens for amitriptyline, clomipramine and desmethylclomipramine, cyclobenzaprine, desipramine, doxepin and desmethyldoxepin, fluoxetine and norfluoxetine, imipramine, maprotiline, nortriptyline, paroxetine, protriptyline, sertraline and desmethylsertraline, trimipramine. Test ordering and specimen information are as detailed below. Test Name: Antidepressant drug screen, Urine quant Test Number: Collect: 3.0 ml Urine Container: Sterile container Transport/Stability: Refrigerated (preferred) Frozen (ok) Ambient - 3 days Alternate Names: TCA, Tricyclics, LAB12784 Performing Lab: Medtox Scientific (885300); R-MX Days Set Up: Daily Expected TAT: 7 days Method: Immunoassay (IA) Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) CPT Codes: G0480 Bupropion (Wellbutrin) specimen requirement change MedTox Scientific has changed the specimen processing requirements for the Bupropion assay. Specimens for this assay must still be collected in a plain red top tube, however, within 30 minutes of collection, the tube must be centrifuged, 3 ml of serum transferred to a MedTox Transfer for Bupropion Analysis transfer tube, mixed well and frozen. These transfer tubes are not currently a stock item, and clients must order a minimum of 2 days prior to specimen collection. 9

10 Lead, venous blood; new orderable test available In response to the recent CDC advisory regarding blood lead testing, a new orderable test has been made available for venous blood samples. Please note that it is preferable that venous samples be collected in a Navy Blue EDTA tube. For capillary collections, order Lead, capillary, #147. Test Name: Lead, venous blood Test Number: Collect: Container: Processing: Transport/Stability: Alternate Names: Performing Lab: Days Set Up: Expected TAT: Ref. Ranges: 0.4 ml EDTA whole blood - Navy blue Navy blue, tan (lead only) or lavender microtainer EDTA tube Do not spin, submit original tube Refrigerated (preferred) - 28 days Ambient - 28 days Frozen - 28 days PBDB LAB12345 Mayo Medical Laboratories (PBDB); R Mon - Fri; 5 p.m. Sat; 2 p.m. 2-4 days All Ages: µg/dl Critical values Pediatrics ( 15 years): 20.0 µg/ml Adults ( 16 years): 70.0 µg/dl Collection/ Processing Details: Method: Useful for detecting lead toxicity. Do not spin. Send original tube Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) CPT Codes: Supply Connection: Navy blue EDTA tube Thank you for choosing Allina Health Laboratory - we value your business! 10