Dear Healthcare Provider, The information contained here may be very important to your practice. Please take a moment to review this document.

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1 February 2018 Dear Healthcare Provider, The information contained here may be very important to your practice. Please take a moment to review this document. TEST BULLETIN CHLAMYDIA/GONORRHEA SPECIMEN COLLECTION DEVICE CHANGE EFFECTIVE 2/15/18 PCL Alverno is moving to a new PCR testing platform for Chlamydia and Gonorrhea testing. Please review page 2 for details on the new multi-collection specimen kit, which will replace the four different collection devices utilized previously, depending on specimen type. MOLECULAR ENTERIC PATHOGEN PANELS START 3/1/2018 Beginning March 1, 2018, PCL Alverno will offer two molecular platforms that will provide flexibility to the Healthcare Provider ordering testing. Please review pages 3 to 6. REMINDER: REFLEX CRITERIA FOR URINE CULTURES CHANGED IN JANUARY! Alverno has recently updated its criteria for urine culture reflex testing from >5 WBCs to >10 WBCs. Effective January, all urinalysis ordered with a urine culture reflex do so based upon the new criteria. EGFR BY PCR PLASMA SPECIMEN FOR LIQUID BIOPSY Please review page 7 for information on a non-invasive supplement to biopsy analysis for identifying non-small cell lung cancers that may benefit from treatment with epidermal growth factor receptor-tyrosine kinase or anaplastic lymphoma kinase inhibitors. WELCOME NEW CLIENTS! We would like to welcome all new Healthcare Providers who joined our team in January! Page 1

2 Chlamydia / Gonorrhea Specimen Collection Update Single Collection Device February 15, 2018 On February 15th, PCL Alverno will move the Chlamydia and Gonorrhea by PCR testing to a new platform. This move will greatly simplify the collection device protocol. Currently the collection device is dependent upon the source of the specimen. This requires the stocking of four different collection kits. The new test has a single multi-collect Specimen Collection Kit that can be used for all specimen types except PAP ThinPrep samples. Ordering Information: Category Item Number Item Description Molecular Chlamydia/Gonorrhea by PCR Kit Specimen Types for CT/NG Collection Kit: Female Male Endocervical swab Urethral swab Physician or Self-Collected Vaginal Swab Urine Rectal Swab Urine Rectal Swab Alternative Specimen: PAP ThinPrep (do not add to multi-collect vial) Specimen Stability: In Collection Kit Room Temp / Refrigerated 14 Days ThinPrep Solution Room Temp 30 Days Cause for Rejection: Urine samples above or below the Min/Max window. Vaginal or Urethral collections without swab in transport tube. Leaking transport tubes. ***Disposal of unused BD collection Devices*** Please box any remaining BD collection devices and return to PCL Alverno via courier after February 15th. Page 2

3 Molecular Enteric Pathogen Panels March 1, 2018 Beginning March 1, PCL Alverno will begin offering molecular detection of gastrointestinal organisms. Acute diarrheal syndromes are usually self-limiting, but may be complicated by dehydration, vomiting and fever. Rapid multiplex panel detection of the most common agents of enteric infections directly from stool specimens is sensitive, specific and provides same-day results. Molecular testing is a rapid alternative to conventional culture technique. Results should be used in conjunction with clinical observation. A negative result cannot rule out the presence of PCR inhibitors in a patient specimen or target concentrations below the level of detection. Due to the high sensitivity of PCR testing, false positives can occur if nonviable organisms are present. Therefore, PCR testing of enteric pathogens is not intended for monitoring treatment. PCL Alverno has two molecular platforms that will provide flexibility in ordering. The BD Max provides targeted testing with smaller panels while the BioFire provides a large panel for more critically ill patient populations. Please see the utilization guidelines and platform testing details on the following pages. Page 3

4 UTILIZATION GUIDELINE: GI Panel Ordering BD Max Enteric Panels Patient History BD Max Panel >7 days OR immunocompromised OR recent travel ENPAR: Enteric Parasite Panel Community acquired; otherwise healthy Child or elderly in closed population (daycare/school/ltc) Patient history positive for RISK Factors: Pork or shellfish consumption Recent travel to high-risk region Recreation in water-based setting Consider seasonality of pathogens ENTBS: Basic Bacterial Panel ENTEX: Extended Bacterial Panel ENTEX: Extended Bacterial Panel BioFire FilmArray The new BioFire GI Panel offers simultaneous detection and identification of multiple gastrointestinal viral, parasitic, and bacterial nucleic acid targets in stool samples obtained from individuals suspected of gastrointestinal tract infections. Testing should be limited to: Severe illness (profuse watery diarrhea, signs of hypovolemia, passage of 3 unformed stools per 24 hours, severe abdominal pain, need for hospitalization) Inflammatory diarrhea (bloody diarrhea, small volume mucous stools, fever) High-risk host (age 70 years, cardiac disease, immunocompromising condition, inflammatory bowel disease, pregnancy) Symptoms lasting more than 7 days Hospitalization 3 days with no history of antibiotic treatment (one order per admission) Public health concerns (diarrheal illness in food handlers, healthcare workers, and day care facility personnel/attendees) For more information on diagnosis of acute diarrheal infections in adults, refer to the following: 1. The American College of Gastroenterology algorithm for diagnosis, treatment, and prevention of acute diarrheal infections in adults: 2. Approach to the adult with acute diarrhea in resource-rich settings. Wanke, MD, Christine A.: approach-to-the-adult-with-acute-diarrhea-in-resource-rich-settings Page 4

5 The BD Max has FDA approval for a basic bacterial panel, an extended bacterial panel and a parasite panel. This allows for selective ordering for cost-effective diagnostic testing. BD Max Basic Bacterial Panel Salmonella spp. Shigella spps. / Enteroinvasive E. coli (EIEC) Campylobacter spp. (jejuni and coli) Shiga toxins DNA (toxins 1 and 2) CPT Code: Soft Code: ENTBS Sample: Fresh stool in Cary Blair Medium BD Max Extended Bacterial Panel Salmonella spp. Shigella spps. / Enteroinvasive E. coli (EIEC) Campylobacter spp. (jejuni and coli) Shiga toxins DNA (toxins 1 and 2) Plesiomonas shigelloides Enterotoxigenic E. coli (ETEC) Vibrio spp. (vulnificus, parahaemolyticus and cholerae) Yersinia enterocolitica CPT Code: Soft Code: ENTEX Sample: Fresh stool in Cary Blair Medium BD Max Parasite Panel Giardia lamblia Cryptosporidium (hominis and parvum) Entamoeba histolytica CPT Code: Soft Code: ENPAR Sample: Fresh stool in 10% Formalin Page 5

6 The BioFire FilmArray Panel is an extensive panel with multiple bacterial, parasitic and viral targets. Please follow the utilization guideline provided when considering the BioFire GI Panel. BioFire FilmArray BACTERIAL PARASITES Campylobacter (jejuni, coli, upsaliensis) Cryptosporidium Clostridium difficile (toxin A/B) Cyclospora cayetanensis Plesiomonas shigelloides Entamoeba histolytica Salmonella spp. Giardia lamblia Yersinia enterocolitica Vibrio spp. (parahaemolyticus, vulnificus, cholerae) Vibrio cholerae (species specific call out) VIRUSES DIARRHEAGENIC E. COLI / SHIGELLA Adenovirus F40/41 Enteroaggregative E. coli (EAEC) Astrovirus Enteropathogenic E. coli (EPEC) Norovirus GI / GII Enterotoxigenic E. coli (ETEC) lt/st Rotavirus A Shiga-like toxin-producing E. coli (STEC) stx1 / stx2 Sapovirus (I, II, IV & V) Shigella/Enteroinvasive E. coli (EIEC) E. coli O157 (serogroup specific call out) CPT Code: Soft Code: BFGI Sample: Fresh stool in Cary Blair Medium Page 6

7 EGFR by PCR Plasma Specimen for Liquid Biopsy February 15, 2018 Clinical Use A non-invasive supplement to biopsy analysis. For use in identifying non-small cell lung cancers that may benefit from treatment with epidermal growth factor receptor-tyrosine kinase or anaplastic lymphoma kinase inhibitors. Clinical Background Non-small cell lung carcinoma (NSCLC) accounts for 75%-80% of all lung cancers. Patients with advanced NSCLC may not be healthy enough for a tissue biopsy, or might only be able to undergo limited tissue procedures, like a Fine Needle Aspirate (FNA) or Core Needle Biopsy (CNB) for diagnosis. After first-line TKI therapy, it is preferable to use a new tumor specimen for EGFR analysis which would require another invasive tissue biopsy procedure. The key benefits of testing with plasma is that it involves a non-invasive procedure for collecting specimen from the patient and can be collected as frequently as needed without putting patients at risk. Patients who are negative for EGFR mutations by this test should be reflexed to tissue biopsy for testing. EGFR-targeted therapies have been approved by the FDA for use in treating patients with NSCLC who previously failed to respond to traditional chemotherapy. Efficacy of EGFR tyrosine kinase inhibitors, such as gefitinib and erlotinib, is confined to patients with tumors demonstrating EGFR mutations, particularly in exons 19 and 21. This assay detects 42 mutations in exons 18, 19, 20 and 21 including the T790M resistant mutation. Specimen Requirements: Specimen: K2 EDTA Plasma. Centrifuge to separate from cells within 4 hours. Stability: 2-8 C, 72 hours Cause for Rejection: Serum Method: Real-Time Polymerase Chain Reaction (PCR) Turnaround Time: Testing is batched once a week CPT code:* SOFT code: EGFRM *CPT codes provided are for informational purposes only. Questions regarding coding should be directed to the payor. Page 7