HOW TO ORDER Revised

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1 HOW TO ORDER Revised How to Order Animal Health Testing Our Mission We have been working hard to get the word out about the risks of zoonotic infection to the veterinary and medical communities through our Healthy Pets, Healthy Families campaign. We suspect that many more animals, veterinary workers, and pet owners are affected by Bartonella spp infection than is currently appreciated. For more information on the clinical picture emerging from the research on Bartonella spp infection, the following links may be helpful: Brochure Quick overview of Bartonella infection and diagnostic challenges Video A One Health Perspective on an Emerging Infectious Disease (Breitschwerdt, NorVect 2014) understanding bartonella/ How to Order Any licensed veterinarian can order our testing. Orders start with the submission of a patient sample for testing. For first time canine orders, we recommend ordering both the Triple Draw Bartonella epcr test panel and IFA serology panel. For feline test orders, we recommend ordering Single Draw Bartonella epcr test panel and IFA serology panel. Forms and additional information are available on our website here: health/. For further convenience, IDEXX is also offering our Bartonella epcr test (#2601 canine, #3631 feline) and Bartonella IFA serology. Please see the IDEXX online test catalog for special pricing for combination of epcr and Bartonella IFA serology (#3688 canine, #3689 feline). How Bartonella epcr Works Bartonella epcr(tm) combines PCR testing with an enrichment culture in our patented BAPGM medium to increase sensitivity of Bartonella detection in patient samples (usually blood, but works well for tissue, lymph node aspirate, and other bodily fluids). NCSU research suggests that it is the best test for atypical presentations of cat scratch disease and other Bartonella spp infections where there is either an absence of immune response (no antibodies) or no antigens available for IFA serology testing. We use genus level primers in our Bartonella PCR and confirm all PCR positives by DNA sequencing. This approach allows us to detect the presence of less common species of Bartonella. Test Performance Our Bartonella epcr method is well validated by a growing list of peer reviewed publications. A review of our recent test performance data indicates that the Triple Draw Bartonella epcr is 9 10 times more sensitive than a single Bartonella PCR. NCSU studies indicate that less than half of the patients who test positive for Bartonella infection by Bartonella epcr, also test positive for antibodies against Bartonella. While DNA tests are more confirmatory than serology tests (antibodies are a reliable indicator prior exposure, not active infection), we recommend that both Bartonella epcr and IFA serology be ordered to provide the best data for diagnosis. Galaxy Diagnostics, Inc Kit Creek Rd, Suite 130 Research Triangle Park, NC t f www galaxydx.com

2 ANIMAL HEALTH TEST OPTIONS Bartonella epcr Single Blood or Single Fluid Draw Enrichment culture in patented BAPGM media provides enhanced detection of Bartonella DNA missed by standard PCR detection methods. Genus-level primers detect the presence of Bartonella DNA occurring at a detectable level. All positive results are verified by sequencing. Bartonella epcr Triple Blood Draw Enrichment culture in patented BAPGM media provides enhanced detection of Bartonella DNA missed by standard PCR detection methods. Genus-level primers detect the presence of Bartonella DNA occurring at a detectable level. All positive results are verified by sequencing. 2-4 ml blood in purple top tube (EDTA) 2-3 weeks $135 3 draws over 1 week (M-W-F ) of: 4 ml blood in purple top tube (EDTA) 2-3 weeks $270 Bartonella epcr Fresh/Frozen Tissue Pre-culture PCR of specimen followed by 10-day BAPGM enrichment culture and post-enrichment PCR. Sequence verification of any positive PCR results. 0.5 to 1 gram in red top or cryotube hydrated with sterile saline 2-3 weeks $210 Bartonella PCR Paraffin-Embedded Tissue Standard PCR is available for testing samples that cannot be cultured. Genus-level primers detect the presence of Bartonella DNA occurring at a detectable level. DNA sequencing and identification are included for positive results. CPT Coding: 2 cuts of minimum 50 microns thickness each, in Eppendorf tube Ambient 1 week 87471x1 $135 Bartonella Serology Panel Tests for antibodies against Bartonella henselae, Bartonella vinsonii subsp. berkhoffii and Bartonella koehlerae. Requires 3ml serum. Results reported within 1 week. 2ml-3ml of serum in a red top tube or in a tiger top tube 1 week $ Kit Creek Rd, Suite 130 Research Triangle Park, NC t f www galaxydx.com AH Test Options: Revised

3 For Internal Use Only: Logged in by Date Received Order No. Animal Health Bartonella Test Request Form Revised Date Entered Account No. Invoice Bartonella Test Options Bartonella epcr combines BAPGM enrichment culture with highly sensitive Bartonella sp. PCR, providing enhanced detection of DNA missed by standard PCR detection methods. All positive PCR results are verified by DNA sequence. Bartonella epcr TM single blood draw $135 Bartonella epcr TM triple draw blood $270 Required sample is 3 ml in EDTA tube. Test turnaround is 3 weeks. Bartonella epcr TM single fluid $135 Fluids such as CSF, joint fluid, pericardial fluid,etc. are suitable for enrichment culture. Required sample is 3ml in serum/red top tube. Test turnaround is 3 weeks. Bartonella epcr TM Fresh/frozen tissue $210 Required sample is 0.5 to 1 gram in cryotube or similar container. Test turnaround is 3 weeks. Bartonella PCR paraffin-embedded tissue $135 Tests for presence of Bartonella spp DNA. Typical sample is 2 cuts of at least 50 microns thickness each in sterile tube. Test turnaround is 2 weeks. Serology Panel $70 Tests for antibodies against B henselae, B koehlerae, and B vinsonii berkhoffi Requires 3ml serum. Test turnaround is 1 week if received by noon Tuesday; otherwise, turnaround time is 2 weeks. Clinic Information Doctor Clinic Address City State Zip Contact Name Tel Report: Fax Billing: Fax Report Delivery Preference Fax Patient Information Animal Name Patient ID Owner (first last) Species Breed DOB Sex M F Condition? On Antibiotics Yes No Type? On Immunosuppressant Yes No Type? Tests Requested (Aseptically collected samples produce the best results.) Sample Type Date Collected Tests Requested Payment Information Method: Check Visa Mastercard Amex Invoice Card Number: Exp: CVV Code: Billing Zip Code: Name on Card: Signature: New Account? Please provide contact name, phone, and . Galaxy Diagnostics, Inc Kit Creek Rd, Suite 130 Research Triangle Park, NC t f www galaxydx.com

4 ANIMAL HEALTH SPECIMEN COLLECTION INSTRUCTIONS Revised Single Blood Draw: 4ml whole blood (EDTA) One whole blood sample is collected aseptically on one day and submitted directly. Triple Blood Draw: 3 x 4ml whole blood (EDTA) Three blood/serum samples from one patient are collected aseptically every other day over a 5-7 day period, stored in the refrigerator, and submitted all at once. EDTA Collection tube (Whole Blood): 1) Following sample collection, gently invert the sample a minimum of 8-10 times 2) Label the tube with name and specimen collection date. 3) Log sample details on test request form. 4) Store samples in refrigerator for up to two weeks prior to shipping. Non-blood fluids: ml fluid Fluid samples should be aseptically collected in a sterile tube (e.g., red top tube) and submitted directly. Fluid samples include: joint fluid, cerebrospinal fluid, pericardial effusions, etc. Samples may be stored in refrigerator for up to two weeks or frozen for up to two months prior to shipping. Lymph node aspirates: 3 ml fluid Following aseptic sample collection, samples should be placed in sealed sterile container and submitted directly. Lymph node aspirates may be injected into 1ml sterile saline in red top tube (no additives). Samples may be stored in refrigerator for up to two weeks or frozen for up to two months prior to shipping. Fresh/frozen biopsy tissue: gram tissue Following aseptic sample collection, fresh/frozen biopsy tissue (min 0.5 to 1 gram) may be placed in sterile tube (no additives) and hydrated with 1ml sterile saline. Samples may be stored in refrigerator for up to two weeks or frozen for up to two months prior to shipping. Serology: 1 ml serum Serum should be collected in SST (yellow top tube) and spun prior to submission. Day 1 Day 3 Day 5 PLEASE SHIP ACCORDING TO ENCLOSED SHIPPING INSTRUCTIONS. SAMPLES WITH ICE PACKS BY OVERNIGHT COURIER. DO NOT SHIP FRIDAY OR PRIOR TO HOLIDAYS. SHIP MON-THU. DO NOT SEND BY REGULAR MAIL. USPS DOES NOT DELIVER TO OUR PHYSICAL LOCATION. DO NOT USE DROP BOXES. CALL FOR COURIER PICKUP. Galaxy Diagnostics, Inc Kit Creek Rd, Suite 130 Research Triangle Park, NC t f www galaxydx.com

5 Shipping Instructions for Clinical Specimens (UN 3373 Cat B) All clinical specimens possibly infected with Bartonella spp bacteria are considered UN 3373 Biological Substances Category B. The UN 3373 Category B designation is regulated under the US Department of Transportation (DOT) Transportation of Hazardous Materials Regulations (HMR) for domestic shipments and under the International Air Transport Association (IATA) Dangerous Goods Regulations (DGR) for international shipments worldwide. Samples should be packed according to UN 3373 Category B packaging, labeling, and shipping requirements. Basic instructions for the required TRIPLE PACKAGING method are provided below with links to more information. TRIPLE PACKAGING REQUIREMENTS (1) Primary containers that meet KPA 85 standards (e.g., vacuum tubes with space left for expansion) (2) Wrap primary containers separately in absorbent material for spills and packed securely against impact in leak-proof secondary container (e.g., biohazard bag, plastic screw top container) (3) Secondary container should be securely packed in rigid outer box with required test form(s) (4) Temperature control devices, e.g., gel packs or ice packs (NO LOOSE ICE!) may be packed in secondary container or in outer box. * (5) All shipping docs should be placed in unsealed pouch with shipping label. *Please note that shipping on dry ice is possible, but more complicated. Dry ice is regulated as hazmat under UN 1845 and special training is required for handling and packaging in foam and rigid outer box. Importantly, some couriers (like Fedex) do not like shipping outer foam boxes, even in rigid cardboard outer box, and will charge an extra pickup fee. HELPFUL LINKS FOR UN 3373 CATEGORY B SHIPPING: DOMESTIC SHIPPING DOCUMENTATION Test Request Form(s) 1 per patient in the box Domestic airbill ground shipping less expensive INTERNATIONAL DOCUMENTATION Test Request Form(s) in the box International airbill 2-3 day 3 copies Proforma/Commercial Invoice Copy of required import/export permits for possibly or known infectious material ** ** Please contact Galaxy directly to request copy of US import permit. Shipper addresses must be reported to the CDC for first time shipments Kit Creek Rd, Suite 130 Research Triangle Park, NC t f www galaxydx.com AH International Shipping Instructions: Revised

6 Sample Commercial Invoice Please note that individual couriers may provide fillable commercial invoice forms. Basic information is reflected in this example. COMMERCIAL INVOICE Date: February 5, 2010 Carrier: Reference #: Airbill #: SHIP FROM SHIP TO Name: Name: Galaxy Diagnostics, Inc. Street Address: Street Address: 7020 Kit Creek Rd, Suite 130 City, State, Postal Code: City, State, Zip: Research Triangle Park, NC Country: Country: USA Phone: Phone: PACKAGE INFORMATION Qty Pkg Volume Description Weight Value 2 tubes 8 ml Diagnostic Specimens: tissue or bodily fluid, possibly infected with Bartonella spp bacteria < 1 lb $10 Total Packages 2 Total <1lb $10 I declare all the information contained in this invoice to be true and correct. Shipper s signature Date 7020 Kit Creek Rd, Suite 130 Research Triangle Park, NC t f www galaxydx.com AH International Shipping Instructions: Revised

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