IDEXX Preclinical Research Services Directory of Tests and Services

Transcription

1 2011 IDEXX Preclinical Research Services Directory of Tests and Services

2 Welcome to IDEXX Thank you for choosing IDEXX. You have partnered with one of the premier diagnostic laboratories in the nation serving the needs of biotechnology, pharmaceutical and medical device companies; private and government contract research organizations; and universities. The enclosed directory summarizes our diagnostic testing and consultation services. In addition, we offer the following outstanding features that have made IDEXX the laboratory of choice for preclinical research work: Complete Range of Testing and Consultation, including biochemistry, hematology, immunology, microbiology, molecular diagnostics-real-time PCR, and anatomic and clinical pathology. Complete Range of Histology and Clinical Pathology Services. Our board-certified pathologists are available to consult on protocol design, test selection and review of slides and/or test results. In addition, IDEXX has developed a very strong reputation in specialized histology preparation that serves the needs of organizations with their own anatomic pathology staff. Ask us for more information about this outstanding service. Certified Technical Staff. Diagnostic tests are performed by experienced technicians and certified medical technologists. A complete staff of board-certified veterinary pathologists, all trained in comparative clinical pathology, provides diagnostic reports and study consultation. Dedicated Research Support Team (RST), whose function is to schedule, receive and monitor studies, and to be available to answer your questions. Customized Tracking and Reporting for Single and Multicenter Clinical Trials. Dedicated GCP Project Planner. Consultation with our clinical pathologist helps you to plan all phases of your study from protocol development to completion. Validated Instrumentation. IDEXX has an ongoing program to prove suitability of laboratory instrumentation.

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4 Table of Contents Clinical Laboratory Services Clinical Laboratory Services Overview Clinical Laboratory Specimen Preparation Recommended Blood Collection Techniques Guide to Blood Collection Tubes Submissions and Pickups Courier Pickups Overnight Services Inventory Forms Overview Clinical Laboratory Tests and Fees Standard Profiles Custom Profiles Send-Out Tests Individual Tests Blood Chemistries Urine Chemistries Endocrinology Hematology Coagulation Fluid Analysis Cytology Avian Profiles Microbiology and Parasitology Services Microbiology and Parasitology Overview Microbiology Specimen Collection Recommendations Interpreting the Microbiology Minimum Inhibitory Concentration (MIC) Antimicrobials Microbiology and Parasitology Tests and Fees Microbiology and Parasitology/Immunology Molecular Diagnostics Real-Time PCR Services Molecular Diagnostics Real-Time PCR Histology and Histopathology Services Histology and Histopathology Overview Histology Specimen Preparation Recommendations Frequently Asked Questions about Histology Immunohistochemistry and Special Stains Fees Basic Histology Services Alphabetical List of Tests and Fees Standard Terms and Conditions

5 Proprietary Rights Notice Information in this document is subject to change without notice. Companies, names and data used in examples herein are fictitious unless otherwise noted. No part of this document may be reproduced or transmitted in any form or by any means, electronic, mechanical or otherwise, for any purpose, without the express written permission of IDEXX Laboratories, Inc. IDEXX may have patents or pending patent applications, trademarks, copyrights or other intellectual property rights covering subject matter in this document. The furnishing of this document does not give you license to these patents, trademarks, copyrights or other intellectual property except as expressly provided in any written license agreement from IDEXX. 4Dx, ADRChek, Cardiopet, Feline ADR Combo, Feline Combo, HealthChek, LabREXX, Quant C 6, SNAP, Spec cpl Spec fpl, Total Health, VetConnect, RealPCR and vetconnect.com are trademarks or registered trademarks of IDEXX Laboratories, Inc. and/or its affiliates in the United States and/or other countries. All other product and company names and logos are trademarks of their respective holders. PCR testing is a service performed pursuant to an agreement with Roche Molecular Systems, Inc IDEXX Laboratories, Inc. All rights reserved. The IDEXX Privacy Policy is available at idexx.com

6 Clinical Laboratory Services Clinical Laboratory Services Overview General Services Health Maintenance Screens. In caring for the animal populations at your facility, you may want to consider regular health screens, which we can help you design to best fit your needs. Esoteric Tests. If we do not perform a specific test that you request, we will research the location of a reference laboratory that performs the test, and make all arrangements for the testing to be completed. NOTE: We do not audit sendout laboratories, and it is the client s responsibility to ensure that the send-out laboratory s compliance is consistent with the client s regulatory and quality requirements. Special Technologies. Special technologies, such as Real-time PCR/Molecular Diagnostics, etc., may be available on a per case basis through our West Sacramento facility. Special Supplies. Some specialized sample collection supplies are not kept in stock but can be special ordered. As much advanced notice as possible is helpful. Specialized Services and Special Requests Dilution. In cases of insufficient sample volume for routine testing, we will dilute the sample at the client s request in order to provide a maximum amount of valid information. We will be certain to note the parameters that were diluted on your report. Priority Testing. We will ask for your priority testing protocol up front to ensure that you receive the needed results whenever there is a possibility of insufficient sample volume or if we find insufficient volume once testing is underway. Manual Hematology Testing. In most cases, hematology testing is performed by automated equipment; however, if it is necessary to perform testing manually due to the nature of the sample, we will discuss this option with you. STAT Turnaround. Prescheduling is a very critical aspect of optimizing work flow, quality and turnaround times (TATs). Unexpected submissions or inadequate prior notice for larger studies can cause undesirable delays in getting reports out. We will make every effort to process and run unscheduled (submitted with less than 72 hours notice) specimens in a timely manner. The necessity for overtime and added staffing will incur a STAT fee. Studies for hematology testing with more than 40 samples total and a 24-hour TAT could result in a STAT fee of 25%. We will make every effort to meet requested TATs for studies with insufficient prescheduling, but we cannot guarantee that requested times will be met. Post-Report Follow-Up. Should you require a follow-up after a final report is issued, please give us a call and we can make arrangements. Please note: Study data is maintained by IDEXX for up to two years. Additional Copies of Final Reports. Additional copies of reports can be sent to any location with advanced notice. There may be an additional charge for extra copies sent by , fax or FedEx. CLINICAL LABORATORY SPECIMEN PREPARATION Accuracy of any result depends on the quality of the specimen. In General Blood specimens should be analyzed within hours of being drawn. Store and ship specimens at the proper recommended temperature. Before submitting, make sure all collection devices that contain fluids are sealed to prevent leakage. Always submit the proper completed paperwork with your specimens. IDEXX Preclinical Research Services 1

7 Clinical Laboratory Services CLINICAL LABORATORY SPECIMEN PREPARATION (continued) Proper Blood Handling In cases of insufficient sample volume, please indicate the priority of tests and whether results on diluted samples are acceptable. If entire profiles are performed by dilution, certain parameters may not be valid and will not be reported. Blood clots will adversely affect CBC and coagulation results. Please inspect lavender-topped tubes/blue-topped tubes for clots prior to submission. If necessary, redraw the specimen to ensure a clot-free submission. Feel free to consult with our clinical pathologist for optimal sampling techniques for coagulation testing. Serum or plasma that is split from the original collection tube must be free of red blood cells. If necessary, centrifuge the split-off tube to obtain a cell button and pipette the serum/plasma to another tube. If submitting plasma, please indicate the anticoagulant that was used on both the tube and the submittal form. Mail-in clients should separate all serum or plasma from the cells prior to shipping, unless the test calls for whole blood. The specimen should be labeled serum or plasma. Proper Specimen Labeling is Critical Proper labeling helps ensure accuracy in testing. If there is a discrepancy in identification between the paperwork and the information on the tube, jar or other collection device, and we cannot obtain clarification from you, we will follow the information on the collection device. Always label tubes, smears, specimen jars, culturettes, etc. with the animal identification (ID) number, study number and collection date. Be sure the handwriting is clear. Split-off tubes must be labeled appropriately (e.g., plasma with anticoagulant used, serum ). Slide Submissions Submit air-dried slides in a slide holder. The slides and holder should not come in contact with ice, water or other fluids and should not be packed with formalin-fixed samples because formalin fumes distort the cells. Do not refrigerate or freeze slides. Fluid Submissions Submit fluids in both a lavender-topped tube (LTT) and red-topped tube (RTT) if possible. If the sample is insufficient for both tubes, please submit in a RTT. If the sample is insufficient for any tube, submit direct smears on unspun samples. Collected fluid specimens should be refrigerated and transported on ice, but not frozen. Please refer to the slide submission section on page 2 of this directory. Refer to the specimen collection guidelines insert or available online at idexx.com/preclinicalresearch. Urine Submissions The best urine specimen is obtained by cystocentesis using aseptic technique. This collection procedure prevents contamination and provides specimens suitable for cultures. Sample volume for rodents is typically ml. For larger animals, 2 5 ml is average. Refrigerate the specimen and ship it on ice (4 C 6 C) as soon as possible (ideally, for analysis within 24 hours of collection). Avoid freezing the sample as this may damage the cells. RECOMMENDED BLOOD COLLECTION TECHNIQUES The Draw Use a 20-gauge or larger needle. When possible, a 22-gauge needle is preferable to 25-gauge for small rodents. A needle too large may collapse the vein, and a needle too small will lyse cells. Use the vacuum type (e.g., Vacutainer ) collection system to obtain samples from larger veins that will not collapse from the vacuum. If blood flow stops, try rotating the needle one quarter turn to start blood flow. Vacuum-type tubes should be used according to vendor specifications and generally should be filled to the fill line or when flow stops naturally in tubes with no fill line. Do not use tubes past their expiration dates. 2 IDEXX Preclinical Research Services

8 Clinical Laboratory Services RECOMMENDED BLOOD COLLECTION TECHNIQUES (continued) How to Fill Tubes Fill all anticoagulated tubes first if collected by syringe method. If a syringe with a very small-bore needle is used, remove the needle before adding the blood to the open tube. If the needle is not removed, remove the cap from the tube before adding the blood to the tube, or puncture the rubber stopper at an angle so the blood is drawn down the side of the tube. If too much force is used to push the blood into the tube, the RBCs can be lysed. Avoid underfilling or overfilling anticoagulated tubes to ensure the proper specimen-to-anticoagulant ratio. Post-Draw After the specimen is drawn, immediately mix the anticoagulant with the specimen by gently inverting all tubes 6 8 times. Make at least one blood smear at the time the blood is drawn and submit it along with the samples. When appropriate, refrigerate sample tubes (not slides) as soon as possible after collection. If there are any questions regarding sufficiency of the sample volume sent, please list tests in order of priority on the inventory form or in a cover letter. For Coagulation Sample Handling For all coagulation assays, please contact the Research Support Team for information on sample collection and processing. See Blue-Topped Tube (BTT) in Guide to Blood Collection Tubes on page 4. GUIDE TO BLOOD COLLECTION TUBES Red-Topped Tube (RTT) Sample Type: Serum or urine Contents: Sterile tube, contains no preservative or anticoagulant Uses: Commonly used for most routine chemistry, urine chemistry, urinalysis and/or immunology testing where a serum or urine sample is required. Tube Sizes: Microtainer, 2-mL, 3-mL, 4-mL, 5-mL Preparation: Let the tube stand upright for approximately minutes (no longer than 60 minutes) at room temperature to clot. Gently rim the sides of the tube with a wooden stick and centrifuge at approximately rpm for minutes. NOTE: These requirements may vary depending upon the type of centrifuge used; please consult the manufacturer s specifications. Separate serum from cells into a plastic tube (for any to be frozen) or another RTT as soon as possible. Storage: Refrigerate or freeze serum until tests are performed. NOTE: Refrigeration prior to clotting delays clot formation and interferes with clot retraction, yielding less serum. Serum Separator Tube (SST) Sample Type: Serum Contents: Silicon gel and a clot activator Uses: Used for most routine chemistries where a serum specimen is required. Do not use for therapeutic drug testing. Tube Sizes: Microtainer, 4-mL, 9.5-mL Preparation: Let the tube stand upright for minutes to clot. Centrifuge at approximately rpm for minutes. NOTE: These requirements may vary depending upon the type of centrifuge used; please consult the manufacturer s specifications. A barrier will form between the serum and cells. If a complete barrier does not form between the serum and cells, re-spin immediately for five minutes. NOTE: Do not re-spin if more than one hour has elapsed since venipuncture. The serum below the barrier may be hemolyzed and will contaminate the clear serum above the barrier during recentrifugation. The well-spun sample is stable on the clot for 24 hours. Refer to the specimen collection guidelines insert or available online at idexx.com/preclinicalresearch. Storage: Refrigerate serum until tests are performed, unless special test instructions call for freezing. NOTE: Refrigeration prior to clotting delays clot formation and interferes with clot retraction, yielding less serum. IDEXX Preclinical Research Services 3

9 Clinical Laboratory Services GUIDE TO BLOOD COLLECTION TUBES (continued) Lavender-Topped Tube (LTT) Sample Type: Whole blood or plasma Contents: Liquid EDTA preservative and anticoagulant Uses: Commonly used for routine hematology and may be used for some chemistries. Call the Research Support Team for details. Tube Sizes: Microtainer, 2-mL, 3-mL, 4-mL Preparation: Avoid underfilling tubes. NOTE: The 2-mL tube can be used to collect microsamples. If ml of sample is collected, gently shake the excess EDTA out of the tube and add the blood. Mix thoroughly by inverting the tube 6 8 times immediately after the sample is added to the tube. Examine the sample for clots. Discard and repeat the draw if clots are present. Storage: Refrigerate (2 C 6 C) as soon as possible after collection. Transport on ice, but not frozen. Perform tests within hours. Blue-Topped Tube (BTT) Sample Type: Plasma Contents: Citrate as a preservative and anticoagulant Uses: Used for coagulation studies. Tube Sizes: 2-mL, 3-mL, 5-mL (Follow the manufacturer s instructions for proper sample volume.) Preparation: This tube must not be over- or under-filled, or results will be affected. Please contact the Research Support Team for special instructions. Centrifuge at rpm for minutes and separate plasma from cells. Transfer plasma to plastic tube with no additive and label as citrated plasma for submission. Freeze sample and ship on ice. (Be sure to separate cells within two hours of collection.) Put plasma in a plastic tube. Do not submit plasma in a BTT. Examine for clots or hemolysis. If either is present, the sample should be redrawn. Storage: If the assay will not be performed within four hours after collection, freeze the plasma and send it on dry ice. Fibrin Degradation Products (FDP) Sample Type: Serum Contents: Thrombin and soybean trypsin Uses: Fibrin degradation products. Tube Sizes: 5-mL Preparation: Fill tube with 2-3 ml of blood and then allow it to stand at room temperature for minutes before centrifuging. The sample must clot in order to get reliable results. Storage: Refrigerate serum after separation. Send on ice. Do not freeze. 4 IDEXX Preclinical Research Services

10 Submissions and Pickups Courier Pickups West Coast We service the extended San Francisco Bay Area; Santa Rosa; parts of San Diego; the Sparks-Reno, Nevada area; and the Sacramento Valley with twice-a-day pickups. We provide once-a-day pickups for more remote areas, including north of Red Bluff; from Fresno south to Porterville; Irvine; parts of San Diego; Oregon; and Hawaii. For areas outside of these, we can arrange pickup using overnight services, IDEXX courier services or commercial airlines. See the following section for overnight services guidelines. East Coast Courier territories cover several metropolitan areas throughout the East Coast. Call the National Research Support Line at , option 5, to see if your location is on a courier route. Lab Locations: For courier pickup, please call , option 5. Please label boxes Biohazard if applicable. West Sacramento Facility Location Call Monday through Friday, anytime between 5:30 a.m. and 5:00 p.m. PT For Guaranteed Daytime Pickup: Call by 11:00 a.m. For Guaranteed Evening Pickup: Call by 5:00 p.m. Please call us immediately if there will be any changes to your pickup schedule KOVR Drive West Sacramento, CA North Grafton Facility Location Call Monday through Friday, anytime between 8:30 a.m. and 8:00 p.m. ET For Guaranteed Daytime Pickup: Call by 10:00 a.m. For Guaranteed Evening Pickup: Call by 5:00 p.m. Please call us immediately if there will be any changes to your pickup schedule. 3 Centennial Drive, Suite 1 North Grafton, MA Important Courier Pickup Reminders: Keep samples stored at proper temperature until pickup time. Store histopathology specimens, slides or blood smears at room temperature. IMPORTANT! Please let us know if a preservative other than 10 percent buffered formalin is used when you call for a pickup. In addition, make sure to note any non-formalin preservative on the Histology Samples Inventory Form and cover letter. Also, package and label all histology specimens in separate boxes from blood and slides. Refrigerate whole blood and serum. Wrap specimens in paper towels, place in plastic bag and then place with ice. Do not place in direct contact with ice. Whole blood samples should never come in contact with ice. Never pack samples containing red blood cells with dry ice. Slides should be kept at room temperature and not packed on ice or dry ice. Please store samples as per the individual test specimen requirement see individual test for recommendations. Label the outside of all boxes with the following: TO: IDEXX Preclinical Research Services FROM: (Your Company Name) Study Identification Number IDEXX Preclinical Research Services 5

11 Submissions and Pickups Overnight Services We recommend FedEx for guaranteed overnight service. Check with FedEx to verify cutoff times for your area. Please follow the same procedure as for courier pickups, and these additional suggestions for best results: Plan to ship all blood samples the same day they are drawn. Secure all caps on tubes and jars. When possible, use screw-cap tubes or jars. Package all specimens in Styrofoam containers encased by a cardboard box. Line the box with plastic or wrap specimens in individual plastic bags. This will prevent the liquid from leaking through the box in case of a spill or breakage. For refrigerated specimens: Place ice packs on the bottom of the container. Whole blood samples should never come in contact with ice. Never pack samples containing red blood cells with dry ice. For frozen specimens: Place dry ice on the bottom of the container. Always use separate containers for frozen and refrigerated samples. Always pack formalin samples in a separate container from non-formalin samples. Slides should be kept at room temperature and not packed on ice or dry ice. Please use slide holder. Place several layers of newspaper or paper towels over the ice packs or dry ice to separate them from the specimens. Place the tubes in the container in an upright position. This can be done by using a test tube rack, by placing samples in a paper cup, or by grouping tubes (5 10 per group) together with a rubber band and standing them in a container. Put several layers of newspaper or paper towels on top of the specimens. Address to: Laboratory FedEx Hub IDEXX Preclinical Research Services IDEXX Preclinical Research Services 2825 KOVR Drive 3950 Development Drive West Sacramento, CA Sacramento, CA or IDEXX Preclinical Research Services 3 Centennial Drive, Suite 1 North Grafton, MA IDEXX Preclinical Research Services

12 Submissions and Pickups Inventory Forms Overview Supplies We provide collection tubes, culture swabs and formalin jars to you free of charge for collecting samples that you will be submitting to us. We recommend that you call us at least one week ahead of your collection date to place your supply order, to ensure you receive the supplies before your study begins. Please be sure to refer to the Clinical Laboratory Specimen Preparation section for submission requirements, including sample collection and sample storage protocol. Availability Forms can be downloaded from our Web site at Clinical Trials For clinical trial studies, call us to schedule a consultation on customized inventory forms. Clinical Specimens All clinical specimens must be submitted with a completed IDEXX Clinical Sample Inventory Form. In addition, please follow these guidelines: Study ID: This can be alphabetic or numeric, and will be printed on all reports. If you do not have a study number, we ll use the date the samples arrived at the laboratory. Purchase order numbers (P.O. #): If provided, P.O. # will appear on your invoice. Species: Is very important as certain equipment has specific settings for different species. Biohazard: Please indicate if the specimen is a biohazard, including the type of biohazard. Number of animals: Enter total number of animals from which samples were taken. Tests requested: List the test codes to be performed. If a custom profile has been set up for you, list this number. NOTE: Custom profiles must be prearranged at least one week in advance. Priority testing: Please list tests in order of priorities in case of insufficient sample volume. Clinical interpretation: All studies that include interpretation must be submitted with a signed protocol. Special instructions: Special instructions must be submitted before or at the first timepoint for each new study. These might cover priority testing, special processing requests, duplicate testing, dilution limits, or other aspects that are either not detailed in the submitted study protocol or constitute a deviation from our standard operating procedure (SOP). SOP deviations require the review and approval of our laboratory manager with recommendations from our clinical pathologist. Histology Specimens All histology specimens must be submitted with a Histology Inventory Form. GCP studies should be submitted with a protocol. In addition, please include: Expected completion date: Turnaround time for histology samples will be determined at receipt of study or preschedule with Client Service Manager. IDEXX calculates turnaround time in terms of business days, which does not include Saturdays or Sundays, nor days when the sample is in transit. Special instructions: List any special requests, trimming instructions, etc., or attach a detailed cover letter. Histopathology evaluation: In general, any animal history that you can provide is helpful to our pathologists in making their evaluation. Necropsy records should include a history. IDEXX Preclinical Research Services 7

13 Clinical Laboratory Tests Standard Profiles Blood Chemistries Test Code Test Name Contents and Specimen Requirements 6006 Comprehensive Chemistry Albumin, albumin/globulin ratio, alkaline phosphatase, ALT (SGPT), AST (SGOT), bicarbonate, direct bilirubin, indirect bilirubin, total bilirubin, BUN, BUN/creatinine ratio, calcium, chloride, cholesterol, CK, creatinine, globulin, glucose, phosphorus, potassium, sodium, sodium/potassium ratio, total protein Specimen Requirements: 0.5-mL serum; For mice: 0.25-mL serum Comprehensive CBC WBC, RBC, Hgb, HCT, erythrocyte indices (MCV, MCH, MCHC), WBC differential, platelet count, smear evaluation by technologist for RBC and WBC blood morphology and parasite screen, pathologist review of abnormal cells, reticulocyte count and absolute reticulocyte count Specimen Requirements: 0.5-mL EDTA blood, one blood smear; for mice: 0.3-mL EDTA blood, one blood smear Basic CBC WBC, RBC, Hgb, Hct, erythrocyte indices (MCV, MCH, MCHC), differential, platelet estimate only* and smear evaluation by technologist for RBC and WBC blood morphology and parasite screen. Specimen Requirements: 0.5-mL EDTA blood, one blood smear; for mice: 0.3-mL EDTA blood, one blood smear 6037 Automated Platelet Count for Canine, Feline, Ovine, Bovine, Lagomorph, Rat, Equine, Mouse, Porcine, Primate Specimen Requirements: 0.5-mL EDTA blood, one blood smear; for mice: 0.3-mL EDTA blood, one blood smear Add-On Automated Platelet Count for Canine, Feline, Ovine, Bovine, Lagomorph, Rat, Equine, Mouse, Porcine, Primate 6027 Manual Platelet Count (All Species) Specimen Requirements: 0.5-mL EDTA blood, one blood smear; for mice: 0.25-mL EDTA blood, one blood smear Add-On Manual Platelet Count (All Species) 6313 Reticulocyte Count Includes absolute reticulocyte and % reticulocyte Specimen Requirements: 0.3-mL EDTA blood 6008 Comprehensive Chemistry and Basic CBC Comprehensive Chemistry and Comprehensive CBC Specimen Requirements: 0.5-mL serum, 0.5-mL EDTA blood, one blood smear; For mice: 0.25-mL serum, 0.3-mL EDTA blood, one blood smear Includes numerical platelet count, reticulocyte count and absolute reticulocyte count Specimen Requirements: 0.5-mL serum, 0.5-mL EDTA blood, one blood smear; for mice: 0.25-mL serum, 0.3-mL EDTA blood, one blood smear 6004 Coagulation 1 CBC, automated platelet count, prothrombin time (PT), activated partial thromboplastin time (PTT) and quantitative fibrinogen * If you need a numerical platelet count, order the add-on platelet count or comprehensive CBC. Specimen Requirements: 0.5-mL EDTA blood, one blood smear, 1.0 ml frozen citrated (BTT) plasma; For mice: 0.3-mL EDTA blood, one blood smear, 0.5-mL frozen citrated (BTT) plasma 6045 Coagulation 2 PT, PTT and quantitative fibrinogen 6005 Coagulation, Mini PT and PTT Specimen Requirements: 1.0-mL frozen citrated (BTT) plasma; for mice: 0.5-mL frozen citrated (BTT) plasma Specimen Requirements: 1.0 ml frozen citrated (BTT) plasma; for mice: 0.5-mL frozen citrated (BTT) plasma 6291 Lipid Profile (nonrodent) Cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (calculation) Specimen Requirements: 0.5-mL serum 6290 Lipid Profile (rodent) Cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (direct) Specimen Requirements: 0.5-mL serum 8 IDEXX Preclinical Research Services

14 Clinical Laboratory Tests Test Code Test Name Contents and Specimen Requirements Liver Panel Albumin, alkaline phosphate, ALT, AST, CK, GGT, total bilirubin, direct bilirubin, indirect bilirubin, total protein Renal Panel Specimen Requirements: 0.5-mL serum; for mice: 0.25-mL serum Albumin, BUN, calcium, chloride, creatinine, phosphorus, potassium, sodium, total protein Specimen Requirements: 0.5-mL serum; for mice: 0.25-mL serum Add-on: Urinalysis (6910) Optional: Urine protein:creatinine ratio, urine protein electrophoresis, urine chemistries; requires 1.0-mL urine (call for setup and/or consultation) Short Tox Panel Bile acids, alkaline phosphate, ALT, AST, total bilirubin, GGT, BUN, creatinine, BUN/creatinine ratio Specimen Requirements: 0.5-mL serum; for mice: 0.25-mL serum Expanded Tox Panel Bile acids, alkaline phosphate, ALT, AST, total bilirubin, GGT, BUN, creatinine, BUN/creatinine ratio, sodium, chloride, potassium, phosphorus, total protein, albumin, CK, cholesterol, glucose, HDL, LDL, triglycerides Specimen Requirements: 0.5-mL serum; for mice: 0.25-mL serum Note: Minimum sample size may vary according to the type of species being assayed. Call to discuss. We may use dilutions if short samples are submitted. To avoid erroneous results, please make sure all LTT and BTT specimens are free of clots prior to submission. Custom Profiles You can design custom profiles to match your diagnostic needs. Custom profiles require seven business days to create and activate. Chemistry Tests When you select a CBC, these parameters will be included: Albumin Bilirubin, Total GGT WBC MCHC Alkaline Phosphatase BUN LDH HCT Differential ALT (SGPT) Calcium Lipase Hgb Platelet Estimate or Count Amylase Chloride Phosphorus MCH MCV Anion Gap Cholesterol Potassium RBC Morphology RBC AST (SGOT) CK Protein, Total Bicarbonate Creatinine Sodium Bilirubin, Direct Globulin Triglycerides^ Bilirubin, Indirect Glucose Uric Acid Test Code Test Name Contents and Specimen Requirements TBA Basic Chemistry Select 1 10 tests from chemistry list. Specimen Requirements: 0.5-mL serum; For mice: 0.25-mL serum TBA Comprehensive Chemistry Select 11 or more tests from chemistry list. Specimen Requirements: 0.5-mL serum; For mice: 0.25-mL serum TBA TBA TBA Comprehensive Chemistry and Basic CBC Basic Chemistry and Basic CBC Comprehensive Chemistry and Comprehensive CBC Select 11 or more tests from chemistry list. Profile includes basic CBC. Specimen Requirements: 0.5-mL serum, 0.5-mL EDTA blood, one blood smear; for mice: 0.25-mL serum, 0.3-mL EDTA blood, one blood smear Select 1 10 tests from chemistry list. Profile includes basic CBC. Specimen Requirements: 0.5-mL serum, 0.5-mL EDTA blood, one blood smear; for mice: 0.25-mL serum, 0.3-mL EDTA blood, one blood smear Select 11 or more tests from chemistry list. Profile includes comprehensive CBC. Specimen Requirements: 0.5-mL serum, 0.5-mL EDTA blood, one blood smear; for mice: 0.25-mL serum, 0.3-mL EDTA blood, one blood smear ^ Add $4.00 to custom panel when ordering triglycerides. TBA = to be assigned at the time the custom profile is designed. Please keep a record of your custom profile test codes. IDEXX Preclinical Research Services 9

15 Clinical Laboratory Tests Test Code Test Name Contents and Specimen Requirements TBA TBA Basic Chemistry and Comprehensive CBC Urine Chemistries Select 1 10 tests from chemistry list. Profile includes comprehensive CBC. Specimen Requirements: 0.5-mL serum, 0.5-mL EDTA blood, one blood smear; for mice: 0.25-mL serum, 0.3-mL EDTA blood, one blood smear 1 4 chemistries Specimen Requirements: 1.0 ml urine; for mice: 0.25-mL urine Send-Out Tests Call for prices and information. ACTH, Endogenous (EDTA Plasma frozen in plastic tube) Iron, TIBC and Ferritin Albumin (Urine) Lactate Catecholamine Panel (Dopamine, Epinephrine and Norepinephrine) Norepinephrine CK Isoenzymes Plasma-Free Hemoglobin (must be frozen) Dopamine Q Fever Epinephrine Troponin I Haptoglobin (must be frozen) Troponin T Ionized Calcium Troponin Panel (I and T) Send-Out Service If we do not perform a specific test that you request, we can research a location of a reference laboratory that performs the test and make all arrangements for the testing to be completed. In addition to the test price, a shipping, handling and administrative fee for each sample and study grouping will be applied. Electronic Data Upon request, electronic data is available in an Excel Matrix format. Please call for other tests not listed. TBA = to be assigned at the time the custom profile is designed. Please keep a record of your custom profile test codes. Check species availability. 10 IDEXX Preclinical Research Services

16 Clinical Laboratory Tests Individual Tests Blood Chemistries Test Code Test Name Specimen Requirements ACTH Stimulation, Endogenous by RIA Ω EDTA plasma (frozen in plastic tube) Alanine Aminotransferase (ALT/SGPT) Albumin Alkaline Phosphatase (ALP) serum serum serum 6203 Amylase serum Aspartate Aminotransferase (AST/SGOT) B12, Folate, TLI Ω Bicarbonate serum serum (after an overnight fast) serum 6257 Bile Acids, Pre and Post serum (two samples) 6258 Bile Acids serum (one sample) 6204 Bilirubin, Direct serum Bilirubin, Indirect Bilirubin, Total Brucella abortus or Brucella ovis Antibody by ELISA Ω serum 6207 Bun serum 6208 Calcium serum 6210 Chloride serum 6292 Cholesterol, HDL Serum For LDL Cholesterol, order Lipid Profile, Test Code Cholesterol, Total serum 6230 Cholinesterase serum CK Isoenzymes Ω serum 6800 Cortisol 6212 Creatine Phosphokinase (CPK) serum 6213 Creatinine serum Direct LDL 6245 Fructosamine serum 6214 Gamma-Glutamyltransferase (GGT) serum Glucose serum (use when ordering only glucose) 6215 Glucose serum (use when ordering 1 2 tests together) Hemoglobin, Plasma-Free Ω serum 1719 Ionized Calcium serum 6962 Iron serum Ω See Send-Out Tests section, pg.10. Reference lab fee will apply. Call for detailed specimen collection and handling guidelines. Check species availability. IDEXX Preclinical Research Services 11

17 Clinical Laboratory Tests Blood Chemistries (continued) Test Code Test Name and Contents Specimen Requirements Iron, TIBC and Ferritin Ω 6218 Lactate Dehydrogenase (LDH) serum Lactate Ω 6219 Lipase serum 6290 Lipid Profile (rodent) : Cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (direct) serum (frozen in plastic tube) call for information serum 6291 Lipid Profile (nonrodent) : Cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (calculation) serum 6220 Magnesium serum 6221 Phosphorus serum 6229 Potassium serum 6223 Protein Electrophoresis, Serum serum Protein Electrophoresis, Urine, CSF, Wash Fluid Urine, CSF, Wash Fluid 6314 Protein, Plasma plasma 6222 Protein, Total serum 745 Q Fever Ω serum 6231 Sodium serum 6227 Sorbitol Dehydrogenase (SDH) serum Spec cpl serum Spec fpl serum 6242 Triglycerides serum Troponin I and T Ω serum 6207 Urea Nitrogen (BUN) serum 6228 Uric Acid serum Urine Chemistries Test Code Test Name Specimen Requirements Albumin Ω urine 6967 Calcium urine 6970 Chloride urine 6993 Creatinine urine 6244 Magnesium urine 6968 Phosphorus urine 6966 Potassium urine 6992 Protein urine 6965 Sodium urine 6969 Urea Nitrogen urine 6944 Uric Acid urine 6910 Urinalysis, Complete Volume, color, clarity, specific gravity, ph, protein, glucose, ketones, urobilinogen, bilirubin, blood, WBC, RBC, bacteria, EPI cell, mucus, casts, crystals Urinalysis, No Sediment Examination urine sterile container of urine Ω See Send-Out Tests section, pg.10. Reference lab fee will apply. Call for detailed specimen collection and handling guidelines. 12 IDEXX Preclinical Research Services

18 Clinical Laboratory Tests Urine Chemistries (continued) Test Code Test Name Specimen Requirements 6946 Urine, Cortisol/Creatinine Ratio urine 6991 Urine, Phosphate/Serum Phosphate Ratio urine/serum 6994 Urine, Protein/Creatinine Ratio urine 6998 Urine, Uric Acid/Creatinine Ratio urine 6942 Urobilinogen urine Endocrinology Test Code Test Name and Contents Specimen Requirements 6800 Cortisol by RIA min. vol mL serum 6805 Insulin, Nonrodent Insulin, Rodent min. vol. 250-uL serum Progesterone T 3, Total (RIA) T 4, Free (Equilibrium Dialysis) T 4, Free (RIA) T 4, Total (RIA) T TSH, Canine TSH, Primate Hematology min. vol mL serum min. vol mL serum min. vol mL serum min. vol. 0.2-mL serum min. vol. 0.2-mL serum min. vol. 0.2-mL serum min. vol mL serum min. vol mL serum Test Code Test Name and Contents Specimen Requirements 6301 Blood Count EDTA blood WBC, RBC, Hgb, Hct and indices (does not include WBC 0.5-mL EDTA blood, one blood smear differential, platelet estimate or platelet count) 0.3-mL EDTA blood, one blood smear for rodents 6607 Bone Marrow Cytology (200-cell count) Bone marrow smears. Call for collection guidelines. Submission of a concurrent CBC or CBC data if available is strongly recommended Bone Marrow Cytology (500-cell count) Bone marrow smears. Call for collection guidelines. Submission of a concurrent CBC or CBC data if available is strongly recommended CBC, Basic EDTA blood WBC, RBC, Hgb, Hct, erythrocyte indices (MCV, MCH, 0.5 ml EDTA blood, one blood smear MCHC), differential, platelet estimate only and smear 0.3 ml EDTA blood, one blood smear for evaluation by technologist for RBC and WBC blood rodents morphology and parasite screen Comprehensive CBC EDTA blood WBC, RBC, Hgb, HCT, erythrocyte indices (MCV, MCH, 0.5 ml EDTA blood, one blood smear MCHC), WBC differential, platelet count, smear evaluation by technologist for RBC and WBC blood morphology and parasite 0.3 ml EDTA blood, one blood smear for screen, pathologist review of abnormal cells, reticulocyte count rodents and absolute reticulocyte count 6303 Coombs (37 C), Canine, Feline EDTA blood Micronuclei Count Bone marrow smears preferred sample 6037 Platelet Count, Automated (rabbits, ovine, bovine, EDTA blood rodents, pigs, canine, feline and primates) 6027 Platelet Count, Manual (all species) EDTA blood Check species availability. Order add-on platelet count or comprehensive CBC for numerical count. IDEXX Preclinical Research Services 13

19 Clinical Laboratory Tests Hematology Test Code Test Name and Contents Specimen Requirements 6026 RBC Count, Manual (avian and reptile) EDTA blood 6313 Reticulocyte Count/Absolute reticulocyte and % EDTA blood reticulocyte 6314 Total Protein (Refractometer) EDTA blood 6335 WBC Count, Automated EDTA blood WBC Count, Automated with Differential EDTA blood 6025 WBC Count, Manual (avian and reptile) EDTA blood 6302 WBC Differential, 100 Cells (for manual WBC) EDTA blood or smears 6327 WBC Differential, 500 Cells (for manual WBC) EDTA blood or smears Coagulation Test Code Test Name Specimen Requirements 6323 D-Dimer Plasma (frozen in plastic tube) 6323 Fibrin Degradation Products (FDP) call lab for special collection tube 6308 Fibrinogen, Quantitative 1 ml frozen citrated (BTT) plasma; For mice: 0.25-mL frozen citrated (BTT) plasma 6312 Partial Thromboplastin Time (PTT) 1 ml frozen citrated (BTT) plasma; For mice: 0.25-mL frozen citrated (BTT) plasma 6311 Prothrombin Time (PT) 1 ml frozen citrated (BTT) plasma; For mice: 0.25-mL frozen citrated (BTT) plasma 6333 Thrombin 1 ml frozen citrated (BTT) plasma; For mice: 0.25-mL frozen citrated (BTT) plasma Fluid Analysis Test Code Test Name and Contents Specimen Requirements Cytologic Interpretation/Differential slides only 6935 Cytology with Fluid Analysis (BAL Cell Count) RBC (estimate), WBC, differential, cytologic interpretation BAL samples are time sensitive. To assure sample integrity IDEXX prefers to receive samples Monday Thursday only. fluid in LTT (EDTA), slides (sterile RTT or tube for culture) 6905 Cytology with Fluid Analysis (Body Cavity Effusion) fluid in LTT (EDTA), Total protein, RBC, WBC, differential, specific gravity, slides (sterile RTT or tube for culture) cytologic interpretation 6900 Cytology with Fluid Analysis (CSF) sterile glass RTT, slides Total protein, glucose, RBC, WBC differential, specific gravity, cytologic interpretation 6906 Cytology with Fluid Analysis (Synovial/Joint) fluid in LTT (EDTA), Total protein, RBC, WBC differential, specific gravity, mucin slides (sterile RTT or tube for culture) and viscosity, cytologic interpretation Cytology Test Code Test Name and Contents Specimen Requirements 6605 Cytology Smears Slides only no differential count Ω See Send-Out Tests section, pg. 10. Reference lab fee will apply. Call for detailed specimen collection and handling guidelines. Please schedule one week in advance of submission. 14 IDEXX Preclinical Research Services

20 Clinical Laboratory Tests Avian Profiles Test Code Test Name and Contents Specimen Requirements 6137 Avian CBC one HCT tube, two blood smears or coverslips, WBC estimate or count, differential, RBC morphology, or lithium heparin tube for manual WBC thrombocyte evaluation, blood parasite screen, hematocrit, plasma protein 6350 Avian CBC and Plasma Protein one HCT tube, two blood smears or coverslips, or lithium heparin tube for manual WBC, 0.2-mL blood minimum 6130 Avian Chemistry 0.3-mL heparinized plasma (GTT)/serum Albumin, albumin/globulin ratio, alkaline phosphatase, ALT (SGOT), amylase, AST (SGPT), BUN, calcium, cholesterol, CK, globulin, glucose, LDH, phosphorus, potassium, sodium, total protein, uric acid 6131 Avian Chemistry and CBC one HCT tube, two blood smears or coverslips, or lithium heparin tube for manual WBC, 0.2-mL blood minimum and 0.3-mL heparinized plasma (GTT)/serum 6358 Avian Differential Only two blood smears or coverslips WBC estimate, no plasma protein Please schedule avian samples one week in advance of submission. IDEXX Preclinical Research Services 15

21 Microbiology and Parasitology Services Microbiology and Parasitology Overview Methodologies and Reporting Specimens submitted for culture are plated and evaluated according to their source. All microorganisms recovered from culture analysis are reported as relative amounts of growth. Colony counts will be performed on urine specimens. Antimicrobial susceptibilities, when requested, are done on appropriate bacterial isolates. Antibiotics reported are based on the organism isolated. Results are reported as susceptible or resistant. MIC is available for urine isolates on request. MICs available for most isolates and antibiotics. Normal Flora, Predictable Susceptibility Patterns and Nonpathogenic Organisms We follow guidelines set by the Clinical and Laboratory Standards Institute (CLSI), combined with our years of experience in performing susceptibility testing. We believe these are best practice microbiology techniques, and would be happy to discuss the following policies with you: Susceptibilities will not be performed on normal flora and nonpathogenic organisms. Pathogens with predictable susceptibility patterns, or no CLSI standards, will be reported with a recommended list of antibiotics. Examples include Beta Strep and Pasteurella. Pathogens with atypical growth characteristics (i.e., slow-growing, anaerobic), render susceptibility testing inaccurate, and, therefore, will be reported with recommended antibiotics. Examples include Corynebacterium pseudotuberculosis and Actinomyces. Direct Gram s Stain A direct Gram s stain will be completed automatically for rabbit/rodent and avian/exotic cultures. The most valuable sources for a direct Gram s stain are wounds, abscesses, fluids, ears, tracheal washes and sterile sources. Direct Gram s stains for other cultures must be requested, and will incur an additional charge. Microbiology Specimen Collection Recommendations Check the Microbiology Specimen Preparation Chart at Collection Devices Please call us to verify appropriate collection bottles, tubes and culturette swabs for microbiology testing. Also, before submitting, please make sure all collection devices that contain fluids are sealed to prevent leakage. We do not accept samples submitted in syringes with needles. If such samples are submitted, a $50.00 charge per sample will be added. To avoid this charge, please remove the needle. Anaerobic and Aerobic Culturette Be certain the swab is immersed in the holding medium. Some culturettes have an ampule to crush. Store culturette swabs at room temperature before sampling. Refrigerate after sampling to ensure greatest recovery of pathogens and to minimize overgrowth. Make sure the lab receives the culturette swab within 48 hours in order to optimize recovery and reduce loss of viability. Blood Culture Bottles Please call for supplies. Store blood culture bottles at room temperature or in an incubator until specimens are picked up. Do not vent bottles. Do not refrigerate. When using a yellow-topped ISOLATOR tube, keep at room temperature until the specimen is picked up. Collection Techniques Abscesses/Wounds. Aseptically prepare the collection site. Aspirate fluid or pus from pustules or vesicular wounds and abscesses. Submit specimen on culturette or in a sterile RTT. Request aerobic and anaerobic culture on submission forms. Blood. Wash the venipuncture site with antiseptic soap. Rinse with sterile water. Apply 1 2 percent tincture of iodine or providone-iodine and allow to dry. Remove iodine with 70 percent alcohol wash. Incubate bottles or leave them at room temperature until delivery to the lab. For animals <25 pounds, use an ISOLATOR tube. Check the Microbiology Specimen Preparation Chart at 16 IDEXX Preclinical Research Services

22 Microbiology and Parasitology Services Bone Marrow. Aseptically prepare the collection site. Submit in a blood culture bottle. Central Nervous System. Collect CSF fluid by subdural tap, ventricular aspiration or lumbar puncture. Submit in a RTT. Ears. Use a swab to collect material from margin of inflammation. Posterior pharynx cultures may also reveal organisms causing otitis media. Eyes. Use a swab to collect suppurative material from the cul-de-sac or medial canthus. Note that topical anesthetic may inhibit bacterial growth. Feces. Avoid contamination with urine and soil. Place fresh fecal specimen (2 5 grams) in fecal culture transport media (preferred) or a RTT. Place Campylobacter specimens in fecal culture transport media. Fungal. Use a sterile blade or swab to collect material from infected nail. Swab or scrape active border of skin lesions. Transport punch biopsies in a sterile container (RTT is acceptable). Hair. Place several involved hairs in a sterile container (RTT is acceptable). Nasal. Aspirate from maxillary, frontal or other sinuses. You may also submit a swab. In cases of chronic sinusitis, anaerobic bacteria are often involved. Indicate on the submission forms if you require an anaerobic culture. Tissue. Submit culture specimen in a sterile container, such as a RTT. NOTE: Use a small amount of sterile saline to keep specimen hydrated. Do not submit in formalin or ethanol. Urine. Cystocentesis is preferred (except large animals). Indicate the urine collection method on your requisition form. Avoid contamination with fecal material. Place specimens collected by syringe in a RTT for transport. Keep urine specimens refrigerated. NOTE: Due to low retrieval of organisms, we are unable to provide colony counts on specimens submitted on swabs. Interpreting the Microbiology Minimum Inhibitory Concentration (MIC) What Is the MIC? The MIC, or minimum inhibitory concentration, is the lowest concentration (in μg/ml) that inhibits the growth of a given strain of bacteria. At IDEXX, a commercial automated system is used to determine MICs. A quantitative method of susceptibility testing, an MIC helps determine which class of antimicrobial is most effective. This MIC information can lead to an appropriate choice of an antimicrobial that will increase chances of treatment success and help in the fight to slow antimicrobial resistance. How Is the MIC Reported? Next to each antimicrobial is the susceptibility interpretation: S (sensitive), I (intermediate) or R (resistant), followed by the MIC in μg/ml. Sensitive implies that the organism is inhibited by the serum concentration of the drug that is achieved using the usual dosage; intermediate implies that the organisms are inhibited only by the maximum recommended dosage; and resistant implies that the organisms are resistant to the usually achievable serum drug levels. These interpretive standards have been established by the Clinical and Laboratory Standards Institute (CLSI), formerly the National Committee for Clinical Laboratory Standards (NCCLS). How Are MICs Used? The breakpoint and range of dilutions differ by drug and bacterial species. Therefore, comparing MICs of different antimicrobials is not based solely on the numerical value, but on how far the MIC is from the breakpoint, the site of the infection and other considerations, such as the age, species and health of the animal. Possible side effects of the drug, price, frequency, and route of administration are also important factors. IDEXX Preclinical Research Services 17

23 Microbiology and Parasitology Services Interpreting MICs Your results will not only identify the organism and list of microbials to which it is susceptible, but most cultures will also include MICs to determine the best drug for successful treatment. For example: A strain of E. coli has an MIC of 2 μg/ml for amoxicillin and an MIC of 8 μg/ml for cephalexin. Looking at the dilutions for amoxicillin, at 2 μg/ml, this strain of E. coli is four dilutions away from the breakpoint. For cephalexin, the same strain of E. coli at an MIC of 8 μg/ml is two dilutions away from the breakpoint. So, based on MICs, this strain of E. coli is more susceptible to amoxicillin than cephalexin. Class-Reference Antimicrobials Some antimicrobials are used to determine the susceptibility of other antimicrobials in the same class. For example, oxacillin is used to predict the susceptibility of methicillin. Amoxicillin-clavulanic ccid Amoxicillin Cephalexin Clindamycin Enrofloxacin Erythromycin Gentamicin synergy Oxacillin Tetracycline Trimethoprim/Sulfa Predicts susceptibility of Clavamox. Predicts susceptibility of ampicillin. Predicts susceptibility of all first-generation cephalosporins, except cefazolin. Predicts susceptibility of lincomycin. Should not be used in horses, rabbits and other herbivores. Not effective against aerobic gram-negative bacteria. Not recommended in young animals. Predicts susceptibility of azithromycin and clarithromycin. Not effective against aerobic gram-negative bacteria. Tested for Enterococcus spp. only. If amoxicillin is resistant, gentamicin synergy is susceptible, treatment with amoxicillin, ampicillin or penicillin in combination with gentamicin is an option in serious infections. Predicts susceptibility to methicillin. Predicts susceptibility of doxycyline and minocycline. Use not recommended in young animals. Predicts susceptibility of other potentiated sulfonamides. 18 IDEXX Preclinical Research Services