Presentation on theme: "Inverness Medical Professional Diagnostics YOUR NAME GOES HERE."— Presentation transcript:
Inverness Medical Professional Diagnostics YOUR NAME GOES HERE
MKT07040.00 Point of Care Diagnostics Louisville, CO Mfg. Optical ImmunoAssay (OIA ® ) Tech Support Center Scarborough, ME Mfg. BinaxNOW ® Product Line Tech Support Center Princeton, NJ Dist. Clearview ® OEM Products Inverness Medical Point of Care Diagnostics Largest Portfolio of Rapid Tests in the Industry 19 different product lines in 49 configurations OEM Manufacturing for Distribution Approximately 90 Sales Representatives nationwide San Diego, CA Represent mfg. Acceava ®, Clearview Manage Distribution, Private Label
MKT07040.00 Inverness Medical is the Global Market Leader in HIV Rapid Testing Acquired Determine ® rapid test business from Abbott in 2005 Owns Orgenics, Israel, important developer and manufacturer of rapid tests Rights to Acon HIV rapid tests in certain markets Inverness sold 38 million rapid HIV tests in 2006!
MKT07040.00 Changes in the CDC HIV Screening Guidelines NEW Routine, voluntary HIV screening for all persons 13-64 in healthcare settings, not risk based Opt-out screening/part of general consent All unknown status at the time of L&D No required consent or counseling OLD Targeted Testing based on risk assessment (MSM or IDU) Voluntary for Prenatal Care Recommend for those seeking STD treatment Required written consent and counseling High prevalence areas >1%
MKT07040.00 Public Health Need for Rapid HIV Tests High rates of non-return for test results –In 2000, 31% did not return for results of HIV-positive conventional tests at publicly funded sites Need for immediate information or referral for treatment choices –Perinatal settings –Post-exposure treatment settings Screening in high-volume, high-prevalence settings
MKT07040.00 What We Offer Local Representation Full On-Site Training for all staff Superior Technical and Customer Service Representatives Online Interactive Training www.invernessmedicalpd.com/poc/flash/flash_clr_hiv_statpak.html www.invernessmedicalpd.com/poc/flash/flash_clr_hiv_statpak.html CLIA CD-includes CLIA Packet information/flash training CLSI Procedures
MKT07040.00 Support Materials Procedure Training In service Training Support –all sites, locations, and shifts Clearview HIV Counseling Guide CLIA Packet/CLSI for STAT-PAK ® CLIA Packet/CLSI Packet for COMPLETE Live Technical 1-800-637-3717 #4 (7am-5 pm MTN)
MKT07040.00 CLIA Materials Quality Control Information, Q.C. document sheets, EQC Evaluation records List of Important Test Procedures Quality Assessment Plan Proficiency Test Information Packet Training Certificate Competency Assessment Forms Quizzes Material Safety Data Sheets
MKT07040.00 HIV Testing Inverness Medical is the Global Leader In HIV Testing 38 Million people tested in 2006 with an Inverness product 3 Million tests exported in 2006 Tests approved by WHO, USAID, and CDC for international sales
MKT07040.00 STAT-PAKCOMPLETECONTROLS KIT SIZE20 Tests25 Tests 1 Set of: Reactive HIV 1 Reactive HIV 2 Non reactive ORDER NO921109211192112 CLIA STATUS Waived for Whole Blood Waived for Whole Blood Only Clearview Tests STORAGE CONDITIONS Room Temperature (46 to 86°F)Refrigerate (36-46°F) SHELF LIFE24 MONTHS SAMPLEFingerstick, Venipuncture Whole Blood, Serum or Plasma PERFORMANCE SensitivitySpecificity 99.7%99.9% For all sample types CPT CODE86703 National Medicare Average is $19.17 Product Information
MKT07040.00 Clearview ® HIV 1/2 Tests Product Training
MKT07040.00 Prior to Testing Remember to always observe “Universal Precautions” Read the package insert first Gather testing materials Let the test come to operating temperature Set up the workspace with cover and timer Put on gloves Provide the “Subject Information” pamphlet to the person being tested.
MKT07040.00 Clearview ® COMPLETE HIV 1/2 Clearview COMPLETE HIV 1/2 is a unique three-in-one testing solution. Patient sample collection, sample processing, and sample analysis takes place in one self-contained system. The test system is individually packaged with a single use lancet, test, solution, and patient band aid providing a COMPLETE solution to testing needs at the point of care.
MKT07040.00 Running Controls Use 2.5µL pipette fill sample tip
MKT07040.00 Negative Sample and Positive Control
MKT07040.00 Features and Benefits 20 or 25 Tests per KitIdeal for lower testing volume locations 24 Month Shelf Life for Tests and ControlsLow-Risk of kit expiration Waived for Whole BloodFingerstick or Venous Draw Moderate for Serum or PlasmaFlexible for WB confirmatory testing QC open vial stability Order what you need to minimize expired QC material Prepared CLIA Packs/CLSI Reduces admin time for documentation compliance Flash Training AvailableCan be minimally customized for your needs Small Sample Size 2.5 or 5 µL Easy to manage patient sample size for reduced exposure risk No Control Line w/o Patient Sample Additional internal control check for sample addition Ease of Use 15 minute walk away time with 5 minute read window for negatives