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Inverness Medical Professional Diagnostics YOUR NAME GOES HERE.

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Presentation on theme: "Inverness Medical Professional Diagnostics YOUR NAME GOES HERE."— Presentation transcript:

1 Inverness Medical Professional Diagnostics YOUR NAME GOES HERE

2 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

3 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!

4 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%

5 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

6 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

7 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)

8 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

9 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

10 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

11 MKT07040.00 Clearview ® HIV 1/2 Tests Product Training

12 MKT07040.00 Additional Materials Required Timer or Watch Biohazard Waste Container Disposable, Absorbent, Workspace Cover Disposable Gloves Sterile Lancet (included with COMPLETE) Antiseptic Wipe Sterile Gauze Pads

13 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.

14 MKT07040.00 Clearview ® HIV 1/2 STAT-PAK ®

15 MKT07040.00 Kit Contents

16 MKT07040.00 Open pouch from black mark

17 MKT07040.00 Test Materials

18 MKT07040.00 Fingertip lancet Fingerstick Collection Clean finger with antiseptic wipe Allow to dry or wipe with sterile gauze Puncture finger with sterile lancet

19 MKT07040.00 Wipe away first drop of blood

20 MKT07040.00 Fill Sample Loop with 2 nd blood drop

21 MKT07040.00 Transfer sample to sample (S) well

22 MKT07040.00 Add 3 drops of Running Buffer

23 MKT07040.00 Wait 15 minutes

24 MKT07040.00 Interpret results (next slide)

25 MKT07040.00 Results Interpretation

26 MKT07040.00 Positive & Negative Controls

27 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.

28 MKT07040.00 Clearview ® COMPLETE HIV 1/2

29 MKT07040.00 Clearview COMPLETE HIV 1/2 Foil wrapped pack Clearview Barrel + Buffer Cap Lancet Band Aid Dessicant

30 MKT07040.00 Kit Contents

31 MKT07040.00 Assemble Tray Note: New CLIA waived procedure uses single-use Test Wells instead of reusable paper tray

32 MKT07040.00 Open pouch from black mark

33 MKT07040.00 Test Materials

34 MKT07040.00 Remove Buffer Cap from Barrel

35 MKT07040.00 Place Buffer Cap in Tray Note: New CLIA waived procedure uses single- use Test Wells instead of reusable paper tray

36 MKT07040.00 Fingertip lancet Fingerstick Collection Clean finger with antiseptic wipe Allow to dry or wipe with sterile gauze Puncture finger with sterile lancet

37 MKT07040.00 Wipe away first drop of blood

38 MKT07040.00 Collect Sample filling narrow tip of Barrel

39 MKT07040.00 Push Barrel through Buffer Cap foil lid

40 MKT07040.00 Push hard! If not completely seated, test may result in an invalid Last blue line should be even with, or below, top of tray

41 MKT07040.00 Wait 15 minutes

42 MKT07040.00 Results Interpretation

43 MKT07040.00 Running Controls Use 2.5µL pipette fill sample tip

44 MKT07040.00 Negative Sample and Positive Control

45 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


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