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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 MKT 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 MKT 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 MKT Changes in the CDC HIV Screening Guidelines NEW Routine, voluntary HIV screening for all persons 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 MKT 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 MKT What We Offer Local Representation Full On-Site Training for all staff Superior Technical and Customer Service Representatives Online Interactive Training CLIA CD-includes CLIA Packet information/flash training CLSI Procedures

7 MKT 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 #4 (7am-5 pm MTN)

8 MKT 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 MKT 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 MKT STAT-PAKCOMPLETECONTROLS KIT SIZE20 Tests25 Tests 1 Set of: Reactive HIV 1 Reactive HIV 2 Non reactive ORDER NO 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 MKT Clearview ® HIV 1/2 Tests Product Training

12 MKT 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 MKT 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 MKT Clearview ® HIV 1/2 STAT-PAK ®

15 MKT Kit Contents

16 MKT Open pouch from black mark

17 MKT Test Materials

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

19 MKT Wipe away first drop of blood

20 MKT Fill Sample Loop with 2 nd blood drop

21 MKT Transfer sample to sample (S) well

22 MKT Add 3 drops of Running Buffer

23 MKT Wait 15 minutes

24 MKT Interpret results (next slide)

25 MKT Results Interpretation

26 MKT Positive & Negative Controls

27 MKT 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 MKT Clearview ® COMPLETE HIV 1/2

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

30 MKT Kit Contents

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

32 MKT Open pouch from black mark

33 MKT Test Materials

34 MKT Remove Buffer Cap from Barrel

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

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

37 MKT Wipe away first drop of blood

38 MKT Collect Sample filling narrow tip of Barrel

39 MKT Push Barrel through Buffer Cap foil lid

40 MKT 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 MKT Wait 15 minutes

42 MKT Results Interpretation

43 MKT Running Controls Use 2.5µL pipette fill sample tip

44 MKT Negative Sample and Positive Control

45 MKT 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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