Inverness Medical Professional Diagnostics Robin Cook 1-800-637-3717 ext. 598

Inverness Medical Professional
Diagnostics
Robin Cook
1-800-637-3717 ext. 598
[email protected]
Online training at www.invernessmedicalpd.com
Point of Care Diagnostics
Scarborough, ME
 Mfg. BinaxNOW® Product Line
 Tech Support Center
Inverness Medical
Point of Care Diagnostics
Louisville, CO
 Mfg. Optical ImmunoAssay (OIA®)
 Tech Support Center
Princeton, NJ
 Dist. Clearview® OEM Products
San Diego, CA
 Represent mfg. Acceava®, Clearview
 Manage Distribution, Private Label
MKT07040.00
 Largest Portfolio of Rapid Tests in the
Industry
• 19 different product lines in 49
configurations
 OEM Manufacturing for Distribution
 Approximately 90 Sales
Representatives nationwide
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
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%
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
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
• 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® (waived and non-waived)
• CLIA Packet/CLSI Packet for COMPLETE (non-waived)
• 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
Product Information
STAT-PAK
KIT SIZE
ORDER NO
CLIA STATUS
STORAGE
CONDITIONS
COMPLETE
CONTROLS
1 Set of:
Reactive HIV 1
Reactive HIV 2
Non reactive
20 Tests
25 Tests
92110
92111
92112
Waived*
*Whole Blood
Moderate*
*Applied
for Waiver
Only Clearview Tests
Room Temperature (46 to 86°F)
Refrigerate (36-46°F)
SHELF LIFE
24 MONTHS
SAMPLE
Fingerstick, Venipuncture Whole Blood, Serum or Plasma
PERFORMANCE
Sensitivity
99.7%
CPT CODE
86703 National Medicare Average is $19.17
MKT07040.00
Specificity
99.9% For all sample types
Clearview® HIV 1/2 Tests
Product Training
MKT07040.00
Additional Materials Required
•
•
•
•
•
•
•
MKT07040.00
Timer or Watch
Biohazard Waste Container
Disposable, Absorbent, Workspace Cover
Disposable Gloves
Sterile Lancet (included with COMPLETE)
Antiseptic Wipe
Sterile Gauze Pads
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® HIV 1/2 STAT-PAK®
MKT07040.00
Kit Contents
MKT07040.00
Open pouch from black mark
MKT07040.00
Test Materials
MKT07040.00
Fingertip lancet
Fingerstick Collection
• Clean finger with
antiseptic wipe
• Allow to dry or wipe with
sterile gauze
• Puncture finger with
sterile lancet
MKT07040.00
Wipe away first drop of blood
MKT07040.00
Fill Sample Loop with 2nd blood drop
MKT07040.00
Transfer sample to sample (S) well
MKT07040.00
Add 3 drops of Running Buffer
MKT07040.00
Wait 15 minutes
MKT07040.00
Interpret results (next slide)
MKT07040.00
Results Interpretation
MKT07040.00
Features and Benefits
20 or 25 Tests per Kit
Ideal for lower testing volume locations
24 Month Shelf Life for Tests and Controls
Low-Risk of kit expiration
Waived for Whole Blood
Fingerstick or Venous Draw
Moderate for Serum or Plasma
Flexible 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 Available
Can 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
MKT07040.00