1. FDA Approved, CLIA-Waived Rapid HIV Test, Results in as Little as 60 Seconds.

2. About bioLytical Laboratories
bioLytical Laboratories is located in Richmond BC, Canada.
Privately owned, federally incorporated Canadian company.
Leading developer of rapid diagnostic assays.
Exclusive manufacturer of the INSTI® HIV-1/HIV-2 Antibody Test.
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3. Research & Development
bioLytical R&D recently built a pre-clinical prototype for a 60-second Ebola antigen test and are currently developing various Class 1-3 individual and multiplex assays, all on the proven, 60 second INSTI’s platform.
bioLytical’s 60 Second Ebola Test announcement in Times Square, NYC.
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4. INSTI HIV Health Canada
Regulatory Approvals
2006
2010
2012
2014
2015
INSTI HIV Health Canada
Approved & CE Marked
INSTI HIV FDA
Approved
INSTI HIV FDA
CLIA Waived
INSTI HIV WHO Pre-
qualified
INSTI Multiplex
CE Marked
Approved for sale in more than 58 countries in Europe, North America, Africa, Middle East, Latin America and Asia
Approved for USAID / PEPFAR Waiver List
World Health Organization pre-qualified
ISO Accredited facility
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5. Global HIV/AIDS Strategy
By 2020
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6. Why INSTI?
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7. 1. Instant Results INSTI uses flow-through technology:
Reagents are added to the membrane unit
well and flow down into an absorbent
pad for results in as little as 60 seconds.
Most diagnostic assays are lateral flow, meaning fluid has to flow laterally or across to generate a result – usually in the form of one or two lines over minutes.
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8. 2. Accuracy INSTI is over 99% accurate. Sample Sensitivity Specificity
Fingerstick Blood (FSB)
99.8%
99.5%
EDTA Whole Blood
99.9%
100%
Plasma
CLIA Fingerstick Blood*
Sensitivity (also called the true positive rate) measures the proportion of actual positives which are correctly identified as such (e.g., the percentage of sick people who are correctly identified as having the condition), and is complementary to the false negative rate. Specificity (sometimes called the true negative rate) measures the proportion of negatives which are correctly identified as such (e.g., the percentage of healthy people who are correctly identified as not having the condition).
Source: INSTI HIV-1/HIV-2 Antibody Test Package Insert *Galli RA, Green KF, La Marca A, et al. Evaluation of the accuracy and ease of use of a rapid HIV-1 Antibody Test performed by untrained operators at the point of care. J Clin Virol 2013;58 Suppl I:e65-9.
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9. 3. Sensitivity
US CDC data shows INSTI as the most sensitive CLIA-waived antibody test, detecting HIV infection 9 days earlier than Western Blot.
For Determine, demonstrating sensitivity of Antibody component.
Window Period: while INSTI can at times produce a reactive result as early as a few weeks after infection, the window period for RULING OUT HIV infection, i.e. with a negative INSTI result, remains 12 weeks. This is the same window period for all HIV antibody tests, whether in the lab or point of care.
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10. 3. Sensitivity Virological and serological markers of HIV-1 infection
Window Period: while INSTI can at times produce a reactive result as early as a few weeks after infection, the window period for RULING OUT HIV infection, i.e. with a negative INSTI result, remains 12 weeks. This is the same window period for all HIV antibody tests, whether in the lab or point of care.
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11. Center for Disease Control, Source Data
Legend: Dark blue (Aptima), RNA Nucleic Acid Amplified Test or NAAT ; Green (Architect, Bio-Rad, and the POC Determine), 4th generation assays detection of antibody and antigen; Blue (Advia, Vitros, GS), laboratory-based antibody detection assays; Pink (INSTI, Multi-Spot, Reveal), flow-through antibody detection assays; Purple (Complete, Stat-Pack, Unigold, OraQuick), rapid Antibody detection assays; Blue (Western Blot), lab-based antibody-detection assay, Brown (Vironostka), lab-based antibody detection assay. CLIA-waived: INSTI (bioLytical), Determine 4G (Alere), Clearview Complete (Alere), Stat-Pack (Chembio), Unigold (Trinity Biotech), OraQuick (OraSure). Recently CLIA-waived, not pictured: DPP (Chembio).
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12. 4. Ease of Use Sample, Pour, Interpret Results Immediately!
*All sample collection materials provided (lancet, pipet and alcohol swab.)
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13. 5. Clear, Stable Results
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14. What is the Significance of a 60 Second Screening Tool?
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15. Never miss an opportunity to test!
INSTI’s 60-Second platform creates greater flexibility for POC healthcare, removing barriers to testing, increasing access to care and empowering testers to adapt to patients’ needs.
Never miss an opportunity to test!
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16. in innovative settings.
In Other Words, INSTI:
Improves efficiency in traditional healthcare settings, & Creates new opportunities to test
in innovative settings.
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17. 1 Minute Models: Real INSTI Users Pharmacy Pre-natal care
Emergency Room
Pre-natal care
AIDS Service Organisation
Correctional Facilities
Mobile/
Outreach
Pharmacy
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18. Format INSTI (Available in Boxes of 50) Instructions for Use
1 membrane unit
3 reagent solutions
Sample collection materials Lancet, pipette, alcohol swab
Note: INSTI 24s have been discontinued.
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19. Contract #: MG01099
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20. “Got a Minute?” Feedback & Testimonials
“This test is a game-changer and will lead to new ways of reaching people.”
-Senior Director of Public Health (AHF)
Survey Feedback from bioLytical’s National HIV Testing Day 2014 Campaign:
This was the most successful National HIV Testing Day that we have ever had based on the numbers tested and number of target population tested.
I love INSTI tests... I would love to use theses tests in the future
The product is amazing, the ease of use, accuracy and speed was such a convenient feature for the patient and the tester. I would definitely recommend your product!!!
Just started using INSTI and it makes a lot of sense. The earlier detection and the speed offering clients results is a plus.
Great test, really easy to use and rapid results. Only test we use during street outreach activities…”
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21. Contacts:
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22. Thank You!
One minute can change the world. It starts with a test; it start with you.
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