SMARTubeTM is a pre-analytical medical device that improves blood samples before antibody analysis for HIV and HCV. It aims to close the "window period", which is the time between infection and detection on antibody-based tests. For HIV, the window period is typically 3 months, and for HCV it is typically 6 months. However, SMARTubeTM claims to be able to detect the vast majority of infections within a week. It works by stimulating a maximal antibody response in the blood sample before testing.

1. SMARTube™ HIV&HCV
for early diagnosis of virus
infections with long
seronegative window period
January 2016
© 2016 SMART Biotech Ltd

2. • The “Window Period” is the time between primary infection and
when a test can reliably detect that infection.
• In antibody-based assays, the window period (a.k.a.
Seroconversion Time) is the time that the body takes to
produce measurable amounts of antibodies after infection.
• If serology test is taken during the window period, it will be
negative since antibodies are not yet present at a detectable level.
• HIV: 95% 3 months (30-90 days).
• HCV: 95% 6 months (80-180 days).
• However, the infected (but unaware about his status) person
may transmit HCV, or HIV, to others during that period.
Window Period

3. S timulating
M aximal
A ntibody
R esponse
Tube
The solution:
SMARTube™ HIV&HCV

4. Тест на
антитела
SMARTube is a pre-analytical medical device for
blood sample improving before AB analysis
The solution:
SMARTube™ HIV&HCV
ELISA
Western Blot
Repitest

5. The time line from HIV infection to
seroconversion
• All the different diagnostic tests are antibody based (e.g. ELISA) testing.
• Seroconversion is the point of HIV diagnosis, i.e. when the body
produces measurable amounts of antibodies
• The other methods detect the virus in the blood days before
seroconversion:
- PCR/NAT – can shorten the window period by 10-12 days.
- Antigen Tests (p24) – can shorten the window period by a week

6. The time line from HCV infection to
seroconversion
• All the different diagnostic tests are antibody based (e.g. ELISA) testing.
• Seroconversion is the point of HIV diagnosis, i.e. when the body
produces measurable amounts of antibodies
• The other methods detect the virus in the blood days before
seroconversion:
- PCR/NAT – can shorten the window period by 8 week
- Antigen Tests (p24) – can shorten the window period by a 6 weeks

7. The solution: SMARTube™
SMARTube™ closes the Window Period - the vast majority
of the infected people can be
detected within a week from the day of infection

8. HCV window Period With
SMARTube™

9. • CE mark.
• Israel.
• Nigeria.
• Russian Federation.
• South Africa.
• Turkey.
• Romania.
• Registration in process in several additional
countries (Including USA-FDA).
• Implementation in testing protocols of FHI and
IAVI.
• In Process with UN/ WHO/ IFRC.
Registration

10. Clinical Data
• Israel
• Russian Federation
• Hungary
• Romania
• China
• South Africa
• Kenya
• Mexico
• Turkey

11. Thank you