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Eternal Health & Wellness

Foundation (USA)
Present s
HIV & HCV
SMART VIRUSES

SMART(ER)- TUBE
A new medical breakthrough for early detection of HIV
& HCV during the window period
Cells– body's basic unit

• The Human body is made up of about a 100 million


cells

• Just one teaspoon of blood contains about 25


billion red blood cells.
The Immune System

• Is the body's defense against infection and illness.

• It recognizes the body's cells and tries to get rid of


anything unfamiliar. It destroys parasites and germs
- bacteria and viruses

• But can sometimes cause problems by attacking


unmatched blood or organs donated by another
person.
How the body defends itself…

A vast army of defender cells comprising of 1000 million different


types of white blood cells are produced in the bone marrow every
day. Some of these cells, called macrophages, constantly patrol
the body, destroying germs as soon as they enter. This is the
'natural' or inborn immunity. But if an infection begins to take hold,
the body fights back with even more powerful T- and B-cells which
give us acquired immunity, so that the germ can not make us ill
again.
HIV or AIDs
• There are 36 million people living with HIV/AIDS while 22 million
people have died of AIDS Worldwide. 15, 000 new infections are
reported per day; i.e. 11 new infections per minute

• AIDS or Acquired Immune Deficiency Syndrome has become a


major world wide epidemic since 1981.

• AIDS has already killed millions of people, millions more continue to


become infected with HIV, and there's no cure and at the moment
the only way to remain safe is not to become infected. .

• AIDS is caused by the human immunodeficiency virus (HIV), which


attacks the immune system, disarming the body's defenses against
infections and certain cancers.

• Germs that cause minor illnesses in healthy people can make


people with AIDS very ill.
HIV in Asia

• An estimated 8.6 million people were living with HIV in Asia in 2006,
including the 960 000 people newly infected in the previous year.

• The highest HIV infection levels in Asia are in south-east Asia, where
combinations of unprotected paid sex and sex between men, along
with unsafe injecting drug use, are fuelling the epidemics.
What is AIDS/ HIV?
• AIDS is a medical condition. People develop AIDS because HIV
has damaged their natural defenses against disease.

• HIV stands for the Human Immunodeficiency Virus. It is a virus


that infects the cells that make up the human body and replicates
i.e. makes new copies of itself within those cells.

• HIV can be passed from one person to another through contact


with the body fluids of an HIV infected or HIV+ person.

• The only reliable way to tell whether someone has HIV is through
blood tests, which can detect the infection -- a few weeks after
the virus first entered the body.

• Like all viruses, HIV cannot grow or reproduce on its own. In


order to make new copies of itself it must infect the cells of a
living organism.
How HIV overpowers the body

HIV seeks and destroys a type of white blood cell called T cells
also known as T-helper cells or CD4 cells which the body must
have to fight disease.

An adult with a healthy immune system generally has a CD4 cell


count of from 600 to 1200

Without T-helper cells, which kill cells that have been infected with
germs, many other immune system cells including B-cells that
make antibodies, cannot not work properly.

A person infected with HIV may not show any symptoms for years.
But untreated, the number of T-helper cells steadily drops.
Eventually, the numbers fall so low that the risk of infection greatly
increases, and the symptoms of AIDS appear.
How does HIV lead to AIDS
• A damaged immune system is not only more vulnerable to HIV,
but also to the attacks of other infections.

• With time HIV+ve persons may become ill more and more often.

• Several years after the infection, the number of immune system


cells left in the body drops below a particular point. At this point
a person may be said to have progressed from HIV to AIDS.
Generally when someone has one or more of these infections
and a low number of T cells, he or she is said to be suffering
from AIDS. Different countries have different parameters for
defining the stage at which a HIV+ve person is said to have
AIDS.

• AIDS (Acquired Immune Deficiency Syndrome) is an extremely


serious condition when the body has very little defense against
any sort of infection.
How long does HIV take to become AIDS?

• Usually an average HIV infection progresses to AIDS in ten


years without drug treatment. This is if the person has a
reasonable diet. A malnourished person may progress to AIDS
and death more rapidly.

• Antiretroviral medication can prolong the time between HIV


infection and the onset of AIDS. Modern combination therapy is
highly effective and, theoretically, someone with HIV can live for
a long time before it becomes AIDS. These medicines, however,
are not widely available in many poor countries around the
world, and millions of people who cannot access medication
continue to die.
Antibodies and diagnosis of infections
• In case of most infections, the immune system sees the foreign
invaders and begins making antibodies against them. Usually it
takes 5-7 days for the antibodies to develop after the infection.
Antibodies help out in detecting any infection in the blood,
before the liver or lungs are affected.

• However, with HIV and HCV, the most devastating and chronic
infection--it could take weeks or up to many months to see any
antibodies in the blood.

• As long as there are no antibodies, these patients are


diagnosed as non-infected. This is called the window period -
the time between infection and the detection of antibodies--
that’s where Smartube comes in.
Symptoms of HIV Infection

• There are no specific tell-tale symptoms of HIV or


AIDS and the only way to know whether you are
infected is to be tested for HIV. You cannot rely on
symptoms alone because many people who are
infected with HIV do not have symptoms for many
years. Someone can look and feel healthy but can
still be infected.
What is a retrovirus?

• HIV is a type of virus called a retrovirus.

• The genes of most living things, including humans, are made of


DNA. The DNA exists as a sequence of a code that can be read
like a book. In the cell the code is read to make RNA which is
then used as the code for the construction of proteins. In other
words, the flow of genetic information in the cell is usually from
DNA to RNA to protein.

• The HIV virus, on the other hand, has its genetic material made
from RNA. It has to insert its genetic code into that of the host
cell in order to replicate. In order to achieve this it must first
make a DNA copy so that it is compatible with the DNA of the
host cell. DNA is then made using the code of the RNA. Since
this is the opposite of the usual case the viruses that do this are
called retroviruses.
What makes the HIV virus different

• Different viruses attack different parts of the body – some attack


the skin, others the lungs…even common cold is caused by a
virus. What makes HIV --dangerous is that it attacks the
immune system particularly a special type of immune system
cell known as a CD4 lymphocyte– that normally gets rid of the
viruses.

• HIV is a smart virus that tricks and evades the body's defenses.
Once the HIV virus takes hold, the immune system can never
fully get rid of it.

• HIV+ve persons may look and feel perfectly well for many years
and may not even know that they are infected. But as the
immune system weakens they may become increasingly
vulnerable to even minor illnesses which a normal person could
have been fought off easily.
What is the size of the HIV virus?
An HIV particle is around 100-150 billionths of a meter in diameter.
That's about the same as:

• 0.1 microns

• 4 millionths of an inch

• one twentieth of the length of an E. coli bacterium

• one seventieth of the diameter of a human CD4+ white blood


cell.

• Unlike most bacteria, HIV particles are much too small to be


seen through an ordinary microscope. However they can be
seen clearly with an electron microscope.
What does the HIV virus look like?
HIV Replication
The HIV Life Cycle
1. ATTACHMENT: Getting in
2. REVERSE TRANSCRIPTION : From viral RNA to
DNA
3. INTEGRATION, TRANSCRIPTION
a. Viral DNA joins host DNA
b. Making multiple viral RNAs

4. TRANSLATION : Producing viral proteins


5. VIRAL PROTEASE : Cleaving viral proteins
6. ASSEMBLY & BUDDING : Getting out
Stages of HIV
HIV and the immune system
• How HIV infection damages the immune system is still being
investigated.
• One thing that can be said for sure is that the virus results in
progressive depletion of CD4+ cells during the process of
replicating itself.
• Although the body continually produces CD4+ cells, it is
eventually unable to keep pace with this destruction, and CD4+
cell numbers ultimately decline.
• Without sufficient numbers of CD4+ cells, the immune system is
unable to function effectively – this is the onset of
immunodeficiency.
• When AIDS develops, the body becomes vulnerable to rare
malignancies and to serious infection from organisms that
usually pose no threat to healthy people.
Diagnoses of HIV

• Once HIV virus enters, the body starts to produce antibodies—


substances the immune system creates after infection. Most
HIV tests look for these antibodies rather than the virus itself.
There are many different kinds of HIV tests, including rapid tests
and home test kits.

• The way to identify the carriers is by detecting the antibodies


against the virus.

• It can take weeks or months after infection before antibodies


against HIV and HCV are produced and detected. The infected
yet serum-negative period is called the “window period”

• Infected people will be considered non-infected as long as they


do not produce detectable levels of antibodies in their blood.
How the HIV virus infect and replicate itself
• In order for viruses to reproduce, they must infect a cell. Viruses are not
technically alive: they are sort of like a brain with no body. In order to
make new viruses, they must hi-jack a cell, and use it to make new
viruses. Just as our body is constantly making new skin cells, or new
blood cells, each cell often makes new proteins in order to stay alive
and reproduce itself. Viruses hide their own DNA in the DNA of the cell,
and then, when the cell tries to make new proteins, it accidentally
makes new viruses as well. HIV mostly infects the immune system.

• Infection: Several different kinds of cells have proteins on their surface


that are called CD4 receptors. HIV searches for cells that have CD4
surface receptors, because this particular protein enables the virus to
bind to the cell. Although HIV infects a variety of cells, its main target is
the T4-lymphocyte (also called the "T-helper cell"), a kind of white blood
cell that has lots of CD4 receptors. The T4-cell is responsible for
warning the immune system that there are invaders in the system.

• Replication: Once HIV binds to a cell, it hides HIV DNA inside the
cell's DNA: this turns the cell into a sort of HIV factory.
Retroviruses are not inactive in the latent period
• Retroviruses are unique in biology. Until their classification in the 1970s, it was
believed that all organisms relied on the same fundamental system to turn their
genetic code into proteins necessary for life. The flow of genetic information was
considered to be one way i.e.– code held in DNA was transcribed into RNA and
then translated into proteins.

• The recognition of retroviruses changed this view. Retroviruses carry their


genetic code as RNA, instead of using the host’s cellular machinery to translate
this RNA they produce a unique enzyme-- reverse transcriptase, which converts
their RNA into DNA.

• This DNA is then spliced into the host cell’s own genes, where they settle down
and wait for the activation of the host cell to make new virus particles.

• After the HIV infection diagnosis is made using a blood test to detect antibodies
to the virus or copies of the virus itself. The length of this period varies from
person to person, and depends on a wide range of factors, such as the amount
of HIV present in the bloodstream, general health, the presence of other
illnesses, and the response to treatment.

• During the asymptomatic period, the virus is far from inactive. It is constantly
replicating and causing damage to the immune system. The immune system is
highly resilient, however, and it takes time for this damage to make an impact.
The
•Whenlifecycle of
HIV virions enter the HIV of a new host, a protein on the surface of the virus
bloodstream
- gp120 develops an affinity for CD4 receptor in the blood called CD4+ or T helper cells.

• When a virion encounters a CD4+ cell there is a reaction, which attaches the virion to the
host cell. This binding is strengthened further by a co-receptor on the cell surface.

• Once the virion has been bound to the host cell surface, its next task is to get inside. This is
achieved through the fusion of the virus coat and the cell membrane. Following fusion, the
genetic material of the virus– i.e. RNA, is released into the cell, along with the viral
enzymes-- reverse transcriptase and integrase.

• Reverse transcriptase reads the viral RNA and builds the corresponding DNA strands. The
DNA copy is known as a provirus. Viral DNA now moves to the cell nucleus, where the
cell’s own genes, also made of DNA, are housed. Another viral enzyme, integrase, splices
the strands of DNA into the host cell genome.

• Secure within the host cell’s genes, the proviral DNA can persist for many years in a latent
state, secretly carrying the genetic instructions for making new virions. When the host cell is
activated – that is it begins to divide – the proviral DNA will be transcribed into RNA, which
is then translated into viral proteins and polyproteins. Together, the RNA and these proteins
then migrate to the inside of the host cell membrane, where they will be assembled into
new virions.

• Among the viral proteins is the enzyme, protease, which cleaves the polyproteins into
smaller, functional proteins, thereby allowing the new viral particles to mature . Following
assembly, the newly formed virions bud from the host cell surface, entering the bloodstream
where they will encounter uninfected CD4+ cells and begin another cycle.
Pathophysiology – how HIV causes disease
• The human immune system is an organ concerned with destroying and eliminating from the
body any organism, substance or particle that threatens the body’s integrity. Like the heart or
the brain, an effective immune system is essential to life. It differs from these organs,
however, in having a wide variety of components dispersed throughout the body and
circulating in the blood.

• To mount an immune response, these various components must communicate and interact in
a precisely orchestrated and organized way. A component with pivotal role in coordinating
this is the CD4+ cell, or T-helper cell. The CD4+ cell is the primary target of HIV.

• The CD4+ cell, also known as the T-helper cell (TH), is a central component of the human
immune response. CD4+ cells bear receptors on their surface, which allow them to pick up
antigens, the specific molecules from the virus or other ‘foreign body’ that alerts the immune
system to the presence of something dangerous. Once the CD4+cells have captured
antigens, they help B cells to make antibodies, and they release lymphokines, chemicals that
stimulate other varieties of immune cell to kill the invader.

• Tc – cytotoxic T cells recognize and destroy cells coated with antigens (the antigen may be
deposited on the surface of a cell as the virus enters, making it a target for Tc activity)
• NK – natural killer cells use the cell-surface changes that result from viral infection to
identify and kill infected cells
• K – killer cells can bind to antibodies, which ‘flag up’ infected cells for killer cells to destroy
• Granulocytes – can engulf and digest infected cells
• Macrophages – release chemicals that stimulate and control the actions of other effector
cells, but also engulf and digest infected cells
Window Period
• HIV and HCV carriers can be identified by detecting the
antibodies against the virus in the patient’s blood. However
antibodies against HIV and HCV take weeks - or months - after
infection to develop in the body. This in essence creates a
‘window period’ in which infected people will be considered non-
infected as long as they do not produce antibodies in their body.

• Blood donated at blood banks during the ‘window period’ test


negative – hence can be transfused into patients and may infect
them.

• This phenomenon that came to prominence in the mid ’90s


when people tested and diagnosed as ’sero-negative’, went out
and infected others.

• You can’t infect somebody if you’re not infected – that’s when


the realization came that there was something wrong with the
present tests which could not diagnose everybody.
Window Period
• Most HIV tests measure the antibodies produced by the body against
HIV. It takes some time for the immune system to produce enough
antibodies for the antibody tests to detect. This time period is commonly
referred to as the “window period.” This can vary from person to person.

• Most people develop detectable antibodies within 2 to 8 weeks (the


average is 25 days). Even so, there is a chance that some
individuals will take longer to develop detectable antibodies.
Therefore, if the initial HIV test was conducted within the
first 3 months of possible exposure, there is a great possibility of a
false-negative result.

• Ninety-seven percent people usually develop antibodies in the first 3


months of the infection. In some rare cases, it may take up to 6 months
to develop antibodies to HIV.

• A test which detects the HIV virus directly is the RNA test. The time
between HIV infection and RNA detection is 9–11 days. These tests,
are more costly and used less often than antibody tests.
Challenges posed by the Window Period
• Medical community has been trying to solve the ‘window period’
problems with modest success. Diagnostic companies are trying
to develop kits to detect lower levels of antibodies and enable
early diagnosis of HIV.

• Some other methods like the p24 antigen test– which look for
proteins or antigens -- have been able to shorten the window
period by a few days but they are not very cost effective.

• A great stride has been in the testing of the viral genome - the
nucleic acid of the virus, which has shortened the window by
about 12 days but it is a very expensive test. For a positive
result there should be virus in the blood which can take weeks
or even months. So, an infected person may test negative.

• Sometimes there may be no antibodies in the blood because


the production of antibodies is suppressed. So even the most
sensitive kit will be unable to detect antibodies - because they
are not there.
ELISA TEST
• The only way to tell if you have the AIDS virus is by being
tested. The ELISA test is the AIDS antibody test you usually
hear about. ELISA, also called EIA, stands for Enzyme-Linked
Immunosorbent Assay. The ELISA test currently in use looks for
the presence of antibodies that your body might have developed
to fight HIV infection, the virus that causes AIDS. It does not test
for the virus itself. A positive ELISA test might not mean you're
infected with the AIDS virus. However, it would be a sign that
further testing is needed.

• A negative test is also not conclusive. If you have been infected


with the virus recently, a negative test may mean that your body
might not have had time to develop antibodies against HIV
infection.

• Once you are infected, you probably will remain infected for life.
It could take years for you to begin showing the symptoms of
AIDS.
Hepatitis C virus (HCV)
• Is a blood-borne infectious disease caused by the Hepatitis C virus (HCV)
affecting some 150-200 million people worldwide.

• The infection is often asymptomatic, but chronic infection can cause


inflammation of the liver, scarring of liver and in some cases liver failure
or liver cancer.

• The hepatitis C virus (HCV) is spread by blood-to-blood contact.

• No vaccine against hepatitis C is available.

• Although early medical intervention is helpful, people with HCV infection


can experience mild symptoms, and consequently do not seek treatment.

• Hepatitis C (originally "non-A non-B hepatitis") is one of five known


hepatitis viruses: A, B, C, D, and E.

• The hepatitis C virus is usually detectable in the blood within one to three
weeks after infection, and antibodies to the virus are generally detectable
within 3 to 12 weeks.
HIV - HCV

• Injecting drugs is one of the main ways people become infected


with HIV. It is also the main way of becoming infected with the
hepatitis C virus (HCV). In fact, 50%-90% of HIV-infected injection
drug users are also infected with hepatitis C

• Persons with HIV, especially injection drug users, may also be


infected with the hepatitis C virus (HCV).

• HCV infection is more serious in persons with HIV.

• Many persons with HCV don’t have any symptoms.


Correlation between HIV & HCV
• Approximately 30% individuals living with HIV in the in the U.S.
and Europe are also infected with hepatitis C virus (HCV).

• Hepatitis C-related Liver disease has emerged as an important


cause of morbidity and mortality in HIV positive patients. As a
result, researchers are focusing on HCV-related liver disease and
treatment-associated issues in HIV-HCV coinfected individuals.

• Studies indicate that HIV-HCV coinfected patients have higher


HCV RNA loads and experience more rapid progression of liver
fibrosis than those with HCV monoinfection. Some researchers
argue that HIV disease is accelerated by HCV-related immune
activation and impairment in immune recovery after effective
antiretroviral therapy.

• Compared with HCV infection alone, HIV-HCV coinfection is


associated with an increased risk of cirrhosis, end-stage liver
disease, and hepatocellular carcinoma (HCC)
Types of HIV tests
• There are three main types of HIV test.

• HIV antibody test: shows whether a person is infected with HIV. Antibody tests
are also known as ELISA (Enzyme-Linked Immunosorbent Assay) tests.
• Antigen test.: Antigens found on a foreign body or germ, trigger the production
of antibodies in the body. The antigen on HIV that most commonly provokes an
antibody response is the protein P24. Early in the infection, P24 is produced in
excess and can be detected in the blood serum by a commercial test (although
as HIV becomes fully established in the body it will fade to undetectable levels).
P24 antigen tests are sometimes used to screen donated blood, but an also be
used for testing for HIV in individuals earlier than standard antibody tests. Some
modern HIV tests combine P24 and other antigen tests with standard antibody
identification methods to enable early and accurate HIV detection.

• PCR test(Polymerase Chain Reaction test): Also called Nucleic Acid-


amplification Test or 'NAT'. PCR tests detect the genetic material of HIV and can
identify HIV in the blood within 2-3 weeks of infection. There are two form of
PCR tests -- DNA PCR and RNA PCR. Babies born to HIV positive mothers are
usually tested using a DNA PCR because they retain their mother's antibodies
for several months. Blood supplies in most countries are screened for HIV using
an RNA PCR test, which can produce results faster than a DNA test. PCR tests
are not often used to test for HIV in adults, as they are very expensive and more
complicated to administer than a standard antibody or P24 test.
HIV detection tests & their limitations - ELISA
• ELISA test is commonly used for screening blood from donors. A high level of
sensitivity means slightly lowered specificity (ability to distinguish HIV antibodies
from other antibodies). Hence there is a greater likelihood of a false positive result
than a false negative.

• There are conflicting views about the reliability and soundness of ELISA, for
instance the ELISA test are not specific for HIV. This is why four repeat ELISA tests
plus a Western Blot are required for a diagnosis of HIV in the USA.

• Even the manufacturers of the ELISA test kit have clearly mentioned on the kit that
ELISA should not be used on its own for HIV diagnosis.

• One of the main drawbacks in ELISA test is that p24 proteins cross react with a
wide variety of uninfected human tissue and blood samples from other diseases like
leprosy, malaria and viral infections. Hence the ELISA test may give false positive
results even without the HIV infection.

• Lack of standardization of ELISA results– A person who tests positive at one


laboratory may test negative in another laboratory in the same city.

• WHO recommends a positive ELISA blood test result needs to be confirmed by


tests using another ELISA kit on the same blood sample, while UNAIDS–WHO
recommends - another blood sample should be obtained from the person before
declaring him seropositive to eliminate any human or technical error.
HIV detection tests & their limitations - Western Blot
• Western Blot -- an antibody test is one of the most expensive tests
used to confirm the diagnosis of HIV infection.

• A positive Western Blot result is synonymous with HIV infection


and potential risk of contracting AIDS. Patients suffering from AIDS
always react positively to the Western Blot test.

• However a number of concerns have been raised about the


effectiveness and consistency of the Western Blot test which is
said to be one of the most unreliable of all the AIDS detection
tests. This is one reason why it is not accepted as a confirmatory
test for HIV infection in United Kingdom and other countries.

• The main argument against the Western Blot test -- based on the
antibody reaction mechanism like the ELISA test, is that it is known
to show non-specific positive reaction to a number of diseases like
leprosy or tuberculosis- a parasitic infection and other viral
infections. Hence the Western Blot is not a determinate diagnostic
tool for indication of HIV.
HIV detection tests & their limitations - PCR Test

• The PCR viral load test studies the magnification of tiny HIV viral
particles in the infected blood.

• It is a confirmatory test, used mainly to track the clinical


progression of HIV infection to AIDS. It is used to determine the
level of viral load in the blood -- associated with an increased risk
of transmission and the clinical progression to AIDS.

• The level of virus in the blood is directly related to the risk of


transmitting the disease to uninfected individuals. Mothers with
high viral loads have the highest chance of transmitting the virus to
their infants.

• One of the main drawbacks of the PCR test is that the viral load
can also increase non-specifically due to other viral and
opportunistic bacterial infections as a result the viral load test may
not always be an indicator for the clinical progression of HIV to
AIDS and may lead to incorrect results.
Risks involved with not detecting all the carriers:

• In the Latent or Window period – when infected people are still


serum-negative – i.e. they do not have enough anti-bodies in
their blood that could be detected by any conventional tests. At
this stage, they pose a greater risk to their community because:
• They continue infecting others without any precautions.
• They think they have a “certified immunity” as they engaged in high risk
behavior and yet did not get infected.

• Blood Banks – blood units donated by donors during the


“window period” could get transfused into unsuspecting patients
thus infect them.

• Epidemiological studies- are incomplete, as critical information


as to the true rate of new infections is missing for incidence
calculations in a study population.

• Researches show that every unidentified carrier could infect,


directly and indirectly, some fifty people a year.
In conclusion….

• Let us have a quick look at some sobering facts - in less than 20


years, over 40 million people have been infected, and UNAIDS
estimates that every day 16,000 people get newly infected with
HIV, 90 % of whom live in the developing world. Without an
immediate stronger response on the prevention, treatment,
monitoring, and above all screening and diagnostic fronts, the
AIDS crisis will continue to grow, and it will not be long before it
threatens to enter every household.
Introducing

SMARTube -- an innovative, simple and cost effective


solution for pretreatment of the blood samples for HIV & HCV
What is SMARTube

S -timulating
M-aximal
A-ntibody
R-esponse
T-ube
SMARTube--The solution
• To enable antibody production, in a small blood sample, within
days from infection, without having to wait for the body to produce
antibodies weeks or months later, & To push for antibody
production at levels that can be detected by current testing.

• The solution to early detection is the “time machine” inside the


SMARTube.
SMARTube--The Smart Choice

• The only way to curtail the HIV-HCV epidemic is early detection


of the respective viruses

• SMARTube enables antibody production, in a small blood


sample, within days from infection, without having to wait for the
body to produce antibodies weeks or months later

• The technology is the culmination of more than 12 years of work


by Jehuda-Cohen, an immunologist with a PhD in immunology
from the Technion - Israel Institute of Technology.
SMARTube -- Extending the reach
• SMARTube is the only technology that enables such early
detection of HIV/HCV.

• Enables earliest detection by enhancing antibody production in-


vitro.

• It is an economical, cost effective blood pre-treatment solution


that does not require complex equipment to use it.

• It can be used in adjunct to any sensitive antibody test in the


market.

• It does not change the testing algorithms as a blood pre-


treatment device.

• Improves both specificity and sensitivity of the existing assays.


SMARTube– Revolutionary Technology

• The core of the technology is overcoming the specific immune


suppressants of the body. A few drops of blood are placed into
the SMARTube and a solution inside helps the cells of the
immune system overcome the suppression, and pushes them
into an extremely fast process of antibody production.

• The end result– We can detect those individuals already


infected when nobody else can - because they’re still at the very
early stages of the window - where there’s no other technology
today can detect them.
How SMARTube is to be used
SMARTube– where is the need
SMARTube can be used in many sectors with equally beneficial results:
• HIV testing centers
• Clinics and laboratories
• Diagnostics (hospitals, labs)
• Epidemiology (governments, world health organizations).
• Research (vaccine design & therapeutics).
• Plasma industry.
• Health & Life insurance companies.
• Army
• Individuals & Corporate
• Pregnant women
• Healthcare workers
• Foreign travelers
• Sex workers
SMARTube – testing requirements

• SMARTube is manufactured under strict ISO9001:2000 and ISO13485:2003 regulations


and high QC standards.

• The sterile Plasma inside the SMARTube has a shelf life of 6 month when kept at 2-8o c.

• Before use, SMARTube is brought to room temperature and 1ml of whole blood collected in
heparin is introduced into it. This is then incubated for five days at 37oC in a humidified
CO2 incubator. After incubation a sample of the supernatant is removed for testing using
ELISA test or any other detection method.

• To start using SMARTube, even for the first time you don't need any special equipment or
qualifications.

• The test also does not require any specialized training or capacity building. The only
requirement of this test is 1ml of whole blood collected in heparin (transferred in lab, using
sterile pipette etc.). The blood sample inside it then needs to be incubated at 37oC in
humidified CO2 incubator for 5 days. After incubation a sample of the supernatant is
removed for testing (separation occurs by gravity during incubation), using any currently
available method for HIV/HCV testing.

• It only requires an incubator which most labs possesses


SMARTube -- Advantages
• SMARTube offers an innovative, simple and cost effective solution for pretreatment of the blood
samples for HIV & HCV. In the context of antibodies to HIV&HCV, this device could enable the
positive detection of infection even in infected yet sero-negative individuals. This has
applications, as a blood pre-treatment device, for early and more complete detection of HIV
and/or HCV infected Individuals and blood donations.

• SMARTube enables antibody production, in a small blood sample, within days from infection,
without having to wait for the body to produce antibodies weeks or months later. This is done by
pushing for antibody production at levels that can be detected by current antibody testing
(ELISA).

• SMART Technology involves in vitro activation of the HIV and/or HCV primed lymphocytes,
pushing them to antibody production even in the phase of active suppression. The result of this
activation is higher levels of antibodies in SMARTube culture using available diagnostic kits.

• The greatest advantage of this cutting edge technology is the flexibility and simplicity of use,
enabling the collection of blood even in remote places. The blood sample thus collected can be
transferred to the SMARTube even a day later, when it reaches the testing lab. Since it is a blood
pre-treatment device, once the blood is treated in the SMARTube it can be tested using any HIV
or HCV antibody ELISA tests. Therefore the labs do not need to change their way of diagnosing
the infection, they only change the way the blood is handled prior to the tests. This makes the
SMARTube very simple to use and with a great return for the money, a safer blood supply and
better detection of infected individuals.

• As a blood pre-treatment device SMARTube also reduces the rate of false positives.
SMARTube - Advantages

• According to clinical studies on high risk populations in Israel and other


countries, the SMARTube successfully enables the detection of all the
patients who are diagnosed in the conventional testing - but also
detects the virus in additional patients that are infected, but otherwise
would have gone undetected at that testing time.

• Having received the CE Mark (the regulatory requirement in Europe for


its registration and marketing) as a blood collection and pre-treatment
device, the SMARTube is available for use in hospitals, diagnostic labs,
blood banks for health or life insurance uses-- basically anywhere blood
samples are taken for HIV testing.
SMARTube– additional benefits

• Increase sensitivity-- More efficient detection-- higher levels of


antibodies in low positive samples.

• Increase specificity: lower incidence of false positives – less


repeat testing, less blood units lost

• Saving in terms of time & money– with improvement in


performance.

• Better indication of incidence rates-- rate of new cases versus


prevalence (rate of positives, total).
SMARTube –Successful Clinical Trials
SMARTube– Global Acceptance
SMARTube– Certified Quality & Standards
SMARTube Success Stories

• Case Study # 1 : Jacob Johnes – a US marine never thought he could


contract HIV, despite risky behavior… A routine HIV test confirmed him
as sero-negetive till a doctor who had heard of Smartube decided to
test again. It took 48 hours for the HIV antibodies to develop in vetro
and Jones was declared HIV +ve… Imagine how many people he could
have infected – if allowed to go scot- free with a false HIV negative
report.
Note : This is a fabricated case… we need 5-7 actual cases like this,
which show world wide acceptance and effectiveness of SMARTube.
For More Details Contact:

•Dr N K Gupta, MD, FRCP(C)


President & CEO
Eternal Health & Wellness Foundation (USA)
10160 Medlock Bridge Road,
Suite 100, Duluth, GA 30097

•Neeraj Mahajan
Country Head (India)
Eternal Health & Wellness Foundation (USA)
Mob: 9999989066, 9818666863