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    EternalEternal Health & WellnessHealth & Wellness

    FoundationFoundation (USA)(USA)

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    HIV & HCV

    SMART VIRUSESSMART VIRUSES

    SMART(ER)- TUBESMART(ER)- TUBE

    A new medical breakthrough for early detection of HIV

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    Cells body's basic unit

    The Human body is made up of about a 100 million

    cells

    Just one teaspoon of blood contains about 25billion red blood cells.

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    The Immune System

    Is the body's defense against infection and illness.

    It recognizes the body's cells and tries to get rid ofanything unfamiliar. It destroys parasites and germs- bacteria and viruses

    But can sometimes cause problems by attackingunmatched blood or organs donated by anotherperson.

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    How the body defends itself

    A vast army of defender cells comprising of 1000 million differenttypes of white blood cells are produced in the bone marrow every

    day. Some of these cells, called macrophages, constantly patrolthe 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 whichgive us acquired immunity, so that the germ can not make us ill

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    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 arereported per day; i.e. 11 new infections per minute

    AIDS or Acquired Immune Deficiency Syndrome has become amajor world wide epidemic since 1981.

    AIDS has already killed millions of people, millions more continue tobecome infected with HIV, and there's no cure and at the momentthe only way to remain safe is not to become infected. .

    AIDS is caused by the human immunodeficiency virus (HIV), whichattacks the immune system, disarming the body's defenses againstinfections and certain cancers.

    Germs that cause minor illnesses in healthy people can makepeople with AIDS very ill.

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    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, wherecombinations of unprotected paid sex and sex between men, alongwith unsafe injecting drug use, are fuelling the epidemics.

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

    HIV can be passed from one person to another through contactwith the body fluids of an HIV infected or HIV+ person.

    The only reliable way to tell whether someone has HIV is throughblood 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. Inorder to make new copies of itself it must infect the cells of aliving organism.

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    How HIV overpowers the body

    HIV seeks and destroys a type of white blood cell called T cellsalso known as T-helper cells or CD4 cells which the body musthave 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 withgerms, many other immune system cells including B-cells thatmake 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 greatlyincreases, and the symptoms of AIDS appear.

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    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 pointa person may be said to have progressed from HIV to AIDS.Generally when someone has one or more of these infectionsand a low number of T cells, he or she is said to be sufferingfrom AIDS. Different countries have different parameters fordefining the stage at which a HIV+ve person is said to have

    AIDS.

    AIDS (Acquired Immune Deficiency Syndrome) is an extremelyserious condition when the body has very little defense againstany sort of infection.

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    How long does HIV take to become AIDS?

    Usually an average HIV infection progresses to AIDS in tenyears without drug treatment. This is if the person has areasonable diet. A malnourished person may progress to AIDSand death more rapidly.

    Antiretroviral medication can prolong the time between HIVinfection and the onset of AIDS. Modern combination therapy ishighly effective and, theoretically, someone with HIV can live fora 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 medicationcontinue to die.

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    Antibodies and diagnosis of infections

    In case of most infections, the immune system sees the foreigninvaders and begins making antibodies against them. Usually ittakes 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 chronicinfection--it could take weeks or up to many months to see anyantibodies in the blood.

    As long as there are no antibodies, these patients arediagnosed as non-infected. This is called the window period -the time between infection and the detection of antibodies--thats where Smartube comes in.

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    Symptoms of HIV Infection

    There are no specific tell-tale symptoms of HIV orAIDS and the only way to know whether you areinfected is to be tested for HIV. You cannot rely on

    symptoms alone because many people who areinfected with HIV do not have symptoms for manyyears. Someone can look and feel healthy but canstill be infected.

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    What is a retrovirus?

    HIV is a type of virus called a retrovirus.

    The genes of most living things, including humans, are made ofDNA. The DNA exists as a sequence of a code that can be readlike a book. In the cell the code is read to make RNA which isthen used as the code for the construction of proteins. In other

    words, the flow of genetic information in the cell is usually fromDNA to RNA to protein.

    The HIV virus, on the other hand, has its genetic material madefrom 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 firstmake a DNA copy so that it is compatible with the DNA of thehost cell. DNA is then made using the code of the RNA. Sincethis is the opposite of the usual case the viruses that do this are

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    What makes the HIV virus different

    Different viruses attack different parts of the body some attackthe skin, others the lungseven common cold is caused by avirus. What makes HIV --dangerous is that it attacks theimmune system particularly a special type of immune systemcell 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 neverfully get rid of it.

    HIV+ve persons may look and feel perfectly well for many yearsand may not even know that they are infected. But as theimmune system weakens they may become increasinglyvulnerable to even minor illnesses which a normal person couldhave been fought off easily.

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    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 bloodcell.

    Unlike most bacteria, HIV particles are much too small to beseen through an ordinary microscope. However they can beseen clearly with an electron microscope.

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    What does the HIV virus look like?

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    HIV Replication

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    The HIV Life Cycle

    1. ATTACHMENT: Getting in

    2. REVERSE TRANSCRIPTION : From viral RNA to

    DNA

    3. INTEGRATION, TRANSCRIPTIONa. 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

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    Stages of HIV

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    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 inprogressive depletion of CD4+ cells during the process ofreplicating itself.

    Although the body continually produces CD4+ cells, it iseventually unable to keep pace with this destruction, and CD4+cell numbers ultimately decline.

    Without sufficient numbers of CD4+ cells, the immune system isunable to function effectively this is the onset of

    immunodeficiency.

    When AIDS develops, the body becomes vulnerable to raremalignancies and to serious infection from organisms thatusually pose no threat to healthy people.

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    Once HIV virus enters, the body starts to produce antibodiessubstances the immune system creates after infection. MostHIV tests look for these antibodies rather than the virus itself.There are many different kinds of HIV tests, including rapid testsand home test kits.

    The way to identify the carriers is by detecting the antibodiesagainst the virus.

    It can take weeks or months after infection before antibodiesagainst 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 theydo not produce detectable levels of antibodies in their blood.

    Diagnoses of HIV

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    How the HIV virus infect and replicate itself

    In order for viruses to reproduce, they must infect a cell. Viruses are nottechnically 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 newviruses. Just as our body is constantly making new skin cells, or newblood cells, each cell often makes new proteins in order to stay aliveand reproduce itself. Viruses hide their own DNA in the DNA of the cell,and then, when the cell tries to make new proteins, it accidentallymakes new viruses as well. HIV mostly infects the immune system.

    Infection: Several different kinds of cells have proteins on their surfacethat are called CD4 receptors. HIV searches for cells that have CD4surface receptors, because this particular protein enables the virus tobind to the cell. Although HIV infects a variety of cells, its main target isthe 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 forwarning the immune system that there are invaders in the system.

    Replication: Once HIV binds to a cell, it hides HIV DNA inside thecell's DNA: this turns the cell into a sort of HIV factory.

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    When HIV virions enter the bloodstream of a new host, a protein on the surface of the virus

    - 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 isachieved through the fusion of the virus coat and the cell membrane. Following fusion, thegenetic material of the virus i.e. RNA, is released into the cell, along with the viralenzymes-- 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 thecells own genes, also made of DNA, are housed. Another viral enzyme, integrase, splicesthe strands of DNA into the host cell genome.

    Secure within the host cells genes, the proviral DNA can persist for many years in a latentstate, secretly carrying the genetic instructions for making new virions. When the host cell isactivated that is it begins to divide the proviral DNA will be transcribed into RNA, whichis 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 intonew virions.

    Among the viral proteins is the enzyme, protease, which cleaves the polyproteins intosmaller, functional proteins, thereby allowing the new viral particles to mature . Followingassembly, the newly formed virions bud from the host cell surface, entering the bloodstreamwhere they will encounter uninfected CD4+ cells and begin another cycle.

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    Pathophysiology how HIV causes disease

    The human immune system is an organ concerned with destroying and eliminating from thebody any organism, substance or particle that threatens the bodys integrity. Like the heart orthe 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 andcirculating in the blood.

    To mount an immune response, these various components must communicate and interact ina precisely orchestrated and organized way. A component with pivotal role in coordinatingthis 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 humanimmune response. CD4+ cells bear receptors on their surface, which allow them to pick upantigens, the specific molecules from the virus or other foreign body that alerts the immunesystem to the presence of something dangerous. Once the CD4+cells have capturedantigens, they help B cells to make antibodies, and they release lymphokines, chemicals thatstimulate other varieties of immune cell to kill the invader.

    Tc cytotoxic T cells recognize and destroy cells coated with antigens (the antigen may bedeposited 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 toidentify 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 effectorcells, but also engulf and digest infected cells

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    Window Period HIV and HCV carriers can be identified by detecting the

    antibodies against the virus in the patients blood. However

    antibodies against HIV and HCV take weeks - or months - afterinfection to develop in the body. This in essence creates awindow 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 testnegative hence can be transfused into patients and may infectthem.

    This phenomenon that came to prominence in the mid 90swhen people tested and diagnosed as sero-negative, went out

    and infected others.

    You cant infect somebody if youre not infected thats whenthe realization came that there was something wrong with thepresent tests which could not diagnose everybody.

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    Window Period

    Most HIV tests measure the antibodies produced by the body againstHIV. It takes some time for the immune system to produce enough

    antibodies for the antibody tests to detect. This time period is commonlyreferred to as the window period. This can vary from person to person.

    Most people develop detectable antibodies within 2 to 8 weeks (theaverage is 25 days). Even so, there is a chance that someindividuals will take longer to develop detectable antibodies.

    Therefore, if the initial HIV test was conducted within thefirst 3 months of possible exposure, there is a great possibility of afalse-negative result.

    Ninety-seven percent people usually develop antibodies in the first 3months 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 timebetween HIV infection and RNA detection is 911 days. These tests,are more costly and used less often than antibody tests.

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    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 enableearly diagnosis of HIV.

    Some other methods like the p24 antigen test which look forproteins or antigens -- have been able to shorten the windowperiod by a few days but they are not very cost effective.

    A great stride has been in the testing of the viral genome - thenucleic acid of the virus, which has shortened the window byabout 12 days but it is a very expensive test. For a positiveresult there should be virus in the blood which can take weeksor even months. So, an infected person may test negative.

    Sometimes there may be no antibodies in the blood becausethe production of antibodies is suppressed. So even the mostsensitive kit will be unable to detect antibodies - because theyare not there.

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    ELISA TEST

    The only way to tell if you have the AIDS virus is by beingtested. The ELISA test is the AIDS antibody test you usuallyhear about. ELISA, also called EIA, stands for Enzyme-LinkedImmunosorbent Assay. The ELISA test currently in use looks forthe presence of antibodies that your body might have developedto fight HIV infection, the virus that causes AIDS. It does not testfor the virus itself. A positive ELISA test might not mean you're

    infected with the AIDS virus. However, it would be a sign thatfurther testing is needed.

    A negative test is also not conclusive. If you have been infectedwith the virus recently, a negative test may mean that your bodymight 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 ofAIDS.

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    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 causeinflammation of the liver, scarring of liver and in some cases liver failureor 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 infectioncan experience mild symptoms, and consequently do not seek treatment.

    Hepatitis C (originally "non-A non-B hepatitis") is one of five knownhepatitis viruses: A, B, C, D, and E.

    The hepatitis C virus is usually detectable in the blood within one to threeweeks after infection, and antibodies to the virus are generally detectablewithin 3 to 12 weeks.

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    HIV - HCV

    Injecting drugs is one of the main ways people become infectedwith HIV. It is also the main way of becoming infected with thehepatitis C virus (HCV). In fact, 50%-90% of HIV-infected injectiondrug users are also infected with hepatitis C

    Persons with HIV, especially injection drug users, may also beinfected with the hepatitis C virus (HCV).

    HCV infection is more serious in persons with HIV.

    Many persons with HCV dont have any symptoms.

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    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 importantcause of morbidity and mortality in HIV positive patients. As aresult, researchers are focusing on HCV-related liver disease andtreatment-associated issues in HIV-HCV coinfected individuals.

    Studies indicate that HIV-HCV coinfected patients have higherHCV RNA loads and experience more rapid progression of liverfibrosis than those with HCV monoinfection. Some researchersargue that HIV disease is accelerated by HCV-related immuneactivation and impairment in immune recovery after effective

    antiretroviral therapy.

    Compared with HCV infection alone, HIV-HCV coinfection isassociated with an increased risk of cirrhosis, end-stage liverdisease, and hepatocellular carcinoma (HCC)

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    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 anantibody response is the protein P24. Early in the infection, P24 is produced inexcess and can be detected in the blood serum by a commercial test (althoughas 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. Somemodern HIV tests combine P24 and other antigen tests with standard antibodyidentification 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 canidentify HIV in the blood within 2-3 weeks of infection. There are two form o

    PCR tests -- DNA PCR and RNA PCR. Babies born to HIV positive mothers areusually tested using a DNA PCR because they retain their mother's antibodiesfor several months. Blood supplies in most countries are screened for HIV usingan RNA PCR test, which can produce results faster than a DNA test. PCR testsare not often used to test for HIV in adults, as they are very expensive and morecomplicated to administer than a standard antibody or P24 test.

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    HIV detection tests & their limitations - ELISA

    ELISA test is commonly used for screening blood from donors. A high level ofsensitivity means slightly lowered specificity (ability to distinguish HIV antibodiesfrom 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, forinstance the ELISA test are not specific for HIV. This is why four repeat ELISA testsplus 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 awide variety of uninfected human tissue and blood samples from other diseases likeleprosy, malaria and viral infections. Hence the ELISA test may give false positiveresults even without the HIV infection.

    Lack of standardization of ELISA results A person who tests positive at onelaboratory may test negative in another laboratory in the same city.

    WHO recommends a positive ELISA blood test result needs to be confirmed bytests using another ELISA kit on the same blood sample, while UNAIDSWHOrecommends - another blood sample should be obtained from the person beforedeclaring him seropositive to eliminate any human or technical error.

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    HIV d t ti t t & th i li it ti

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    HIV detection tests & their limitations - PCR Test

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

    It is a confirmatory test, used mainly to track the clinicalprogression of HIV infection to AIDS. It is used to determine thelevel of viral load in the blood -- associated with an increased riskof transmission and the clinical progression to AIDS.

    The level of virus in the blood is directly related to the risk oftransmitting the disease to uninfected individuals. Mothers withhigh viral loads have the highest chance of transmitting the virus totheir infants.

    One of the main drawbacks of the PCR test is that the viral loadcan also increase non-specifically due to other viral andopportunistic bacterial infections as a result the viral load test maynot always be an indicator for the clinical progression of HIV toAIDS and may lead to incorrect results.

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    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 intheir blood that could be detected by any conventional tests. Atthis 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 thewindow period could get transfused into unsuspecting patientsthus infect them.

    Epidemiological studies- are incomplete, as critical information

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

    Researches show that every unidentified carrier could infect,directly and indirectly, some fifty people a year.

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    In conclusion.

    Let us have a quick look at some sobering facts - in less than 20years, over 40 million people have been infected, and UNAIDS

    estimates that every day 16,000 people get newly infected withHIV, 90 % of whom live in the developing world. Without animmediate stronger response on the prevention, treatment,monitoring, and above all screening and diagnostic fronts, theAIDS crisis will continue to grow, and it will not be long before itthreatens to enter every household.

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    Introducin

    SMARTube -- an innovative, simple and cost effectivesolution for pretreatment of the blood samples for HIV & HCV

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    What is SMARTube

    S -timulating

    M-aximal

    A-ntibodyR-esponse

    T-ube

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    SMARTube--The solution

    To enable antibody production, in a small blood sample, withindays from infection, without having to wait for the body to produce

    antibodies weeks or months later, & To push for antibodyproduction at levels that can be detected by current testing.

    The solution to early detection is the time machine inside theSMARTube.

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    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 bloodsample, within days from infection, without having to wait for thebody to produce antibodies weeks or months later

    The technology is the culmination of more than 12 years of workby Jehuda-Cohen, an immunologist with a PhD in immunologyfrom the Technion - Israel Institute of Technology.

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    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 solutionthat does not require complex equipment to use it.

    It can be used in adjunct to any sensitive antibody test in themarket.

    It does not change the testing algorithms as a blood pre-treatment device.

    Improves both specificity and sensitivity of the existing assays.

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    SMARTube Revolutionary Technology

    The core of the technology is overcoming the specific immunesuppressants of the body. A few drops of blood are placed intothe SMARTube and a solution inside helps the cells of theimmune system overcome the suppression, and pushes theminto an extremely fast process of antibody production.

    The end result We can detect those individuals alreadyinfected when nobody else can - because theyre still at the veryearly stages of the window - where theres no other technology

    today can detect them.

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    How SMARTube is to be used

    SMARTube where is the need

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    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

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    SMARTube testing requirements

    SMARTube is manufactured under strict ISO9001:2000 and ISO13485:2003 regulationsand 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 inheparin is introduced into it. This is then incubated for five days at 37 oC in a humidified

    CO2 incubator. After incubation a sample of the supernatant is removed for testing usingELISA test or any other detection method.

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

    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, usingsterile pipette etc.). The blood sample inside it then needs to be incubated at 37 oC inhumidified CO2 incubator for 5 days. After incubation a sample of the supernatant isremoved for testing (separation occurs by gravity during incubation), using any currentlyavailable method for HIV/HCV testing.

    It only requires an incubator which most labs possesses

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    SMARTube -- Advanta es

    SMARTube offers an innovative, simple and cost effective solution for pretreatment of the bloodsamples 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 hasapplications, as a blood pre-treatment device, for early and more complete detection of HIVand/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 bypushing 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 thisactivation 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 betransferred to the SMARTube even a day later, when it reaches the testing lab. Since it is a bloodpre-treatment device, once the blood is treated in the SMARTube it can be tested using any HIVor HCV antibody ELISA tests. Therefore the labs do not need to change their way of diagnosingthe infection, they only change the way the blood is handled prior to the tests. This makes theSMARTube very simple to use and with a great return for the money, a safer blood supply andbetter detection of infected individuals.

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

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    SMARTube - Advantages

    According to clinical studies on high risk populations in Israel and othercountries, the SMARTube successfully enables the detection of all thepatients who are diagnosed in the conventional testing - but alsodetects the virus in additional patients that are infected, but otherwisewould have gone undetected at that testing time.

    Having received the CE Mark (the regulatory requirement in Europe forits registration and marketing) as a blood collection and pre-treatmentdevice, the SMARTube is available for use in hospitals, diagnostic labs,blood banks for health or life insurance uses-- basically anywhere bloodsamples are taken for HIV testing.

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    SMARTube additional benefits

    Increase sensitivity-- More efficient detection-- higher levels ofantibodies in low positive samples.

    Increase specificity: lower incidence of false positives lessrepeat testing, less blood units lost

    Saving in terms of time & money with improvement inperformance.

    Better indication of incidence rates-- rate of new cases versusprevalence (rate of positives, total).

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    SMARTube Successful Clinical Trials

    SMARTube Global Acceptance

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    SMARTube Global Acceptance

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    SMARTube Certified Quality & Standards

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    SMARTube Success Stories

    Case Study # 1 : Jacob Johnes a US marine never thought he couldcontract HIV, despite risky behavior A routine HIV test confirmed himas 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 vetroand Jones was declared HIV +ve Imagine how many people he couldhave infected if allowed to go scot- free with a false HIV negativereport.

    Note : This is a fabricated case we need 5-7 actual cases like this,which show world wide acceptance and effectiveness of SMARTube.

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    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