smart tube intro & faqs

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The SMART Solution

v

INDIA needs

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SMARTubeTM

being introduced for the first time in India – is a simple, yet revolutionary

breakthrough in medical technology for early warning and detection of HIV & HCV infections

in human beings, months before any other known test or diagnostic method.

Stimulating Maximal Antibody Response Tube – SMARTube™ will revolutionize HIV & HCV

detection by enabling one of the earliest and complete detection of HIV/HCV just a week

after exposure. SMARTube™ not only enables the detection of all the patients who are

diagnosed in the conventional testing - but also enables detection in additional patients that

are infected, but otherwise would have gone undetected at that testing time. As a cost

effective method that increases the SENSITIVITY and SPECIFICITY of other known HIV & HCV

detection devises—with very little additional training or cost input, it will help in saving

millions of lives.

SMARTube™ is manufactured under strict ISO 9001:2000 and ISO 13485:2003 regulations

and the highest global Quality Control, R&D and professional standards. SMARTube™ has

been awarded-- CE Mark—the regulatory stamp of approval in the whole of Europe (the EU

countries) and is certified for public and individual use in Germany, Russian Federation,

South Africa, Israel, Romania, Nigeria, and Turkey. It is being used in these countries in

hospitals, diagnostic labs, blood banks, health or life insurance uses—anywhere blood

samples need to be tested for HIV.

SMARTube™ has been tested in controlled clinical trials on over 10,000 patients/individuals

in several countries like China, Israel, Kenya, Mexico, Romania and South Africa. Most of

these clinical trials and tests were done by reputed government agencies, blood banks,

reference laboratories, academic and professional bodies.

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Q . What is SMARTubeTM

?

A. The name SMARTubeTM

being introduced for the first time in India – is derived from:

S –timulating,

M-aximal

A-ntibody

R-esponse

T-ube

It is a simple, yet revolutionary breakthrough in

medical technology for early warning and

detection of HIV & HCV infections in human

beings, months before any other known test or

diagnostic method.

Q . What is its Unique Selling Proposition - USP ?

A. The main USPs of SMARTubeTM

are as under:

1. It simulates the production and growth of a higher level antibodies in the blood

sample—upto a level that can be easily detected by the dignostic tests.

2. False negetive becomes positive: The same tests which had otherwise given a false

negetive report – can now give a confirmed positive result

3. Earliest possible detection of HIV-HCV within days of the infection.

4. Eliminate chances of a false positive results- SMARTubeTM

could prove to be a medical

blessing in terms of eliminating the possibility of doubt and reduce the incidence of false

positive result in some of the existing tests.

5. Reduces the period of uncertianity-- You don’t have to wait for weeks or months for the

body to produce antibodies in the due, natural course.

6. Increases the Specificity and Sentivity of the existing tests

7. No additional cost for add-on test-lab infrastructure or training of technicians.

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Q . Why is something like SMARTubeTM

the SMART solution to India’s needs?

A. One of main purpose behind any dignostic test – is to act like an early warning radar

system to detect the presence of invading germs and virus before they can cause irrepareble

damage to the human body.

However despite advancement of technology, one problem with most aviation radars is that

they cannot detect low flying, light aircraft. Likewise most HIV/HCV diagnostic tests can

detect only the antibodies produced against the infections and not the actual virus… This is

a major problem as during the window period –or the deceptive dark period just after a new

infection—many infected individuals could go undetected due to false negetive test results

due to low or inadequqte antibodies produced in the human body.

Even in case of a normal viral infection it takes 5-7 days for the antibodies to develop after

the infection. In case of both HIV or HCV it could take weeks or many months before any

antibodies could be found in the blood.

Using the radar terminology-- SMARTubeTM

is like an early warning radar system for the

detection and diagnosis of HIV and/or HCV infections – in the early stages of the disease

when most tests cannot diagnose it on the basis of antibodies produced in the infected

blood.

SMARTubeTM

is a scientifically engineered -- medical

boon– which makes it possible to detect an HIV carrier

even during the so-called window or latent period of the

infection.

All this makes SMARTubeTM

– the smart and the ultimate weapon to attack

and fight against the killer twins – HIV & HCV both of whom are smart and

lethal invaders – and masters in the art of camoflage, deception and hidden

combat after silently crippling the defenders – inside the human body.

Putting things in perspective—

• It’s a world wide trend that many HIV infected though medically

undiagnosed people are actually walking the on streets blissfully unaware

of their HIV+ve status. They are like potential Human Time Bombs that can

explode any moment causing irreparable damage by actually infecting 100s

of other innocent and unsuspecting people

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• Given the trend that only less than 1 % population of India get themseleves

tested for HIV-HCV even once in the lifetime and worst still upto 27 % HIV

infected people remain undiagnosed… Can India be left to the mercy of

these Zombies !!

• It is not a just medical but human rights issue very much akin to the right to

live and stay away from any accidental HIV contamination

• The only alternative before India which is

already the home to one of the highest

number of HIV+ve

people and one of the

highest number of AIDS related orphans in

the world – is to detect and segregate the

carriers of the deadly killer twin diseases – HIV & HCV before its too late.

• Ignorance is not bliss—Eliminating the false –ves as well as false +ves -- is

the only way to realistically combat the HIV-HCV menance

• Early and confirmed diagnosis of the HIV/HCV careers – well before the

antibodies in their blood can be taken as evidence – may actually prove to

be a turning point in their lives leading to a better management of their

infection besides the U-turn towards the road to damage control and

possible recovery.

In this sense-- SMARTubeTM

is +vely the solution India needs…

Q. Medically which are the sectors where the use of SMARTubeTM

could prove to be a

blessing in disguise?

A. SMARTube could prove to be extremely useful in Hospitals, laboratories, research centres

and the blood banks where everyday hundreds of new donors come to donate blood. None

of them is carrying a sign board on their faces – that they are HIV+ve. And if it's been just 2-

3 days before they have been infected by say visiting a prostitute or injectable drug abuse –

none of the existing test would be able to confirm the presence of virus in their blood. This

is where SMARTube can help. Besides this SMARTubeTM

could prove to be really useful in

the Army, Airforce, Navy and other central and state police forces as well as large

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corporates both in terms of pre-recruitment screening and periodic in-service monitoring of

the HIV status.

Q. What can be the various uses and applications of SMARTube in India?

A. SMARTube can have uses and applications in many sectors like:

• HIV testing centers

• Clinics and laboratories

• Diagnostics (hospitals, labs)

• Epidemiology (governments, health organizations)

• Research (vaccine design & therapeutics).

• Plasma industry.

• Health & Life insurance companies.

• Army, Police & Police – Pre-recruitment screening

• Individuals & Corporate -- Pregnant women, Healthcare workers, Foreign travelers,

Sex workers

Q. What are the risks involved if all the carriers of the HIV virus are not detected well in

time?

A. HIV and HCV carriers can be identified by detecting the antibodies against the virus in

their blood. After the HIV infection has set in, diagnosis is made using a blood test to detect

antibodies to the virus or copies of the virus itself.

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 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. 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.

Blood donated at blood banks during the ‘window period’ test negative and hence can be

transfused into unsuspecting patients – requiring urgent blood tranmission – for instance

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in cases of accidents, surgeries or say for instance pateients of heomophilia or thalesemia.

Imagime the magnitiude of the problem if every such person requiring blood transfusion

for one reason or the other came back infected with HIV+ve virus.

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.

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.

The only alternative is the RNA test which can detect the HIV virus directly. Even the time

between HIV infection and RNA detection is 9–11 days. However these tests, are more

costly and used less often than antibody tests.

Researches show that every unidentified carrier could infect, directly and indirectly, some

fifty people a year.

• 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.

So in conclusion we can say:

• SMARTube– has opened up newer possibilities for fool-proof diagnosis of HIV or HCV

• SMARTube has reduced the suspense and made it possible to take on HIV in the

earliest stage of progression of the infection in the body.

• SMARTube will help save millions of innocent lives by early diagnosis of high risk

carriers

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• SMARTube– will help to eliminate doubt and reduce the incidence of false-positive

results in most of the existing tests. Imagine the trauma of a person and his family

members who has been falsely diagnosed as HIV+ve

.

Q. What is the technological background behind SMARTubeTM

and how is ito be used?

A: 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.

The core of the technology is overcoming the specific immune suppressants of the body. It is

a simple three step process.

Step 1: A few drops of blood are placed into the SMARTubeTM

which is like a sealed test

tube with a pink coloured plasma solution inside it. This plasma solution gives a false sense

of security to the invading virus to grow without bothering about suppression by the body’s

immune system. In this way the it simulates an extremely fast process of antibody

production.

Step 2: The solution inside the SMARTubeTM

is allowed to incubate at 370C for 3-5 days

Step 3: The end result– even routine test by any of the existing methods can now detect a

suffiecient level of antibodies of HIV+ve virus in the same the individuals still in the very

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early stages of the window period- who was earliar misdiagnosed as a false negetive. So to

say SMARTube makes it possible to reverse the false positive or negetive as the case may be

much before any other technology today can detect the virus inside the body.

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Q. How does the detection process using SMARTubeTM

compare with regards to some of

the other known methods ?

A. This can be explained with the help of the following diagrams which clearly indicates that

SMARTubeTM

allows the earliest detection of the HIV & HCV at the most affordable cost

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Q. Why SMART? What is so smart about SMARTube?

A. Well this is because the HIV virus itself is a smart virus, just

around 100-150 billionths of a meter in diameter that it is

about 0.1 microns or 4 millionths of an inch in size. Unlike most

bacteria, it is much too small to be seen through an ordinary

microscope, yet it manages to trick and evade the body's

defenses. Once the Smart HIV virus takes hold, the

immune system can never fully get rid of it and the

HIV+ve

person may not even know that they are

infected and may look and feel perfectly well for

many years. But deep inside the immune system

becomes weak and increasingly vulnerable to even

minor illnesses which a normal person can easily fight off.

To fight such a smart virus, you really have to be SMART. Though inside the human body,

the Smart HIV/HCV virus can conceal its presence for a fairly long time by inhibiting the

immune system's ability to produce antibodies from 30-90 days in case HIV or 70-180 days

in case of HCV— the proprietary plasma solution inside the SMARTube is able to see

through this game.

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So it gives a false sense of security to the HIV/HCV virus by convincing it to grow as there are

no immune system cells inside the SMARTube trying to attack it. This encourages the virus

to grow and the blood sample to develop antibodies against it during the incubation phase.

Once the incubation of 3-5 days is over, enough anti-bodies have been developed by the

blood sample inside the SMARTube that even a routine ELISA test – which 3-5 days back

gave a false negative report—can now confirm the seroconversion. It's a warfare in which

the SMARTube technology manages to outsmart the opponent i.e. the HIV/HCV virus.

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.

Q. What is the technological basis behind SMARTube and what is it called?

A. SMARTube is based on a unique and innovative technology called Stimmunology-- a

breakthrough technology that holds the key to detect hidden antibodies by

stimulating specific humeral immune response. The core philosophy behind

this technology is to overcome 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 to 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 period-

when no other technology today can detect them.

Q. What does SMARTube actually contain?

A. SMARTube is a pretreatment test tube that holds two ml of a pink colored proprietary

liquid solution which is sterile in nature and has a shelf life of six months 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.

Q. Does it require extraordinary laboratory apparatus; space required or specifically trained

technicians to conduct the test using SMARTube?

A. There is no specific requirement for any special laboratory equipment except an

incubator which is usually present in any diagnostic or testing laboratory. For tests using

SMARTube we also do not need any extra space in the laboratory where just one ml of

blood is required to be collected. This too any normal trained technician can collect. The

blood sample for the SMARTube can be collected in any of the following ways:

• Direct draw – directly into the vacuum packed SMARTubes in the laboratory

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• Indirect draw – using heparin wash tubes or syringes and later transferring it in the

laboratory into the SMARTube using sterile pipette.

The blood sample thus collected by any of the above methods is transferred inside the

SMARTube and incubated at 37oC in a humidified CO2

incubator for 5 days. After incubation a sample of the

supernatant is removed for testing using any currently

available method for HIV/HCV testing.

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 -- with great return for the money and better

detection of infected individuals.

Q. How long does it take for the test results using SMARTube?

A. Usually the blood sample inside the SMARTube has to be incubated at 5% CO2 and 37oC

for 3–5 days in a humidified CO2 incubator. For the blood banks, the protocol for using

SMARTube is 3 days. Towards this end a validation and implementation protocol has been

developed by experts in the field.

Q. Does SMARTube require any specific diagnostic platform? What will happen to the

existing and available tests?

A. SMARTube does not require any specific diagnostic method to be adopted. It is a pre-

testing device which does not replace or make diagnostic test redundant. It only improves

or accelerates the development of antibodies to enable early antibody detection using ELISA

(or other antibody test methods). During the incubation period, in-vitro antibody production

is accelerated to such an extent that even regular tests become completely effective. Hence

SMARTube only enables earlier, better and complete detection of HIV/HCV, while excluding

the chances of false negative of false positive reports.

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Q. Does SMARTube substantiate any International quality control and production

standards?

A. SMARTube is manufactured under strict ISO 9001:2000 and ISO 13485:2003 regulations

and highest globally acceptable Quality Control, R&D and professional standards.

Flag Country Certificate

European

Union CE Mark-EU

Russian

Federation

Registration

Certificate

Israel AMAR Certificate

South Africa Registration

Certificate

Romania Registration

Certificate

Nigeria DOR Registration

SMARTube has been awarded-- CE Mark—the regulatory stamp of approval for

registration and marketing as a blood collection and pre-treatment device in the whole of

Europe. It has also been permitted and certified for public and individual use in Germany,

Russian Federation, South Africa, Israel, Romania and Nigeria. It is now being reviewed by

FDA (USA) for use in hospitals, diagnostic labs, blood banks, health or life insurance uses—

basically anywhere blood samples need to be tested for presence of HIV. Proceedings are

also on for implementation by prestigious world bodies like World Heath Organization,

Family Health Initiative (FHI) and the International AIDS Vaccine Initiative (IAVI).

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Q. Has SMARTube been clinically tried? If so what were the results?

A. SMARTube has been tested in controlled clinical trials on over 10,000 patients/individuals

in several countries like China, Israel, Kenya, Mexico, Romania and South Africa. Most of

these clinical trials and tests were done by reputed government agencies, blood banks,

reference laboratories, academic and professional bodies.

Extracts of Clinical Trials in different parts of the world :

Clinical studies of the HIV&HCV SMARTube™ for HIV/HCV have been performed in

• China

• USA.

• South Africa,

• Mexico,

• Israel,

• Kenya

Country Sample Size Trial Agency

China 6,000 approx

Department of Cell Biology, National

Institute for Control of Pharmaceutical and

Biological Products (China). Trials

conducted in five different regions of

China.

Israel HIV 2,000, high risk

HCV 300

Kenya HIV 2,000, blood units

HCV 300 , blood units

Mexico HIV 200 High Risk approved government agency

South Africa HIV 90 High Risk

China: Clinical Trials in China were conducted, executed and reported by the Department of

Cell Biology, National Institute for Control of Pharmaceutical and Biological Products. The

trials were done in 5 different regions in China (Total samples tested: approximately 6,000).

1. Trial in high risk population (IVD) in Sichuan District:

HIV

• 653 individuals tested.

• 149 Seropositive.

• 151 Seropositive after pre-treatment in the SMARTube™.

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HCV




2. Trials in blood banks: HIV

• Beijing Blood Bank: 2000 low risk samples, no positives.

• Clearance of false positives by the SMARTube™.

U.S.A : Studies were performed in monkeys. naïve monkeys were infected with a very low

dose of SIV virus (the equivalent to HIV in monkeys).

• 4 monkeys tested.

• 4 seronegative (one week from infection).

• 4 Seropositive after pre-treatment in SMARTube™ (one week-

infection).

All monkeys seroconverted between 1-5 months from infection.

South Africa: Clinical trials were carried out in South Africa among high risk population

(blood donors):

HIV


• 3 Seropositive.


Mexico : Clinical trials were carried out in Mexico, by an approved government agency.

HIV

• 200 Individuals tested, very high risk, multiple, current exposures.



Israel : Several high risk populations were screened using the SMARTube™ as a blood pre-

treatment device in a number of trials (total: over 2,000 individuals).

1. Immigrants from High risk areas:

HIV




HCV


• 1 Seropositive


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2. Low risk populations were screened using the SMARTube™:

HIV

• Over 1,500 individuals tested – no positives.

HCV

• Over 600 individuals tested – no positives.

Kenya : Clinical trials were carried out in Kenya.

1. Screening of high risk population:

HIV




2. Additional trials conducted in the blood bank in Kenya for complete detection

of HIV infected blood units:

HIV

Adults:




Youth:




HCV

• Over 300 individuals tested.



3. A study was conducted on pregnant women:

HIV

• 40 Seronegative women tested.

• 8 out of the 40 Seronegative women, were positive after pre-

treatment in the SMARTube™.

Based on these clinical trials the following observations were recorded:

• After pre-treatment with SMARTube: 1.4% to 40.0% additional positives

• All seropositives are positive after SMARTube

• Increase in specificity

• No adverse affect on specificity

• 30% to-95% reduction in false positive rate

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• Increase in antibody levels in low seropositives (and new ones)

• Safer blood transfusion – detection of infected blood units missed by current

serology

• More efficient detection.

• 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).

Q. What are SMARTube's plans for India?

A. Initially SMARTube test kits will be imported into India, later as the demand grows,

SMARTube will be manufactured in India for the domestic market as well as exports to

neighboring countries in the region.

Q. How much are tests using SMARTube likely to cost in India?

A. It is still too early to predict the final costs, which would depend on many factors like

quantities to be imported, infrastructure, logistics and operational costs. A fair idea of the

actual cost could only be worked out after the final codal formalities of registration and

import license as completed—still we estimate the cost to consumer should be around Rs

1000 per test – which is very reasonable considering the fact without SMARTube it takes –

atleast 2-3 different types of tests – which consume much more time and money to

positively diagnose or rule out HIV in India, today.

Q. Who are the people behind importing SMARTube technology into India?

A. The vision and moving spirit behind SMARTube operations and import into India – is Dr

Narendra.K. Gupta – a Indian born US & Canadian citizen who is President of the Society for

Medicare as well founder President & CEO of the Eternal Health & Wellness Foundation

(USA).

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The Team Composition is as follows:

Name Designation Brief Background

Dr Narendra K.

Gupta

MD, FRCP(C)

President – Society

for Medicare

Founder President &

CEO, Eternal Health

& Wellness

Foundation (USA)

Medical Director & CEO, Diabetes &

Hypertension Center, Duluth, GA,

Member: Vascular Biology working Group

University of Gainesville, Florida.

Principal Investigator: Multiple Trials on

Diabetes, Hypertension and cardiovascular

diseases.

Clinical Associate Professor of Medicine,

Medical College of Ohio, Toledo

Research Grant: Merck & Co., Novartis

Pharmaceuticals, and Takeda

Consultant Nephrologist - Regina General

Hospital, Canada

America’s Top Physician— 2007 Award by

the Consumer Council of America

Yisrael Serok –

Founder and CEO,

SMARTube Bio

Yisrael Serok has over 20 years experience in

managing small and large scale operations,

both in Israel and other parts of the world.

With a world-wide and established network

of government and strategic relations, he is

on the Board of Directors of several

companies with investment portfolio in a

variety of projects.

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Dr. Tamar Jehuda-

Cohen

Founder and CTO,

SMARTube Bio

With in-depth experience in immunology,

diagnostics and AIDS, Dr. Jehuda-Cohen is the

inventor of Stimmunology technology. She

holds over 10 patents, has authored over 30

publications, and more than 100 abstracts—

many of them as presentations at

international conferences.

Dr. Tamar is currently serving as a consultant

for the Family Health Initiative (FHI), funded

by the UNAIDS. Dr Tamar holds Ph.D in

Immunology and cell Differentiation from the

Technion Medical school, Haifa Israel and

completed post doctoral studies at Emery

University in Atlanta, home of U.S Centers for

Disease Control and Prevention.

Neeraj Mahajan Secretary, Society

for Medicare and

Country Head

(India), Eternal

Health & Wellness

Foundation (USA)

A media professional with over 20 years

experience, proven competence and

consistency in Print, Electronic, Web or New

media as well as Corporate Communications,

PR, Image building and Perception

Management. He has held various

assignments in print and electronic media

from staff reporter to Editor (Print) &

Producer-Director (TV).

He specializes in image building and has

conceptualized and executed various

propaganda, counter-propaganda and

Perception Management and psychological

operations for the Indian Army in counter-

insurgency areas in J&K and North East.

Rakshak video magazine– produced and

directed by him was recognized as the official

medium for audio-visual communications of

Indian Army.

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Case Study # 1 : Diagnosis by default-- 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

Case Study 2: A baby saved: Mayama was 22 when she came to the antenatal clinic. This

was her third pregnancy, yet her first visit to that clinic. She has come because her friend

told her that she could save her baby if would go there. She was five months pregnant, and

the nurse explained the risks of transmitting HIV to the un-born baby, and that there was

medicine that could save the baby form getting AIDS. Mayama was tested for HIV, using a

rapid test, which was negative.

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The nurse explained that such a result does not mean that she is not infected for sure, as

she could have been infected in the last few months, and then the test will not detect it yet.

Mayama was worried. She was sure one of her regular clients on the truck route was sick

with

AIDS and seeing she got pregnant… When she shared her fears with the nurse she was told

that she could come back in 3 months or so and re-test. Mayama wanted to know. She was

worried, and she really wanted to give that baby the best chance possible. “I cannot wait for

3 months; if I am infected I want to take the medicine now. In three months I will give birth,

it will be too late. Plus, I cannot come back here heavy with pregnancy – everyone will talk!

The nurse shrugged her shoulders. “There is nothing we can do for you now. We cannot see

the infection during the window period, when the virus is hiding and the tests are negative.

Mayama started crying. The head nurse took her into her office. “There is a new way we can

use to see if you are infected, even if it happened recently. But for that we need to draw

blood and send it to the laboratory in town. The results will come back next week. You will

need to come back then, and if you're positive we will give you the ART.”

Mayama agreed to come back. A test tube with her blood was sent to the laboratory. There

they treated the blood with the SMARTube™, an innovative blood pre-treatment which

closes the window period and thus eliminates the false negative results in the early stages of

the infection. On the fifth day, the lab sent the results back to the clinic. While negative on

the tests using the regular methods, Mayama was clearly positive after the SMARTube™

was added to the testing in the laboratory. When Mayama came back, she got the results

with tears of fear and a smile of relief. She was going to save her baby; she was going to get

the drugs to protect him from the virus that has invaded her. As she was walking out of the

clinic, holding on to the medicine for both her and for the baby, when it will be born, she

turned around and ask the head nurse “How do they do it, there in the laboratory? How can

see what is still hidden”. “Well” answered the nurse, “

it is as if they go behind the stage and peak into the

dressing rooms, this way they know about the actors

even before they get on stage”. Mayama gave birth to

healthy baby girl.

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Case Study 3: If we only knew! Katub had her fifth child less than a year after she

immigrated to Israel. Upon arrival her whole family had their blood tested for different

things, including HIV. Her husband was the only one that tested positive for HIV. He figured

he must have gotten it in the camp on route to Israel. Katub was upset, but relieved for

herself and the unborn baby. The baby was born slightly underweight, but pink and

beautiful. When he was six months old he had a bad cold that would not go away. Then, the

doctor said it was probably some infection in the lungs. The antibiotics did not help. The

baby was hospitalized, but could not be saved. In the blood tests, he was found to be HIV

positive, but it was too late, he died of lung infection typical to AIDS patients.

The doctors were upset “If only you would have told your doctor that you are HIV positive,

you could have saved that baby. We know how to treat these type of infections, we just do

not suspect it in a baby without an HIV record.” Katub was very bewildered. How could she

transmit HIV to her baby if she is not infected? Did they not tell her in the immigration

center that she tested negative? She told the doctors it must be a mistake. “No”, said the

young doctor, “it is not a mistake. Unfortunately we cannot detect the HIV infection in the

first few months. You must have gotten infected shortly before the pregnancy, this is why

the results were negative, but it was not a true negative result.

A year later, in a scientific-medical conference, An immunologist presented some interesting

results with a new method which enables the detection of those infected even when still

missed by regular testing in the first months of infection. She called the method

“Stimmunology”, as it stimulates the immune system in the blood sample to “tell” us about

the infection “right away”. “I would like to share with you some alarming results we got

when studying some families with one seropositive HIV carrier. We used the Stimmunology

process for stimulating antibody production even in blood samples form infected individuals

during the window period. This was we can detect them using the regular diagnostic

antibody tests.” On the screen appeared results

showing seronegative wives who were actually

infected, and their infected babies. The doctors in the

audience sighed “If only we would have known”.

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Case study 4: Building a new relationship -- Seth and Diane decided to move in together

and formalize their relationship. They both went together for HIV testing, and, to their relief,

both tested negative. Because of their lifestyle, Seth’s doctor recommended to do an

additional blood test using an experimental pre-treatment of the blood in the university

laboratory. They agreed. The following week the doctor called them in for consultation and

told then that using the experimental new technology; Seth was found to be infected with

HIV. “It must be a recent encounter, in the last half a year or so” said the doctor. “But it is

still experimental, right” said Seth hopefully… Diane was silent all the way home. They have

been together for some time now, she wanted to believe Seth that “it could not be”, yet she

insisted that for their future they should use precaution “Just for the next few months. The

window period is not forever, right?” Three months later, Seth tested positive in a routine

testing.

Case Study 5: Organ donor -- Sheila has been waiting for a kidney transplant for 2 years. The

phone finally rang with the news – “we have a donor”. The young motorcyclist was brain

dead and his family agreed to donate his organs. A battery of tests was run, including HIV

and HCV antibody tests. All came negative. Additional testing was using very sensitive

molecular biology techniques to detect the virus even before the antibody tests detect the

infection. They were negative for both HIV and HCV. Sheila got the kidney, and stayed on

immunosuppressive drugs to reduce the risk of rejection of the transplanted kidney. Less

than a year later, Sheila was diagnosed with HIV and HCV infection. The source of the

infection was the transplanted kidney. All the recipients from that donor were now

positive for HIV and HCV. When Sheila sued the hospital the doctors testified that they have

used all known measures for testing the donor for these infectious and deadly viruses. “But

even with the most sensitive tests, there is a window period in which we cannot detect the

infection, and this window period can take three to six months and sometimes even longer”

testified the laboratory expert. “So there is nothing that could have been done?” asked

Sheila’s lawyer. “Well, responded the expert “there is a way to eliminate that window

period. It is a simple system of pre-treating the blood in a way that expresses the antibodies

prior to their appearance in the body. It works like

magic; it exposes those early infections we currently

miss.” “So if you would have used that method, you

would have been able to prevent all those terrible

infections! Why did you not use it?!”. “We do, but only experimentally, and unlinked, as it

has not yet been approved for use in our country...” responded the expert.

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ROAD MAP TO SMART BENEFITS

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Follow Up Questions / Clarifications:

Finally, please do not hesitate to contact us with whatever

technical or practical questions or comments you might have.

We would be happy to help out with whatever data, analyse

and share our thoughts and ideas.

For More Details Contact:

1. Dr Narendra K. Gupta

President

Society for Medicare.

Founder President & CEO

Eternal Health & Wellness

Foundation (USA)

Email: [email protected]

2. NEERAJ MAHAJAN

Secretary General

Society for Medicare &

Country Head (India),

3. Eternal Health & Wellness Foundation (USA)

4. Email: [email protected]

5. Mob: 9999989066, 9818666863

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