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INSTI HIV Self Test – KEMRI (Kenya) 2017 IAS Poster

PDF >> INSTI HIV Self Test – KEMRI (Kenya) 2017 IAS Poster


IgM 2015 IAS Conference Poster

PDF >> IgM 2015 IAS Poster


Results from INSTI’s Canadian Clinical Studies

 PDF >> Canadian Clinical Studies


Results from INSTI’S US Clinical Studies

PDF >> US Clinical Studies


CLIA Poster from 2012 AIDS Conference

 PDF >> 2012 AIDS CLIA Poster



Training



HIV/AIDS 101: The Basics


HIV spreads through contact with blood, semen, vaginal fluids, or the breast milk of an infected person.

Transmission can occur through:
Unprotected sex (sex without a condom), that involves anal, vaginal or oral penetration
The sharing of used syringes or needles
Maternal transfer from an HIV positive woman to her child during pregnancy, childbirth or breastfeeding (The chance of having a healthy baby can be greatly increased with proper medical care during and after pregnancy).

It is also possible to become infected with HIV through a blood transfusion, although this is now very rare. Blood transfusions and medical procedures in the U.S. are safe. Giving blood is completely risk-free. Although there have been some cases of HIV transmission through blood transfusions in the past, tests have been in place for several years to make sure that the blood you get in the hospital contains no HIV.
HIV cannot be passed on from one person to another through casual contact. There is no risk of infection when we share everyday items such as food, dishes, utensils, clothes, beds and toilets with an HIV positive individual. The virus is not spread from contact with sweat, tears, saliva, or a casual kiss from an infected person (deep, or “French” kissing is not advised). People do not become infected from eating food prepared by an HIV-infected person. People have not become infected with HIV through insect bites.

HIV stands for Human Immunodeficiency Virus.

HIV is the virus that causes AIDS (Acquired Immunodeficiency Syndrome)
It can take years for an HIV-infected person to develop AIDS. When a person becomes infected with HIV, the virus begins to attack his or her immune system, which is the body’s defense against illness. As a result, that person becomes more susceptible to disease and infection. When his or her body loses the ability to fight diseases, that person is diagnosed with AIDS. There is no cure for HIV infection. Antiretroviral drugs can slow down the disease progression.

Anyone can become infected with HIV regardless of age, gender, sexual identity (straight, gay or bisexual), financial status, and racial/ethnic identity. Your risk comes from what activities you do, and who you do it with – that is, how likely it is that the person you have sex or share needles with is infected. But even if you are part of a community with a high infection rate, you can avoid getting HIV. Preventing infection involves reducing your risks by thinking, planning and follow-through. Often it means talking about things that may make you uncomfortable. It can help to “practice” talking with people you can trust or who are going through the same thing.

It is important that you consider all the risks, consequences and benefits of any choice you make that may impact your health. Only you can decide what risks are worth taking and what risks are not.

Using a new, clean needle is the best protection against the virus if you are injecting drugs (including medications or steriods). Some states have needle exchange programs (where you can get free, clean needles) or needles for sale in drugstores. If you are planning on getting any body art, it is important that you go to a reputable establishment with qualified professionals that use new sterile equipment for every procedure. Latex condoms (“rubbers”) prevent HIV infection. Using a condom may not always be easy, but it does prevent the tranmission of STIs. When used right, condoms seldom break, tear or slip. Dental dams stop HIV when used for oral sex on a woman or for oral-anal sex. Dental dams are latex squares available in medical supply stores and from some adult shops. Be sure the dam covers the entire vulva (clitoris and vaginal opening) and that you hold it at both edges. Be careful not to turn the dam inside-out while you use it. If you don’t have a dental dam, you can improvise and use plastic wrap or cut a condom in half. The “female condom” is a plastic sheath that women can insert in their vaginas and use for protection against HIV. The female condom can be inserted up to 8 hours before sex, has rings at both ends to hold it in place. This kind of condom takes practice to use, and is more expensive than a latex condom. Some men have also used the female condom for anal sex, though it has not been tested or approved for this use.

In the US, the CDC estimates that up to 21% of individuals living with HIV are unaware of their infection. Moreover, those who are unaware of their infection are more likely to transmit than those who are aware. It can be scary to consider, but taking the HIV test is one of the best ways to stay healthy. Finding out that you have HIV can be an important step toward taking care of your health and planning for the future. Learning that you are HIV negative, too, can help you to figure out how to stay that way. Testing is voluntary, confidential and can even be anonymous. In all testing situations counseling is offered before and after the test.

Standard HIV tests look for HIV antibodies, which are proteins the body makes after HIV enters the blood. It can take up to three months to make enough antibodies to be detectable on the test, although in most cases, infection can be detected in four to six weeks following infection. If the test is taken too soon after exposure to infection during the “window period”, the test results may be negative for HIV antibodies. HIV can still be transmitted during the window period. There are different kinds of blood tests, including a new test that can give you quicker results and tests that look for the virus instead of antibodies.

In many locations, public clinics offer a free nominal, non-nominal or anonymous test. Private clinics, hospitals and medical facilities may also offer testing, please check with your local healthcare provider for testing locations near you. In all cases testing is confidential.

People with HIV or AIDS can do a number of things to stay healthy, which is why it is important to know your status. People who test positive for HIV infection can stay healthy for many years. Although there is no cure for HIV infection, antiretroviral drugs can slow down the disease progression. There are medications that can slow down virus activity and help maintain your immune system. See your doctor so that he or she can watch your health closely. Always use care not to pass HIV onto others.

If you have any question or want additional information, ask your healthcare provider or contact your local health department. In Canada you can also visit the Public Health Agency HIV/AIDS website or the Canadian AIDS Treatment Information Exchange (CATIE). In the US you can also call the National AIDS Hotline at 1-800-342-AIDS (1-800-342-2437) to talk with an HIV specialist. They can give you quick, private answers at any time, day or night. An AIDS service organization near you can also provide information, education and the help you may need.

What is AIDS?


AIDS is the medical diagnosis given to the most advanced stage of HIV infection. The criteria for diagnosis of AIDS varies from country to country. In general, the criteria for the definition of AIDS includes all HIV-infected people who have fewer than 200 CD4+ T cells per cubic millimeter of blood.

(Healthy adults usually have CD4+ T-cell counts of 1,000 or more.) The definition usually also includes clinical conditions that affect people with advanced HIV disease. Most of these conditions are opportunistic infections, which rarely cause harm in healthy people. In people with AIDS, these infections are often severe and sometimes fatal because the immune system is so ravaged by HIV that the body cannot fight off certain bacteria, viruses, fungi, parasites and other microbes. Some examples of Opportunistic Infections include: Candiadis (Thrush), Pneumocystis Pneumonia (PCP), Tuberculosis, Karposi Sarcoma and Herpes Simplex Virus. Check with your local health agency to get a full list of Opportunistic Infections common in people with AIDS.

AIDS is a medical diagnosis and can not be transmitted. Individuals who are diagnosed with AIDS are still HIV positive and it is the Human Immunodeficiency Virus that is transmitted from person to person. Please refer to the HIV transmission section of HIV/AIDS Basics on this website.

The most effective form of HIV/AIDS treatment is medication called Anti-Retroviral Therapy (ART). There are a number of ART medications that work directly on the virus and stop it from replicating itself in your body and allow your immune system to stay healthy. The combination of medications help individuals keep their HIV disease under control. By living a healthy lifestyle, recieving the right combination of medication and visiting your healthcare provider regularly, HIV can be a chronic, manageable disease.

Please see the Prevention section of our HIV/AIDS 101 website or the prevention section of www.aids.gov for information on preventing HIV infection.

For information about being diagnosed with HIV/AIDS and living with HIV/AIDS please contact your local healthcare provider. More information can also be found at www.aids.gov

Prevention


There is currently no vaccine to prevent HIV infection. Until a vaccine is approved, other HIV prevention methods such as safer sex practices, avoiding needle-sharing, and even HIV treatment-as-prevention programs will remain essential.

If you are sexually active, protect yourself from HIV infection by practicing safer sex.
Use Protection.
Latex condoms (and female condoms) prevent HIV infection. Using a condom may not always be easy, but it does prevent the transmission of HIV and other Sexually Transmitted Infections (STIs). When used right, condoms are extremely effective. If you are allergic to latex, polyurethane condoms are also available and is an appropriate alternative to latex condoms.
Dental Dams prevent the transmission of HIV and other STIs when used for oral-genital or oral-anal sex. Dental dams are latex squares available in medical supply stores and from some adult shops. Be sure the dam covers the entire vulva (clitoris and vaginal opening) and that you hold it at both edges. Be careful not to turn the dam inside-out while you use it. If you don’t have a dental dam you can improvise and cut open a condom.
Use only water-based lubricants. Latex condoms break down when combined with oil- or petroleum-based lubricants such as Vaseline or hand lotion.
If needed, consult a nurse, doctor or health educator for guidance on safer sex practices.

If you are injecting drugs of any type, including medications and steroids, do not share syringes or other injection equipment with anyone else.
If you are planning on getting any body art, it is important that you go to a reputable establishment with qualified professionals that use new sterile equipment for every procedure.

Having a sexually transmitted disease can increase your risk of acquiring and transmitting HIV. This is true whether you have open sores or breaks in the skin (as with syphilis, herpes, chancroid) or not (as with chlamydia and gonorrhea). Where there are breaks in the skin, HIV can enter and exit the body more easily. Even when there are no breaks in the skin, STIs can cause biological changes that may make HIV transmission more likely. Studies show that HIV-infected individuals who are infected with another STI are three to five times more likely to contract or transmit the virus through sexual contact.

HIV does not discriminate. Anyone can become infected with HIV regardless of age, gender, sexual identity (straight, gay or bisexual), financial status, and racial/ethnic identity. Being at risk of HIV infection depends on the activities you participate in and the associated level of risk. The greater the level of risk the activity is, the greater your risk of HIV infection.

Women are four times more likely to contract HIV through vaginal sex with infected males than vice versa. This biological vulnerability can be worsened by social and cultural factors that often undermine women’s ability to take care of her own health such as: being unable to avoid sex with partners who are HIV-infected, being unable to insist on condom use or having to put her own health secondary to that of her family.
For more information on the biological vulnerability of women to HIV, please visit the Canadian AIDS Treatment Information Exchange (CATIE).
For more information on prevention please visit www.aids.gov

HIV/AIDS Frequently Asked Questions


For the most recent information on prevalence and incidence of HIV in Canada, please go to the Public Health Agency of Canada HIV/AIDS reports and publications website. The summary of HIV prevalance and incidence estimates for 2008 can be found here.
For the most recent information on the prevalence and incidence of HIV in the United States, please go to the Center for Disease Control and Prevention (CDC) HIV Resources and Factsheets website for the US.
For the most recent information on the prevalence and incidence of HIV globally, please go to the World Health Organization HIV/AIDS Data and Statistics website.

The Human Immunodeficiency Virus (HIV) attacks the immune system – the body’s defense against disease/illness. When HIV weakens the immune system, the HIV positive individual becomes more susceptible to diseases/infections that normally would not affect him or her.

HIV spreads through contact with blood, semen, vaginal fluids, or the breast milk of an infected person.
Transmission can occur through:
Unprotected sex (sex without a condom), that involves anal, vaginal or oral penetration
The sharing of used syringes or needles (for drugs, medications or body art)
Maternal transfer from an HIV positive woman to her child during pregnancy, childbirth or breastfeeding (The chance of having a healthy baby can be greatly increased with proper medical care during and after pregnancy).
HIV cannot be passed on from one person to another through casual contact and there is no risk of infection when we share everyday items such as food, dishes, utensils, clothes, beds and toilets with an HIV positive individual.
Your risk of infection depends on your level of exposure to HIV positive body fluids during the activities you partcipate in. Different activities have different level of risks. For more information on prevention of HIV, please refer to the World Health Organization HIV Prevention website.

Anyone can become infected with HIV regardless of age, gender, sexual identity (straight, gay or bisexual), financial status, and racial/ethnic identity.

It is possible to become infected with HIV through a blood transfusion, however it is very rare. Although there have been some cases of HIV transmission through blood transfusions in the past, tests have been in place for several years to make sure that the blood you get in the hospital contains no HIV.

Giving blood is compltely risk-free; needles and syringes for collecting blood are only used once.

You can not tell if someone is HIV positive. Testing is the only way to someone can find out his or her HIV status

Some people may develop symptoms that are similar to those of other illnesses (shortly after being infected) and may only last a few weeks; symptoms like diarrhea, dramatic weight loss, fever, or constant fatigue. Such symptoms are often caused by other illnesses. However, if you have concerns about these symptoms please check-in with your doctor. For many people, if often takes many years before a person infected with HIV displays any symptoms of infection.
For more information on HIV and the signs and symptoms please go to www.aids.gov

She should consult a health care provider who knows about HIV disease. Prenatal HIV testing is routinely offered to all pregnant women in Canada and the US. Maternal transfer of HIV from a HIV positive woman to her child can occur during pregnancy, childbirth or breastfeeding. However, the use of anti-viral drugs, cesarean delivery and refraining from breast feeding can greatly reduce the risk of mother to child transmission of HIV.

The most effective form of HIV/AIDS treatment is medication called Anti-Retroviral Therapy (ART). There are a number of ART medications that work directly on the virus and stop it from replicating itself in your body and allow your immune system to stay healthy. The combination of medications help individuals keep their HIV disease under control. By living a healthy lifestyle, recieving the right combination of medication and visiting your healthcare provider regularly, HIV can be a chronic, manageable disease.

INSTI® Frequently Asked Questions


Proven accuracy of ? 99.8% Sensitivity and ? 99.5% Specificity

No. As in all assays for HIV antibody, false Reactives can occur infrequently with INSTI®. INSTI® is considered as an initial test only, and all patients with Reactive or Invalid INSTI® results should be re-tested with a licensed or approved HIV confirmatory assay before final HIV antibody status can be determined.

Yes. INSTI® is an FDA approved, Health Canada approved and CE Marked medical device and has undergone extensive clinical and non-clinical studies that have demonstrated its accuracy in direct comparison to licensed or approved laboratory-based methods. Data from these clinical and non-clinical studies are published in the INSTI® package insert.

Yes. In commercial HIV seroconversion panels and low titer panels, INSTI® is equivalent to the most sensitive licensed or approved laboratory-based assays in early antibody detection. However, patients who may be in the “window period” of HIV infection may test Non-Reactive in the INSTI® test.

The INSTI® test utilizes unique recombinant transmembrane proteins from HIV-1 and HIV-2.

Yes, the procedural control for the INSTI® consists of a protein capable of capturing the IgG normally present in human blood components. IgG is present in blood components in both HIV negative and HIV positive human specimens. Captured IgG reacts with a chromatic agent to produce a visual signal (spot) on the control membrane.

INSTI® preparation is minimal and results show up in as little as 60 seconds. Results are interpreted immediately after the absorption of Clarifying Solution (vial #3) into the Membrane Unit.

The test results will remain visible in the INSTI® Membrane Unit for an indefinite period after performing the test. Results are intended to be read immediately. Reading the test results after more than 5 minutes has elapsed following the addition of Clarifying Solution might produce erroneous results.

INSTI® should be stored at 15-30°C (59-86°F).

INSTI® has a shelf life 12 months in Canada, the U.S. and the European Union. In the rest of the world, INSTI® has a shelf life of 15 months.

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