Frequently Asked Questions

HIV stands for Human Immunodeficiency Virus and is the name given to the virus that causes AIDS (Acquired Immunodeficiency Syndrome). Once a person first gets infected with HIV, the virus can stay inactive for many years and the person has no signs or symptoms of infection. Eventually HIV starts attacking the defense cells in the body called lymphocytes and weakens the immune system (the body’s defense system that fights infections). The final stage of HIV infection, known as AIDS, occurs when the immune system becomes so weak and badly damaged that it is unable to fight against infection or disease and the person dies as a result. Although there is no cure for HIV, people infected with the virus today can be treated with medications that interferes with the viruses growth by preventing it from multiplying (making more copies of itself) within the body. This treatment, known as antiretroviral therapy, or ART, now means HIV infection is no longer a death sentence. Today, people are living longer and healthier lives and HIV infection is now considered by some to be a ‘chronic disease’. This highlights even more the importance of getting tested for HIV. A positive result means treatment is available!

There are three stages of HIV infection and each may or may not have symptoms associated:

At stage 1, the bloodstream contains high levels of the virus. At this time, it can easily be passed to other people. Within 2 to 4 weeks of exposure, many people develop flu-like symptoms. Not everyone has these symptoms, however, and it is possible for HIV to progress without any indication that the virus is present in the body.
At stage 1, symptoms may include:
• muscle and joint aches and pains
• tiredness
• raised temperature
• ulcers in the mouth
• night sweats
• body rash
• sore throat
• swollen glands
It is important to seek medical help if these symptoms occur, especially if the individual believes they may have been exposed to the HIV virus. Early treatment can be effective in reducing the impact of HIV.

During stage 2, the virus is active but reproduces at very low levels. At this stage, there are usually no symptoms, or very mild ones. This is why stage 2 is also known as the “asymptomatic stage” and is considered the clinical latency period of HIV infection. Those who follow a treatment program may remain in this stage for many decades, possibly for the rest of their life, as drug therapy reduces viral activity. Without treatment, the clinical latency stage lasts around 10 years.

Stage 3 HIV is also known as AIDS, but AIDS is a different and separate diagnosis from HIV. HIV is a virus, but AIDS is a syndrome, with a range of features and symptoms.
Symptoms at this stage vary greatly, as they tend to be associated with various opportunistic infections. Some of the more common symptoms include: • blotches under the skin or in the mouth and nose
• blurred vision
• diarrhea lasting longer than 1 week
• swollen lymph glands
• constant tiredness
• fever that keeps coming back
• memory loss
• depression
• pneumonia
• weight loss
• mouth, anus, or genital sores
Conditions that commonly develop at this stage include tuberculosis (TB), fungal infections of the respiratory system, lymphoma, hepatitis, and some types of cancer.

In people who are undergoing drug therapy for HIV, their level of immunity remains strong enough to prevent the condition from progressing to AIDS. With current treatment options, AIDS is unlikely to develop.

Without treatment, however, the viral load can increase, and the CD4 cell count can drop. This reduced immunity leaves the body susceptible to various infections and diseases, which can be life-threatening. An AIDS diagnosis is made when the CD4 cell count of someone with HIV drops to under 200. A healthy CD4 count is between 500 and 1,500 cells per millimeter cubed (cells/mm3). Alternatively, the development of one or more opportunistic infections can also indicate that the HIV infection has progressed to AIDS.

Antibodies are produced by your body’s immune system in response to pathogens. Their purpose is to defend us against infection.

HIV is passed on from one person to another when the blood, semen, pre-seminal fluid, rectal fluid or vaginal fluids from a HIV positive person enters someone else’s body. People may get infected from having unprotected penetrative vaginal or anal sex (not using a condom) and by having more than one sexual partner. Sharing needles, such as needles used to inject drugs, steroids, and other substances, or sharing needles used for tattooing with someone who is HIV positive are also linked to infection. In addition, if a woman with HIV is pregnant, her newborn baby can catch the virus from her before she gives birth, during delivery of the baby, or from breastfeeding. However, there are various means to prevent mother to child HIV transmission. HIV cannot be passed on from one person to another through casual contact. There is no risk of infection when everyday items are shared e.g. food, dishes, utensils, clothes, beds and toilets with a person who is HIV positive. The virus is not spread from contact with sweat, tears, saliva, or a casual closed-mouth kiss from an infected person. People do not become infected from eating food prepared by a person living with HIV. People have not become infected with HIV through insect bites.

The most effective way to avoid getting infected with HIV is to always use condoms during penetrative vaginal, anal sex and oral sex. When used correctly a condom acts as a barrier and will prevent the mixing of body fluids from an HIV infected person entering the body of their sexual partner. Needles, syringes or any other injecting equipment for drug taking use should not be shared.

The Centers for Disease Control and Prevention (CDC) recommends that everyone between the ages of 13 and 64 get tested for HIV at least once as part of routine health care. For individuals with specific risk factors, CDC recommends getting tested once a year. Anyone participating in high risk activities (E.g. sharing needles for injecting drugs, having sex with HIV positive individuals without the use of a condom) should have HIV testing carried out every 3 months. This frequency of testing would ensure the infection is identified as quickly as possible.

After exposure to HIV, it can take 3 to 12 weeks (21-84 days) for an infected person’s body to make enough antibodies for a screening test to detect them. This is called the window period. IgM is typically released around 3 weeks after infection which is one of the antibodies the INSTI Test is designed to detect. An individual may test positive with the INSTI Test in as little as 21-22 days after infection, however it can take as long as 3 months to produce a positive result. Approximately 97% of people will develop detectable antibodies during this window period. A negative result may not be accurate until 3 months after after a possible exposure. If someone has been exposed to HIV and obtains a negative test result during the window period, they should re-test 3 months after possible exposure to HIV.

There is no cure for HIV or AIDS at this time. However, treatment with anti-retroviral therapy (ART) can control HIV and enable people to live a long and healthy life. The only way to avoid infection from HIV is by abstaining from sexual activity, or practicing safe sex by always using a condom.

Anti-retroviral therapy (ART) is the name given to the medication that is taken by a HIV positive person. ART is usually a combination of at least three anti-retroviral medications, now combined in a single pill, that interferes with the growth of the virus by preventing it from multiplying (making more copies of itself) within the body. The combination of medications is found to be better at treating HIV than by using just one medication alone. A person infected with HIV can still live a long, happy and fulfilling life. With the right treatment and support, it is possible to live as long as the average person.

PrEP stands for Pre-Exposure Prophylaxis. PrEP is prescribed medication which can be taken by individuals at very high risk of becoming infected with HIV. PrEP can stop HIV from infecting and spreading through the body. It is highly effective for preventing HIV if used as prescribed by a doctor, but it is much less effective when not taken consistently. Taking PrEP daily reduces the risk of HIV infection from sex by over 90% and 70% among individuals who inject drugs. The risk of HIV infection can be lowered further with use of PrEP and condoms.

PEP stands for Post-Exposure Prophylaxis. This is antiretroviral medication (ART) which can be taken after potential exposure to HIV. The goal of taking to antiretroviral medication is to prevent the individual from becoming infected. PEP should be used only in emergency situations and must be started within 72 hours after a recent possible exposure to HIV. If someone has recently been exposed to HIV during sex, sharing needles for drug use or sexual assault, they should talk to their health care provider or an emergency room doctor about PEP immediately.

In 2016, an estimated 36.7 million people were living with HIV (including 1.8 million children) – with a global HIV prevalence of 0.8% among adults. Around 30% of these individuals do not know that they have the virus. Since the start of the epidemic, an estimated 78 million people have become infected with HIV and 35 million people have died of AIDS-related illnesses. In 2016, 1 million people died of AIDS-related illnesses.

The US Center for Disease Control (CDC) recommends that HIV-infected women do not breastfeed. HIV can be passed from mother to child through breast milk. By not breastfeeding, transmission (spread) of HIV to infants through breast milk can be avoided.

Also, if you have HIV and are taking drugs to treat HIV these can be passed through breast milk to the baby. This is another reason why women who are taking drugs to treat HIV should not breastfeed.

If you're pregnant and are worried that you've been exposed to HIV, you should get tested as soon as possible.

There are three main types of HIV tests: antibody tests, combination tests (antibody/antigen tests), and nucleic acid tests (NATs). How soon each test can detect HIV infection differs, because each test has a different window period. The window period is the time between when a person gets HIV and when a test can accurately detect HIV infection.

• Antibody tests check for HIV antibodies in blood or fluids from the mouth. HIV antibodies are disease-fighting proteins that the body produces in response to HIV infection. It can take 3 to 12 weeks for a person’s body to make enough antibodies for an antibody test to detect HIV infection. (In other words, the window period for antibody tests in most people is somewhere between 3 to 12 weeks from the time of infection.) In general, blood testing is more accurate than oral fluid testing.
• Combination tests (antibody/antigen tests) can detect both HIV antibodies and HIV antigens (a part of the virus) in blood. It can take 2 to 6 weeks for a person’s body to make enough antigens and antibodies for a combination test to detect HIV infection.
• Nucleic Acid Tests (NATs) look for HIV in the blood. NATs can detect HIV infection about 7 to 28 days after a person has been infected with HIV. NATs are very expensive and not routinely used for HIV screening unless the person had a high-risk exposure or a possible exposure with early symptoms of HIV infection.

A person’s initial HIV test will usually be either an antibody test or a combination test. If the initial test result is positive for HIV infection, then follow-up testing will be done to make sure that the diagnosis is correct. If the initial test result is negative and the test was done during the window period, re-testing should be done 3 months after the possible exposure to HIV.

HIV tests can be conducted in laboratories, at home, in non-clinical settings and in clinical settings. Simple, rapid test methods are available that produce results in as little as 60 seconds. The CDC has posted links to information on testing resources for FDA-approved laboratory tests and home tests. Learn more about testing in nonclinical settings and testing in clinical settings. Your doctor can help you figure out which type of test is best for you.

The INSTI HIV-1/HIV-2 Antibody Test is a one-time use, rapid, visually read, flow-through immunoassay which detects antibodies to Human Immunodeficiency Virus (HIV) Type 1 and Type 2 using a drop of human fingerstick blood. Other sample types which can be tested are venous whole blood, plasma and serum..

The INSTI HIV-1/HIV-2 Antibody Test kit contains a test device, 3 solutions, lancet, pipette and alcohol swab. Unlike other HIV tests, there is no additional timing device required to complete the test as results are available immediately.

The INSTI HIV-1/HIV-2 Antibody Test is considered a 3rd generation screening test since it is designed to detect antibodies that are generated in response to HIV infection.

Once each solution has been added to the membrane unit, the result is visible immediately.

Training can be arranged with your local sales representative or distributor. Contact customercare@bioLytical.com who can arrange that for you.

Extensive research studies have shown that the INSTI HIV-1/HIV-2 Antibody Test is extremely accurate when performed correctly. The accuracy of medical tests are typically described in terms of sensitivity and specificity. Sensitivity means that all truly positive individuals test positive. Specificity means that all truly negative persons test negative. The INSTI Test is a screening test and is used to test individuals who may have been exposed to HIV. The INSTI Test looks for antibodies which are produced in response to the HIV infection. The Test is not a final confirmation of HIV infection, therefore if a positive result is given, it must be followed up on with a doctor for a confirmatory test. All positive results generated from a screening test, require follow up with a doctor for final confirmation.

The INSTI Test kits have a shelf life of 15 months.

The storage temperature for the INSTI Test is 2 - 30°C.

The test uses simple flow-through technology to detect HIV-1 and HIV-2 antibodies using a drop of human fingerstick blood. The test does not detect the virus itself. The test dot will only be visible if HIV antibodies are present. The INSTI® HIV Self Test is simple to perform and very accurate, but it will only work correctly if you carefully read and follow the instructions. You may test positive with INSTI® HIV Self Test in as little as 21-22 days after infection, however, it can take as long as 3 months to produce a positive result. A negative result may not be accurate until 3 months after a possible exposure.

The INSTI® HIV Self Test has a built-in control dot to show that the test has been performed correctly and that you have added the proper amount of fingerstick blood. If the control dot does not appear, your test has not worked. Please discard your test and retest with a new test. If only the control dot is visible it means that your result is negative and you probably do not have HIV. If two dots are visible your test result is positive. This means you likely have HIV. Although the results of the INSTI® HIV Self Test are very accurate, you MUST have a positive result confirmed by a doctor as soon as possible so that treatment can be started immediately. It is essential for your health and wellbeing that you seek medical advice if your result is positive.

The INSTI HIV Self Test is a 3rd generation screening test since it is designed to detect IgM and IgG antibodies that are generated in response to HIV infection.

After the test is complete, you can read your result instantly. No timers needed!

No – the INSTI COVID-19 antibody test is currently in development. Sign up to insti.com/covid19] for future updates.

Soon - we understand the urgency for an accurate SARS-CoV-2 test that can produce a result quickly and we are working hard on this project.

An antibody test like INSTI looks for the antibodies in your blood. Antibodies are what your body’s immune system produces when it’s fighting a virus or infection. Their purpose is to defend us against infection. Antibody tests can also be called serology tests. Visit INSTI.com to see a video of the INSTI HIV Self Test being run in real-time.

A positive INSTI test indicates you were infected with the virus at some point. A negative INSTI test indicates you were probably not infected when your sample was collected.

It usually takes your body 1 to 3 weeks to develop antibodies to SARS-CoV-2 so an antibody test might not be able to tell you if you are currently infected. Current infections are diagnosed by tests that identify the virus in samples from your upper respiratory system, such as a nasopharyngeal swab.

No – the test is still in development. bioLytical’s existing line of INSTI tests have a footprint of worldwide regulatory approvals including US FDA approval, Health Canada approval, WHO Prequalification and CE Mark. We will pursue these same regulatory approvals for the INSTI COVID-19 Test when it is available.

• The 1-minute INSTI HIV-1/HIV-2 Antibody Test • The 1-minute INSTI Multiplex HIV/Syphilis Antibody Test • The 1-minute INSTI HIV Self Test • The 1-minute Hepatitis C (HCV) Test • bioLytical has also developed proven concepts for the detection of Zika & Ebola within 1 minute

A recent Lancet article explained: “Antibody testing is multipurpose: it can verify that vaccines are working as intended during clinical trials, or be used in contact tracing weeks or longer after a suspected infection in an individual. Probably its most important current use, en masse, is to help inform public policy makers how many asymptomatic cases have occurred in a population. Antibodies reveal evidence of a previous infection any time from about a week after the infection occurred.”

The technology behind antibody tests can be hard to get right. It can take time and rigorous research to develop a product that is as accurate as bioLytical’s INSTI tests. While it is important to ensure quick access to antibody testing in a global pandemic scenario, there have been concerns that some newly developed antibody tests do not meet the usual stringent quality standards for rapid diagnostic tests. The World Health Organization recently released a briefing on the risks associated with these new point-of-care tests for SARS-CoV-2: “… Before these tests can be recommended, they must be validated in the appropriate populations and settings. Inadequate tests may miss patients with active infection or falsely categorize patients as having the disease when they do not, further hampering disease control efforts. At present, based on current evidence, WHO recommends the use of these new point-of-care immunodiagnostic tests only in research settings. They should not be used in any other setting, including for clinical decision-making, until evidence supporting use for specific indications is available.”

At this stage, scientists don’t know if the antibodies to SARS-CoV-2 protect you from reinfection (give you immunity) or how long they could protect you for. Research into this is ongoing, so a positive antibody test result cannot confirm you are immune.

Viral tests used to diagnose COVID-19 identify the virus in samples from the upper respiratory system, such as nasopharyngeal swabs. Some tests will be conducted on-site, with results available to you in the same visit. Other tests must be sent to a laboratory for analysis, a process that takes 1-2 days after a lab has received your samples. Some tests also allow you to collect your own sample at home – either a nasal swab or an oral fluid (saliva) sample – which you will send onto the lab for processing. The locations and types of testing generally depends on what is available in your area. Put simply, • A viral test tells you if you have a current infection • An antibody test tells you if you were previously infected

The test uses innovative flow-through technology to detect SARS-CoV-2 antibodies using one drop of human fingerstick blood. The test dot will be visible if SARS-CoV-2 antibodies are present.

Yes – because INSTI detects the antibodies that appear in your blood, it is known as a serology test.

Like the other INSTI tests, the INSTI COVID-19 Antibody Test procedure provides results in one minute.

INSTI is a Point of Care test. Because of its performance and flexibility, the test may be used both in a centralized laboratory or hospital setting, as well as at the point-of-care including clinics, pharmacies, drive through testing events and more.

No – your sample will be collected using a fingerstick method, taking one small drop of blood from your finger.

No - specialized training isn’t required. The INSTI HIV Antibody Test holds a CLIA Waiver in the US and is the only HIV point of care test approved by Health Canada. The INSTI platform, which has been adapted for SARS-CoV-2 has been demonstrated repeatedly to be simple and easy to use.

No - sample processing isn’t required for whole blood samples.