U.S. Fda Approves First Over-The-Counter Hiv Test Kit

[News_Editor]

U.S. FDA approves first over-the-counter HIV test kit < br />

2012-07-05 02:35:26 GMT+7 (ICT)

SILVER SPRING, MARYLAND (BNO NEWS) -- The U.S. Food and Drug Administration (FDA) on Tuesday approved the first over-the-counter, self-administered HIV test kit.

The FDA-approved OraQuick In-Home HIV Test detects the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome, better known as AIDS.

The test kit allows individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes. However, the FDA noted that positive results should be followed by additional testing in a medical setting as it is not a definite result and requires medical confirmation.

Likewise, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months. Nonetheless, the test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods.

Studies showed that the OraQuick In-Home HIV Test has an expected performance of 92 percent for test sensitivity, the percentage of results that will be positive when HIV is present, which means that one false negative result would be expected out of every 12 test results in HIV-infected individuals. It is also expected to have 99.98 percent performance for test specificity, the percentage of results that will be negative when HIV is not present.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

The Centers for Disease Control and Prevention (CDC) estimates that 1.2 million people in the United States are living with HIV infection. About one in five are not aware they are infected. Every year, there are about 50,000 new HIV infections, many of which are transmitted by people who are unaware of their HIV status.

-- © BNO News All rights reserved 2012-07-05

[yougivemebaby]

Is this something that is available in Thailand? I have some friends that go to the bars and I want them to be safer. Please give any info if you have it.

Thank you

[GentlemanJim]

Is this something that is available in Thailand? I have some friends that go to the bars and I want them to be safer. Please give any info if you have it.

Thank you

The problem i guess is that in the 'bar environment if you pick up 'company' for the evening, it is not always practical to get your new partner to do a mouth swab before you agree to be with them for the evening. Good for regular checks though for those exposed to the risk. I wonder how much the kits cost.

[Jingthing]

I think the cost in the US is about 50 dollars. It would probably be more in Thailand if it gets here. Not economically viable for on the fly testing for butterflies ...

[JUDAS]

Is this something that is available in Thailand? I have some friends that go to the bars and I want them to be safer. Please give any info if you have it.

Thank you

The problem i guess is that in the 'bar environment if you pick up 'company' for the evening, it is not always practical to get your new partner to do a mouth swab before you agree to be with them for the evening. Good for regular checks though for those exposed to the risk. I wonder how much the kits cost.

A quick search on google shows single and twin pack test kits priced at 40 and 70 USD respectively including international shipping.

[Jingthing]

Thailand should make a copy and sell for 100 baht!

[GentlemanJim]

Is this something that is available in Thailand? I have some friends that go to the bars and I want them to be safer. Please give any info if you have it.

Thank you

The problem i guess is that in the 'bar environment if you pick up 'company' for the evening, it is not always practical to get your new partner to do a mouth swab before you agree to be with them for the evening. Good for regular checks though for those exposed to the risk. I wonder how much the kits cost.

A quick search on google shows single and twin pack test kits priced at 40 and 70 USD respectively including international shipping.

Just seen thanks. I read that the exact price will be set nearer the time but the manufacturers say it will be slightly higher than the $17.50 it charges professional users. So i guess $20-25. It would be nice to think with the importance of the product it attracted the minimal possible tax coming in to Thailand, then there may be a chance it will remain affordable enough for people to use it.

Thailand should make a copy and sell for 100 baht!

I bet the Indians are on it already!

[kerryk]

If memory serves me the quick test in Pattaya is about 500 baht and only takes a couple of minutes.

[Jingthing]

If memory serves me the quick test in Pattaya is about 500 baht and only takes a couple of minutes.

This new test is a test you buy yourself, do yourself, view the results yourself, and don't need to deal with a clinic. That is a huge change.

[kerryk]

If memory serves me the quick test in Pattaya is about 500 baht and only takes a couple of minutes.

This new test is a test you buy yourself, do yourself, view the results yourself, and don't need to deal with a clinic. That is a huge change.

I understand that but it is already so cheap in Thailand why not just go to the clinic? It is not like the clinic is going to tell anyone. I even listened to a working woman tell the nurse in Thai not to mention to her boyfriend who didn't speak Thai that she was positive.

[Jingthing]

If memory serves me the quick test in Pattaya is about 500 baht and only takes a couple of minutes.

This new test is a test you buy yourself, do yourself, view the results yourself, and don't need to deal with a clinic. That is a huge change.

I understand that but it is already so cheap in Thailand why not just go to the clinic? It is not like the clinic is going to tell anyone. I even listened to a working woman tell the nurse in Thai not to mention to her boyfriend who didn't speak Thai that she was positive.

Social reasons. A lot of people would rather face this reality privately than dealing with ANYONE, even a clinic worker.

ANYTHING, anything at all, that can expand the number of people who get tested is a good thing. It would be good if they included a help line for people to call who test positive.

I remember the days when a lot of people who tested positive then just killed themselves. I think those days are largely over in countries like Thailand where there is awareness that there are effective life extending treatments.

Edited July 5, 2012 by Jingthing

[JUDAS]

If memory serves me the quick test in Pattaya is about 500 baht and only takes a couple of minutes.

This new test is a test you buy yourself, do yourself, view the results yourself, and don't need to deal with a clinic. That is a huge change.

I understand that but it is already so cheap in Thailand why not just go to the clinic? It is not like the clinic is going to tell anyone. I even listened to a working woman tell the nurse in Thai not to mention to her boyfriend who didn't speak Thai that she was positive.

Slightly off topic: I wonder what the legal situation is regarding a health worker being asked not to inform the bf. If the infected victim went on to give HIV to her bf would there be any legal come backs on the nurse?

[Scott]

A health worker should never disclose medical information to anyone other than the patient. To do so is unethical and only a court-order should alter that.

[kerryk]

I have been there in Thailand. I had a chat with the doctor before the tests and told him since I was paying for the tests I expected to be informed. He then obtained consent from both of us. It has been my experience in Thailand that the hospitals are more lax about these things then in the West. I was in one hospital for an emergency and the doctor announced to my 4 women visitors after a blood test, with a big smile, he's OK.

[geriatrickid]

I think the cost in the US is about 50 dollars. It would probably be more in Thailand if it gets here. Not economically viable for on the fly testing for butterflies ...

The proposed US retail price is approximately $65. They are sold in bulk for approximately $15.

The test kits available in Thailand are not the same ones and I anticipate that soon the market will be flooded with counterfeits which will be unreliable, much as the cialis and viagra is. The only sure way to obtain the kit will be to purchase from an authorized retailer or distributor and it will take time to get that set up. The kits were already available in foreign markets, but distribution was limited to bonafide health professionals.

As a side note, the 92% reliability was due to testing errors and failures to use the kits properly. Also as noted, the kits are not going to pick up those carriers that are asymptomatic, i.e. newly infected. I suppose the best way of ensuring a good screening if one wishes to use on a date is to select the "experienced" candidate, someone well worn and used.

[geriatrickid]

A health worker should never disclose medical information to anyone other than the patient. To do so is unethical and only a court-order should alter that.

You are correct. Unfortunately, patient confidentiality and the keeping of patient files in a secure state is a novel idea in this part of the world.

[geriatrickid]

ANYTHING, anything at all, that can expand the number of people who get tested is a good thing. It would be good if they included a help line for people to call who test positive.

I remember the days when a lot of people who tested positive then just killed themselves. I think those days are largely over in countries like Thailand where there is awareness that there are effective life extending treatments.

If I may clip to answer your intelligent question(s).

This was one of the reasons for the delay in allowing distribution. A large part of the retail cost of the kits will be used to fund the call center.

The FDA imposed this requirement. It was the concern that was raised by the social service groups that offer this screening service. I at first had dismissed the concern as it being made by people who had a vested interest, but after seeing their presentations, I now understand that many people are in panic mode and don't know who to turn to or what to do. The ability to talk to someone who can help and who is understanding is a major factor in the diagnosed person actually seeking help. Those without access to counselling are more likely to go into denial for a period of time or to do self harm.