Re: Why the FDA should say Yes on rapid over-the-counter HIV Test

[Guest guest]

Why the FDA should say "Yes" on rapid over-the-counter HIV TestVery well written comments.My concern is about counseling. Could there be suicides among those who get positive tests without bothering to make that call? Overall, the idea of getting a test without entering a facility that announces to the world what you're there for could be a huge boost in testing.JB

[Guest guest]

I still think this is extremely dangerous

on many levels. Trust me, there will be

armies of fags marching their new boyfriends to CVS, along with thousands of

spouses of all flavors, and parents trying to scare their teenage kids being

corralled into the drug store and forced to take this OTC test by anyone who

has

“ the power “ in the

relationship.

I wonder how comfortable a new employee

would feel if they were “ pressured “ ( not forced

) to take this test as a condition of employment.

This whole notion is so short-sighted I

can’t even stand it. OMG, I don’t

believe that we are now gonna drink this Kool-Aid. Christ.

Phil

Any

original elements and / or substance count in the virtual void. Please

display your own perticular brand of it.

Cheers.

[Guest guest]

I still think this is extremely dangerous

on many levels. Trust me, there will be

armies of fags marching their new boyfriends to CVS, along with thousands of

spouses of all flavors, and parents trying to scare their teenage kids being

corralled into the drug store and forced to take this OTC test by anyone who

has

“ the power “ in the

relationship.

I wonder how comfortable a new employee

would feel if they were “ pressured “ ( not forced

) to take this test as a condition of employment.

This whole notion is so short-sighted I

can’t even stand it. OMG, I don’t

believe that we are now gonna drink this Kool-Aid. Christ.

Phil

Any

original elements and / or substance count in the virtual void. Please

display your own perticular brand of it.

Cheers.

[Guest guest]

I'm not aware of issues with the rapid tests that are available now. My main

concern is that an antibody-only test will have a longer " window " period which

would lead to more infections in sexually active populations.

Permanently etched on your screen by my iPad's phaser gun app.

On Apr 29, 2012, at 8:36 AM, " mark_h_hubbard " <mhubbard@...>

wrote:

> One of the research nurses I respect the made the same point about suicide

just before the roll-out of rapid testing. Fortunately we never saw it. My

guess is that we won't here either.

>

> The bottom line is that the FDA and marketers need to hear from us about the

necessity to make by phone and online counseling available and the need for

emphasis concerning getting into care.

>

> mark

>

> Nashville TN

>

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>

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>>

>> Why the FDA should say " Yes " on rapid over-the-counter HIV Test

>>

>> Very well written comments.

>>

>> My concern is about counseling. Could there be suicides among those who get

positive tests without bothering to make that call?

>>

>> Overall, the idea of getting a test without entering a facility that

announces to the world what you're there for could be a huge boost in testing.

>>

>> JB

>>

>

>

[Guest guest]

"This whole notion is so short-sighted I can't even stand it. OMG, I don'tbelieve that we are now gonna drink this Kool-Aid. Christ." There are already home HIV tests. The difference is that the test is mailed in and done in a laboratory, 24 hours later.I do see your point. I'm having trouble imagining the balance between the benefits of ease of testing vs the scenarios you describe.JB

[Guest guest]

,

Although there are 3rd and 4th generation screening tests for blood that

look for both antibody and antigen, they are as you say *lab* (not field)

tests and require blood. Ironically old technology with a longer window

period (the Western blot) is generally still being used to confirm all

positive results.

Although the CDC has recommended a new testing algorithm that calls for the

use of new screening technologies and mothballs the western blot, there are

major financial and infrastructure challenges to roll-out. States will have

to change their entire surveillance systems, which are currently keyed to

the western blot, in order to adapt. That will take considerable time,

effort and money.

What is on the table for self-testing is basically new use / packaging of

the current technology used in other quick tests. As with those, follow-up

confirmatory testing will be indicated, and until the new algorithm is fully

adopted in most cases that confirmatory test will be a western blot.

So to the extent these tests take place in folks who wouldn't be tested

otherwise, there is no negative impact and a significant possibility of

positive impact in terms of identifying infections.

To the extent they replace the rapid tests, there is no impact as there no

window difference.

In cases where these tests replace blood tests provided by institutions

using newer screening lab tests, there could be a small number of infections

missed.

The potential of testing with narrower windows is an important one,

particularly in gay and bi men. At CROI it was stated that in one study 80%

of MSM said they would test more rapidly if they could use a home self-test

IF the cost was under $20.

We can only hope the technological advances in lab tests will eventually be

extended to rapid testing.

mark

Mark Hubbard

Educational Liaison, Tennessee Association of People With AIDS

Convener, HIV Empowerment & Action League

Nashville TN

615-715-1517 C

Re: Why the FDA should say " Yes " on rapid over-the-counter HIV Test

I think the proposed over the counter test looks for antibodies only.

Current lab tests measure both those and virus, detecting infection much

earlier.

Beamed in from the asteroid belt for your pleasure.

On Apr 30, 2012, at 12:17 PM, " mark_h_hubbard "

<mhubbard@...> wrote:

> Can you explain? Longer " window " period compared to what?

>

> Thanks,

>

> mark

>

> Nashville

>

>

>>>>

>>>> Why the FDA should say " Yes " on rapid over-the-counter HIV Test

>>>>

>>>> Very well written comments.

>>>>

>>>> My concern is about counseling. Could there be suicides among those

who get positive tests without bothering to make that call?

>>>>

>>>> Overall, the idea of getting a test without entering a facility that

announces to the world what you're there for could be a huge boost in

testing.

>>>>

>>>> JB

>>>>

>>>

>>>

>>

>

>

[Guest guest]

What are the metrics for false positives

so far in the studies ?

Any

original elements and / or substance count in the virtual void. Please

display your own perticular brand of it.

Cheers.

[Guest guest]

Here is an off-the-wall question about the rapid tests at home. Now, if a person tests at home, will that qualify as knowing that they are positive under the criminalization statutes around the country? If it does, then everyone better know the reliability because a false positive could have unintended consequences. E

[Guest guest]

The OraQuick® In-Home HIV Test is an over-the-counter version of the OraQuick

ADVANCE ® product currently sold into the professional market. You can read the

product info, including performance data here:

http://www.orasure.com/docs/pdfs/products/oraquick_advance/OraQuick-Advance-Pack\

age-Insert-English.pdf

Like all screening tests, the test is designed to " fail to positive " which means

to err on the side of caution. The results is termed " preliminary positive " or

" reactive " for that reason.

There were some reports of clusters of higher than expected false positives in

the early years of testing. To my knowledge, although several theories of

explanation were posed, nothing was definitively proven. Some improvements to

the product have been made since then. The package insert claims less than half

a percent should be expected regardless of population.

The rates of false positives is expected to be slightly higher (if you think

about it, this makes perfect sense) when the test is used in low risk

populations. I couldn't find any very recent studies or articles about false

positives.

I hope this helps.

mark

Mark Hubbard

Nashville TN

Users will simply be using what is commonly used for field testing in the home.

So there shouldn't be any significant difference in the rates of false

positives.

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> What are the metrics for false positives so far in the studies ?

>

>

> Any original elements and / or substance count in the virtual void. Please

> display your own perticular brand of it.

> Cheers.

>