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sabio

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Sabio, thanks for posting this very interesting stuff. It would mean that it is possible to reduce risk of getting HIV by up to factor 140, by combining condom AND a test, right?

 

While checking about the "windows" period, did you come across anything interesting about PCR-DNA HIV testing?

 

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Says Runkarna:

It would mean that it is possible to reduce risk of getting HIV by up to factor 140, by combining condom AND a test, right?

Right. This assumes independence which is quite plausible here. It is interesting to note that the absolute risk of infection per sexual act is quite small (about one in a thousand). Of course the stakes are so high and the risk adds up, so the factor of safety provided by condoms and testing is vital.

 

About the DNA-PCR HIV test that you are asking about, I looked into it years ago. The test can typically detect the virus in less than 2 weeks after exposure, but they recommend waiting for 3 weeks instead just to be sure. It is a highly sensitive test, so a negative result would be extremely reliable. DNA-PCR is more expensive than antibody tests, though.

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Nested PCR typically becomes reliable after about 10-14 days and always after about 20 days. The trouble with nested PCR, is that it takes days before you get the result. Note that an HIV antigen test typically goes positive within three days of infection but tends to go negative again when the antibodies kick in. Theoretically, a combination of HIV antigen testing and nested PCR is almost certain to detect the HIV virus in an infected individual.

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The POCKit 10-minute herpes test kit is no longer available as the company Diagonology has gone out of business.

 

This was the only FDA-approved fast test kit available for HSV-2 :( . Not clear yet if another company will take it over, or it is gone for good. Genital herpes is of course far more prevalent than HIV, and much easier to catch (can happen even without an outbreak).

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  • 2 weeks later...

Title :

Evaluation of the performance of non-laboratory staff in the use of simple rapid HIV antibody assays at New Start voluntary counseling and testing (VCT) centers

 

Recommendations: Simple and rapid HIV testing algorithms performed by non-laboratory staff are recommended for VCT and MTCT programs in resource-poor settings.

 

Authors :

Z Ziyambi1, P Osewe2, N Taruberekera3

1Ministry of Health, Harare, Zimbabwe; 2USAID, Harare, Zimbabwe; 3PSI , Harare, Zimbabwe

 

Abstract:

 

Issues: Across Africa, HIV infection is detected using ELISA done at central laboratories by few highly skilled technicians with results taking up to two weeks. Due to increased demand for voluntary counseling and testing (VCT) and the priority to prevent mother-to-child transmission (MTCT) of HIV, simple and rapid HIV testing algorithms performed by non-laboratory staff are urgently needed.

 

Description: A two-phase evaluation was conducted at two New Start centers. In Phase I, specimens were collected from 522 clients to evaluate the performance of rapid HIV antibody assays ( Determine,Unigold, Capillus and Virochek), and to formulate an algorithm for the diagnosis of HIV. The rapid tests were performed by technicians. Two test kits were identified for phase II evaluation to determine field performance by non-laboratory staff trained for one week prior to evaluation. Specimens were collected from 3791 clients. At one site (Site A), tests were performed by counselors supervised by a technician, and at the second site (Site B), tests were performed by counselors without supervision. All specimens in phase I & II were sent to a reference laboratory for confirmatory testing. Lessons Learned: In phase I, Determine, Unigold and Capillus had sensitivity and specificity of 100% while Virochek had a sensitivity of 98.5% and specificity of 93.4%. Determine and Unigold were selected for phase II evaluation where Determine had a sensitivity of 100% at both sites and a specificity of 99.8% at Site A and 100% at Site B. Unigold had a specificity of 100% at both sites and sensitivity of 97% at site A and 98.6% at site B. When run in parallel, the combined sensitivity and specificity was 100%.

 

Recommendations: Simple and rapid HIV testing algorithms performed by non-laboratory staff are recommended for VCT and MTCT programs in resource-poor settings.

 

http://www.aids2002.com/program/viewabstract.asp?id=/T-CMS_Content/Abstract/200206290751002902.xml

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  • 2 weeks later...

4 snips about OraQuick from the periodic HIV Prevention News Updates of the US Centers for Disease Control over the past month.

 

Friday, September 12, 2003:

A total of 225 women were tested using point-of-care HIV testing, and 155 were tested relying on the laboratory. The average turnaround time for getting the results was 45 minutes for the three hospitals using point-of-care testing. This was four times shorter than the 3.5-hour turnaround time at the hospital using laboratory testing. The OraQuick test itself takes just 20-30 minutes to run. At each hospital, OraQuick rapid test results were confirmed to be 100 percent accurate using standard lab tests, when needed.

 

Monday, September 29, 2003:

"Prevention Effort on HIV Transfers Focus to Carriers" - Los Angeles Times (09.29.03)::Daniel Costello - For two decades, health officials focused most HIV prevention efforts on keeping high-risk groups from being infected. However, in a strategic shift last year, California's Office of AIDS redirected up to 25 percent of the state's annual prevention budget to "prevention for positives" programs. In April, CDC announced it would begin heavily favoring programs aimed at preventing HIV-positive people from spreading the virus. Programs expected to benefit under the state and federal mandates include: individual counseling with HIV-positive patients and their partners; routine HIV testing both inside and outside medical settings (aided by the rapid OraQuick test)

 

Tuesday, September 30, 2003:

Associated Press (09.29.03) - Bethlehem, Pa.-based OraSure Technologies Inc. said it was applying Monday to the US Food and Drug Administration for pre-market approval of its OraQuick rapid test for use in detecting HIV antibodies in saliva or plasma samples. "This filing is the next major step in our efforts to expand the versatility of the OraQuick test," said OraSure CEO Mike Gausling. The OraQuick test was the first rapid, point-of-care test approved by the FDA to detect HIV antibodies in blood specimens - giving results in about 20 minutes. FDA approval for testing saliva or plasma would broaden the appeal of the test by providing advantages over competing blood or urine HIV tests, said Gausling.

 

Wednesday, October 01, 2003:

Other research presented at the conference demonstrated the value of the OraQuick Rapid HIV-1 Antibody Test in reaching high-risk individuals outside medical settings, and also showed that health care workers do not need extensive training to perform the test correctly.

 

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  • 1 year later...

Here is an update about test kits since the last post:

 

1. The US Food and Drug Administration approved the saliva version of OraQuick in March of last year

 

FDA Approves Rapid Saliva Test for AIDS Virus

 

By Lisa Richwine 3/26/2004

 

WASHINGTON (Reuters) - The United States approved the first rapid saliva test for the HIV virus that causes AIDS, health officials said on Friday.

 

The test, made by OraSure Technologies Inc., provides results within 20 minutes with 99 percent accuracy. Other approved rapid HIV tests require blood samples.

 

2. In a major policy shift, the US administration is considering allowing OTC sale of OraQuick

 

"This oral test provides another important option for people who might be afraid of a blood test," Health and Human Services Secretary Tommy Thompson said.

 

The saliva tests could eventually be sold without prescription in drug stores, as pregnancy tests are, Thompson said. The test would have to clear several regulatory hurdles first.

 

3. The kits can now be ordered on the Internet

 

A poster on another board who ordered them through http://www.bsafehiv.com/ commented: "A 10 year old could follow the simple directions."

 

4. The kits test for both HIV-1 and HIV-2

 

"This oral test provides another important option for people who might be afraid of a blood test," Health and Human Services Secretary Tommy Thompson said.

 

Officials also said the test, called the OraQuick Rapid HIV-1/2, could help on two fronts, encouraging more people to get tested as well as actually getting them the results.

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Thanks for the update, but over the counter sales of OraQuick 20 minute HIV self test kits in the USA? Yeah, right, I?ll believe that when I see it.

 

Hell, you can?t even buy sterile water at a US pharmacy. It?s illegal of course, as a dope addict might actually use it to mix his fix instead of using regular tap water? I?ll bet that law has had a major impact on preventing junkies from shooting dope? :rolleyes:

 

ST

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