Wednesday, May 16, 2012

Orasure In-Home HIV Test Gets Unanimous Approval Recommendation

via - by Tim Horn

Orasure’s oral swab-based rapid in-home HIV test has been recommended for approval by the U.S. Food and Drug Administration’s Blood Products Advisory Committee. If the FDA follows its advisory committee’s recommendation, the Oraquick In-Home HIV Test will be the first complete home-based screening assay for any infectious disease available for purchase over-the-counter (OTC) from pharmacies and internet retailers.

The advisory committee voted unanimously, 17-0, in favor of the test upon being asked two questions: Do the available clinical trial results provide reasonable assurance that the test is safe and effective? And, importantly, do the benefits of in-home HIV testing outweigh the potential risks, notably false negative and false positive results?

The particulars of the second question were hotly discussed throughout the May 15 meeting in Gaithersburg, Maryland. Of concern to the FDA presenters and advisory committee panelists is the test’s reduced sensitivity—its effectiveness at screening for HIV antibodies in those infected with the virus—compared with the professional oral swab OraQuick assay.

However, even with reduced sensitivity, Elliott Cowan, PhD, of the FDA acknowledged, the in-home HIV test is anticipated to have a net public health benefit. "The OraQuick In-Home HIV Test is expected to be associated with a net increase in the number of HIV infections newly identified each year," he said, "with evidence of new infections averted with use of the test."

According to an FDA analysis of available data, in the first year of the test's commercial availability, the OTC test may potentially identify 45,000 people living with HIV in the U.S..

Only one OTC HIV testing kit has been approved by the FDA. The Home Access HIV test, approved in 1996, requires blood samples to be collected at home, followed by shipment to a laboratory for analysis—results are provided by a Home Access telephone operator. The retail price is between $30 and $40.

The OraQuick In-Home HIV Test allows users to collect samples, conduct the test and interpret the results on their own. The test result is read after 20 minutes, but not longer than 40 minutes, after inserting the oral swab device into the vial of developer solution provided with the OTC kit. The price of the test is not yet known, but the company expects it to retail for under $60.

Read the rest

No comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...

select key words

2007 National HIV Prevention Conference 2009 National LGBTI Health Summit 2011 LGBTI Health Summit 2012 Gay Men's Health Summit 2012 International AIDS Conference abstinence only ACT Up activism advocacy Africa african-american aging issues AIDS AIDS Foundation of Chicago anal cancer anal carcinoma anal health anal sex andrew's anus athlete ball scene bareback porn barebacking bathhouses bears big bold and beautiful Bisexual Bisexual Health Summit bisexuality black gay men black msm blood ban blood donor body image bottom Brian Mustanski BUTT Center on Halsted Charles Stephens Chicago Chicago Black Gay Men's Caucus Chicago Task Force on LGBT Substance Use and Abuse Chris Bartlett chubby chaser circumcision civil rights civil union Coaching with Jake communication community organizing condoms Congress crystal meth dating dating and mating with alan irgang David Halperin David Munar depression disclosure discrimination domestic violence don't ask don't tell douche downlow Dr. James Holsinger Dr. Jesus Ramirez-Valles Dr. Rafael Diaz Dr. Ron Stall drag queen Ed Negron emotional health ENDA Eric Rofes exercise Feast of Fun Feel the love... female condom fitness Friday is for Faeries FTM gay culture gay identity gay latino gay male sex gay marriage gay men gay men of color gay men's health Gay Men's Health Summit 2010 gay pride gay rights gay rugby gay sex gay youth gender harm reduction hate crime HCV health care health care reform health insurance hepatitis C HIV HIV care HIV drugs HIV negative HIV positive HIV prevention HIV stigma HIV strategic plan HIV testing hiv vaccine HIV/AIDS homophobia homosexuality hottie hotties how are you healthy? Howard Brown Health Center HPV human rights humor hunk Illinois IML immigration International AIDS Conference international mr. leather internet intimacy IRMA Jim Pickett leather community leathersex Leon Liberman LGBT LGBT adoption LGBT culture LGBT health LGBT rights LGBT seniors LGBT youth LGBTI community LGBTI culture LGBTI health LGBTI rights LGBTI spirituality LGV LifeLube LifeLube forum LifeLube poll LifeLube subscription lifelube survey Lorenzo Herrera y Lozano love lube lubricant Lymphogranuloma Venereum masturbation mental health microbicides middle Monday Morning Perk-Up MRSA MSM music National AIDS Strategy National Gay Men's Health Summit negotiated safety nutrition One Fey's Tale oral sex Peter Pointers physical health Pistol Pete pleasure PnP podcast policy politics poppers porn post-exposure prophylaxis PrEP President Barack Obama Presidential Campaign prevention Project CRYSP prostate prostate cancer public health public sex venues queer identity racism Radical Faerie recovery rectal microbicides relationships religion research safe sex semen Senator Barack Obama sero-adaptation sero-sorting seroguessing sex sexual abuse sexual addiction sexual health sexual orientation Sister Glo Sisters of Perpetual Indulgence smoking social marketing spirituality STD stigma stonewall riots substance abuse treatment substance use suicide super-bug superinfection Susan Kingston Swiss declaration syphilis Ted Kerr Test Positive Aware Network testicle self-examination testicular cancer testing The "Work-In" The 2009 Gay Men's Health Agenda Tony Valenzuela top Trans and Intersex Association trans group blog Trans Gynecology Access Program transgender transgender day of remembrance transgendered transmen transphobia transsexual Trevor Hoppe universal health care unsafe sex vaccines video violence viral load Who's That Queer Woof Wednesday writers yoga You Tube youtube