The US Food and Drug Administration (FDA) has approved the first over-the-counter HIV test, allowing Americans to check themselves for the virus that causes AIDS in the privacy of their homes.
The OraQuick test detects the presence of HIV in saliva collected using a mouth swab. The test is designed to return a result within 20 to 40 minutes.
Government officials estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the US are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.
FDA officials said the test is aimed at people who might not otherwise get tested. The company’s marketing efforts will focus on populations at greatest risk of being infected, including gay and bisexual men, African Americans and Hispanics.
HIV awareness groups hailed the approval as an important step in expanding testing for the virus.
“This test will allow anyone to empower themselves to know their HIV status when, how and with whom they want to,” said Tom Donohue, founding director of Who’s Positive.
HIV eventually develops into AIDS, unless treated with antiviral drugs. AIDS causes the body’s immune system to break down, leading to infections that become fatal.
The FDA previously approved several HIV test kits designed to be used at home, although those kits — which usually require a blood sample — must be sent to a laboratory to be developed.
FDA stressed in its approval announcement that the test is not 100 percent accurate.
A trial conducted by Orasure showed the home test correctly detected HIV in those carrying the virus only 92 percent of the time. That means the test could miss one person for every 12 HIV-infected people who use the kit.
The test was accurate 99 percent in ruling out HIV in patients not carrying the virus. That means the test would incorrectly identify one patient as having HIV for every 5,000 HIV-negative people tested.
People who test negative should get re-tested after three months because it can take several weeks for detectable antibodies to HIV to appear, according to Jonathan Mermin, director of the Centers for Disease Control and Prevention’s HIV unit.
Orasure has marketed a version of OraQuick to doctors, nurses and other healthcare practitioners since 2002. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time.
While it is not clear why the test appears less accurate in consumer trials, company researchers said they expected the test’s specificity to drop when used by consumers versus professionals.
Orasure plans to launch the test in October, selling it through retailers like Walgreens, CVS and Walmart, as well as online pharmacies. Whereas the test marketed to health professionals costs about US$17.50,
Orasure expects the consumer version to sell for more. The company is not announcing a price yet, but said it would be less than US$60. CEO Doug Michels said the additional cost would help pay for a toll-free call center to provide counseling and medical referrals to test users.
The government is aiming to recruit 1,096 foreign English teachers and teaching assistants this year, the Ministry of Education said yesterday. The foreign teachers would work closely with elementary and junior-high instructors to create and teach courses, ministry official Tsai Yi-ching (蔡宜靜) said. Together, they would create an immersive language environment, helping to motivate students while enhancing the skills of local teachers, she said. The ministry has since 2021 been recruiting foreign teachers through the Taiwan Foreign English Teacher Program, which offers placement, salary, housing and other benefits to eligible foreign teachers. Two centers serving northern and southern Taiwan assist in recruiting and training
WIDE NET: Health officials said they are considering all possibilities, such as bongkrekic acid, while the city mayor said they have not ruled out the possibility of a malicious act of poisoning Two people who dined at a restaurant in Taipei’s Far Eastern Department Store Xinyi A13 last week have died, while four are in intensive care, the Taipei Department of Health said yesterday. All of the outlets of Malaysian vegetarian restaurant franchise Polam Kopitiam have been ordered to close pending an investigation after 11 people became ill due to suspected food poisoning, city officials told a news conference in Taipei. The first fatality, a 39-year-old man who ate at the restaurant on Friday last week, died of kidney failure two days later at the city’s Mackay Memorial Hospital. A 66-year-old man who dined
RESTAURANT POISONING? Deputy Minister of Health and Welfare Victor Wang at a press conference last night said this was the first time bongkrekic acid was detected in Taiwan An autopsy discovered bongkrekic acid in a specimen collected from a person who died from food poisoning after dining at the Malaysian restaurant chain Polam Kopitiam, the Ministry of Health and Welfare said at a news conference last night. It was the first time bongkrekic acid was detected in Taiwan, Deputy Minister of Health and Welfare Victor Wang (王必勝) said. The testing conducted by forensic specialists at National Taiwan University was facilitated after a hospital voluntarily offered standard samples it had in stock that are required to test for bongkrekic acid, he said. Wang told the news conference that testing would continue despite
‘CARRIER KILLERS’: The Tuo Chiang-class corvettes’ stealth capability means they have a radar cross-section as small as the size of a fishing boat, an analyst said President Tsai Ing-wen (蔡英文) yesterday presided over a ceremony at Yilan County’s Suao Harbor (蘇澳港), where the navy took delivery of two indigenous Tuo Chiang-class corvettes. The corvettes, An Chiang (安江) and Wan Chiang (萬江), along with the introduction of the coast guard’s third and fourth 4,000-tonne cutters earlier this month, are a testament to Taiwan’s shipbuilding capability and signify the nation’s resolve to defend democracy and freedom, Tsai said. The vessels are also the last two of six Tuo Chiang-class corvettes ordered from Lungteh Shipbuilding Co (龍德造船) by the navy, Tsai said. The first Tuo Chiang-class vessel delivered was Ta Chiang (塔江)