HEALTH : FDA to Review AIDS Test Kits
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WASHINGTON — The Food and Drug Administration will consider applications for AIDS home test kits that would enable people to send a small blood sample to a laboratory and get the results by telephone, a spokesman said today.
The agency has accepted one application and has sent letters to 30 other companies that are developing test kits or have expressed interest in doing so, said FDA spokesman Brad Stone.
Until now, the FDA has refused to accept home test kit applications because of technical concerns, such as how well people could be instructed with written material to draw their own blood and whether samples could be shipped safely through the mail.
The agency also worried about how people using the tests would be counseled about the disease.
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