2009年6月26日星期五

【China AIDS:4383】 不要使用未经许可的家庭HIV检测工具包,这些工具可能会产生假性结果:加拿大卫生署(Health Canada)

不要使用未经许可的家庭HIV检测工具包,这些工具可能会产生假性结果:加拿大卫生署(Health Canada)

2009年6月22日

加通社(The Canadian Press)供稿

加通社撰稿

 

    多伦多——加拿大卫生署建议顾客不要使用清洁检测的HIV家庭检测工具包(Clean Testing HIV Home Test Kit)或任何HIV家庭检测工具包,因为这些是未经许可的医疗器械,可能会给出假性结果。

    cleantesting.com上能够在线购买的清洁检测的HIV家庭检测工具包,被宣传为测定一个人是否感染人类免疫缺陷病毒(HIV)的自测工具包。

    "这一工具包是未经许可的,其安全性和有效性没有经过加拿大卫生署的评估,"该联邦部门周一在一份公告中说到,"不精确的检测结果可能未发现感染者有HIV,或者发现未感染者有HIV。"

    根据加拿大医疗器械法规(Medical Devices Regulations),家庭HIV检测工具包在宣传和出售前需要有加拿大卫生署颁发的医疗器械许可。在加拿大,宣传或出售未经许可的医疗器械是违法的。

    目前加拿大没有经过许可的家庭HIV检测工具包出售。

    加拿大卫生署已经要求清洁检测停止出售该器械,并且通知所有顾客不要使用该工具包。该部门会继续监督这一情况并采取适当的行动。加拿大人不应通过互联网或其他来源购买这些产品。

    关心自己的HIV状况的人应该去找医生。使用过这些检测工具包的人也应该咨询医师,以便评估是否需要进行适当的检测。加拿大卫生署还说,使用过家庭HIV检测工具包的人应该与医生联系,以便进行后续检测和咨询。

    与家庭HIV检测工具包有关的投诉可以通过免费电话1-800-267-9675向卫生产品及食物科检查室(Health Products and Food Branch Inspectorate)报告。

 

Ted Gaudet——地区协调人——GNP+NA

电子邮件:ted.gaudet@gnb.ca


Sent: Thursday, June 25, 2009 7:08 PM
Subject: ITPC Avoid unapproved home HIV test kits, could yield false results: Health Canada


Avoid unapproved home HIV test kits, could yield false results: Health Canada

Jun. 22, 2009

 



Provided by: The Canadian Press
Written by: THE CANADIAN PRESS


TORONTO - Health Canada is advising consumers not to use the Clean Testing HIV Home Test Kit, or any HIV home test kits, as they are unlicensed medical devices and may provide false results.
The Clean Testing HIV Home Test Kit, available online at cleantesting.com, is advertised as a self-test kit to determine whether an individual has been infected with the human immunodeficiency virus (HIV).
"This kit is unlicensed and has not been evaluated by Health Canada for safety and effectiveness," the federal department said Monday in an advisory. "Inaccurate test results may fail to indicate HIV in an infected individual or indicate HIV when none is present."
Under the Medical Devices Regulations, home HIV test kits require a device licence issued by Health Canada before they can be advertised or sold. It is illegal to advertise or sell unlicensed medical devices of this class in Canada.
Currently, there are no HIV test kits that have been authorized for sale for home use in Canada.
Health Canada has asked Clean Testing to stop selling the device and to notify all customers not to use the kit. The department will continue to monitor the situation and take appropriate action. Canadians should not purchase these products via the Internet or from any other source.
Anyone concerned about his or her HIV status should talk to their doctor. Those who have used these test kits should also consult their physician to evaluate the need to conduct proper testing. As well, Health Canada says anyone who has used a home HIV test kit should contact their doctor for follow-up testing and counselling.
Complaints involving home HIV test kits can be reported to the Health Products and Food Branch Inspectorate by calling, toll-free, 1-800-267-9675.
Ted Gaudet  - Regional Coordinator – GNP+NA
Email/Courriel: ted.gaudet@gnb.ca
 


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