新的披衣菌和淋病家庭檢測獲批
麗莎·奧瑪麗 / 2023年11月16日 / 新聞 / WebMD 健康新聞
想要接受性傳染病衣原體和淋病檢測的人們現在無需離開家就可以進行檢測。
它被稱為“Simple 2”，是美國食品藥物管制局 (FDA) 批准的第一個使用在家採集的樣本來檢測性病 (STD) 的檢測，而不是 HIV 檢測。該測試可以在商店櫃檯購買，也可以在網上訂購並以謹慎的包裝交付。收集陰道拭子或尿液樣本，然後使用預付費運輸標籤送去實驗室檢測。
FDA 於週三發布了最終所需的批准，該產品已在製造商 LetsGetChecked 的網站上出售。單一測試套件的標價為 99 美元，免費送貨，該網站提供折扣訂閱，每 3 個月收到一個套件，每個套件 69.30 美元。
CDC 數據顯示，自 2017 年以來，淋病病例激增 28%，2021 年達到 70 萬例。披衣菌感染人數也呈現上升趨勢，從2020年到2021年增加了4%，每年感染人數為160萬人。披衣菌和淋病均透過不戴保險套的性行為（包括口交）傳播，在 25 歲以下的人中尤其常見。
通常，淋病和披衣菌感染沒有症狀。但根據疾病預防控制中心的情況說明書，症狀可能包括陰道分泌物或小便分泌物或小便時的灼熱感，這些可能會被誤認為是其他情況，因此測試很重要。
這種情況影響男性和女性，可以透過藥物治癒。但未接受披衣菌治療的女性的生殖系統面臨永久性損害的風險。淋病可導致女性骨盆腔炎，增加不孕的風險。未經治療的男性也會出現不孕症。淋病和披衣菌都可以從孕婦傳染給未出生的嬰兒。
此前，這兩種性傳染病的檢測需要在醫生辦公室等醫療保健場所採集樣本。Simple 2 測試結果可以在線上檢索，醫療保健提供者將聯繫測試結果呈陽性或無效的人。根據 LetsGetChecked 的新聞稿，該公司通常會在 2 至 5 天內收到結果，該公司還提供治療服務。
FDA 設備和放射健康中心主任、醫學博士、法學博士傑夫舒倫 (Jeff Shuren) 在一份聲明中表示：「這項授權標誌著一個重要的公共衛生里程碑，讓患者在自己家中的隱私中獲得更多有關其健康的信息」。「我們渴望繼續支持更多消費者獲得診斷測試，這有助於進一步實現我們將更多醫療保健帶入家庭的目標」。
資料來源：
FDA：「FDA 授予首次透過家庭樣本採集檢測衣原體和淋病的營銷授權」。
CDC：「2021 年性傳染病監測」、「淋病 — CDC 基本情況說明書」、「披衣菌 — CDC 基本情況說明書」。
LetsGetChecked：「LetsGetChecked 獲得美國食品和藥物管理局 (FDA) 家用衣原體和淋病檢測系統的 De Novo 授權」。
引用此內容：針對衣原體和淋病的新家庭測試已獲批准 – Medscape – 2023 年 11 月 16 日。麗莎·奧瑪麗 / 十一月 16, 2023 / 新聞 / WebMD 健康新聞
New at-Home Test Approved for Chlamydia and Gonorrhea
Lisa O’Mary / November 16, 2023 / News / WebMD Health New
People who want to be tested for the sexually transmitted diseases chlamydia and gonorrhea are now able to do so without leaving their homes.
Called Simple 2, it’s the first test approved by the FDA that uses a sample collected at home to test for an STD, other than tests for HIV. The test can be purchased over-the-counter in stores or ordered online and delivered in discreet packaging. A vaginal swab or urine sample is collected and then sent for laboratory testing using a prepaid shipping label.
The FDA issued the final needed approval on Wednesday, and the product is already for sale on the website of the manufacturer, LetsGetChecked. The listed price is $99 with free shipping for a single test kit, and the site offers a discounted subscription to receive a kit every 3 months for $69.30 per kit.
Gonorrhea cases have surged 28% since 2017, reaching 700,000 cases during 2021, CDC data show. Chlamydia has also been on the rise, up 4% from 2020 to 2021, with 1.6 million annual infections. Both chlamydia and gonorrhea are transmitted by having sex, including oral sex, without a condom and are especially common in people under the age of 25.
Oftentimes, gonorrhea and chlamydia don’t have symptoms. But signs can include vaginal or penal discharge or a burning sensation while peeing that can be mistaken for other conditions, so testing is important, according to CDC fact sheets.
The conditions affect both men and women and can be cured with medication. But women who don’t get treatment for chlamydia are at risk of permanent damage to their reproductive systems. Gonorrhea can lead to pelvic inflammatory disease in women, which increases the risk of infertility. Men who are not treated can experience infertility as well. Both gonorrhea and chlamydia can be passed from a pregnant person to an unborn baby.
Previously, tests for the two STDs required that samples be taken at a health care location such as a doctor’s office. The Simple 2 test results can be retrieved online, and a health care provider will reach out to people whose tests are positive or invalid. Results are typically received in 2 to 5 days, according to a press release from LetsGetChecked, which also offers treatment services.
“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a statement. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.”
Sources:
FDA: “FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with at-home Sample Collection.”
CDC: “Sexually Transmitted Disease Surveillance 2021,” “Gonorrhea — CDC Basic Fact Sheet,” “Chlamydia — CDC Basic Fact Sheet.”
LetsGetChecked: “LetsGetChecked Receives U.S. Food and Drug Administration (FDA) De Novo Authorization for At-Home Chlamydia and Gonorrhea Testing System.”
Cite this: New at-Home Test Approved for Chlamydia and Gonorrhea – Medscape – Nov 16, 2023.