(Boston Orange 編譯)羅氏製藥(Roche)今(1)日宣佈，該公司新的新型冠狀病毒(SARS-CoV-2)快速抗體鼻測試已取得歐洲合格認證(CE mark)。該測試將於2021年2月中起在接受歐洲合格認證的國家中發行。
和現有的羅氏新型冠狀病毒快速抗體測試相比，這新的新型冠狀病毒快速抗體鼻測試收集來自鼻子前端，而不是鼻咽的樣本，使得測試過程更為簡單，快速。這測試方法可以幫助減少病人的不舒服感，特別是比較敏感的小孩，老人，以及殘障人士等。
除了侵入性較低之外，這種方法還讓病人可以選擇，在專業醫護人員督導下，由自己採集鼻測試樣本。藉此減少實際接觸，這方法也減少醫護人暴露於病毒下的危險。這測試方法是否可在無專業醫護人督導下執行，將視乎地方法規要求。
羅氏診斷執行長Thomas Schinecker表示，快速測試在對抗新冠病毒上，仍然有著重要角色，特別是在沒有實驗室測試，又需要快速得到結果的地方，例如頤養院，醫護場所及學校。
羅氏和SD Biosensor公司合作，正準備向美國食品藥物局(FDA)遞交緊急使用授權申請。
Roche announces the upcoming launch of the SARS-CoV-2 Rapid Antigen Test Nasal allowing for patient self-collection
- The
SARS-CoV-2 Rapid Antigen Test Nasal uses a nasal swab to quickly and conveniently
collect specimens from people suspected of having an active infection
- Nasal
sampling allows for collection of the sample from the front area of the
nose instead of the nasopharynx resulting on a less invasive testing
experience for patients
- The
test also provides patients with the option to self-collect their nasal
sample
In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure1. This testing method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and/or people with disabilities.
Besides being less invasive, the test also provides patients with the option to self-collect their nasal sample under the supervision of a healthcare professional. Through reduced physical contact, this method of testing can help to decrease the risk of exposure to the virus for healthcare professionals. Whether the test could also be used without supervision of a healthcare professional will depend on local regulatory requirements.
“Rapid testing continues to play an important role in the fight against COVID-19, especially in places when laboratory testing is not available and quick results are needed, such as nursing homes, healthcare facilities, and schools.” said Thomas Schinecker, CEO Roche Diagnostics. “The SARS-CoV-2 Rapid Antigen Test Nasal provides patients with a more comfortable testing experience.”
The launch is a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July and a SARS-CoV-2 Rapid Antigen Test in September 2020. SD Biosensor, is currently preparing to submit an Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA).
The test is the latest addition to Roche's comprehensive COVID-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection.
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