• SARS-CoV-2 Antigen kit1
  • SARS-CoV-2 Antigen kit
  • SARS-CoV-2 IgGIgM Rapid Test
You can check the list on the UK Department of Health website : https://www.gov.uk/.../medical-devices-regulations-2002... If you need to purchase our products, you can contact us at any time!

我們的產品已進入英國豁免冠狀病毒體外診斷設備清單!

您可以在英國衛生部網站上查看列表:https://www.gov.uk/.../medical-devices-regulations-2002... 如果您需要購買我們的產品,您可以通過以下方式聯繫我們任何時候!
SARS-CoV-2 has now evolved several mutations with serious consequences,some like B.1.1.7,B.1.351,B.1.2,B.1.1.28,B.1.617,Including the omicron mutant strain(B1.1.529) reported in recent days. As an IVD reagent manufacturer, we always pay attention to the development of relevant events, check the changes of relevant amino acids and evaluate the possible impact of mutations on reagents.

StrongStep® SARS-CoV-2 抗原快速檢測不同 SARS-CoV-2 變體的檢測報告和計算機分析

SARS-CoV-2 現已進化出多種突變,造成嚴重後果,如 B.1.1.7,B.1.351,B.1.2,B.1.1.28,B.1.617,包括 omicron 突變株(B1.1.529)近日報導。作為IVD試劑生產商,我們時刻關注相關事件的發展,檢查相關氨基酸的變化,評估突變對試劑可能產生的影響。
StrongStep® SARS-CoV-2 Antigen Rapid Test Enter the EU common list of hygiene and food safety, which is one of the few manufacturers that has 100% sensitivity when the CT value is less than 25%.

StrongStep® SARS-CoV-2 抗原快速檢測進入歐盟衛生和食品安全通用清單

StrongStep® SARS-CoV-2 抗原快速檢測進入歐盟衛生和食品安全通用清單,是少數幾家在 CT 值小於 25% 時具有 100% 靈敏度的製造商之一。
StrongStep® SARS-CoV-2 Antigen Rapid Test ncluded in the FIND evaluation list. The Foundation for Innovative New Diagnostics (FIND), is an organization that specializes in evaluating the performance of kits in strategic cooperation with WHO.

列入 FIND 評估列表的 StrongStep® SARS-CoV-2 抗原快速檢測

StrongStep® SARS-CoV-2 抗原快速檢測包含在 FIND 評估列表中。創新新診斷基金會 (FIND) 是一個專門評估與世衛組織戰略合作的試劑盒性能的組織。
Sequence alignment analysis showed that the mutation site of the SARS-CoV-2 variant observed in the in the United Kingdom , South Africa and India are all not in the design region of the primer and probe at present. StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) can cover and detect mutant strains ( shown in the following table) without affecting the performance at present. Because there is no change in the region of the detection sequence.

關於變種病毒的聲明

序列比對分析表明,目前在英國、南非和印度觀察到的SARS-CoV-2變異體的突變位點均不在引物和探針的設計區域內。StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit(檢測三個基因)可以覆蓋和檢測突變株(見下表),而不影響目前的性能。因為檢測序列的區域沒有變化。
We have received many certificate or EUA from different countries, such as United Kingdom, Singapore, Brazil, South Africa, Malaysia,Indonesia,Philippine, Argentine, Guatemala and so on. Also, we have send our products to many institue for evaluation, below are the summary of some data. Please contact us via guangming@limingbio.com if you need full artical of following report.

StrongStep® SARS-CoV-2抗原快速檢測不同研究所評估報告總結

We have received many certificate or EUA from different countries, such as United Kingdom, Singapore, Brazil, South Africa, Malaysia,Indonesia,Philippine, Argentine, Guatemala and so on. Also, we have send our products to many institue for evaluation, below are the summary of some data. Please contact us via guangming@limingbio.com if you need full artical of following report.
Recently, the StrongStep® SARS-CoV-2 Antigen Rapid Test produced by Nanjing Liming Bio-products Co. Ltd has successfully obtained the Thailand FDA certificate (registration number T 6400429,T 6400430,T 6400431,T 6400432 ), and now has been approved to enter the Thailand market.

泰國 FDA COVID 19 ATK 2021 T6400429

近日,南京黎明生物製品有限公司生產的StrongStep® SARS-CoV-2抗原快速檢測儀成功獲得泰國FDA證書(註冊號T 6400429,T 6400430,T 6400431,T 6400432),現已獲得泰國FDA證書。獲准進入泰國市場。
Recently, Nanjing LimingBio‘s Novel Coronavirus (SARS-CoV-2) antigen detection reagent

StrongStep® SARS-CoV-2 抗原快速檢測已獲得德國 Paul-Ehrlich-Institut (PEI) 的性能驗證!

近日,南京黎明生物的新型冠狀病毒(SARS-CoV-2)抗原檢測試劑“StrongStep® SARS-CoV-2抗原快速檢測”獲得德國保羅-埃利希研究所(PEI*)的性能驗證,該產品已通過由德國聯邦藥品和醫療器械管理局 (BfArM) 認證。黎明生物已成為國內少數獲得德國BfArM+PEI雙重認證的廠商之一。黎明生物的抗原快速檢測通過了多個國家衛生部的權威認證,充分證明了試劑盒的卓越性能。
StrongStep® SARS-CoV-2 Antigen Rapid Test is a rapid immunochromatographic assay for the detection of COVID-19 antigen to SARS-CoV-2 virus in human Throat/Nasopharyngeal swab.

SARS-CoV-2 抗原快速檢測

StrongStep® SARS-CoV-2 抗原快速檢測是一種快速免疫色譜法,用於檢測人類咽喉/鼻咽拭子中 SARS-CoV-2 病毒的 COVID-19 抗原。
This highly sensitive, ready-to-use PCR kit is available in lyophilized format (freeze-drying process) for long-term storage. The kit can be transported and stored at room temperature and is stable for one year.

新型冠狀病毒 (SARS-CoV-2) 多重實時熒光定量 PCR 試劑盒

這種高度靈敏的即用型 PCR 試劑盒以凍乾形式(冷凍乾燥過程)可供長期儲存。該試劑盒可在室溫下運輸和儲存,穩定一年。

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關於我們

南京黎明生物製品有限公司成立於2001年,專業從事傳染病特別是性病快速檢測試劑的研發、生產和銷售。除了 ISO13485,我們幾乎所有的產品都帶有 CE 標誌和 CFDA 批准。與耗時且昂貴的其他方法(包括 PCR 或培養)相比,我們的產品表現出相似的性能。使用我們的快速測試,患者或醫療保健專業人員可以節省大量等待時間,因為它只需要 10 分鐘。

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