Our products have entered the UK list of exempted coronavirus invitro diagnostic devices!
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!
Testing Report and in Silico Analysis for StrongStep® SARS-CoV-2 Antigen Rapid Test on Different SARS-CoV-2 Variant
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 Antigen Rapid Test Enter the EU common list of hygiene and food safety
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 Antigen Rapid Test included in the FIND evaluation list
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.
Statement on variant viruses
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.
Summarize of Evaluation Report from Different Institute on StrongStep® SARS-CoV-2 Antigen Rapid Test
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.
Thailand FDA COVID 19 ATK 2021 T6400429
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.
OUR LATEST PRODUCTS
-
SARS-CoV-2 Antigen Rapid Test（Professional Use）
INTENDED USE The StrongStep® SARS-CoV-2 Antigen... -
SARS-CoV-2 Antigen Rapid Test for Saliva
INTENDED USE The StrongStep® SARS-CoV-2 Antige... -
SARS-CoV-2 & Influenza A/B Multiplex Real-...
StrongStep® SARS-CoV-2 & Influenza A/B Mult... -
System Device for SARS-CoV-2 & Influenza A...
The novel coronaviruses belong to the β genus. ... -
Dual Biosafety System Device for SARS-CoV-2 Ant...
INTENDED USE The StrongStep® Procalcitonin ... -
SARS-CoV-2 Antigen Rapid Test（nasal）
The product has an exclusive agent in New Zeala... -
Novel Coronavirus (SARS-CoV-2) Multiplex Real-T...
This highly sensitive, ready-to-use PCR kit is... -
FOB Rapid Test
NTENDED USE The StrongStep® FOB Rapid Test Stri... -
Cryptococcal Antigen Rapid Test Device
INTENDED USE The StrongStep® Cryptococcal Ant... -
Salmonella Antigen Rapid Test
Benefits Accurate High sensitivi... -
Factory wholesale Fungusclear™ Fungal Fluoresce...
NTENDED USE The StrongStep® FOB Rapid Test...
ABOUT US
Nanjing Liming Bio-products Co., Ltd. founded in 2001, our company has been specialized in developing, manufacturing and marketing rapid tests for infectious diseases especially STDs. Apart from ISO13485, nearly all of our products are CE marked and CFDA approved. Our products have shown similar performance compared to other methods (including PCR or culture) which are time-consuming and costly. Using our rapid tests, either patient or healthcare professionals can save a lot of time for waiting because it just needs 10 minute.
-
No.12, Huayuan Road, Nanjing,Jiangsu, 210042 P.R CHINA