Dynamiker Cryptococcal Antigen LFA got NMPA (CFDA) registration

Major technological breakthroughs, special press releases

Cryptococcal Antigen Lateral Flow Assay (LFA) which is independently developed by Dynamiker successfully obtained the third class medical device registration certificate of the NMPA (CFDA) on December 12, 2019. The registration certificate number is: National Machinery Note Standard 20193400995. This product is currently the first and unique innovative product that can be used to detect Cryptococcus capsular polysaccharide (GXM) biomarkers in human serum and cerebrospinal fluid samples (CFS). It also covers the domestic blank of serological detection of Cryptococcus capsular polysaccharide antigen markers!

Product superiority

The Cryptococcal Antigen Lateral Flow Assay (LFA) can be used for qualitative detection of Cryptococcus capsular polysaccharide (GXM) biomarkers in human serum or cerebrospinal fluid samples(CFS) in vitro. In addition, this product can be equipped with an immunological quantitative analyzer, which can read the detection value in addition to the positive/negative reading. Compared with similar products on the market, it has the advantages of no pretreatment of samples, simple operation, high sensitivity and specificity.

Clinical evaluation results both at home and in abroad

Many well-known clinical and research institutions at home and abroad have evaluated the performance of Cryptococcal Antigen Lateral Flow Assay (LFA). The clinical performance of the product has been highly praised, including:

• In 2017, A study by Professor Fayemiwo of Nigeria showed that the detection sensitivity of the Dynamiker Cryptococcal Antigen Lateral Flow Assay (LFA) was 100% and the specificity was 98.8%.

• The research results of Professor M. Muhammad of Malaysia at the International Conference on Pathology and Laboratory Medicine (ICPaLM) in 2018 showed that the detection sensitivity of the Dynamiker Cryptococcal Antigen Lateral Flow Assay (LFA) was 100% and the specificity was 89.5%.

• At the ECCMID conference in 2018, Professor Arendrup of Denmark published research results showing that the detection sensitivity and specificity of the Dynamiker Cryptococcal Antigen Lateral Flow Assay (LFA) were 100%.

• The results of the MiraVista Clinical Services Laboratory in the United States in 2019 showed that the sensitivity of the Dynamiker Cryptococcal Antigen Lateral Flow Assay (LFA) was 100% and the specificity was 94.8%.