Development Of Rapid Diagnostic Test Reagent For Syphilis Recombinate Antigen

Syphilis is a chronic,systemic sexually transmitted disease(STD)caused by infection with the bacteria Treponema pallidum,which can invade the central nervous system,damage the bones,cause tissue and organ damage,and lead to disability and death more seriously.It isn't only now spread all over the world and there are about 12 million new cases each year according to WHO estimates,but also growing rapidly and become the largest number of reported cases of sexually transmitted diseases in China.Early and effective detection of Syphilis is particularly critical because of it can be spread through the slightly damaged skin or mucous membranes.In 2003,our company developed the TP diagnostic reagents which have a risk of false negative because of only contain a single Tp17 fragment.The new constructed recombinant antigens for rapid detection syphilis,fusion more core fragments and using biotin amplification system,not only improve the sensitivity and specificity of tests and reduce the cost of raw materials,but also prevention of the spread of syphilis effectively because of early diagnosis and treatment.We constructed recombinant antigens using immunodominant Syphilis epitops(TpN17,TpN47,TpN15)and then transfered the recombinant expression vector to the Escherichia coil.We selected good performance paired recombinant prot eins which obtained high purity through purification and dialysis of cultured ce lls induced by IPTG for syphilis detection using rapid diagnosis platform.Results and conclusion: Acquired the good performance paired recombinant proteins which contain immunodominant Syphilis epitops(TpN17,TpN47,TpN15).The target proteins contain His tags were expressed in the supernatant of ba cteria.We acquired high purity recombinant proteins through purification and dia lysis using Ni-NTA column.We product the device for rapid detection of Syphil is,demonstrated 100% sensitivity and 99.38% specificity,is higher performance t han current products.Our company greatly enhance the competitiveness of the market through the improved product performance.