Development Of Rapid Diagnostic Test For Plasmodium Falciparum In Malaria Patient

Malaria is a serious parasitic disease caused by Plasmodium parasites and spread by Anopheles,and threatens human health.According to the latest WHO report in 2017,malaria still exist in 91 countries.216 million cases of malaria were recored in 2016 and brought to 445,000 deaths.90% of these cases were occurred in Africa.Plasmodium falciparum,Plasmodium vivax,Plasmodium malariae,and Plasmodium ovale can infect human and result in Malaria.Plasmodium falciparum is the most highly pathogenic and is prevalent in Africa.Prompt diagnosis is important for prevention and control of malaria.So the diagnostic reagent is required to be rapid,easy and accurate,and can guide accurate medication,avoid drug resistance strains and the worse disease.Moreover it can help to monitor the disease and prevent the large-scale outbreak of malaria.Histidine-rich protein 2(HRP2)and lactate dehydrogenase(LDH)are two commonly used markers for the detection of Plasmodium falciparum(P.falciparum).HRP2 is more widely used than LDH,because of its high sensitivity,and LDH can rescue the detection faiture derived from HRP2 gene deletion.Therefore,if the reagent could detect two kinds of markers at the same time,it will show higher detection sensitivity and avoid the deficiency of single biomarker.In this study we have developed a rapid diagnostic reagent to detect P.falciparum specific protein HRP2 and LDH in human blood,using colloidal gold immune chromatography technology and double antibody sandwich method.The detection method was optimized,performance analysis was evaluated,and finally clinical trials were performed in several hospital.The detection limit of our method is 100 parasite/μl blood.Using the thick and thin films microscopy,which is the‘gold standard’in detection of P.falciparum,as control,a total of 1110 cases of whole blood specimens were detected,the positive and negative coincidence rate were 99.47% and 100%,respectively.In contrast,the total coincidence rate with microscopy was 99.82%.The reagent is easy to operate and doesn’t require instruments.The detection time is as short as 15 minutes,but with good specificity and high sensitivity.It could detect the P.falciparum infection rapidly,easily and accurately.