Pre-eclampsia (PE) is a disease in which pregnant women 20 weeks beginning to emerge, based on blood pressure and proteinuria characterized by this, that in severe cases can be fatal. Currently, there is no ability to predict, diagnose pre-eclampsia or expected level of progression of clinical testing. Pre-eclampsia has been shown to be a patent applicant to protein misfolding disease characterized, by identifying protein misfolding to diagnose pre-eclampsia. Accordingly, the present invention discloses a method and composition for the diagnosis of pre-eclampsia or predict the risk of pre-eclampsia in vitro diagnostics: Through the use of the labeling reagent misfolded protein polymers and protein composition having an affinity for the surface of the support in vitro diagnostic kits, are mixed with the urine of pregnant women, the subject can be diagnosed pregnant woman is suffering from pre-eclampsia or risk of pre-eclampsia. The present invention is suitable for early pregnancies disease screening and prevention.