文摘
Standardized methods need to be established for evaluating low-prevalence pathogen diagnostic devices. Biothreat and emerging agents such as Francisella tularensis and Babesia microti are examples of low-prevalence pathogens. The effectiveness of standardized methods was demonstrated on two testing platforms, real-time PCR and TEM-PCR. Compared results from two types of sample matrix, healthy donor blood and blood from patients with signs of infection. Reproducibility of comparisons demonstrated the standardized methods are effective for evaluating diagnostic devices.