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Novara di Sicilia, Italy

Nicosia A.M.,Laboratorio Of Virologia Molecolare | Ravanini P.,Laboratorio Of Virologia Molecolare | Villani A.,Coordinatore GdS POCT SIMeL
Rivista Italiana della Medicina di Laboratorio

Summary Background. POCT (point of care testing) is defined as medical testing performed nearby or at the site of patient care. This type of analysis allows to obtain the result immediately or very quickly, with the purpose to allow the clinicians to do a rapid diagnosis or to take fast therapeutic decisions. Until recently, among the tests listed in the POCT panel, the molecular biology tests for the diagnosis of viral infections were not included, because of the complexity of the procedures of these tests. However, in recent years, there has been growing evidence of the need of rapid and simple diagnoses also in this field, with the purpose to allow fast therapeutic decisions. One of these necessities concerns the diagnosis of viral meningitis and meningoencephalitis caused by Enteroviruses (EV). A correct and timely identification of the aetiology would allow a more suitable therapy for the patients. The aim of the present study has been to compare the performance characteristics of a POCT instrument for the molecular diagnosis of enteroviral infections, with the data obtained by the analytical method currently used by our Laboratory. We have compared the costs, the rapidity of test execution and clinical diagnosis, the simplification of the procedures, the management of the personnel, and the consequences in the patient's clinical outcome. Methods. Currently, in our Laboratory we use a Real Time qualitative RT-PCR test for the diagnosis of enteroviral infections (Enterovirus R-gene, Argene, North Massapequa, NY, USA). In this study we have first collected the data about the test currently used in the Laboratory (time and costs of execution, working time of the personnel, operative difficulties, rate of clinically useful tests). Subsequently these data have been compared with the characteristics and features of an alternative molecular Real Time qualitative RTPCR test (Xpert EV, Cepheid, Sunnyvale, CA, USA) using a new POCT instrument (GeneXpert, Cepheid, Sunnyvale, CA, USA), as described by several published studies. Results. The comparison between the two methods in the study show a substantial overlap of sensitivity and specificity of the two systems. From the results of this study, it appears that the current method used in our Laboratory requires an organization that cannot be considered suitable for emergency care diagnostics. On the contrary, the use of the GeneXpert system can cause a strong reduction in the response time (from 5/6 days to 3 hours), in the execution time of the analysis (from 5 hours to 2.45 hours) and in the handling time for the technician (from 2 hours to just 10 minutes). The reduction in the length of hospital stay (from 6.6 to 1.2 days for infants and from 7.3 to 1.9 days for adults) and in unnecessary antibiotic and antiviral therapy, makes this test very attractive to improve the overall management of patients. A further advantage is represented by the complete automation of the test and the very simple handling. These features allow this system to be implemented also in point-of-care settings and to be used also by not particularly trained personnel. The analysis of costs shows a significant money savings, with lower expenses of hospitalization and clinical management (up to 33% of saving), along with a substantial reduction in the cost of the tests (from€92.25 to€59.95 per sample). Conclusions. In conclusion, the data obtained in this study strongly suggest that the new POCT test for Enteroviruses shows optimal characteristics for its useful introduction in the diagnostic routine of viral emergencies. © Springer-Verlag Italia 2013. Source

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