Safety and efficacy of FebriDx® test in Spain

In the middle of October 2018, the Andalusian Agency for the Evaluation of Health Technologies, AETSA, has published a health technology report in which they have assessed the safety, efficacy and efficiency of FebriDx® test.

FebriDx® test is a portable rapid test (point of care) that detects, in a non-invasive and qualitative way, capillary blood levels of the protein A biomarkers of myxovirus (MxA) resistance and C-reactive protein. In this way, the test is a fast and accurate method for the differential diagnosis of bacterial and viral origin of acute febrile upper respiratory infections in the outpatient setting. As a consequence, this test could reduce the unnecessary use of antibiotics, resistance and costs. It is developed and manufactured by the Florida-based company RPS.

In order to assess this test, the authors have performed a systematic search of the literature on the websites such as MedLine, Embase and Web of Science, but have also checked the databases such as the clinical trial register of the Cochrane Library, the International Network of Technology Assessment Agencies and EuroScan. Other websites were also screen manually. Only the publications that described the comparison of this test with the standard laboratory tests were considered. Eventually, two (2) studies (designed and financed by the manufacturer) and one (1) descriptive publication were included.

Based on the literature identified, the test correctly detected 100% whether the patient had upper tract infection (positive result for bacteria or viruses). However, we must keep in mind the small sample (n=16) in the study by Sambursky et al. The study by Self et al. showed a specificity of 71.6% and a false negative rate of 12.8% (n=78). Regarding the differentiation between bacteria or viruses, the authors have concluded that FebriDx® test correctly detected 80% of bacterial infections and between 75% and 87% of viral infections. The test was less accurate (60%) for bacterial and more accurate (96%) for viral infections when tested in minors.

The test poses no risk to the users since it only requires a sample of capillary blood, preferably from the finger pulp.

See the full report in Spanish here.

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