Akademik Veri Yönetim Sistemi
3rd International Conference on Crimean-Congo Hemorrhagic Fever, Thessaloniki, Yunanistan, 19 - 21 Eylül 2023, ss.1-53
Introduction & aim: CCHFV infection occur annually in the rural areas around Sivas city in
Turkey (Figure 1). The aim of VHFMoDRAD European project was to adapt a simple TaqManbased RT-PCR assay using Cepheid GeneXpert system.
Methods: Between April-June 2020, serum from 85 individuals was used in the study. Samples
were tested using (i) the TaqMan RT-qPCR system (Anatolia Geneworks, Turkey) performed at
Sivas Cumhuriyet University Hospital (SCUH); SCUH ASSAY) (ii) TaqMan RT-qPCR system
(Bioeksen R&D Technologies, Turkey) used by the Turkish Ministry of Health; ANKARA ASSAY)
(iii) the FLEX-NP RT-qPCR as well as (iv) the FLEX-L RT-qPCR cartridge assay (Cepheid),
targeting the NP and the polymerase gene, respectively.
Results: Analytical performances of the FLEX-L and FLEX-NP using virus-spiked plasma
samples provided LoD95 of 20 RNA copies/µL and <2 RNA copies/µL, respectively. For
composite analysis, a sample was positive if ≥3 tests were providing the same qualitative result.
Sixty-six samples were positive and 19 were negative. The FLEX-NP and SCUH assays provided
the best performances with respective sensitivity at 98.5% and 100%, and specificity at 100% and
94.7% (Table 1).
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Conclusions: The SCUH & FLEX-NP provided excellent performances. FLEX-NP showed an
excellent sensitivity by using either contrived samples or clinical samples. FLEX-NP can be
operated with minimal technical training and provides results in less than 75 minutes and being
operated at point-of-care diagnostic settings. It proves that the Cepheid GeneXpert technology is
amenable to the Flex open cartridge when combined with the cold-chain free Lyoph-P&P
reagents.