Description
Abstract text We evaluated the ELITe InGenius® device, together with its Bordetella ELITe MGB Kit® (ELITechGroup) as an IVD-approved alternative to our in-house qPCR assay for the detection of Bordetella pertussis, B. parapertussis and B. holmesii (Martini et al., 2017). Both assays are based on two screening targets: IS481 and IS1001; as well as two confirmation targets: recA, and IS1002 (in-house assay) or ptxA-Pr (ELITe assay). Accuracy was evaluated by performing the assay on a selection of 85 respiratory samples, previously tested with the in-house PCR. Both methods showed full concordance with regard to the common targets. Forty-four clinical isolates and reference strains were also tested, 2 old B. pertussis strains showed lower sensitivity towards the ptxA-Pr target. A limited verification of the sensitivity confirmed or surpassed the limits of detection claimed by ELITechGroup. This verification was done for all three species, using negative nasopharyngeal aspirates spiked with a known concentration of a reference strain or recent clinical strain. Both intra-run and inter-run precision sufficed, with coefficients of variation < 2.5% for any of the targets or species. Two runs were performed with alternating high-concentration samples and negative controls in order to check for cross-contamination. None was detected Finally, a selection of Bordetella spp. different from the three target species was tested in order to assess specificity. Some cross-reactivity was observed for the IS481 target for B. bronchialis and B. bronchiseptica, these results were concordant with the in-house PCR. Significant cross-reactivity was observed for B. petrii, this is currently being investigated further. In conclusion, the ELITe InGenius® platform showed satisfactory results in terms of accuracy, sensitivity, precision and specificity, for the detection of B. pertussis, B. parapertussis and B. holmesii.| Periode | 12 okt 2022 → 14 okt 2022 |
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| Evenementstitel | EMMD: European Meeting on Molecular Diagnostics 2022 (12th edition) |
| Evenementstype | Conference |
| Locatie | Noordwijk aan zee, Netherlands |
| Mate van erkenning | International |