B-254 A Novel Multiplex Aspergillus PCR Assay for Detection of Invasive Aspergillosis

Background Invasive aspergillosis (IA) has been a well- known infectious complication in patients with severe immunosuppression, associated with high morbidity and mortality. Although IA was reported to contribute to increased mortality in the ICU population the diagnosis in not straightforward. The novel MycoMDx Aspergillus PCR assay with melting curve analysis produced by Dynamiker Biotechnology (Tianjin) Co., Ltd was a rapid, reliable and sensitive clinical diagnostic technique. The study evaluated the Multiplex PCR Assay for the diagnosis of IA. Methods A total of 611 BALF samples with proven IA (n =114), probable IA (n = 177) and control samples (not fulfilling 2019 EORTC/MSG guideline IA criteria, n=320) were included. All the samples were tested using the MycoMDx Aspergillus PCR Assay Kit. Results The sensitivity and specificity of MycoMDx Aspergillus PCR were 90.03% (262/291) and 95.63% (306/320), respectively. The concordance of detection results between Dynamiker MycoMDx Aspergillus PCR and Sanger sequencing assays was high. The results of Dynamiker MycoMDx PCR and Sanger sequencing for the identification of different Aspergillus species showed that the total percent agreement of the two methods for Aflatus, Aspergillus Niger and Aspergillus terreus reached 100%, and the total percent agreement for Aspergillus fumigus was 99.37%. Conclusion The Dynamiker MycoMDx Aspergillus PCR is a useful tool for the rapid identification of Aspergillus species and might be useful as an early diagnostic tool to detect an invasive aspergillosis.