Analytical Validation of TaqMan™ Assays on the OpenArray™ Platform Using Applied Biosystems QuantStudio™ 12K Flex for the Rapid Identification of Nail Microbiota

Abstract

Several microorganisms are known to play a role in nail infections. For the successful treatment of nail microbiota, especially fungi, there is a need for precise and robust diagnostic methods. This test utilizes real-time PCR amplification to detect the presence of a microorganism in a nail sample by amplifying the genomic DNA of the organism. Here, we described a TaqMan™-OpenArray™ nail microbiota assay that is efficient and easy-to-use for the characterization of key nail microbial targets through real-time PCR. The analytical accuracy and specificity of the nail panel were 100% and 99.90% across all assays and controls tested, respectively, and it was significantly more sensitive than culture. TaqMan™-OpenArray™ testing is fast and robust to contamination. In this paper, the main questions discussed were the replacement of culture by a broad-spectrum fungal TaqMan™-OpenArray™ testing and the implementation of TaqMan™-OpenArray™ testing into routine clinical laboratory settings.