A-271 Verification of a multiplexed STI Pathogen Microarray Test with Saliva Collected With SDNA-1000 Kit

Abstract

Abstract Background Sexually transmitted infections (STI) spread through oral sex potentially cause infections of the mouth, throat, genitals, or rectum. Saliva may be an important source of transmission of STI following oral sex. Multiplexed STI assays are useful diagnostically for patients with risk factors for STI as co-infections occur frequently. Methods Alimetrix STI is a multiplexed laboratory developed test for the identification of STI pathogens present in clinical specimens. DNA was collected in SDNA-1000 devices, extracted, purified, underwent multiplex PCR, and labeled amplicons were hybridized to a microarray with gene-specific 50mer capture probes. Fluorescently tagged amplicons were detected on a microarray scanner. Verification included analytical sensitivity (Limit of Detection (LOD), competition, and inclusivity), stability, and analytical specificity (exclusivity, precision and accuracy). Pathogens included in the multiplexed microarray included N. gonorrhea, C. trachomatis, T. vaginalis, T. pallidum , herpes 1 and 2, M. genitalium, U. urealyticum, and monkeypox. Results LOD for each pathogen in the Spectrum Solutions SDNA Collection System, throat swab, and first catch urine is found in Table 1. Competition of organisms showed the ability to co-detect up to 5 organisms from a single sample. Saliva collected using Spectrum Solutions SDNA Collection System was stable for 35 days at room temperature enabling discreet at home collection. Inclusivity showed related strains were detectable at 1× LOD, while maintaining 100% precision, 100% accuracy, and 97% exclusivity for high concentrations of closely related analytes in normal flora. Conclusion Control of STI associated with oral sex is dependent upon the demonstration of all pathogens present. Saliva collected in the SDNA-1000 device a high degree of sensitivity, precision, and accuracy, as well as the ability to detect multiple analytes (co-infection) within a given sample. Saliva is a clinically informative specimen source useful for the diagnosis, monitoring, and management of patients with oral and systemic disease.