A-271 Expansion of sample viability for self-collected urine specimens containing CT/NG & TV/MG utilizing the Roche cobas® 6800 System

Background The CDC estimates that 1 in 5 Americans have an STI. Home collection for STIs could help mitigate the stigma, cost, and accessibility, which contribute to low diagnosis rates and disparities in diagnosis and treatment. Home self-collected specimens occasionally arrive in the lab with volumes higher or lower than what is required by the assay manufacturer’s specifications for self-collection. This study demonstrates that sample stability is retained after temperature fluctuation via shipping - even when the correct ratio of buffer to sample has been disturbed, a precise and accurate measurement persists. Our goal is to improve accessibility to discreet, patient collected STI tests. Methods Positive samples were prepared by spiking negative urine with organisms near the manufacturer’s limit of detection (LoD). Properly collected samples were aliquoted into tubes with 5mL volumes as per manufacturer specifications. Improperly collected samples were either overfilled (9mL for CT/NG, 7mL for TV/MG) or underfilled (1mL for CT/NG, 2mL for TV/MG). Samples underwent temperature cycling to mimic summer or winter shipping conditions. Ambient temperature studies were conducted on over/underfilled specimens. All samples were baseline tested and compared qualitatively to the manufacturer's claimed LoD using the Roche c6800 and the IVD assays for CT/NG & TV/MG. Results Improperly filled samples were stable at ambient temperature for 63 days for CT/NG, and 59 days for TV/MG. See chart for temperature cycling results. All samples (n=164) showed 100% qualitative agreement with their baseline result after summer and winter shipping challenges. Conclusions Urine samples that fail to satisfy the manufacturer’s self-collection specifications or have endured temperature fluctuations still yield accurate CT/NG & TV/MG results. These results indicate the potential to enhance sample viability and patient accessibility utilizing validated IVD assays.