Stability of spiked-in saliva samples used for the limit of detection experiment was determined by placing 3 different concentrations (12, 25, and 50 copies/µL) for 7 days under different temperature regimes (4°C, room temperature, and 30°C). Results were compared to results obtained in the limit of detection experiment (fresh). Samples were treated with ThermoFisher Scientific proteinase K and tested with the ThermoFisher TaqPath RT-qPCR kit on the Bio-Rad CFX96. Overall, samples were stable under each condition for at least 7 days.
addition to cross-reactivity tests performed by the CDC, Yale has tested SalivaDirect™ on 52 saliva specimens collected from adults during the 2018/2019 and 2019/2020 (pre-COVID19) autumn/winter influenza seasons and detected 51 negative, and 1 invalid results.
Performance of SalivaDirect™ was compared to the authorized ThermoFisher Scientific TaqPath RT-PCR COVID-19 kit by testing 37 paired positive and 30 paired negative nasopharyngeal (NP) and saliva samples. Nasopharyngeal swabs and saliva were collected from inpatients and healthcare workers in the Yale-New Haven Hospital. Saliva was collected in sterile urine cups or 5 mL tubes without addition of any preservatives. The ThermoFisher Scientific TaqPath COVID-19 combo kit combines RNA extraction using the MagMax Viral/Pathogen Nucleic Acid Isolation Kit with a multiplex RT-PCR diagnostic assay targeting 3 regions of the SARS-CoV-2 genome (N, S, and ORF1ab). For SalivaDirect™ we used the ThermoFisher Scientific proteinase K, ThermoFisher Scientific TaqPath RT-PCR kit, and Bio-Rad CFX96 instrument. Yale University selected the positive and negative pairs based on preliminary results of our modified research protocol based on the US CDC primer-probe sets. Out of the 37 nasopharyngeal swabs that were tested with the TaqPath COVID-19 kit, three specimens tested negative (Ct value cut-off of 37). However, earlier results with the modified CDC assay indicated a (weakly) positive signal, and the paired saliva specimen tested positive with both SalivaDirect™ and the TaqPath COVID-19 kit. Two saliva specimens tested negative for SalivaDirect™ while the NP swab and saliva tested positive or inconclusive with the TaqPath COVID-19 kit. All negative NP and saliva specimens tested negative with both the TaqPath COVID-19 kit and SalivaDirect™.
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