COVID-19 RT-PCR SALIVA DIRECT TEST

SalivaDirect™ was developed by the Yale School of Medicine to efficiently test for SARS-CoV-2. This requires a high complexity CLIA certified laboratory,  to perform the testing. While the difficult RNA-extraction process has been removed, this test is still considered complex, as it requires PCR instrumentation. SalivaDirect also protects healthcare workers from potential exposure to sick patients, and works around worldwide swab shortages.

Accurate: The SalivaDirect method reflects 100% Clinical Specificity and 94% Clinical Sensitivity.

Clinical Validation

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™.

COVID-19 RT-PCR TEST

$250.00 Regular Price
$199.00Sale Price