PCR and Antigen Testing Methodologies Sample Clauses

PCR and Antigen Testing Methodologies. All test samples are procured by trained healthcare professionals with experience in clinical specimen collection, infection control and the use of PPE. Visit Healthcare has found anterior nares nasal swab collection for RT-PCR test processing of the samples collected by our trained healthcare workers to be best tolerated sample collection method and most sensitive and specific type of lab-based testing and would preferentially use this technique for our testing operation. However, we are proficient in all modes of specimen collection, and can accommodate the preferences of the client for nasopharyngeal specimen collection, oropharyngeal, mid-turbinate or anterior nares nasal swabbing. Additional training will be provided to newly hired sample collection personnel to reinforce adherence to best practices as recommended by the CDC and to address sample collection kit and test kit specific requirements. Based on our experience in statewide community-based testing in Illinois, it is relatively easy to pivot to a self-swab model where our trained healthcare workers instruct and observe those being tested to collect their own samples - providing an acceptable alternative that minimizes exposure of our staff and perhaps provide a more efficient manner to collect samples. Whether the final determination is to have our testing sites perform standard PCR tests for COVID-19 or to have our specimen collection personnel instead conduct a rapid antigen test on site, with results available and reportable to the person tested within 15-20 minutes, our personnel would use the same sampling technique. Regarding rapid antigen test kits, also performed under the CLIA of our partner lab, all kits will have received FDA EUA or will be registered with the FDA with application for EUA in progress. Rapid antigen testing kits currently only have EUA for use in symptomatic patients within the first five days of symptom onset (when they are most accurate) but are currently being used “off label” for the screening of asymptomatic individuals. For asymptomatic testing with these kits the sensitivity is not expected to be as high as the “gold standard” RT-PCR testing, although the specificity still approaches 98% - meaning very few false positive results. Visit Healthcare understands that if testing is not collected properly by our staff at the time of a test, it is Visit Healthcare’s responsibility to re-test the individual who was improperly tested, with no financial obligation from ...