NO QUANTIFIED VIRUS ISOLATES OF 2019-nCoV are currently AVAILABLE …. so we used In VITRO STOCKS (grown and ASSUMED) for the PCR TESTS so we could MIMIC A CLINICAL SPECIMEN.
YEAH. FDA actually PRINTED that shit.
THIS is from page 39 of this FDA Pdf Document re: CoVID-19:
https://www.fda.gov/media/134922/download
Performance Characteristics Analytical Performance:
Limit of Detection (LoD): LoD studies determine the lowest detectable concentration of 2019-nCoV at which approximately 95% of all (true positive) replicates test positive. The LoD was determined by limiting dilution studies using characterized samples. The analytical sensitivity of the rRT-PCR assays contained in the CDC 2019 Novel Coronavirus (2019- nCoV) Real-Time RT-PCR Diagnostic Panel were determined in Limit of Detection studies.
Sinceno quantified virus isolates of the 2019-nCoV are currently availableassays designed for detection of the 2019-nCoV RNA were testedwith characterized stocks of in vitrotranscribed full length RNA (N gene; GenBank accession: MN908947.2) of known titer (RNA copies/µL) spiked into a diluent consisting of a suspension of human A549 cells and viral transport medium (VTM)to mimic clinical specimen.