COVID-19 molecular test performance measures

Developer Test Date EUA authorized Sample types Authorized setting: Laboratories certified under the CLIA to perform high complexity tests Authorized setting: Laboratories certified under the CLIA to perform moderate complexity tests Authorized setting: Patient care settings operating under a CLIA Certificate of Waiver Time until test results (Hours) Positive percent aggreement (95% CI) Negative percent aggrement (95% CI) Cross-reactivity with common respiratory pathogens (Specificity) Primer target region Primer specificity to SARS COV-2 Primer number of target regions LOD: Minimum amount in a spiked sample that can be detected at least 95% of the time RNA extraction efffciency check More Information