![]() ![]() 11 Many of the RT-PCR assays have a 100% sensitivity in this analysis as reported by the manufacturers. 10 For analytical specificity they ask for in vitro cross-reactivity studies to demonstrate that the test does not react with related pathogens, high prevalence disease agents, and normal or pathogenic flora that are reasonably likely to be encountered in a clinical specimen. The FDA has published recommendations concerning the data and information that test manufacturers should supply in their application for Emergency Use Authorization (EUA). The overall accuracy of a RT-PCR test is based upon its sensitivity representing the ability to detect infected individuals and the specificity, which is the percentage of uninfected people who test negative. 9 Finally, periodic screening programs have been developed for educational institutions, sport teams, and the workplace to detect asymptomatic, presymptomatic, and symptomatic infected individuals early and isolate them to reduce them infecting others. 9 Later, the Federal Drug Administration (FDA) approved testing to be extended to screen for infection in individuals without known or suspected exposure to SARS-CoV-2 living in congregate settings, such as long-term care facilities or prisons. In the United States, because of a shortage of tests and testing facilities during the early months of the pandemic tests were primarily used for diagnoses to identify a person with an active infection associated with signs or symptoms of COVID-19 or who had definite or suspected recent exposure to the virus. 7, 8 Less has been published about the problem of false positive RT-PCR or other NAAT tests. 7, 8 Much has been written about the issue of false negative RT-PCR tests in symptomatic, presymptomatic, and asymptomatic persons infected with the virus. 1– 6 However, none of the tests have sufficient clinical sensitivity to detect virus during the first several days after infection, nor are they 100% sensitive at the time of peak infectiveness. Although there is a several log difference in the sensitivity of the different RT-PCR tests to pick up viral RNA, many have sufficient analytical sensitivity to detect a viral load during the preinfectious stage in infected individuals. The most widely utilized Nucleic Acid Amplification Test (NAAT) to detect SARS-CoV-2 RNA is the reverse transcriptase-polymerase chain reaction (RT-PCR) test, manufactured by many companies targeting one or more genomic regions of the virus. Form available at under Author and Reviewer information. Choose “Submit New Manuscript.” A signed copyright assignment and financial disclosure form must be submitted with the letter. Readers are invited to submit letters for publication in this department.
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