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What is RT-PCR?
Reverse transcription polymerase chain reaction (RT-PCR) is a laboratory technique combining reverse transcription of RNA into DNA followed by amplification of specific DNA targets using polymerase chain reaction (PCR). It is primarily used to measure the amount of a specific RNA via amplification using fluorescence, a technique called real-time PCR or quantitative PCR (qPCR). Combining RT-PCR and qPCR we are able to quantify viral RNA [COVID-19] for diagnoses.
What is Serology?
Serological tests for SARS-CoV-2 are intended for individuals who may have been exposed to COVID-19 and either had symptoms but are no longer symptomatic, or were asymptomatic. The tests analyze serum in blood samples to determine the presence of antibodies (IgG, IgM). A positive serologic result indicates that an individual has likely produced an immune response to the SARS-CoV-2 virus. A negative serologic result indicates that an individual has not developed detectable antibodies at the time of testing.
What is FDA’s guideline on Serology?
Considering that serology tests are less complex than molecular tests and are solely used to identify antibodies to the virus, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where test have been validated, notification is provided to FDA. CELLUM BioMedical is disclosing the following information pertaining serology testing.
This test has not been reviewed by the FDA.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.