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The Coronavirus SARS-CoV-2 (COVID-19) by nucleic acid amplification test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA) for U.S. laboratories certified under CLIA to perform high complexity tests. This test has not been FDA cleared or approved. In compliance with this authorization, please visit https://www ...
May 12, 2023 · A Nucleic Acid Amplification Test, or NAAT, is a type of viral diagnostic test for SARS-CoV-2, the virus that causes COVID-19. NAATs detect genetic material (nucleic acids). NAATs for SARS-CoV-2 specifically identify the RNA (ribonucleic acid) sequences that comprise the genetic material of the virus. NAATs for SARS-CoV-2 test specimens from ...
- Diagnostic Testing For Sars-Cov-2 Infection
- Antigen Testing For Sars-Cov-2 Infection
- Nucleic Acid Amplification Testing For Sars-Cov-2 Infection
- Serologic Or Antibody Testing For Diagnosis of Sars-Cov-2 Infection
- Serologic Testing and Immunity to Sars-Cov-2 Infection
For diagnosing current SARS-CoV-2 infection, the Centers for Disease Control and Prevention (CDC) recommends using either a nucleic acid amplification test (NAAT) or an antigen test.1 Testing may also be used for screening and to determine the length of a patient’s isolation period.2There may be a window period of up to 5 days after exposure before...
Antigen-based diagnostic tests are widely used at home, at the point of care, and in the laboratory because of their low cost, rapid turnaround time, and availability. Antigen tests and laboratory-based NAATs have similar high specificity. False positive test results can occur with antigen tests, although they are unlikely when the tests are used c...
NAATs, such as reverse transcription polymerase chain reaction–based diagnostic tests, which detect viral nucleic acids,7are the most sensitive tests for detecting current SARS-CoV-2 infection. Diagnostically, some NAATs may produce false negative results if a mutation occurs in the part of the virus’s genome that is assessed by that test.8 The FDA...
Unlike NAATs and antigen tests, which detect the presence of SARS-CoV-2, serologic or antibody tests can detect recent or prior SARS-CoV-2 infection or vaccination. The CDC recommends that antibody tests should not be used to diagnose current SARS-CoV-2 infection.12 It may take 21 days or longer after symptom onset for seroconversion to occur (i.e....
Currently, antibody tests are not recommended for assessing SARS-CoV-2 immunity following COVID-19 vaccination or for assessing the need for vaccination in a person who is unvaccinated. The FDA has issued EUAs for more than 80 SARS-CoV-2 serologic tests since the beginning of the pandemic. However, these tests are not currently authorized for routi...
Jan 9, 2024 · Viral tests: Nucleic acid amplification tests (NAATs) are highly sensitive and highly specific tests that detect one or more viral ribonucleic acid (RNA) genes. PCR tests are the most common type of NAAT used for COVID-19 testing. Viral RNA may stay in a person’s body for up to 90 days after they test positive.
COVID-19 Positive (SARS-CoV-2 RNA Detected) Test Result. If your COVID-19 test was positive, this means that the test did detect the presence of COVID-19 in your nasal secretions. This result would suggest that you are currently infected with COVID-19. If you had a positive COVID-19 test, please self-isolate at home as much as possible ...
Viral transport medium acceptable for collection of influenza specimens in 1 mL or 3 mL volumes can be used to transport swabs for COVID-19 testing. For swabs in saline: OP, NP or anterior nasal swabs may be placed in 1 to 3 mL of sterile saline (0.85 to 0.9%) in a sterile screw cap container. Do not use vacutainer or "pop-top" tubes.
Apr 15, 2021 · A study of 193 symptomatic and 110 asymptomatic patients with SARS-CoV-2 infection found that viral RNA detection lasted a median of 17 to 19 days. 35 Although viral load peaks near symptom onset ...
