COVID-19 Viral Confirmation PCR, NAA – Swab Test (High-Complexity)




Viral Confirmation Test: The test is intended for the detection of virus of the 2019 novel coronavirus (SARS-CoV-2 COVID-19) from a Nasopharyngeal or Oropharyngeal swab. This test was developed, and its performance characteristics were determined by American Research Labs. This test has not been FDA cleared or approved. This test has not been authorized by FDA under an Emergency Use Authorization (EUA). This test is to be performed only using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. Many patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). However, limited information is currently available to characterize the full spectrum of clinical illness associated with COVID-19. Based on what is known about the virus that causes COVID-19, signs and symptoms may appear any time from 2 to 14 days after exposure to the virus. Based on preliminary data, the median incubation period is approximately 5 days, but may range 2-14 days. Public health officials have identified cases of COVID-19 infection throughout the world, including the United States, which may pose risks for public health. Please check the CDC webpage for the most up to date information. When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient`s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. An individual without symptoms of COVID-19 and who is not shedding SARS-CoV-2 virus would expect to have a negative result in this assay. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. When diagnostic testing is positive, the result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Patient management should follow current CDC guidelines. 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 in such assays. However, American Research Labs have performed specificity studies or cross-reactivity studies against the following respiratory markers; Influenza A H3N2 (Brisbane/10/07), Influenza A H1 (New Caledonia/20/99), Influenza A H1N1 (NY/02/2009), Influenza B (Florida/02/06), Rhinovirus (Type 1A), RSV (Type A), Adenovirus (Type 3) Parainfluenza (Type 2), Parainfluenza (Type 1), Parainfluenza (Type 3), Parainfluenza (Type 4), Coronavirus (HKU-1 recombinant), Metapneumovirus, (Peru 6-2003), Coronavirus (OC43), C. pneumoniae (CWL-029) Coronavirus (NL63), M. pneumoniae (M129), Coronavirus (229E), Coxsackievirus (Type A1), Bordetella pertussis (A639) and did not observe any cross-reactivity against SARS-CoV-2 virus. American Research Labs is a CLIA and COLA accredited high-complexity clinical diagnostic laboratory.

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