COVID-19 is a respiratory disease caused by infection with a new form of coronavirus (SARS CoV-2) that has now been detected in multiple locations around the world, including the U.S. Access is supporting the public health response as part of a lab industry consortium that is working very hard to expand the availability of testing.
Below are answers to questions about COVID-19 testing including test methodology, appropriate specimen types, specimen packaging and shipping, and test result reporting.
A: Yes. The 2019 Novel Coronavirus (COVID-19), NAA [C19] is available for ordering by physicians and other authorized health care providers anywhere in the U.S. The test detects the presence of the underlying virus (SARS CoV-2) that causes COVID-19 and is for use with patients who meet current guidance for evaluation of infection with COVID-19.
A: This is a qualitative test using PCR technology.
A: By physicians and individuals.
A: The following are acceptable sample types, all preferably shipped refrigerated:
A: Samples can be shipped at room temperature and are stable up to 72hours.
A: Unacceptable specimens include those that are:
A: Up to 3-4 days from receiving samples at our laboratory.
A: Positive results will be treated as a critical result and will be called to the ordering physician or health care provider. Indeterminate results and negative results will not be called.
A: Not necessarily. COVID-19 assay detects the virus directly, within the established limits of detection for which it was validated. A positive result is considered definitive evidence of infection. However, a negative result does not definitively rule out infection. As with any test, the accuracy relies on many factors:
Test results are a critical part of any diagnosis, but must be used by the clinician along with other information to form a diagnosis.
A: Most patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). Additional criteria include close contact with a laboratory- confirmed COVID-19 patient within 14 days of symptom onset, or a history of travel from affected geographic areas within 14 days of symptom onset.
More information about risk evaluation criteria can be found on the Centers for Disease Control and Prevention websiteand may also be available from state or local health authorities.