You are using an outdated browser. For a faster, safer browsing experience, upgrade for free today.
  • cap accredited
COVID-19 | Q&A ACCESS 2019 NOVEL CORONAVIRUS (COVID-19), NAA TEST [C19]

COVID-19 is a respiratory disease caused by infection with a new form of coronavirus (SARSĀ­ 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.

1. Does Access offer a test to detect the presence of the 2019 novel coronavirus?

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 (SARSĀ­ CoV-2) that causes COVID-19 and is for use with patients who meet current guidance for evaluation of infection with COVID-19.

2. What is the test methodology for 2019 Novel Coronavirus (COVI0-19), NAA?

A: This is a qualitative test using PCR technology.

3. Who can order the 2019 Novel Coronavirus (COVI0-19), NAA test?

A: By physicians and individuals.

4. What are acceptable samples types for 2019 Novel Coronavirus (COVI0-19), NAA?

A: The following are acceptable sample types, all preferably shipped refrigerated:

  • Nasopharyngeal(NP) swab submitted in viral transport media, which is a preferred sample type;
  • Oropharyngeal (OP) swab submitted in viral transport media, which is a preferred sample type;
  • Oropharyngeal (OP) aspirate or washing submitted in a sterile, leak-proof, screw cap sputum collection cup or sterile dry container;
  • Nasopharyngeal(NP) aspirate or washing submitted in a sterile, leak-proof, screw cap sputum collection cup or sterile dry container;
  • Bronchoalveolar lavage (BAL) or bronchial wash, 2-3 ml collected into a sterile, leak-proof, screw cap sputum collection cup or sterile dry container.

5. How should samples be shipped?

A: Samples can be shipped at room temperature and are stable up to 72hours.

6. What are the criteria for sample rejection?

A: Unacceptable specimens include those that are:

  • Improperly labeled, grossly contaminated, broken or with significant leakage in transit;
  • Improperly collected, i.e., swabs with calcium alginate or cotton tips, swabs with wooden shafts;
  • Collected in contact with substances inhibitory to polymerase chain reaction (PCR) techno logy including heparin, hemoglobin, ethanol and EDTA.

7. How long will it take to report results back?

A: Up to 3-4 days from receiving samples at our laboratory.

8. How will ordering physicians be notified of positive results?

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.

9. Will positive COVID-19 results be reported to local and state public health entities?

A: Yes.

10. Will you send positive tests to the CDC or state health labs for confirmatory testing?

A: Yes.

11. Does a negative result from the COVID-19 test mean that a patient is definitely not infected?

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:

  • The test may might not detect virus in an infected patient if the virus is not being actively shed at the time or site of sample collection.
  • The amount of time that a n individual was exposed prior to the collection of the specimen can also influence whether the test will l detect the virus.
  • Individual response to the virus can differ.
  • Whether the specimen we receive was collected properly, sent promptly, and packaged correctly.

Test results are a critical part of any diagnosis, but must be used by the clinician along with other information to form a diagnosis.

12. What are the symptoms of COVI D-19?

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.