Massachusetts Medical Society: Testing

Testing

What patients should be tested for COVID-19?
The CDC is regularly updating guidance on who physicians should test for COVID-19. Patients presenting with fever or signs of lower respiratory illness—especially in those who may have been exposed to the virus should be tested. Decisions on testing may be made based on local epidemiology of COVID-19.  View testing criteria from the Massachusetts State Public Health Laboratory. Full criteria for evaluating and reporting persons under investigation can be found on the CDC site.

Patients who do not have symptoms of a respiratory infection are not being tested for COVID-19 at this time. This is to ensure adequate testing capacity for patients who have medical need and that the necessary PPE is conserved for testing and caring for those patients who are ill.

How do I test patients for COVID-19?
The CDC has developed a laboratory test kit for use in testing patient specimens called the “Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.” Laboratory testing is currently being conducted at the MA State Public Health Laboratory. For more information visit the FDA’s FAQs on Diagnostic Testing for SARS-CoV-2.

Physicians are also able to access lab tests through commercial and hospital laboratories authorized by the FDA. Quest and LabCorp indicate that they are performing COVID-19 tests and have information on their websites regarding how the tests can be ordered. Both labs indicate on their website that specimens must be collected by providers. Their laboratory in-office phlebotomists will NOT collect respiratory (nasopharyngeal/oropharyngeal swab) specimens, including those from patients suspected of having COVID-19. Specimens must be sent by the provider using standard procedures. View the list of current MA COVID-19 Testing Sites.

What is the sensitivity and specificity of COVID-19 Test?
There is currently not one standard diagnostic test to assess the PCR against, in order to get true sensitivities and specificities. The other variable that impacts the ability to answer the question definitively is that there is not one single PCR test for COVID-19; there are multiple tests now, many of which are laboratory-developed tests. Additionally, all of these tests are being used under what is called an Emergency Use Authorization which means that while some data has been provided to the FDA, it is not as complete as what is required for full FDA licensure. The documentation for the PCR test that DPH knows the most about is the CDC developed test which is what most State Public Health Laboratories are using. Full sensitivity and specificity will be determined later using an FDA developed protocol. 

The current information MA DPH has is that when this test is done on appropriately symptomatic patients during the acute phase of the illness, sensitivity and specificity are thought to be above 90% and likely above 95%.

Is COVID-19 self-testing available?
Self-testing for COVID-19 is not currently available in Massachusetts.

 

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