Updated July 17, 2020

The CDC suggests that molecular testing (eg, PCR, NAA) can be used for diagnostic purposes (eg, when testing individuals with symptoms consistent with COVID-19), screening purposes (eg, when testing asymptomatic individuals with known or suspected recent exposure to SARS-CoV-2), and surveillance purposes (eg, when testing asymptomatic individuals to detect transmission hot spots or characterize disease trends).¹

Updated July 17, 2020

According to the CDC, molecular diagnostic testing (eg, NAA, PCR) is appropriate for the following groups¹:

• Individuals with signs or symptoms consistent with COVID-19
• Asymptomatic individuals with recent known or suspected exposure to SARS-CoV-2 to control transmission
• Asymptomatic individuals without known or suspected exposure to SARS-CoV-2 for early identification in special settings
• Individuals being tested to determine if infections have resolved
• Individuals being testing for purposes of public health surveillance for SARS-CoV-2

Local and regional health authorities may provide additional guidance for prioritizing patients for COVID-19 testing. Clinicians are also encouraged to consider testing for other causes of respiratory illness, including influenza.

The environment surrounding COVID-19 testing is evolving rapidly. For the most up-to-date guidance, please visit the CDC’s Overview of Testing for SARS-CoV-2 page.

Updated May 23, 2020

Antibody testing is not currently recommended to diagnose infection or to infer an individual’s immunity to the virus. It may aid in determining the rate of exposure in a given population. Antibody testing can also help identify individuals who have been exposed to SARS-CoV-2 in order to qualify potential convalescent plasma donors. COVID-19 convalescent plasma is currently being studied as a possible treatment for individuals who are critically ill with COVID-19 and as a prophylactic means of protecting individuals at high risk of exposure.²

Updated July 17, 2020

Based on available evidence, children do not appear to be at higher risk for COVID-19 than adults. Limited information is available about the spectrum of clinical illness related to COVID-19 in children, although they do appear to present with more mild signs and symptoms than adults.³ Although severe disease is uncommon, early case studies and reports suggest that infants may be at a higher risk for severe illness from COVID-19 compared with older children.³

The CDC is investigating reports of multisystem inflammatory syndrome in children (MIS-C), a serious condition marked by inflammation that may be related to resolved COVID-19 infection. At this time, there is limited information available about risk factors, pathogenesis, and clinical course. The CDC has issued a health advisory instructing clinicians to watch for signs and symptoms, which may include a persistent fever, elevated inflammatory markers, and multiorgan (eg, cardiac, gastrointestinal, renal) involvement.³

Updated July 7, 2020

Yes, some multipathogen molecular assays can detect SARS-CoV-2.⁴

Clinicians are advised to confirm which respiratory viruses are detected by an assay before ordering it.

Updated July 24, 2020

Nasopharyngeal (NP) specimens are preferred for swab-based COVID-19 diagnostic testing. If NP specimens are not available, an oropharyngeal (OP), midturbinate, or anterior nares specimen is acceptable.^5,6

Detection rates in specimen types vary from patient to patient and may change over the course of the illness. For example, because of potentially discordant shedding of virus in the upper versus the lower respiratory tract, patients with pneumonia may have negative nasal or OP samples but positive lower airway samples.^7,8

Swab specimens should be collected with NP ultrafine or equivalent swabs. Dacron, polyester-tipped, or any other flocked swabs are acceptable alternatives. Calcium alginate swabs or swabs with wooden shafts are NOT acceptable due to test interference. Viral transport media and universal transport media (VTM/UTM) are the preferred collection systems for swabs. Media types that are equivalent to VTM/UTM are also acceptable. For alternative transport media, refer to the FDA’s guidance on specimen collection for SARS-CoV-2 molecular diagnostic testing.⁶

Some laboratories may accept alternative specimen types; clinicians are advised to check with their performing laboratory for specific specimen requirements. There are limited data on how alternative specimen types affect test sensitivity, but evidence thus far suggests that specimens such as nasal swabs may be less sensitive than NP swabs.⁹

For the FDA’s full recommendations on specimen type and collection, refer to FAQs on Testing for SARS-CoV-2.