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ii. On July 22, 2020, the U.S. Department of Health and Human Services (HHS)
announced the distribution of rapid, antigen point-of-care (POC) testing devices
to some nursing homes, and that nursing homes have the option to purchase
additional instruments and supplies. On August 26, 2020, CMS issued QSO-20-
38-NH (https://www.cms.gov/files/document/qso-20-38-nh.pdf), which
specifies nursing homes with a CLIA waiver (https://www.cms.gov/Regulations-
and-Guidance/Legislation/CLIA/Downloads/HowObtainCertificateofWaiver.pdf)
can meet testing requirements using the POC devices.
iii. While having the benefit of rapid turnaround times, antigen tests generally have
lower sensitivity compared to PCR, and the FDA Emergency Use Authorization
recommends negative antigen tests be considered presumptive.
iv. If antigen testing is available, it can be used for rapid testing of symptomatic
residents and staff, and all negative antigen tests for these individuals must be
followed by collection and shipment of a specimen for PCR testing within 48
hours. Clinicians should use their judgment to determine if a patient has signs
or symptoms compatible with COVID-19
(https://www.cdc.gov/coronavirus/2019-ncov/symptoms-
testing/symptoms.html) and whether the patient should be tested. Most
patients with confirmed COVID-19 have developed fever and/or symptoms of
acute respiratory illness (e.g., cough) but some infected patients may present
with other symptoms (e.g., altered smell or taste) as well. Clinicians are
encouraged to consider testing for other causes of respiratory illness, for
example influenza, in addition to testing for SARS-CoV-2 depending on patient
age, season, or clinical setting; detection of one respiratory pathogen (e.g.,
influenza) does not exclude the potential for co-infection with SARS-CoV-2.
v. Antigen tests may be used to test asymptomatic staff to meet CMS staff serial
testing requirements based on local incidence of COVID-19
(https://www.cdc.gov/coronavirus/2019-ncov/symptoms-
testing/symptoms.html). Facilities should follow CDC test considerations
(https://www.cdc.gov/coronavirus/2019-ncov/hcp/nursing-homes-antigen-
testing.html) and interpretation guidance
(https://www.cdc.gov/coronavirus/2019-ncov/downloads/hcp/nursing-home-
testing-algorithm-508.pdf).
vi. Antigen tests may be used to test asymptomatic residents and staff as part of a
COVID-19 outbreak response. Facilities should follow CDC test considerations
and interpretation guidance. COVID-19 outbreaks must be reported to the
district health department
, including the use of PCR or antigen testing as part of
the response.
vii. All positive and negative results for PCR and antigen testing of residents and
staff must be reported to the health department. Procedures to report these
data are under development and will be published at a later date.