FACT SHEET FOR HEALTHCARE PROVIDERS Coronavirus
Disease 2019
cobas® SARS-CoV-2 – Roche Molecular Systems, Inc. Updated: May 13, 2020 (COVID-19)
This Fact Sheet informs you of the significant known and
potential risks and benefits of the emergency use of the This test is to be performed only using respiratory
cobas® SARS-CoV-2 test. specimens collected from individuals who meet
clinical and/or epidemiological criteria for COVID-19
The cobas® SARS-CoV-2 test is authorized for use on
respiratory specimens from people who meet clinical
testing.
and/or epidemiological criteria for Coronavirus Disease
2019 (COVID-19) testing.
Healthcare Professionals (see links provided in “Where
can I go for updates and more information” section).
All patients whose specimens are tested with this • The cobas® SARS-CoV-2 test can be used to test
assay will receive the Fact Sheet for Patients: clinician-instructed self-collected nasal swab
cobas® SARS-CoV-2. specimens samples (collected on site), and clinician-
collected nasal, nasopharyngeal, and oropharyngeal
swab samples.
• The cobas® SARS-CoV-2 test should be ordered for
What are the symptoms of COVID-19? the detection of COVID-19 in individuals who meet
Most patients with confirmed COVID-19 have developed the COVID-19 clinical and/or epidemiological criteria
fever and/or symptoms of acute respiratory illness (e.g., for testing.
cough, difficulty breathing). The current information • The cobas® SARS-CoV-2 test is only authorized for
available to characterize the spectrum of clinical illness use in laboratories in the United States, certified
associated with COVID-19 suggests that symptoms under the Clinical Laboratory Improvement
include cough, shortness of breath or dyspnea, fever, Amendments of 1988 (CLIA), 42 U.S.C. §263a, to
chills, myalgias, headache, sore throat or new loss of perform moderate or high complexity tests.
taste or smell. Based on what is known about the virus
that causes COVID-19, signs and symptoms may Specimens should be collected with appropriate infection
appear any time from 2 to 14 days after exposure to the control precautions following CDC Interim Infection
virus. Based on preliminary data, the median incubation Prevention and Control Recommendations for Patients
period is approximately 4 days. with Confirmed Coronavirus Disease 2019 (COVID-19)
or Persons Under Investigation for COVID-19 in
Public health officials have identified cases of COVID-19 Healthcare Settings.
infection in the United States, which may pose risks for
public health. Cases of COVID-19 have now been Use appropriate personal protective equipment when
identified in 43 US States and over 115 international collecting and handling specimens from individuals
locations. There also are reports of human to human suspected of having COVID-19 as outlined in the CDC
transmission through close contact with an individual Interim Laboratory Biosafety Guidelines for Handling and
confirmed to be ill with COVID-19, in the United States Processing Specimens Associated with Coronavirus
and globally. Please check the CDC webpage for the Disease 2019 (COVID-19)). For additional information,
most up to date information. refer to CDC Interim Guidelines for Collecting, Handling,
and Testing Clinical Specimens from Persons Under
Investigation (PUIs) for Coronavirus Disease 2019
What do I need to know about COVID-19 testing? (COVID-19) (see links provided in “Where can I go for
Current information on COVID-19 for healthcare updates and more information” section).
providers, including case definitions and infection
control, is available at CDC’s webpage, Information for
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
1|Page
FACT SHEET FOR HEALTHCARE PROVIDERS Coronavirus
Disease 2019
cobas® SARS-CoV-2 – Roche Molecular Systems, Inc. Updated: May 13, 2020 (COVID-19)
What does it mean if the specimen tests positive for COVID-19 is still suspected based on exposure history
the virus that causes COVID-19? together with other clinical findings, re-testing should be
A positive test result for COVID-19 indicates that RNA considered in consultation with public health authorities.
from SARS-CoV-2 was detected, and the patient is
infected with the virus and presumed to be contagious. Risks to a patient of a false negative include: delayed or
Laboratory test results should always be considered in lack of supportive treatment, lack of monitoring of
the context of clinical observations and epidemiological infected individuals and their household or other close
data in making a final diagnosis and patient contacts for symptoms resulting in increased risk of
management decisions. Patient management should spread of COVID-19 within the community, or other
follow current CDC guidelines. unintended adverse events.
The cobas® SARS-CoV-2 test has been designed to What is an EUA?
minimize the likelihood of false positive test results. The United States FDA has made this test available
However, in the event of a false positive result, risks to under an emergency access mechanism called an
patients could include the following: a recommendation Emergency Use Authorization (EUA). The EUA is
for isolation of the patient, monitoring of household or supported by the Secretary of Health and Human
other close contacts for symptoms, patient isolation that Service’s (HHS’s) declaration that circumstances exist to
might limit contact with family or friends and may justify the emergency use of in vitro diagnostics (IVDs)
increase contact with other potentially COVID-19 for the detection and/or diagnosis of the virus that
patients, limits in the ability to work, the delayed causes COVID-19.
diagnosis and treatment for the true infection causing the
symptoms, unnecessary prescription of a treatment or An IVD made available under an EUA has not
therapy, or other unintended adverse effects. undergone the same type of review as an FDA-approved
or cleared IVD. FDA may issue an EUA when certain
All laboratories using this test must follow the standard criteria are met, which includes that there are no
confirmatory testing and reporting guidelines according adequate, approved, available alternatives, and based
to their appropriate public health authorities. on the totality of scientific evidence available, it is
reasonable to believe that this IVD may be effective in
What does it mean if the specimen tests negative for the detection of the virus that causes COVID-19.
the virus that causes COVID-19?
A negative test result for this test means that SARS- The EUA for this test is in effect for the duration of the
CoV-2 RNA was not present in the specimen above the COVID-19 declaration justifying emergency use of IVDs,
limit of detection. However, a negative result does not unless terminated or revoked (after which the test may
rule out COVID-19 and should not be used as the sole no longer be used).
basis for treatment or patient management decisions. A
negative result does not exclude the possibility of
COVID-19.
When diagnostic testing is negative, the possibility of a
false negative result should be considered in the context
of a patient’s recent exposures and the presence of
clinical signs and symptoms consistent with COVID-19.
The possibility of a false negative result should
especially be considered if the patient’s recent
exposures or clinical presentation indicate that COVID-
19 is likely, and diagnostic tests for other causes of
illness (e.g., other respiratory illness) are negative. If
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
2|Page
FACT SHEET FOR HEALTHCARE PROVIDERS Coronavirus
Disease 2019
cobas® SARS-CoV-2 – Roche Molecular Systems, Inc. Updated: May 13, 2020 (COVID-19)
Where can I go for updates and more information?
CDC webpages:
General: https://www.cdc.gov/COVID19
Healthcare Professionals:
https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html
Information for Laboratories: https://www.cdc.gov/coronavirus/2019-
nCoV/guidance-laboratories.html
Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019-
nCoV/lab-biosafety-guidelines.html
Isolation Precautions in Healthcare Settings:
https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-
recommendations.html
Specimen Collection: https://www.cdc.gov/coronavirus/2019-
nCoV/guidelines-clinical-specimens.html
FDA webpages:
General: www.fda.gov/novelcoronavirus
EUAs:(includes links to patient fact sheet and manufacturer’s
instructions) https://www.fda.gov/medical-devices/emergency-
situations-medical-devices/emergency-use-authorizations
Roche Molecular Systems, Inc.:
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588
Roche HCP Support
1-866-987-6243
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
3|Page
