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This means that SARS-CoV-2 (the virus that causes COVID-19) was not detected in the patient’s sample collected on
Oct 24, 2021.
• A negative result does not rule out a SARS-CoV-2 infection, irrespective of the sample type. If clinical suspicions
exist, no clinical action and management should be based solely on a negative test result. Clinical symptoms,
patient history, and epidemiological information must be considered when interpreting a negative result.
• Variability in collection technique can reduce the sensitivity of the test, and SARS-CoV-2 may not be detected
in early stages of infection.
• False negatives are possible.
• If this patient is experiencing symptoms, consider collecting a new sample for COVID-19 testing or testing for
other respiratory viruses.
• Collection of multiple specimens may be necessary to detect the SARS-CoV-2 virus.
To learn more about the technical details of this test, please see the test methodology and
limitations section.
HELPFUL Because it is possible for this test to give a false negative in some people with COVID-19, if you
INFORMATION have symptoms of illness (such as fever, cough, and/or shortness of breath), you should discuss
FOR THE PATIENT your symptoms and your test results with your doctor, who can decide how to care for you.
The US Centers for Disease Control and Prevention (CDC) has provided useful information on
how to care for yourself at home and how others in your household may protect themselves. The
CDC has also provided information on when to seek medical attention. Key points are outlined
below for your reference, and you can find more information at: https://www.cdc.gov/
coronavirus/2019-ncov.
The CDC recommends that individuals experiencing the following symptoms get medical
attention immediately:
• Trouble breathing
• Persistent pain or pressure in the chest
• New confusion
• Inability to stay awake or wake after sleeping
• Bluish lips or face
If you are a healthcare professional, first responder, or frontline worker with questions about
returning to work, consider contacting your place of employment or local health department in
regards to discontinuation of self-isolation, as they may differ from the CDC’s guidelines.
The SARS-CoV-2 RT-PCR amplification test was performed at the CDPH Branch Laboratory, 28454 Livingston Ave.,
Valencia, CA 91355, CLIA #05D2197416). Data were transmitted to Color Genomics (863A Mitten Road, Suite 100F,
Burlingame, CA 94010, CLIA #05D2081492), for report generation and distribution.
The SARS-CoV-2 RT-PCR amplification test is not FDA approved; it is a laboratory-developed test (LDT). The FDA has
determined that emergency use authorization (EUA) review of SARS-CoV-2 LDTs is not required at this time.
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Disclaimer:
The detection of viral nucleic acids by this SARS-CoV-2 RT-PCR assay depends on proper sample collection, handling,
transportation, storage, and preparation. False negative results may occur due to improperly collected, transported, or
handled swab samples, inadequate numbers of organisms for amplification, or the presence of inhibitors or sequence
variation in the targets of the assay. False positive results may occur due to potential cross-contamination by target
organisms, their nucleic acid or amplified product, or from non-specific signals in the assay. This SARS-CoV-2 RT-PCR
test does not detect or differentiate any other respiratory virus types. Results from this test should be interpreted in
conjunction with other clinical and laboratory findings.
This test was developed and its performance characteristics determined by the CDPH Branch Laboratory, Valencia, CA. It
has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such
clearance or approval is not necessary.