CEPHEID COVID-19 RSV INFLUENZA A/B PCR – Details

Influenza A PCR

NEGATIVE results indicate that viral RNA was not detected. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus and/or respiratory syncytial virus (RSV) infection and should not be used as the sole basis for diagnosis,
treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information. Negative results in asymptomatic individuals cannot be used as definite evidence that an
individual has not been exposed to SARS-CoV-2, influenza viruses, or RSV and has not been infected with any of these viruses.

Specimen source is Nasopharyngeal Swab. Results from Accession 42-21-098-00096 NEGATIVE results indicate that viral RNA was not detected. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus and/or respiratory syncytial virus
(RSV) infection and should not be used as the sole basis for diagnosis, treatment or other patient management
decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information. Negative results
in asymptomatic individuals cannot be used as definite evidence that an individual has not been exposed to SARS-CoV-2, influenza viruses, or RSV and has not been infected with any of these viruses.

Specimen source is Nasopharyngeal Swab. Results from Accession 42-21-098-00096
NOTE:
This test has been authorized by the FDA on September 24,2020 for emergency use by authorized laboratories only for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV)
until emergency authorization is terminated or revoked.
Please refer to the following fact sheets for further information:
Fact Sheet for Healthcare providers – <https://www.fda.gov/media/142435/download>
Fact Sheet for Patients – <https://ww w.fda.gov/media/142436/download>
Testing performed on Cepheid Xp
ertXpress platform.

Influenza B PCR

NEGATIVE results indicate that viral RNA was not detected. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus and/or respiratory syncytial virus (RSV) infection and should not be used as the sole basis for diagnosis,
treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information. Negative results in asymptomatic individuals cannot be used as definite evidence that an
individual has not been exposed to SARS-CoV-2, influenza viruses, or RSV and has not been infected with any of these viruses.

Specimen source is Nasopharyngeal Swab. Results from Accession 42-21-098-00096 NEGATIVE results indicate that viral RNA was not detected. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus and/or respiratory syncytial virus
(RSV) infection and should not be used as the sole basis for diagnosis, treatment or other patient management
decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information. Negative results
in asymptomatic individuals cannot be used as definite evidence that an individual has not been exposed to SARS-CoV-2, influenza viruses, or RSV and has not been infected with any of these viruses.

Specimen source is Nasopharyngeal Swab. Results from Accession 42-21-098-00096
NOTE:
This test has been authorized by the FDA on September 24,2020 for emergency use by authorized laboratories only for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV)
until emergency authorization is terminated or revoked.
Please refer to the following fact sheets for further information:
Fact Sheet for Healthcare providers – <https://www.fda.gov/media/142435/download>
Fact Sheet for Patients – <https://www.fda.gov/media/142436/download>
Testing performed on Cepheid Xp
ertXpress platform.

RSV

NEGATIVE results indicate that viral RNA was not detected. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus and/or respiratory syncytial virus (RSV) infection and should not be used as the sole basis for diagnosis,
treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information. Negative results in asymptomatic individuals cannot be used as definite evidence that an
individual has not been exposed to SARS-CoV-2, influenza viruses, or RSV and has not been infected with any of these viruses.

Specimen source is Nasopharyngeal Swab. Results from Accession 42-21-098-00096 NEGATIVE results indicate that viral RNA was not detected. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus and/or respiratory syncytial virus
(RSV) infection and should not be used as the sole basis for diagnosis, treatment or other patient management
decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information. Negative results
in asymptomatic individuals cannot be used as definite evidence that an individual has not been exposed to SARS-CoV-2, influenza viruses, or RSV and has not been infected with any of these viruses.

Specimen source is Nasopharyngeal Swab. Results from Accession 42-21-098-00096
NOTE:
This test has been authorized by the FDA on September 24,2020 for emergency use by authorized laboratories only for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV)
until emergency authorization is terminated or revoked.
Please refer to the following fact sheets for further information:
Fact Sheet for Healthcare providers – <https://www.fda.gov/media/142435/download>
Fact Sheet for Patients – <https://www.fda.gov/media/142436/download>
Testing performed on Cepheid Xp
ertXpress platform.

SARS-CoV-2 PCR