SARS-CoV-2 PCR Test EUA
In response to the public health emergency declared by the U.S. Secretary of Health and Human Services, Eurofins Diatherix has developed three highly sensitive and specific assays for the SARS-CoV-2 virus that is the cause of the COVID-19 respiratory infection.
SARS-CoV-2 (Single-target)
Flu Plus (SARS-CoV-2, plus five viral pathogens)
COVID-19 Test (SARS-CoV-2, plus five bacterial pathogens)
Please refer to Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test (EUA200269):
https://eurofins-diatherix.com/covid-19/sars-cov-2-pcr-test-eua
SARS-CoV-2 (Single-target):
Eurofins Diatherix offers identification of the SARS-CoV-2 virus as an individual test.
Flu Plus:
Eurofins Diatherix has developed the Flu Plus test, which includes the SARS-CoV-2 virus along with five additional viral pathogens that can be used to assist healthcare providers with the accurate identification of specific viruses which can be known to exacerbate the recovery for high-risk patients. Flu Plus includes the following viruses:
SARS-CoV-2, Influenza A, A(H1N1)pdm09, Influenza B, Respiratory Syncytial Virus (A&B), Human Rhinovirus/Enterovirus
COVID-19:
Eurofins Diatherix also offers the COVID-19 test which includes the SARS-CoV-2 virus along with five bacterial pathogens which are known to be more prevalent and relevant to the severity of complications in both upper and lower respiratory tract infections. The COVID-19 test includes the following pathogens:
SARS-CoV-2, Chlamydia pneumoniae, Haemophilus influenzae, including Haemophilus influenzae (type B), Moraxella catarrhalis, Mycoplasma pneumoniae, and Streptococcus pneumonia
Please refer to Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test (EUA200269):
https://eurofins-diatherix.com/covid-19/sars-cov-2-pcr-test-eua
Specimen Collection Procedures
Specimen collection procedures for all three tests include:
Nasopharyngeal Aspirate/Wash, Nasopharyngeal Swab, Nasal Swab, Throat Swab, Bronchial Aspirate, and Sputum Specimen Swab
Specimen collection procedures for the COVID-19 Panel are referenced on pages 20 and 21 in our online Client Services Manual at:
../../wp-content/uploads/2022/05/Client_Services_Manual_web_print_052622.pdf
Please refer to Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test (EUA200269):
https://eurofins-diatherix.com/covid-19/sars-cov-2-pcr-test-eua
CMS has defined Local Coverage Determinations (LCDs) for respiratory viral panels. A completed ABN is required for all viral targets. Diatherix Eurofins Flu Plus test includes viral targets. The ABN must be completed by the patient in advance of testing to acknowledge financial responsibility. Please refer to the Eurofins Diatherix Lab Requisition for guidance for all Medicare Part B patients.
Eurofins Diatherix SARS-CoV-2 and COVID-19 test are not a part of these determinations and do not require an Advanced Beneficiary Notice (ABN).
The ABN can be downloaded from our website in the Resource Directory tab under the Miscellaneous Documents section at: https://eurofins-diatherix.com/resources/resource-directory/
Results are typically reported out on the same day as specimen receipt. However, the potential for abnormally high volumes may merit a delay with these results.
Please refer to Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test (EUA200269):
https://eurofins-diatherix.com/covid-19/sars-cov-2-pcr-test-eua
To view our comprehensive Test Menu, please visit: https://eurofins-diatherix.com/resources/test-menu/
Please fill out the form below to have a Eurofins Diatherix representative contact you as soon as possible.
Otherwise, please call 866.979.4242 or
email Client Services at: ClientServices@eurofins-diatherix.com
Links related to COVID-19:
https://www.cdc.gov/coronavirus/2019-ncov/index.html
https://coronavirus.jhu.edu/map.html
Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test (EUA200269) has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories, and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
