Coronaviruses (CoV) are a large family of viruses that cause illnesses ranging from the common cold to more severe diseases, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new viral strain that has not been previously identified in humans but has caused a pandemic worldwide.
Sema4 is offering a qualitative real-time PCR assay (RT-PCR) for the detection of active infection with the SARS-CoV-2 virus, consistent with the diagnosis of COVID-19. This testing is recommended for use on respiratory specimens (human oropharyngeal swab and nasopharyngeal swab) from patients suspected by their healthcare providers to have COVID-19. The test utilizes the PerkinElmer New Coronavirus Nucleic Acid Detection Kit, which has been granted emergency use authorization (EUA) by the FDA, and will be available until the FDA revokes its use. This assay is designed to target two specific regions of SARS-CoV-2: the nucleocapsid (N) gene and the ORF1ab gene.
- Oropharyngeal swab: Minimum 1 oropharyngeal swab specimen collected from the patient and submitted in 3mL universal transport medium is required.
- Nasopharyngeal swab: Minimum 1 nasopharyngeal swab specimen collected from the patient and submitted in 3mL universal transport medium is required.
Specimen Rejection Criteria
- Any samples that are received in the following state will not be processed:
- Tube is broken or leaking
- No swab is present
- Tube is not labeled
- Up to 72 hours after collection: Store specimens at 2-8°C
- Any delay in shipping past 72 hours: Store specimens at -70°C or below
Shipping: Please contact laboratory before shipping samples directly
- Specimen stored at 2-8°C: Ship overnight to the lab on ice pack
- Specimen stored at -70°C or below: Ship overnight to the lab on dry ice
- Laboratory Contact Information:
- Tel: 833-486-6260
- Fax: 516-853-8154
- Results for samples received during hours of laboratory operation (Monday-Saturday, 7AM-5PM) are reported to the referring physician within 24 hours of the receipt of the specimen.