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.
- Upper Respiratory Swab: Minimum of one upper respiratory swab (i.e. oropharyngeal, nasopharyngeal, nasal) specimen collected from the patient and submitted in 3mL universal transport medium is required.
Specimen Rejection Criteria
- Any specimens that arrive at the facility in any of the following conditions will not be processed:
- Broken or leaking tube
- No swab is present
- Tube is not labeled
- Use of calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and/or inhibit PCR testing.
- Use of metal or organic material swabs.
- Up to 72 hours after collection: Store specimens at 2-8°C
Shipping: Please contact laboratory before shipping samples directly
- Specimen stored at 2-8°C: Ship overnight to the lab on ice pack
- Laboratory Contact Information:
- Tel: 800-298-6470
- Fax: 646-859-6870
- 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.