The SARS-CoV-2 Detection Test detects the presence of nucleic acid from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that causes novel coronavirus disease (COVID-19). Its intended use is for patients who meet the Centers for Disease Control and Prevention (CDC) criteria for evaluation of infection with COVID-19.
The SARS-CoV-2 Detection kit is a real-time RT-PCR (rRT-PCR) assay used to detect the presence of SARS-CoV-2 RNA isolated from nasal swab specimens. The SARS-CoV-2Detection kit will contain a specimen swab, transport media and instruction for use. All kits will be processed only at Gene By Gene. Following receiving swab specimens, nucleic acid will be extracted using an automated system followed by an rRT-PCR assay. We are using the exact primer and probe sequences as the FDA authorized CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (EUA200001/A002). In the assay, two regions of the nucleocapsid phosphoprotein (gene N) are targeted to detect the presence of SARS-CoV-2RNA while the human Ribonuclease P (RNase P) is used as an endogenous control. Each assay run will contain a non-template control, internal process/extraction control, and positive control to monitor assay performance.
Gene By Gene does not collect specimens for COVID-19 testing. Patients for whom testing has been ordered should not be sent to Gene By Gene to have a specimen collected.
Gene By Gene will provide nasal swab kits with each order. All samples must be collected by a qualified healthcare professional.
Shipping: Sender is responsible for ensuring the correct designation, packaging, labellingand documentation of substances.
Samples can be stored and shipped at room temperature (if received for testing within 7 days of collection).
When shipping, label the packaging with “UN3373 Substance Category B”. Please follow shipping and transport guidelines set forth by the Centers for Disease Control and Prevention (CDC). Further information can be found at https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html
For additional information, please go to the healthcare provider page.
If you are a healthcare provider or employer interested in our COVID-19 testing services, please contact us at email@example.com.
SARS-CoV-2 Detection Test (U0004) Cash Price: $100