SARS-CoV-2 Detection Test

Description

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 thepresence 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 willbe processed only at Gene By Gene. Following receiving swab specimens, nucleic acid willbe extracted using an automated system followed by an rRT-PCR assay. We are using theexact 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 ofthe 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. Eachassay run will contain a non-template control, internal process/extraction control, and positivecontrol 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.

Sample requirements

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). 

Samples that are expected to be received within 7-30 days after collection should be stored and shipped at 4°C.  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.

ordering a test

If you are a healthcare provider or employer interested in our COVID-19 testing services, please contact us at covid19@genebygene.com.

SARS-CoV-2 Detection Test (U0004) Cash Price: $100

Additional Statements About COVID-19 Tests

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
  • This 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.