SARS-CoV-2 Detection Test
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).
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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).
Enquire OnlineThe 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.
Cost
SARS-CoV-2 Detection Test (U0004) Cash Price: $300
SARS-CoV-2 Detection Test (U0005) Cash Price: $75
SARS-CoV-2 Detection Test (G2023) Cash Price: $100
SARS-CoV-2 Detection Test (G2024) Cash Price: $100
HCPCS P9603: Per Mile Travel Allowance to be used in situations when the round trip is greater than 20 miles. Reimbursement computed using the Federal mileage rate of $0.575 per mile plus as additional $0.45 per mile to cover time and travel costs.
HCPCS P9604: Flat-Rate Trip based on travel allowance is $10.10.
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.
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.
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, labelling and 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.
Results
Shipping
Testing Methodology
Turnaround Time
Price
$75 - $300 (See Below)
Inquire for pricing
Product Brochure
Submit the adjacent Test Request Form and our laboratory will be in touch to confirm your inquiry.