COVID-19 Viral RNA Test
- GTR Test IDHelpEach Test is a specific, orderable test from a particular laboratory, and is assigned a unique GTR accession number. The format is GTR00000001.1, with a leading prefix 'GTR' followed by 8 digits, a period, then 1 or more digits representing the version. When a laboratory updates a registered test, a new version number is assigned.: GTR000592470.2
- Last updated: 2021-07-14
- Test version history
Clinical microbial testHelpIn the U.S., clinical tests must be performed under CLIA certification. When a lab uses the same methods for a test in both clinical and research settings, the test appears as two separate GTR records. for COVID-19
Offered by Histogenetics
Overview
Test name
HelpThe name the laboratory assigns the test. Used as the default title of the page specific to the test.COVID-19 Viral RNA Test (COVID-19)
This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Therapeutic management, Diagnosis, Recurrence, Predictive, Screening, Monitoring
Click Indication tab for more information.
Follow Online Instructions
Order URL HelpLink to the laboratory webpage with information about how to order this test. Please note that clicking on this link will open a new tab in your internet browser.: https://clients.histogenetics.com/Covid/CovidClientRegistration.aspx
Specimen source
Sample requirements
Histogenetics COVID-19 Home Kit Instruction ** Please follow the instructions exactly. If the steps are not performed correctly, the results may not be correct. 1. There should be 1 Tube containing 1 FLOQSwab sticks, 1 Biohazard specimen bag per testing individual. 2. Wash and dry hands before opening the kit. Open your kit and place all the contents on a clean, dry surface. 3. Label your name and date of birth on the label on the tube. 4. Open the screw cap of the tube and take the swabs out. Do not touch the tip of the FLOQSwab with your hands. 5. Insert the tip of the FLOQSwab ½ inches inside the nostril (naris). The FLOQSwab does not need to be inserted far – insert just until the tip of the swab is no longer visible. Rotate the swab in a circle around the entire inside mucosa of your nostril at least 3 times and leaving in place for 10 to 15 seconds. Repeat the same action for the other nostril using the same FLOQSwab. 6. Remove the FLOQSwab from your nostril and place in the tube. The tip of the FLOQSwab that touched your nostril should be placed into the tube first. 7. Wash and dry hands thoroughly again. Insert the tube into the biohazard specimen bag. Seal the biohazard specimen bag (See the sealing instruction on the biohazard specimen bag.) 8. Specimens should be delivered at HistoGenetics at room temperature within 24 hours or within 72 hours at 2-4°C after collection. However, it is strongly recommended to return the specimen kit to HistoGenetics within 24 hours by overnight shipping on the same day sample is collected (avoid weekend delivery). 9. Return shipping address (return label not included): Attn: COVID-19 lab HistoGenetics 300 Executive Blvd. Ossining, NY 10562 Phone: +1 914-762-0300 Delivery arrival time should be no later than 10am of each day.Methodology
HelpThe assay's major method category (biochemical, cytogenetic or molecular genetics); method category (i.e. enzyme assay, chromosome breakage studies, targeted mutation analysis); methodology (i.e. the name of the method used) and instruments used when performing this test.- Molecular Genetics
- RRNA analysis
- RT-qPCR
- Applied Biosystems QuantStudio 6 flex Real-Time PCR System
Not provided
Clinical validity
HelpHow consistently and accurately the test detects or predicts the intermediate or final outcomes of interest. Lab-provided.Not provided
Minimal microbe load test can detect
The study results showed that the LoD of the COVID-19 RT-PCR test is 2copies/μL with mean Ct values 35.26 for the N1 target, 35.66 for the N2 targetTest services
HelpLaboratory's order or catalog code for the test (used in the order requisition form).- Result interpretation
- Data Storage and Backup
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