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HelpTest Code CoV2 RNA SARS-CoV-2 Molecular Test
Useful For
This test is intended for the qualitative detection of nucleic acid obtained from respiratory specimens from individuals suspected of Coronavirus Disease 2019 (COVID-19) by their healthcare provider. The SARS-CoV-2 RNA is normally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of the SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine the patient infection status. Positive results do not rule out bacterial infection or co- infection with other viruses. Negative results do not preclude SARS-CoV-2 infection, should not be used as the sole basis for patient management decisions, and must be combined with clinical observations, patient history, and epidemiological information.
Patient Preparation
Patient should be seated comfortably with head tilted back for nasopharyngeal collection.
Special Collection Instructions
Collect NP swab, or OP swab specimens according to standard technique using a polyester-, rayon-, or nylon-tipped swab. Immediately place the swab specimen into 3mL of VTM or UTM. Swab specimens may alternatively be added to saline, Liquid Amies or STM.
Use appropriate personal protective equipment when collecting and handling specimens from individuals suspected of being infected with SARS-CoV-2 as outlined in CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV).
Collection Method
Nasopharyngeal or Oropharyngeal Swab
Minimum Volume
1 swab in 5 mL viral transport media
Container
Universal Viral Transport Media
Preferred Specimen
Nasopharyngeal (NP) Swab
Acceptable Specimens
Oropharyngeal (OP) Swab
Reference or Target Ranges
Negative/Not Detected
Reportable Units
Postiive/Negative or Not Detected /Invalid
Critical Value
None defined
Reasons for Rejection
| Hemolysis Threshold | N/A |
| Icterus Threshold | N/A |
| Lipemia Threshold | N/A |
| Interfering Subtances/Other | If a swab is received in an inadequate volume of viral transport media, it must be rejected. |
Specimen Stability
| Ambient | Swab in APTIMA tube: 6 Days |
| Refrigerated (4°C to 8°C) | Swab in transport media: 96 hours Swab in APTIMA tube: 3 months |
| Frozen(-70°C to 0°C) | Swab in transport Media: 3 months |
Performance Information
| Days and Time Performed | Monday - Saturday |
| Expected Turn Around Time | 24 Hours on receipt in lab |
| Stat Availabilty | No |
| Performing Bench | Molecular Pathology |
| Methodology/Method Description | Transcription Mediated Amplification/Dual Kinetic Assay by Hologic Panther® |
Special Handling
Handle all specimens as if they contain potentially infectious agents. Use Universal Precautions.
Take care to avoid cross-contamination during specimen handling steps. For example, discard used material without passing over open tubes.
Additional Information/Important Notes
FTD SARS-CoV-2 is only for use under the Food and Drug Administration’s (FDA) Emergency Use Authorization. This test has not been reviewed by the FDA. This test is being distributed in accordance with Section IV.C. of the FDA’s policy for diagnostic tests for Coronavirus disease – 2019 during the public health emergency.
CPT Codes
87635