Sign in →

Test Code LAB6104A2 COVID-19 PCR

Important Note

Intended Use:  For the qualitative detection of SARS-CoV-2 virus RNA in upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

This test is only approved for testing human upper respiratory specimens under U.S. FDA emergency use authorization (EUA).  Fact sheets for this EUA assay can be found at the following links:

For Healthcare Providers:  https://www.fda.gov/media/136313/download

For Patients:  https://www.fda.gov/media/136312/download

Performance of this SARS-CoV-2 RNA test has only been established in individuals suspected of having COVID-19 by their healthcare provider.  A negative result may not rule out COVID-19 in the patient, as the sensitivity of the test depends on the timing of the specimen collection, type of specimen, and the quality of the specimen. Result should be correlated with patient's history and clinical presentation.

Methodology

Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) performed using the Xpert Xpress SARS-CoV-2 test (Cepheid).

Performing Laboratory

RCH

Specimen Requirements

Preferred:  Nasopharyngeal Swab in 3 mL Viral Transport Medium (VTM). 

Alternative Sample Types: Nasal wash/aspirate, Mid-Turbinate Swab or Nasal Swab in VTM

Proper specimen collection, storage, and transport are critical to the performance of this test. 

Specimen Stability:

Store and Transport Refrigerated (2–8 °C)

Stable up to seven days refrigerated.

Stable at Room temperature (15–30 °C) up to 8 hours

 

Nasopharyngeal Swab Collection Procedure

Insert the swab into a nostril, passing it into the posterior nasopharynx (see Figure 1). Rotate swab by firmly brushing against the nasopharynx several times. Repeat the procedure for the other nostril using the same swab.  Place the swab into the tube containing 3 ml of viral transport medium. Break swab at the indicated break line and cap the specimen collection tube tightly.

 

Mid-Turbinate Swab Collection Procedure

Insert the mid-turbinate swab into a nostril, passing it into the mid-turbinate area (see Figure 4). Rotate swab by firmly brushing against the mid-turbinate area several times. Repeat the procedure for the other nostril using the same swab.  Place the swab into the tube containing 3 ml of viral transport medium. Break swab at the indicated break line and cap the specimen collection tube tightly.

 

 

Nasal Swab Collection Procedure

Insert a nasal swab 1 to 1.5 cm into a nostril. Rotate the swab against the inside of the nostril for 3 seconds while applying pressure with a finger to the outside of the nostril (see Figure 2). Repeat on the other nostril with the same swab, using external pressure on the outside of the other nostril.  To avoid specimen contamination, do not touch the swab tip to anything other than the inside of the nostril.   Remove and place the swab into the tube containing 3 ml of viral transport medium. Break swab at the indicated break line and cap the specimen collection tube tightly.

 

Day(s) Test Set Up

Monday-Sunday

Test Classification and CPT Coding

87635