Clinical Lab Handbook

Specimen: Nasopharyngeal or nares swab in M4RT viral transport tube.

Specimen Viability: Nasopharyngeal swab, and anterior nasal swab, and mid-nasal turbinate swab specimens can be stored refrigerated (2–8 °C) up to seven days in viral transport medium, saline or eNAT medium

The Xpert Xpress SARS-CoV-2 test is an automated in vitro diagnostic test for qualitative detection of nucleic acid from SARS-CoV-2. The Xpert Xpress SARS-CoV-2 test is performed on GeneXpert Instrument Systems.

The primers and probes in the Xpert Xpress CoV-2 plus test are designed to amplify and detect unique sequences in the nucleocapsid (N), envelope (E) and RNA-dependent RNA polymerase (RdRP) genes of the SARS-CoV-2 virus genome.

The Xpert Xpress SARS-CoV-2 test is a rapid, real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in either nasopharyngeal, anterior nasal or mid-turbinate swabs specimens collected from individuals suspected of COVID-19 by their healthcare provider, as well as anterior nasal swab from any individual, including those without symptoms.

Results are for the detection of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal swab specimens and/or nasal wash/ aspirate specimens during the acute phase of infection. Positive results are indicative of active infection with SARS-CoV-2; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

Monday through Sunday

Available STAT

CPT 87635

Nasopharyngeal Swab Collection Procedure

1. Insert the swab into either nostril, passing it into the posterior nasopharynx
2. Rotate swab by firmly brushing against the nasopharynx several times.
3. Remove the swab and place into M4RT media tube.
4. Break swab at the indicated break line and cap the specimen collection tube tightly.

Mid-turbinate swab collection

1. Insert the swab into either nostril, passing it into the mid-turbinate area (just distal to the nasopharynx) nasopharynx .
2. Rotate swab by firmly brushing against the nasopharynx several times.
3. Remove the swab and place into M4RT media tube.
4. Break swab at the indicated break line and cap the specimen collection tube tightly.

Anterior Nasal swab collection.

1. Insert the swab into either nostril 1 to 1.5 cm into nostril.
2. Insert the swab into either nostril 1 to 1.5 cm into nostril.
3. Rotate swab against the inside of the nostril for 3 seconds while applying pressure with a finger to the outside of the nostril.
4. Repeat in opposite nostril.
5. Remove the swab and place into M4RT media tube.
6. Break swab at the indicated break line and cap the specimen collection tube tightly.