The laboratory has 2 methods for this test.

Hologic assay - TMA

Cepheid Assay - PCR

Rapid testing is limited by reagent availability, therefore will be performed under specific criteria set by incident command. 

Rapid TAT is approximately 2 hr. All others will be performed on our routine method with a TAT of 1-3 days.

**This test is NOT for BAL, oropharyngeal swab, nasal swab, saliva or expectorated sputum specimens.  See Coronavirus Disease 2019 (COVID-19), PCR (WSLH) test instead. ** 

One Nasopharyngeal swab in viral transport medium (UTM w/NP Swab) or Hologic Direct Load Capture Cap Collection container with FLOQSwabs (Catalog Number PRD-06952).

1. Collect and label specimen. Make sure cap is on tightly.

2. Place specimen in a biohazard specimen bag and send to the lab.

Refer to Nasopharyngeal Swab Collection for Respiratory PCR Testing for proper collection.  

Collection Fee-HBC9803

Tracheal Aspirates are also acceptable. Please collect 1-2 mL of aspirate in a tracheal collection device. If tracheal aspirate is viscous it can be transported in the collection container. If aspirate is runny then it should be poured over in a sterile urine container. Please ensure caps are tight and container double bagged.

Stability Ambient: Refrigerate as soon as possible

Stability Refrigerated: 72 hours

Stability Frozen: 4 weeks

Tracheal aspirates should be refrigerated not frozen. 

Store specimens refrigerated (2-8 °C) and transport with chilled cool pack. Specimens must arrive at the laboratory < 72 hours after collection.

If testing is needed >72 hours after collection, freeze (-70°C) samples within 72 hours and ship on dry ice.

Ship as Category B

Tracheal aspirates should be refrigerated not frozen during transportation.

Samples stored at 4°C for >72 hours

Swabs other than nasopharyngeal are not acceptable

Transport media received without a swab are not acceptable

Dry swabs or swabs in unapproved media

Expected results: SARS-CoV-2 PCR Not Detected

Negative results do not preclude SARS-CoV-2 infection.

False negative results may be due to the suppression of viral replication to levels below the detection threshold, or to inhibitory substances present in the specimen.

Inadequate specimen collection, processing and storage may invalidate test results. This test should not be used as the only criterion to form a clinical conclusion; instead, results should be correlated with other test results, patient symptoms and clinical presentation.

Collection Fee-HBC9803

Hologic Panther SARS-CoV-2  TMA Assay (Hologic Assay): The Hologic assay is a Transciption-Mediated Amplification (TMA) in vitro diagnostic test intended for the qualitative detection of RNA from the SARS-CoV-2. The Panther SARS-CoV-2 assay is for use only under Emergency Use Authorization (EUA) in U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. Hologic FDA Fact Sheet for Healthcare Providers

Patient Fact Sheet: https://www.fda.gov/media/136155/download

Cepheid Xpert Xpress SARS-CoV-2 (Cepheid Assay): The Xpert Xpress SARS-CoV-2 assay is a real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of RNA from the SARS-CoV-2 isolated and purified from primarily nasopharyngeal (NP) swab specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria. The Xpert Xpress SARS-CoV-2 assay is for use only under Emergency Use Authorization (EUA) in U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high and moderate complexity tests. 

Fact Sheets for Providers and Patients: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

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 Positive results are indicative of the detection of SARS-CoV-2 RNA and the patient is presumptively infected with the virus and presumed to be contagious. Results should he correlated with patient history and other clinical information as necessary to determine patient infection status. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions.

 A negative result does not exclude the possibility of COVID-19, but rather indicates that SARS-CoV-2 RNA was not present in the specimen above the limit of detection or due to presence of inhibitory substances present in the specimen. Inadequate specimen collection, processing and storage may invalidate test results. Consequently, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions.

The performance characteristics, including analytical sensitivity, of this test using specimens other than nasopharyngeal (NP) swabs has not been established and may result in false negative results.  Based on validation results, an NP swab in UTM transport media is recommended for testing.  Other specimens and combinations of swabs and transport media may be acceptable based on limited validation data.  Negative results must be combined with clinical observations, patient history, and epidemiological information and should not be used as the sole basis for patient management decisions or treatment, as they do not preclude infection.

Under the Clinical Laboratory Improvment Amendments of 1988 (CLIA) for high complexity labs, this test has been validated by the University of Wisconsin Hospital Clinical Laboratories and its performance  evaluated in accordance with Emergency Use Authorization (EUA) requirements.