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Rapid COVID-19 PCR

eD-H Order Code

LAB4237

Specimen Collection Information

Specimen Minimum Test Volume Container Special Handling
NP Swab 3.0 ML See Below  

Due to limitations of collection devices, this is the preferred collection device

Specimen Transport Temperature

Refrigerate

Reference Ranges / Critical Values

Assay Gender Age Range Normal Range Critical Values Units
SARS-CoV-2 RNA (Rapid) All 0 Minutes – 150 Years Not Detected    

Specimen Stability

72 hours

Additional Specimen Instructions

Additional acceptable specimens:

NP swab collected in viral transport media or universal transport media

Interpretive Data

Assay Display Interpretive Data
SARS-CoV-2 RNA (Rapid) This result should be interpreted in combination with the clinical observations patient history and epidemiological information. For testing of asymptomatic individuals assay performance characteristics and clinical utility have not been evaluated. Testing for SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2 formerly known as 2019 novel coronavirus or 2019-nCoV) to aid in the diagnosis of COVID-19 is performed using the Simplexa COVID-19 Direct Assay by DiaSorin Molecular as authorized by the FDA issued Emergency Use Authorization (EUA). This assay is intended for In-vitro Diagnostic (IVD) use with nasopharyngeal swabs collected from individuals meeting the CDC criteria for testing. The assay is performed based on the instructions for use and additional guidance provided by the FDA. Testing is performed in the Microbiology Laboratory within the Department of Pathology and Laboratory Medicine at Dartmouth-Hitchcock Medical Center certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 42 U.S.C. section 263a to perform high complexity tests. Assay performance has been verified according to clinical laboratory regulatory requirements. Test results are provided above. A result of “Not Detected” indicates that the viral RNA target is not present but does not preclude SARS-CoV-2 infection. False negative results may occur if a specimen is improperly collected transported or handled; if amplification inhibitors are present; or if inadequate numbers of viral particles are present in the specimen. A result of “Detected” suggests a current or recent infection and the patient is presumed to be infected. Positive and negative predictive values for this test are highly dependent on disease prevalence. A result of “Invalid” indicates the inability to conclusively determine the presence or absence of SARS-CoV-2 RNA in the sample which can be due to a variety of factors. Recollection is recommended in the case of an invalid result. CDC COVID-19 criteria for testing on human specimens and clinical management guidance information are available at the CDC Coronavirus Disease 2019 (COVID-19) webpage under “Information for Healthcare Professionals” (https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html). Additional information about this and other EUA tests can be found in provider and patient fact sheets at the following FDA website: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas

Day(s) Performed

Monday through Sunday; continuously

CPT(s)

_

Performing Lab Section

Microbiology