2019 Novel Coronavirus (COVID-19) With Influenza A and Influenza B

Casandra

Casandra Test Code LC95321Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID 140147CPT Code 87636

2019 Novel Coronavirus (COVID-19) With Influenza A and Influenza B

Clinical Use

Order Test

Use

Results are for the identification and differentiation of RNA from SARS-CoV-2, Influenza A and Influenza B.

Special Instructions

Labcorp does not currently collect specimens for this test at their locations. Patients should have specimen collection performed at the healthcare facility where they receive treatment or testing orders. Specimens should then be sent to Labcorp using standard procedures for processing.

Limitations

The test is intended for use under the FDA's Emergency Use Authorization and has not been FDA cleared or approved. False negatives may occur depending on the timing of sample collection or variability in viral shedding. In such cases, test results should be interpreted in the context of clinical signs and symptoms as well as patient exposure history. Additionally, substances such as heparin, hemoglobin, ethanol, and EDTA at concentrations above 0.01M should not be present in specimens as these can inhibit PCR and potentially cause test failure.

Test Details

Methodology

PCR-based (RT-PCR)

Biomarkers

Influenza A

Microorganism

Influenza A NAA • Other • Binary (Detected / Not Detected)

Influenza B

Microorganism

Influenza B NAA • Other • Binary (Detected / Not Detected)

SARS-CoV-2

Microorganism

SARS-CoV-2 NAA • Other • Binary (Detected / Not Detected)

LOINC Codes

Order Codes

95380-2

Result Codes

94759-8
76078-5
76080-1

Result Turnaround Time

1-3 days

Specimen

Nasopharyngeal Swab

Volume

1 - 3 mL

Minimum Volume

1 mL

Container

nasopharyngeal (NP) swab in VTM/UTM or 0.9% saline

Collection Instructions

Collect using standard techniques. Place the swab into VTM/UTM and cap tightly.

Storage Instructions

Frozen at -20° C (preferred). Refrigerated specimens and room temperature specimens (if received for testing within 72 hours of collection) are also acceptable.

Causes for Rejection

Specimens that are beyond the established stability, improperly labeled, grossly contaminated, broken, with significant leakage in transit, improperly collected or shipped, or containing substances inhibitory to PCR.