SARS-CoV-2(COVID-19) and Influenza A&B
Ordering Recommendation
Beginning to feel symptoms (coughing, fever, runny nose, difficulty breathing, loss of smell or taste, etc.) Contact with someone who tested positive for COVID-19.
Methodology
Real Time – Polymerase Chain Reaction (RT-PCR)
Reported
36 hrs by text and email
Specimen Required
Patient Preparation:
Collect:
Nasopharyngeal swab
Specimen Preparation:
Place swab in viral transport media. Place each specimen in an individually sealed bag. Note: Please ensure the swab tip comes into contact with the collection site only.
Storage/Transport Temperature:
Storage: 2-8°C for up to 72 hrs.
Transport: 15-30°C
Unacceptable Conditions:
Less than 400mL of sample, visibly contaminated, and stored at room temperature for longer than 72 hrs (3 days)
Stability:
Ambient: 72 hrs
Refrigerated: 14 days
Notes
Positive results indicate active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by this test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of the disease. Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B 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/or epidemiological information.
Testing was performed at a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, meeting the requirements for high-complexity tests.
This test employs the kit authorized by FDA under an Emergency Use Authorization (EUA). It has been validated per the FDA’s Guidance Document (Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA before Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency) issued on February 29th, 2020. This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of ACT, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is determined of revoked sooner.
Tests are performed by Promis Diagnostics, 1 Post, Suite, Irvine, Ca92618 CLIA#: 05D2185450 CAP # 879466501
CPT Codes
87636