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COVID-19 (SARS-CoV-2)

Clinical Specimen Submission Guidance

Submit all specimens to 50 Orms St, Providence RI 02904. Open Monday to Friday 8:30 AM to 4:30 PM

Lab

Molecular Diagnostics Laboratory 401-222-5538

Analyte Name

Coronavirus

Disease

COVID-19 (Coronavirus Disease 2019)

Test Description

CDC INFLUENZA SARS-COV-2 (Flu SC2) MULTIPLEX

The Centers for Disease Control (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay is a real-time reverse transcriptase polymerase chain reaction (RT-PCR) test that detects and differentiates RNA from SARS-CoV-2, influenza A virus, and influenza B virus in upper and lower respiratory patients in the acute phase of infection. The Flu SC2 Multiplex Assay is only for use under FDA Emergency Use Authorization and assay performance characteristics were verified by the RISHL.

Results should be used in conjunction with the patient's clinical symptoms, medical history, and other clinical/laboratory findings to determine an overall clinical diagnosis. Negative results do not preclude infection with SARS-CoV-2.

Provider Fact Sheet: https://www.fda.gov/media/139742/download

Patient Fact Sheet: https://www.fda.gov/media/139745/download

HOLOGIC APTIMA SARS-COV-2

The Hologic Aptima SARS-CoV-2 Assay is a transcription mediated nucleic acid amplification test intended for the qualitative molecular detection of RNA from SARS-CoV-2 in upper respiratory specimens from individuals suspected of COVID-19.The Hologic Aptima SARS-CoV-2 Assay is only for use under FDA Emergency Use Authorization and assay performance characteristics were verified by the RISHL.

Results should be used in conjunction with the patient's clinical symptoms, medical history, and other clinical/laboratory findings to determine an overall clinical diagnosis. Negative results do not preclude infection with SARS-CoV-2.

Provider Fact Sheet: https://www.fda.gov/media/138095/download

Patient Fact Sheet:https://www.fda.gov/media/138098/download

CEPHEID XPERT SARS-COV-2/FLU/RSV Plus MULTIPLEX ASSAY

The Cepheid Xpert SARS-CoV-2/Flu/RSV Plus Multiplex Assay is a real-time reverse-transcriptase polymerase chain reaction (RT-PCR) test that detects and differentiates RNA from SARS-CoV-2, influenza A virus, influenza B virus, and RSV in upper or lower respiratory specimens from patients in the acute phase of infection. The SARS-CoV-2/ Flu/RSV Plus Multiplex Assay is only for use under FDA Emergency Use Authorization and assay performance characteristics were verified by the RISHL.

Results should be used in conjunction with the patient's clinical symptoms, medical history, and other clinical/laboratory findings to determine and overall clinical diagnosis.

Provider Fact Sheet: https://www.fda.gov/media/152162/download

Patient Fact Sheet:https://www.fda.gov/media/152166/download

Specimen

For RISHL COVID-19 specimen collection instructions, click here.

Store specimens at 2° to 8° C up to 3 days.  If unable to transport within 3 days specimens may be frozen at -20° C.

Collected specimens must be delivered to the RISHL within 3 days of collection for specific SARS-CoV-2 testing and a respiratory panel (upon request only).

For questions regarding collection or transport of specimens contact the Molecular Diagnostics Laboratory at (401) 222-5538.

CLIA regulations require two patient identifiers on the specimen container and the test requisition.

Form Required

Rhode Island State Health Laboratories (RISHL) test requisition form /forms/LabRequisitionForm.pdf

Test Request

COVID-19 PCR

Transport

Specimens must be transported in accordance with current federal shipping regulations and must be received within 3 days of collection.

Normal Value

Negative / Not Detected

Reporting Requirement

Providers must report patient information on COVID-19 immediately using the RIDOH reportable disease form.

Turnaround Time

3 business days