Clinical Specimen Submission Guidance: Department of Health

Centers for Medicare & Medicaid Services
CLIA Certificate of Compliance for High Complexity Clinical Laboratory
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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

Influenza Virus
Lab	Molecular Diagnostics Laboratory 401-222-5538
Pathogen	Influenza Virus
Disease	Influenza (Flu)
Test Description	CDC INFLUENZA VIRUS REAL-TIME RT-PCR Influenza virus testing is performed using the Centers for Disease Control Human Influenza Virus Real-Time RT-PCR Diagnostic Panel which has been cleared by the U.S. Food and Drug Administration for the detection and subtyping of influenza virus type A and the detection and lineage determination of influenza virus type B. The performance characteristics of the assay 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. 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
Special Instructions	Specimens are only accepted from designated RI Sentinal Sites that are approved by the RIDOH Center for Acute Infectious Disease Epidemiology (401) 222-2577. All other laboratory sites must obtain PREAUTHORIZATION by the RIDOH Center for Acute Infectious Disease Epidemiology (401) 222-2577 prior to transporting specimens. REPORT INFLUENZA ASSOCATED DEATHS, HOSPITALIZATIONS, AND NOVEL VIRUS INFECTIONS WITHIN 4 DAYS OF RECOGNITION OR SUSPICION OF DISEASE
Specimen	Refer to the Influenza Specimen Collection Kit Instructions for specimen collection. Specimen Type: Collect nasopharyngeal, nasal swab or upper respiratory specimens with a flexible wire or plastic shaft nasopharyngeal (NP) swab. Swab must have synthetic tip such as dacron or nylon. (Swabs with a calcium alginate or cotton tip are unacceptable) After specimen is obtained, inoculate the tube of Universal Transport Media (UTM) by inserting the swab into the tube making certain that the liquid in the tube covers the swab tip. The shaft should be clipped equal with the top of the tube. Store at 2-8°C for up to 72 hours. If unable to transport within 72 hours, the specimen must be frozen at -70°C. 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 https://health.ri.gov/forms/LabRequisitionForm.pdf
Test Request	Select Influenza PCR (Sentinel Provider Only)
Transport	Specimens must be transported on wet ice or equivalent cooling material and packaged in accordance with current federal shipping regulations. If specimen previously frozen it must be transported on dry ice. Containers specifically labeled for transport of specimens to the RISHL Molecular Diagnostics Laboratory are available in all Microbiology Labs and Sendout Departments.
Normal Value	Not Detected
Reporting Requirement	Providers must report patient information on Influenza within 4 days using the RIDOH reportable disease form.
Turnaround Time	3 business days

Influenza Virus

Lab

Molecular Diagnostics Laboratory 401-222-5538

Pathogen

Influenza Virus

Disease

Influenza (Flu)

Test Description

CDC INFLUENZA VIRUS REAL-TIME RT-PCR

Influenza virus testing is performed using the Centers for Disease Control Human Influenza Virus Real-Time RT-PCR Diagnostic Panel which has been cleared by the U.S. Food and Drug Administration for the detection and subtyping of influenza virus type A and the detection and lineage determination of influenza virus type B. The performance characteristics of the assay 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.

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

Special Instructions

Specimens are only accepted from designated RI Sentinal Sites that are approved by the RIDOH Center for Acute Infectious Disease Epidemiology (401) 222-2577.

All other laboratory sites must obtain PREAUTHORIZATION by the RIDOH Center for Acute Infectious Disease Epidemiology (401) 222-2577 prior to transporting specimens.

REPORT INFLUENZA ASSOCATED DEATHS, HOSPITALIZATIONS, AND NOVEL VIRUS INFECTIONS WITHIN 4 DAYS OF RECOGNITION OR SUSPICION OF DISEASE

Specimen

Refer to the Influenza Specimen Collection Kit Instructions for specimen collection.

Specimen Type:

Collect nasopharyngeal, nasal swab or upper respiratory specimens with a flexible wire or plastic shaft nasopharyngeal (NP) swab. Swab must have synthetic tip such as dacron or nylon. (Swabs with a calcium alginate or cotton tip are unacceptable)

After specimen is obtained, inoculate the tube of Universal Transport Media (UTM) by inserting the swab into the tube making certain that the liquid in the tube covers the swab tip. The shaft should be clipped equal with the top of the tube.

Store at 2-8°C for up to 72 hours. If unable to transport within 72 hours, the specimen must be frozen at -70°C.

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 https://health.ri.gov/forms/LabRequisitionForm.pdf

Test Request

Select Influenza PCR (Sentinel Provider Only)

Transport

Specimens must be transported on wet ice or equivalent cooling material and packaged in accordance with current federal shipping regulations.

If specimen previously frozen it must be transported on dry ice.

Containers specifically labeled for transport of specimens to the RISHL Molecular Diagnostics Laboratory are available in all Microbiology Labs and Sendout Departments.

Normal Value

Not Detected

Reporting Requirement

Providers must report patient information on Influenza within 4 days using the RIDOH reportable disease form.

Turnaround Time

3 business days