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Global Fever Special Pathogens Panel

Clinical Specimen Submission Guidance

Submit all specimens to 150 Richmond Street, Suite 100, Providence, RI 02903. Open Monday to Friday 8:30 AM to 4:30 PM.   Learn how and where to drop off your lab samples at our Laboratory Central Services webpage.

Lab

Molecular Diagnostics Laboratory 401-222-5538

Analyte Name

Bacillus anthracis; Chikungunya virus; Crimean-Congo hemorrhagic fever virus (CCHFV); Dengue virus (serotypes 1, 2, 3, and 4); Ebolavirus spp. (Bundibugyo, Reston, Sudan, Tai Forest, Zaire); Francisella tularensis; Lassa virus; Leishmania spp. (e.g., L. donovani and L. infantum); Leptospira spp.; Marburgvirus; Plasmodium spp., Plasmodium falciparum and Plasmodium vivax/ovale; West Nile virus; Yellow fever virus; Yersinia pestis.

Disease

Acute febrile illness or recent acute febrile illness and known or suspected exposure to the target pathogens listed in analyte section.

Test Description

The BioFire Global Fever Special Pathogens Panel (GFSPP) is an FDA-cleared, qualitative, multiplexed, nucleic acid-based PCR assay.

Note: Positive results do not rule out co-infection with pathogens not included on the GFSPP. Patients with high suspicion for a VHF who have an initial negative test may require a repeat test/should be tested again within 72 hours of symptom onset. Not all pathogens that cause acute febrile illness are detected by this test, and negative results do not preclude infection with the pathogens targeted by the test and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Note: The GFSPP is not intended for screening asymptomatic individuals. The complete list of the limitations of the GFP can be found in the most recent version of the GFSPP assay package insert.

Note: When testing for mosquito-borne viruses (Chikungunya, Dengue, West Nile, Yellow Fever), the GFSPP may not reliably detect the presence of arbovirus RNA once patients are outside the acute phase of infection, namely the first 1 to 7 days after symptoms onset.

Note: The presence of a P. vivax or P. ovale infection must be confirmed before consideration of treatment for the hypnozoite liver form owing to potential cross-reaction with Plasmodium malariae and Plasmodium knowlesi.

Note: Pathogens for which the panel provides presumptive identification results require additional testing and confirmation procedures at the Rhode Island State Health Laboratories and /or a reference laboratory, such as the Centers for Disease Control (CDC). In cases of patients under investigation for infection with a select agent, consultation with the CDC may be required prior to testing with the GFSPP, and patients may need to remain in isolation until confirmation of negative results is obtained from CDC.

Note: RIDOH recommends consideration of the GFSPP for patients with a high suspicion for a targeted viral hemorrhagic fever (VHF). Decisions to test for VHFs should be based on compatible clinical presentation and driven by epidemiologic risk factors including recent travel history and identification high-risk exposures. The GFSPP may also be appropriate for patients with fever of unknown origin and relevant travel history when more common infectious etiologies have already been reasonably excluded. Providers should consider utilizing existing commercial or hospital-based testing for more routine pathogens included in the differential diagnosis prior to requesting the GFSPP.

 

Special Instructions

Prior approval for the GFSPP from RIDOH's Center for Acute Infectious Disease Epidemiology (CAIDE) is required, whether a select agent is suspected or not - the ordering physician must consult with CAIDE at (401) 222-2577 or (401) 276-8046 (afterhours).

Healthcare providers who suspect a viral hemorrhagic fever (VHF) or are considering use of the GFSPP based on a patient's clinical presentation, travel history, or exposure history must immediately contact the Rhode Island Department of Health (RIDOH) Center for Acute Infectious Disease Epidemiology (CAIDE) for consultation prior to specimen collection or submission.

Please contact the RISHL Special Pathogens Lab prior to shipping and with any further questions (401) 222-5587.

Specimen

Collect two 4.0mL tubes of human whole blood collected in EDTA tubes. One tube will suffice if a select agent is not on the differential diagnosis, e.g. based on travel history or with the visualization of parasite forms on blood smear.

Specimens should be refrigerated immediately upon collection and can remain refrigerated for up to 7 days (2-8°C).

Specimen Identification

CLIA regulations require specimens be labeled with at least two patient identifiers. Examples of identifiers are first and last name, date of birth, chart/medical record number. The specimen container must be labeled to match the test requisition or the electronic order.

Form Required

Rhode Island State Health Laboratories (RISHL) test requisition form https://health.ri.gov/forms/LabRequisitionForm.pdf

Test Request

Global Fever Special Pathogens Panel

Transport

Blood specimens potentially containing a select agent-designated hemorrhagic fever virus (CCHF, Ebola, Lassa, Marburg) must always be packaged and shipped as Category A and comply with all Department of Transportation requirements.

Specimens for GFSPP testing from patients for whom a hemorrhagic fever virus is clearly not on the differential may be shipped as Category B. 

Specimens must be packaged with frozen ice packs so at maintain a transport temperature of 2-8°C.

Integrity

Bleach can damage organisms/nucleic acids within the specimen, potentially causing false negative results. Contact between bleach and specimens during collection, disinfection, and testing procedure should be avoided.

Specimen Rejection Criteria

The following rejection criteria will be used to ensure accurate specimen information and specimen condition for testing:

  • Specimen received outside acceptable transport range
  • Demographics different / Unable to read identifiers on specimen
  • Two identifiers required on specimen
  • Expired / Incorrect collection kit
  • Insufficient quantity
  • Urine cup received
  • No specimen received
  • Specimen leaked in transit
  • Specimen too old
Normal Value

Not detected all pathogens

Reporting Requirement

Certain pathogens evaluated through the GFSPP are immediately reportable to RIDOH pursuant to the Rhode Island regulations for the reporting and testing of infectious, environmental, and occupational diseases (216-RICR-30-05-1).
 

Turnaround Time

4 hours from time of specimen receipt at the RI State Health Laboratories