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Francisella tularensis Antibodies (IgG, IgM)
Test Code18516
CPT Codes
86668 (x2)
Preferred Specimen
0.6 mL serum
Minimum Volume
0.5 mL
Instructions
Centrifuge and aliquot serum into a plastic vial
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 7 days
Refrigerated: 14 days
Frozen: 30 days
Refrigerated: 14 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Grossly lipemic • Grossly icteric
Methodology
Enzyme Linked Immunosorbent Assay (ELISA) • Immunoassay (IA)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Tue, Thu, Sat; Report available: 3-5 days
Clinical Significance
This immunoassay is for the qualitative detection of antibodies (IgG, IgM) against Francisella tularensis, the causative agent of Tularemia disease. Antibodies can be detected starting 2-3 weeks after the onset of symptoms. Paired sera 2-3 weeks apart to observe seroconversion is recommended to confirm infection in patients with high clinical suspicion.
This assay is intended for patients with signs and symptoms consistent with acute Tularemia and not useful for patients with resolved infection. Tularemia can cause a wide spectrum of symptoms depending on exposure. People rarely can be infected through tick and deer fly bites, contact with infected animals, drinking contaminated water, or inhalation.
Antibodies against other bacteria, including Brucella, can cross-react with assays targeting Francisella. Therefore, positive serologic results should be interpreted in the context of clinical illness and exposure consistent with Tularemia infection. Antibodies can persist for years and IgM in a single sample is not a reliable indicator of recent infection. Positive IgG and IgM results can represent current, recent, or past infection since they can be detected for several years post infection. A negative result can occur early during acute infection, before the development of antibodies.
References:
1. Clinical Testing and Diagnosis for Tularemia, Centers for Disease Control and Prevention. http://www.cdc.gov/tularemia/hcp/diagnosis-testing/index.html Last updated May 15, 2024.
2. Jeannine M Petersen, and Elizabeth A Dietrich, 2023. 13.4 Detection of Francisella tularensis Antibodies, Leber AL, Burnham CD Clinical Microbiology Procedures Handbook, 5th Edition. ASM Press, Washington, DC. doi: 10.1128/9781683670438.CMPH.ch13.4.
3. Maurin, Max. Francisella tularensis, Tularemia and Serological Diagnosis. Front Cell Infect Microbiol. 2020; 10:512090.
This assay is intended for patients with signs and symptoms consistent with acute Tularemia and not useful for patients with resolved infection. Tularemia can cause a wide spectrum of symptoms depending on exposure. People rarely can be infected through tick and deer fly bites, contact with infected animals, drinking contaminated water, or inhalation.
Antibodies against other bacteria, including Brucella, can cross-react with assays targeting Francisella. Therefore, positive serologic results should be interpreted in the context of clinical illness and exposure consistent with Tularemia infection. Antibodies can persist for years and IgM in a single sample is not a reliable indicator of recent infection. Positive IgG and IgM results can represent current, recent, or past infection since they can be detected for several years post infection. A negative result can occur early during acute infection, before the development of antibodies.
References:
1. Clinical Testing and Diagnosis for Tularemia, Centers for Disease Control and Prevention. http://www.cdc.gov/tularemia/hcp/diagnosis-testing/index.html Last updated May 15, 2024.
2. Jeannine M Petersen, and Elizabeth A Dietrich, 2023. 13.4 Detection of Francisella tularensis Antibodies, Leber AL, Burnham CD Clinical Microbiology Procedures Handbook, 5th Edition. ASM Press, Washington, DC. doi: 10.1128/9781683670438.CMPH.ch13.4.
3. Maurin, Max. Francisella tularensis, Tularemia and Serological Diagnosis. Front Cell Infect Microbiol. 2020; 10:512090.
