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LEGRP<br />

89564<br />

LEIS<br />

86219<br />

elevated as long as the IgG response remains elevated. Cross-reactions have been described with several<br />

species of bacteria and mycoplasma.<br />

<strong>Test</strong> Performed by: Focus Diagnostics, Inc.<br />

5785 Corporate Avenue<br />

Cypress, CA 90630-4750<br />

Legionella species, Molecular Detection, PCR<br />

Clinical Information: Legionnaires' disease was first recognized during a pneumonia outbreak at the<br />

Legionnaires convention in Philadelphia in 1976. Investigators with the CDC isolated a novel,<br />

gram-negative bacillus, later named Legionella pneumophila. It is now widely recognized that Legionella<br />

pneumophila (and other members of the genus Legionella) cause Legionnaires' disease.<br />

Useful For: Sensitive and rapid diagnosis of pneumonia caused by Legionella species<br />

Interpretation: A positive PCR result for the presence of a specific sequence found within the<br />

Legionella 5S rRNA gene indicates the presence of a Legionella species DNA, which may be due to<br />

Legionella infection or environmental/water Legionella DNA in the specimen. A negative PCR result<br />

indicates the absence of detectable Legionella DNA in the specimen, but does not rule-out legionellosis as<br />

false-negative results may occur due to inhibition of PCR, sequence variability underlying the primers<br />

and/or probes, or the presence of Legionella species in quantities less than the limit of detection of the<br />

assay.<br />

Reference Values:<br />

Not applicable<br />

Clinical References: 1. Cunningham SA, Sloan LM, Uhl JA, et al: Validation of a real-time PCR<br />

assay for the detection of Legionella species in respiratory samples. Abstracts of the Annual Meeting of<br />

the Association for Molecular Pathology, 2009 General Meeting, Kissimmee, FL, Nov. 19-22, 2009 2.<br />

Hayden RT, Uhl JR, Qian X, et al: Direct detection of Legionella species from bronchoalveolar lavage<br />

and open lung biopsy specimens: comparison of LightCycler PCR, in situ hybridization, direct<br />

fluorescence antigen detection, and culture. J Clin Microbiol 2001;39(7):2618-2626 3. Diederen BM,<br />

Kluytmans JA, Vandenbroucke-Grauls CM, Peeters MF: Utility of real-time PCR for diagnosis of<br />

Legionnaires' disease in routine clinical practice. J Clin Microbiol 2008;46(2):671-677 4. MacDonell MT,<br />

Colwell RR: The nucleotide sequence of the 5S rRNA from Legionella pneumophila. Nucleic Acids Res<br />

1987;15(3):1335<br />

Leishmaniasis (Visceral) Antibody, Serum<br />

Clinical Information: Visceral leishmaniasis (kala azar) is a disseminated intracellular protozoal<br />

infection that targets primarily the reticuloendothelial system (liver, spleen, bone marrow) and is caused<br />

by Leishmania donovani, Leishmania chagasi, or Leishmania infantum (Leishmania donovani complex).<br />

Transmission is by the bite of sandflies. Clinical symptoms include fever, weight loss, and splenomegaly;<br />

pancytopenia and hypergammaglobulinemia are often present. Most (90%) new cases each year arise in<br />

rural areas of India, Nepal, Bangladesh, Sudan, and Brazil but the disease has a worldwide distribution,<br />

including the Middle East. Definitive diagnosis has required the microscopic documentation of<br />

characteristic intracellular amastigotes in stained smears from culture of aspirates of tissue (spleen, lymph<br />

node) or bone marrow. The detection of serum antibodies to the recombinant K39 antigen of Leishmania<br />

donovani is an alternative non invasive sensitive (95%-100%) method for the diagnosis of active, visceral<br />

leishmaniasis.<br />

Useful For: Diagnosis of active visceral leishmaniasis<br />

Interpretation: A positive result is consistent with a diagnosis of active visceral leishmaniasis.<br />

Reference Values:<br />

Negative<br />

Current as of January 4, 2013 7:15 pm CST 800-533-1710 or 507-266-5700 or <strong>Mayo</strong><strong>Medical</strong><strong>Laboratories</strong>.com Page 1100

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