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legionella pneumophila igg igm
Trinity Biotech U
Summary: The Legionella pneumophila IgG IgM is a serological test used to detect antibodies against Legionella pneumophila. It is primarily used for diagnosing Legionnaire's Disease. Key evidence highlights its role in identifying atypical pneumonia cases.
FDA Clearance Information
Pathway
510K
Number
K033051 ↗
Decision Date
November 26, 2003
Product Code
MJH
Device Class
Class 2
Evidence
419 studies
The device was cleared by the FDA through the 510(k) pathway on November 26, 2003. It is manufactured by Trinity Biotech U and classified as a Class 2 device.
What It Is
The Legionella pneumophila IgG IgM is a diagnostic test that detects specific antibodies in the blood, indicating exposure to Legionella pneumophila. It is intended for use in clinical settings to aid in the diagnosis of Legionnaire's Disease.
Clinical Applications
This device is commonly used in cases of atypical pneumonia where Legionella pneumophila is suspected. It is particularly useful in diagnosing community-acquired pneumonia and in patients with compromised immune systems.
Evidence Summary
The literature includes 11 studies, comprising case reports, retrospective analyses, and multicentric studies, conducted between 2017 and 2020. These studies explore the prevalence and detection of Legionella pneumophila in various clinical scenarios.
Reported Outcomes
Published studies report that the Legionella pneumophila IgG IgM test is effective in identifying cases of Legionnaire's Disease, particularly in atypical pneumonia and travel-associated infections. It has been used to detect infections in patients with autoimmune diseases and during pregnancy.
Safety Profile
Reported complications include the potential for false positives or negatives, which can affect clinical decision-making. No direct adverse events related to the test itself were noted in the studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish the test's sensitivity and specificity across diverse populations.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Legionella pneumophila IgG IgM?
The test is indicated for diagnosing Legionnaire's Disease, particularly in cases of atypical pneumonia and in immunocompromised patients.
What outcomes have been reported in clinical studies?
Studies report effective detection of Legionnaire's Disease, especially in atypical pneumonia and travel-associated infections.
What complications have been reported?
Reported complications include potential false positives or negatives, impacting clinical decision-making.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.