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legionella pneumophila ser 1 antigen latex test
Medical Diagnostic Technologies
Summary: The Legionella Pneumophila Ser 1 Antigen Latex Test is a diagnostic tool used to detect Legionella pneumophila serogroup 1 antigens in clinical specimens. It is primarily used by infectious disease specialists and laboratory technicians.
FDA Clearance Information
Pathway
510K
Number
K864006 ↗
Decision Date
April 20, 1987
Product Code
LHL
Device Class
Class 2
Evidence
419 studies
The Legionella Pneumophila Ser 1 Antigen Latex Test was cleared through the FDA 510(k) pathway on April 20, 1987. It is manufactured by Medical Diagnostic Technologies and classified as a Class 2 device.
What It Is
This device is a latex agglutination test designed to detect antigens of Legionella pneumophila serogroup 1 in clinical specimens. It works by using latex particles coated with antibodies that bind specifically to the Legionella antigens, causing visible clumping if the antigen is present. This test provides a rapid and specific method for diagnosing Legionella infections, which are a common cause of Legionnaires' disease.
Clinical Applications
The Legionella Pneumophila Ser 1 Antigen Latex Test is commonly used in hospital laboratories and public health settings to quickly diagnose Legionnaires' disease, especially in patients presenting with pneumonia-like symptoms. It is particularly useful in outbreak situations or when rapid diagnosis is critical for patient management. Infectious disease specialists and clinical microbiologists are the primary users of this test.
Indications for Use
The FDA indications for this test include the detection of Legionella pneumophila serogroup 1 antigens in clinical specimens, which is crucial for diagnosing Legionnaires' disease. It is intended for use in patients with suspected Legionella infections.
Practical Considerations
The test is typically performed on urine samples, which are easy to collect and handle. It is important to follow the manufacturer's instructions for sample preparation and test execution to ensure accurate results. The test is compatible with standard laboratory equipment.
Related Literature
The linked study, although not directly related to the device, involved the nucleotide sequencing of a gene for a lipoprotein in Escherichia coli. The study found that the gene encodes a lipoprotein with properties similar to other gram-negative bacteria lipoproteins. While not directly applicable to the Legionella test, it highlights the importance of genetic studies in understanding bacterial proteins.
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
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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
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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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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
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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 is the Legionella Pneumophila Ser 1 Antigen Latex Test used for?
It is used to detect Legionella pneumophila serogroup 1 antigens in clinical specimens, aiding in the diagnosis of Legionnaires' disease.
What specialties typically use this device?
Infectious disease specialists and clinical microbiologists typically use this device in laboratory settings.
What are the FDA-cleared indications?
The test is indicated for detecting Legionella pneumophila serogroup 1 antigens in clinical specimens, particularly for diagnosing Legionnaires' disease.
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.