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bd probetec et legionella pneumophila lp amplified dna assay
Becton, Dickinson &
Summary: The BD ProbeTec ET Legionella Pneumophila LP Amplified DNA Assay is a diagnostic tool used to detect Legionella pneumophila in clinical specimens. It is primarily used by microbiologists and clinicians in infectious disease settings.
FDA Clearance Information
Pathway
510K
Number
K033861 ↗
Decision Date
March 9, 2004
Product Code
LQH
Device Class
Class 2
Evidence
419 studies
The BD ProbeTec ET Legionella Pneumophila LP Amplified DNA Assay was cleared through the FDA 510(k) pathway on March 9, 2004. Manufactured by Becton, Dickinson, it is classified as a Class 2 device under product code LQH.
What It Is
The BD ProbeTec ET Legionella Pneumophila LP Amplified DNA Assay is a nucleic acid amplification test designed to detect Legionella pneumophila DNA in clinical specimens. It utilizes a proprietary amplification technology to provide rapid and accurate results. This assay is particularly useful in diagnosing Legionnaires' disease, a severe form of pneumonia caused by Legionella bacteria.
Clinical Applications
This assay is commonly used in hospital laboratories and public health settings to diagnose Legionnaires' disease, especially in patients presenting with pneumonia symptoms. It is particularly valuable in cases where rapid diagnosis is critical for patient management and outbreak control. Infectious disease specialists and microbiologists frequently use this assay to confirm the presence of Legionella pneumophila in respiratory specimens.
Indications for Use
The FDA-cleared indications for this assay include the detection of Legionella pneumophila in clinical specimens from patients suspected of having Legionnaires' disease. It is intended for use in patients with symptoms of pneumonia, especially when Legionella infection is suspected.
Practical Considerations
The assay requires specific laboratory equipment compatible with the BD ProbeTec system. Specimen collection and handling should follow standard protocols to ensure accurate results. Clinicians should be aware of the assay's sensitivity and specificity when interpreting results.
Related Literature
The linked study compared the effectiveness of sputum and nasopharyngeal swab specimens for detecting Legionella pneumophila, among other pathogens, using a molecular diagnostic assay. It found that both specimen types could be used effectively, but highlighted the importance of selecting the appropriate specimen type based on clinical presentation. Limitations included a small sample size and the use of a single assay platform.
Linked Studies (20)
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RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the BD ProbeTec ET Legionella Pneumophila LP Amplified DNA Assay used for?
It is used to detect Legionella pneumophila DNA in clinical specimens, aiding in the diagnosis of Legionnaires' disease.
What specialties typically use this device?
Infectious disease specialists and microbiologists in hospital and public health laboratories commonly use this assay.
What are the FDA-cleared indications?
The assay is indicated for detecting Legionella pneumophila in patients suspected of having Legionnaires' disease, particularly those with pneumonia symptoms.
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.