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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 ?
510(k)
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.
FDA-Cleared Indications
- Detection of Legionella pneumophila DNA in clinical specimens from patients suspected of having Legionnaires’ disease.
- Use as an in vitro diagnostic assay with the compatible BD ProbeTec ET system.
Clinical Applications
- Testing clinical specimens from patients with pneumonia when Legionella pneumophila infection is suspected.
- Supporting laboratory diagnosis of Legionnaires’ disease.
- Testing respiratory specimens in hospital or public health laboratory settings when the assay’s specimen and handling requirements are met.
Practical Considerations
- The assay requires the compatible BD ProbeTec ET instrumentation, reagents and laboratory workflow.
- Specimen type, collection, transport and storage must follow the device labeling and laboratory protocols.
- A positive result indicates detection of Legionella pneumophila DNA but must be interpreted with the patient’s symptoms, imaging and other laboratory findings.
- A negative result does not exclude Legionella infection if the specimen is inadequate, collected late or the organism is not present in the tested sample.
- This is an in vitro diagnostic laboratory assay, not an implantable device; MRI safety, device size and implant duration do not apply.
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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Clinical progress note: Haemophilus influenzae type b.
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Pilot study of social media promotion of home-based self-testing for syphilis.
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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
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Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
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Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
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Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
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Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
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Nature
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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
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History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
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A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
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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.