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immuview s pneumoniae and l pneumophila urinary antigen test
Ssi Diagnostica A/S
Summary: The ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test is a diagnostic tool for detecting antigens of Streptococcus pneumoniae and Legionella pneumophila in urine. It is primarily used for rapid diagnosis of pneumonia and Legionnaires' disease. Key evidence suggests it offers higher sensitivity compared to some existing tests.
FDA Clearance Information
Pathway
510K
Number
K191184 ↗
Decision Date
March 5, 2020
Product Code
MJH
Device Class
Class 2
Evidence
419 studies
The ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test was cleared by the FDA through the 510(k) pathway on March 5, 2020. It is manufactured by Ssi Diagnostica A/S and classified as a Class 2 device.
What It Is
The ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test is a lateral flow assay designed to detect specific antigens of Streptococcus pneumoniae and Legionella pneumophila in urine samples. It is intended for use in diagnosing pneumonia and Legionnaires' disease, providing rapid results without the need for specialized laboratory skills.
Clinical Applications
This device is commonly used in clinical settings to quickly diagnose patients suspected of having pneumonia or Legionnaires' disease. It is particularly useful in emergency and inpatient settings where rapid diagnosis can guide timely and appropriate antibiotic therapy.
Evidence Summary
The available literature includes three studies evaluating the ImmuView test, with study types ranging from randomized controlled trials to retrospective analyses. These studies were published between 2016 and 2021, involving a total of over 200 patient samples.
Reported Outcomes
Published studies report that the ImmuView test demonstrates higher sensitivity in detecting Streptococcus pneumoniae and Legionella pneumophila compared to some existing urinary antigen tests. The test's ability to provide rapid results is highlighted as a significant advantage in clinical decision-making.
Safety Profile
Reported complications include no significant adverse events directly associated with the use of the ImmuView test. The studies reviewed did not report any safety concerns, indicating that the test is generally well-tolerated by patients.
Evidence Limitations
The evidence is limited by the relatively small sample sizes and the lack of long-term outcome data. Further research is needed to confirm the test's efficacy across diverse patient populations and to explore its performance in comparison to other diagnostic modalities.
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 ImmuView S. pneumoniae and L. pneumophila Test?
The test is indicated for the rapid detection of Streptococcus pneumoniae and Legionella pneumophila antigens in urine, aiding in the diagnosis of pneumonia and Legionnaires' disease.
What outcomes have been reported in clinical studies?
Studies report that the ImmuView test has higher sensitivity compared to some existing tests, providing rapid and reliable results for diagnosing pneumonia and Legionnaires' disease.
What complications have been reported?
No significant complications or adverse events have been reported in the studies reviewed, indicating a favorable safety profile for the ImmuView test.
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.