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phadebact haemophilus test
Pharmacia
Summary: The Phadebact Haemophilus Test is a diagnostic tool used for serotyping Haemophilus influenzae. It is primarily used in clinical settings to detect H. influenzae type b, particularly in cerebrospinal fluid. Key evidence shows high sensitivity in detecting culture-positive cases.
FDA Clearance Information
Pathway
510K
Number
K802423 ↗
Decision Date
November 12, 1980
Product Code
GRO
Device Class
Class 2
Evidence
419 studies
The Phadebact Haemophilus Test was cleared by the FDA through the 510(k) pathway on November 12, 1980. It is manufactured by Pharmacia and classified as a Class 2 device.
What It Is
The Phadebact Haemophilus Test is a coagglutination test designed to detect Haemophilus influenzae type b antigens. It is used in clinical laboratories to aid in the diagnosis of infections caused by this bacterium, particularly in cerebrospinal fluid samples.
Clinical Applications
The device is commonly used in the diagnosis of bacterial meningitis and other infections where Haemophilus influenzae type b is suspected. It is particularly useful in settings where rapid identification of the pathogen is critical for patient management.
Evidence Summary
The available literature includes four studies, ranging from 1983 to 2005, involving various methodologies such as coagglutination and latex agglutination. These studies provide evidence on the test's sensitivity and specificity in detecting H. influenzae type b.
Reported Outcomes
Published studies report that the Phadebact Haemophilus Test demonstrates high sensitivity in detecting Haemophilus influenzae type b in cerebrospinal fluid, with one study noting a detection rate of 95% in culture-positive fluids. The test is more sensitive than counterimmunoelectrophoresis.
Safety Profile
Reported complications include no significant adverse events directly associated with the use of the Phadebact Haemophilus Test. The studies reviewed did not highlight any safety concerns specific to the device.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent research. Further studies are needed to confirm the test's efficacy in diverse clinical settings and to explore its performance in comparison to newer diagnostic technologies.
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 Phadebact Haemophilus Test?
The test is indicated for the detection of Haemophilus influenzae type b in clinical specimens, particularly cerebrospinal fluid, to aid in the diagnosis of bacterial infections such as meningitis.
What outcomes have been reported in clinical studies?
Clinical studies have reported high sensitivity of the Phadebact Haemophilus Test in detecting H. influenzae type b, with detection rates up to 95% in culture-positive cerebrospinal fluid samples.
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 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.