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agglutinotest-syphilis
Volu Sol Medical Industries
Summary: The Agglutinotest-Syphilis is a diagnostic test used to detect syphilis antibodies in patients. It is primarily used by healthcare professionals in clinical laboratories to aid in the diagnosis of syphilis infection.
FDA Clearance Information
Pathway
510K
Number
K791457 ↗
Decision Date
September 24, 1979
Product Code
GMT
Device Class
Class 2
Evidence
419 studies
The Agglutinotest-Syphilis was cleared through the FDA 510(k) pathway on September 24, 1979. It is manufactured by Volu Sol Medical Industries and is classified as a Class 2 device under product code GMT.
What It Is
The Agglutinotest-Syphilis is a serological test designed to detect antibodies against Treponema pallidum, the bacterium responsible for syphilis. This test works by agglutination, where the presence of antibodies causes particles to clump together, indicating a positive result. It is a valuable tool in the early detection and management of syphilis, allowing for timely intervention and treatment.
Clinical Applications
This test is commonly used in clinical laboratory settings, particularly in infectious disease departments and sexual health clinics. It is utilized by laboratory technicians and clinicians to screen patients suspected of having syphilis, including those with symptoms or who are at high risk. The test is applicable to a wide range of patient populations, including pregnant women, individuals with multiple sexual partners, and those with other sexually transmitted infections.
Indications for Use
The Agglutinotest-Syphilis is indicated for use in the detection of syphilis antibodies in human serum. It is specifically used to identify individuals who may have an active or past syphilis infection, aiding in diagnosis and treatment planning.
Practical Considerations
The test requires a serum sample and is typically performed in a laboratory setting. It is important to follow the manufacturer's instructions for accurate results. Compatibility with standard laboratory equipment and adherence to proper technique are essential for reliable outcomes.
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 is Agglutinotest-Syphilis used for?
The Agglutinotest-Syphilis is used to detect antibodies against the syphilis-causing bacterium, Treponema pallidum, in patient serum samples.
What specialties typically use this device?
This test is typically used in infectious disease, sexual health, and clinical laboratory settings.
What are the FDA-cleared indications?
The test is indicated for detecting syphilis antibodies in human serum to aid in diagnosing syphilis infections.
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.