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syphilis igm human serum controls
Pyramid Biological
Summary: The syphilis IgM human serum controls by Pyramid Biological are used for serological testing in syphilis diagnosis. Key evidence highlights its role in identifying syphilis reinfection and monitoring treatment efficacy.
FDA Clearance Information
Pathway
510K
Number
K961317 ↗
Decision Date
June 24, 1996
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The device was cleared through the FDA 510(k) pathway on June 24, 1996. It is manufactured by Pyramid Biological and is classified as a Class 2 device under product code LIP.
What It Is
The syphilis IgM human serum controls are used in serological assays to detect IgM antibodies specific to Treponema pallidum, the causative agent of syphilis. It aids in the diagnosis and monitoring of syphilis, particularly in identifying active infection.
Clinical Applications
Commonly used in clinical laboratories for the diagnosis of syphilis, these controls help differentiate between active and past infections by measuring IgM levels. They are particularly useful in cases of suspected syphilis reinfection or relapse.
Evidence Summary
The literature includes 10 studies, with a mix of prospective and retrospective designs, published between 2019 and 2023. These studies explore the diagnostic utility of IgM testing in syphilis and its role in treatment follow-up.
Reported Outcomes
Published studies report that IgM testing can assist in diagnosing syphilis reinfection and monitoring treatment efficacy. It has been shown to differentiate active syphilis from past infections, providing valuable information for clinical management.
Safety Profile
Reported complications include potential false-positive results due to cross-reactivity in serological assays. Studies have explored methods to mitigate these issues, such as urea-mediated dissociation to reduce false positives.
Evidence Limitations
The evidence is limited by the small sample sizes and the potential for cross-reactivity leading to false-positive results. Further research is needed to refine testing methods and validate findings across diverse populations.
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 syphilis IgM human serum controls?
The device is indicated for use in serological testing to detect IgM antibodies in patients suspected of having syphilis, aiding in diagnosis and monitoring treatment.
What outcomes have been reported in clinical studies?
Studies report that IgM testing is effective in diagnosing syphilis reinfection and monitoring treatment efficacy, differentiating active from past infections.
What complications have been reported?
Safety data indicate potential false-positive results due to cross-reactivity, with studies suggesting methods to mitigate these issues.
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.