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captia r syphilis-m
Mercia Diagnostics
Summary: The Captia R Syphilis-M is a diagnostic test used to detect syphilis antibodies. It is primarily used by clinicians in laboratories to aid in the diagnosis of syphilis infections.
FDA Clearance Information
Pathway
510K
Number
K871548 ↗
Decision Date
August 7, 1987
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The Captia R Syphilis-M was cleared through the FDA 510(k) pathway on August 7, 1987. Manufactured by Mercia Diagnostics, it is classified as a Class 2 device under product code LIP.
What It Is
The Captia R Syphilis-M is a serological test designed to detect antibodies specific to Treponema pallidum, the bacterium responsible for syphilis. It operates as an enzyme immunoassay (EIA), providing qualitative results that help in diagnosing active or past syphilis infections. This test is crucial in clinical settings for early detection and management of syphilis, especially in prenatal screening and high-risk populations.
Clinical Applications
This device is commonly used in clinical laboratories, particularly in infectious disease departments, to screen and confirm syphilis infections. It is vital in prenatal care settings to prevent congenital syphilis and is also used in public health clinics to monitor and control syphilis outbreaks. The test is applicable to adult and pediatric populations, especially those at higher risk of sexually transmitted infections.
Indications for Use
The FDA indications suggest that the Captia R Syphilis-M is used for the detection of antibodies to Treponema pallidum, aiding in the diagnosis of syphilis. It is intended for use in patients suspected of having syphilis, including those with symptoms or those who are part of routine screening programs.
Practical Considerations
The test requires serum or plasma samples and is compatible with standard laboratory equipment used for enzyme immunoassays. Clinicians should ensure proper sample collection and handling to avoid false results. Regular calibration and quality control are recommended to maintain test accuracy.
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 Captia R Syphilis-M used for?
It is used to detect antibodies to Treponema pallidum, aiding in the diagnosis of syphilis.
What specialties typically use this device?
Infectious disease specialists, laboratory technicians, and public health professionals commonly use this test.
What are the FDA-cleared indications?
The device is indicated for detecting syphilis antibodies to diagnose syphilis in suspected patients.
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.