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Captia Syphilis-G Elisa Test System
Trinity Biotech
Summary: The Captia Syphilis-G ELISA Test System is a diagnostic tool used to detect antibodies to Treponema pallidum, the bacterium responsible for syphilis. It is primarily used by laboratory professionals in clinical settings to aid in the diagnosis of syphilis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K001525 ↗
Decision Date ?
November 29, 2000
Product Code ?
LIP
Device Class ?
Class 2
Evidence ?
419 studies
The Captia Syphilis-G ELISA Test System by Trinity Biotech was cleared through the FDA 510(k) pathway on November 29, 2000. It is classified as a Class 2 device under product code LIP.
What It Is
The Captia Syphilis-G ELISA Test System is an enzyme-linked immunosorbent assay designed to detect IgG antibodies against Treponema pallidum in human serum or plasma. This test helps clinicians diagnose syphilis by identifying the presence of antibodies, indicating a current or past infection. The system uses specific antigens to capture antibodies, which are then detected using enzyme-linked secondary antibodies, providing a quantitative measure of antibody levels.
FDA-Cleared Indications
- Detection of IgG antibodies to Treponema pallidum in human serum or plasma.
- Use as an aid in the diagnosis of syphilis.
Clinical Applications
- Laboratory testing of serum or plasma from patients suspected of having syphilis.
- Serologic evaluation as part of a syphilis diagnostic workup.
- Testing performed in clinical laboratories using standard ELISA equipment.
Practical Considerations
- The test uses human serum or plasma; specimens must be collected, handled, stored and processed according to the manufacturer’s instructions.
- It requires compatible laboratory equipment for enzyme-linked immunosorbent assay testing and is not a point-of-care or imaging device.
- A reactive result indicates antibodies to Treponema pallidum but does not by itself distinguish active infection from past infection; interpretation should follow current syphilis testing algorithms and may require additional testing.
- False-positive and false-negative results are possible, so results should be interpreted with the patient’s symptoms, history and other laboratory findings.
- This assay has no MRI, implant-size or anatomic compatibility considerations because it is an in vitro laboratory test.
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 the Captia Syphilis-G ELISA Test System used for?
It is used to detect IgG antibodies to Treponema pallidum, aiding in the diagnosis of syphilis.
What specialties typically use this device?
Infectious disease specialists, obstetricians, general practitioners, and laboratory professionals typically use this test.
What are the FDA-cleared indications?
The test is indicated for detecting IgG antibodies to Treponema pallidum to help diagnose syphilis.
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.