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ortho syphilis-g antibody elisa test
Ortho Diagnostic Systems
Summary: The Ortho Syphilis-G Antibody ELISA Test is a diagnostic tool used to detect antibodies against Treponema pallidum, the bacterium responsible for syphilis. It is primarily used by laboratory technicians and clinicians in infectious disease and sexual health settings.
FDA Clearance Information
Pathway
510K
Number
K883939 ↗
Decision Date
December 22, 1988
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The Ortho Syphilis-G Antibody ELISA Test was cleared through the FDA 510k pathway on December 22, 1988. Manufactured by Ortho Diagnostic Systems, it is classified as a Class 2 device under product code LIP.
What It Is
The Ortho Syphilis-G Antibody ELISA Test is an enzyme-linked immunosorbent assay designed to detect antibodies against Treponema pallidum. This test is used to aid in the diagnosis of syphilis, a sexually transmitted infection. The test works by detecting specific antibodies in the patient's blood sample, indicating exposure to the bacterium. It is a valuable tool in both screening and confirming syphilis infection.
Clinical Applications
This ELISA test is commonly used in clinical laboratories, hospitals, and sexual health clinics. It is particularly useful in screening programs for sexually transmitted infections (STIs), prenatal care settings, and in the management of patients with suspected or confirmed syphilis. Infectious disease specialists, primary care physicians, and obstetricians may rely on this test to guide treatment decisions.
Indications for Use
The FDA-cleared indications for this test include the detection of antibodies against Treponema pallidum in individuals suspected of having syphilis. It is used for both screening and diagnostic purposes in patients presenting with symptoms or at risk of syphilis.
Practical Considerations
The test requires a blood sample, typically collected via venipuncture. Results should be interpreted in conjunction with clinical findings and other laboratory tests. It is important to follow the manufacturer's instructions for test preparation and execution to ensure accurate results.
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 Ortho Syphilis-G Antibody ELISA Test used for?
It is used to detect antibodies against Treponema pallidum, aiding in the diagnosis of syphilis.
What specialties typically use this device?
Infectious disease specialists, primary care physicians, and obstetricians commonly use this test.
What are the FDA-cleared indications?
The test is indicated for detecting antibodies to Treponema pallidum in individuals suspected of having 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.