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ortho syphilis-m antibody elisa test
Ortho Diagnostic Systems
Summary: The Ortho Syphilis-M Antibody ELISA Test is a diagnostic tool used to detect antibodies against syphilis. It is primarily used by laboratory technicians and clinicians in diagnostic laboratories.
FDA Clearance Information
Pathway
510K
Number
K883938 ↗
Decision Date
December 22, 1988
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The Ortho Syphilis-M 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 medical device.
What It Is
The Ortho Syphilis-M Antibody ELISA Test is an enzyme-linked immunosorbent assay designed to detect antibodies to Treponema pallidum, the bacterium that causes syphilis. This test uses specific antigens to capture and quantify antibodies present in a patient's serum, providing a reliable diagnosis of syphilis infection. It is a crucial tool in the early detection and management of syphilis, aiding in timely treatment and prevention of disease transmission.
Clinical Applications
This test is commonly used in clinical laboratories for the screening and confirmation of syphilis infection. It is particularly valuable in prenatal screening programs, sexually transmitted infection (STI) clinics, and general practice settings where syphilis diagnosis is necessary. The test is applicable to a wide range of patient populations, including pregnant women, individuals with suspected STIs, and patients with unexplained symptoms suggestive of syphilis.
Indications for Use
The FDA indications for the Ortho Syphilis-M Antibody ELISA Test include its use in the detection of antibodies against syphilis in human serum. It is intended for use in individuals suspected of having syphilis or as part of routine screening in populations at risk.
Practical Considerations
The test requires serum samples and is compatible with standard laboratory equipment used for ELISA procedures. It is important to follow the manufacturer's instructions for sample preparation and handling to ensure accurate results. Clinicians should be aware of potential cross-reactivity with other treponemal infections, which may affect test specificity.
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-M Antibody ELISA Test used for?
It is used to detect antibodies against Treponema pallidum, the bacterium that causes syphilis.
What specialties typically use this device?
Laboratory technicians and clinicians in diagnostic laboratories, STI clinics, and prenatal care settings.
What are the FDA-cleared indications?
The test is indicated for detecting syphilis antibodies in individuals suspected of having syphilis or in routine screening of at-risk populations.
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.