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syphilis serological reagents
New Horizons Diagnostics
Summary: Syphilis serological reagents by New Horizons Diagnostics are used for the detection of syphilis. Cleared by FDA via 510k pathway. Key evidence highlights diagnostic performance and potential new markers.
FDA Clearance Information
Pathway
510K
Number
K871226 ↗
Decision Date
May 28, 1987
Product Code
GMQ
Device Class
Class 2
Evidence
419 studies
The syphilis serological reagents were cleared by the FDA via the 510k pathway on May 28, 1987. Manufactured by New Horizons Diagnostics, they are classified as Class 2 devices.
What It Is
Syphilis serological reagents are diagnostic tools used to detect antibodies against Treponema pallidum, the causative agent of syphilis. They are intended for use in clinical laboratories to aid in the diagnosis of syphilis.
Clinical Applications
These reagents are commonly used in clinical settings for the diagnosis of syphilis, particularly in patients presenting with symptoms or those at high risk. They are part of routine screening protocols in sexually transmitted infection clinics.
Evidence Summary
The literature includes 10 studies, ranging from 2020 to 2025, covering various study types such as RCTs and prospective evaluations. These studies explore diagnostic performance, molecular surveillance, and potential new markers for syphilis.
Reported Outcomes
Published studies report promising diagnostic performance using non-invasive saliva specimens, with a sensitivity of 54.1% for qPCR. A dual HIV/syphilis rapid test shows potential for enhanced screening. Novel markers like Tp40 are being investigated for their diagnostic utility.
Safety Profile
Reported complications include limited sensitivity in certain non-invasive tests, such as urine samples with a sensitivity of 30.3%. No significant adverse events were noted in the studies reviewed.
Evidence Limitations
Evidence gaps include the need for further validation of non-invasive testing methods and exploration of new diagnostic markers. Some studies lack large sample sizes and long-term follow-up data.
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 serological reagents?
These reagents are indicated for the detection of syphilis antibodies in patients suspected of having the infection or those at high risk.
What outcomes have been reported in clinical studies?
Studies report effective detection of syphilis using saliva specimens and potential for dual HIV/syphilis rapid testing.
What complications have been reported?
Safety data indicate limited sensitivity in urine-based tests and no significant adverse events in the reviewed studies.
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.