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visuwell syphilis antigen
Adi Diagnostics
Summary: The Visuwell Syphilis Antigen by Adi Diagnostics is a non-treponemal test used for screening syphilis. It is primarily used by clinicians in laboratories for serological testing.
FDA Clearance Information
Pathway
510K
Number
K910487 ↗
Decision Date
June 24, 1991
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The Visuwell Syphilis Antigen was cleared through the FDA 510k pathway on June 24, 1991. It is manufactured by Adi Diagnostics and is classified as a Class 2 device.
What It Is
The Visuwell Syphilis Antigen is a non-treponemal enzyme-linked immunosorbent assay (ELISA) designed to detect reagin antibodies in serum. It uses a urease-based method for the serodiagnosis of syphilis, allowing for large batch testing and objective result interpretation. This device facilitates the screening process by automating the detection of antibodies bound to a cardiolipin-lecithin-cholesterol antigen.
Clinical Applications
This device is commonly used in clinical laboratories for the screening of syphilis, particularly in settings where large volumes of tests are conducted, such as public health clinics and hospitals. It is particularly useful in the initial screening of patients suspected of having syphilis, including those in high-risk populations. The device is also used in prenatal screenings to prevent congenital syphilis.
Indications for Use
The Visuwell Syphilis Antigen is indicated for the serological screening of syphilis in patients. It is used to detect reagin antibodies, which are indicative of syphilis infection, in serum samples.
Practical Considerations
The test is performed using unheated, undiluted serum samples in a 96-well microtiter plate format. It is compatible with standard laboratory equipment and requires a total test time of about 60 minutes. Clinicians should ensure proper sample handling to maintain test accuracy.
Related Literature
The linked study evaluated the Visuwell Reagin ELISA as a non-treponemal test for syphilis. It highlighted the test's ability to automate and objectively interpret results compared to traditional methods like the VDRL test. The study found the ELISA method to be efficient for large batch testing, though it did not compare the sensitivity and specificity directly with other tests.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
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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
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PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
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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
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PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
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PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
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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
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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
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PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
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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 Visuwell Syphilis Antigen used for?
It is used for the serological screening of syphilis by detecting reagin antibodies in serum.
What specialties typically use this device?
This device is primarily used in laboratory medicine, particularly in clinical pathology and infectious disease specialties.
What are the FDA-cleared indications?
The device is indicated for the detection of reagin antibodies in serum for the screening of 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.