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syphilis bio-enzabead kit
Biometics Laboratory Products
Summary: The Syphilis Bio-EnzaBead Kit is an FDA-cleared diagnostic tool used to detect treponemal antibodies in patients suspected of having syphilis. It is primarily used by laboratory professionals in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K820934 ↗
Decision Date
June 10, 1982
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The Syphilis Bio-EnzaBead Kit was cleared through the FDA 510(k) pathway on June 10, 1982. Manufactured by Biometics Laboratory Products, it is classified as a Class 2 device under product code LIP.
What It Is
The Syphilis Bio-EnzaBead Kit is an enzyme-linked immunosorbent assay (ELISA) designed to detect antibodies against Treponema pallidum, the bacterium responsible for syphilis. This diagnostic kit uses a bead-based format to capture and identify specific antibodies in patient serum samples, providing a reliable method for confirming syphilis infection.
Clinical Applications
This device is commonly used in clinical laboratories for the serological diagnosis of syphilis. It is particularly useful in infectious disease departments and sexual health clinics where rapid and accurate detection of syphilis is crucial. The kit is suitable for testing patients with suspected syphilis, those with a history of the disease, or individuals undergoing routine screening.
Indications for Use
The FDA-cleared indications for the Syphilis Bio-EnzaBead Kit include its use in detecting treponemal antibodies in patients suspected of having syphilis. It is intended for use in clinical settings to aid in the diagnosis of syphilis infection.
Practical Considerations
The Syphilis Bio-EnzaBead Kit requires standard laboratory equipment for ELISA procedures. It is compatible with serum samples and provides results that can be interpreted by trained laboratory personnel. Proper handling and storage of reagents are essential to maintain the kit's efficacy.
Related Literature
The linked study evaluated the Syphilis Bio-EnzaBead Kit's performance in detecting treponemal antibodies compared to the standard fluorescent treponemal antibody absorption test. The study involved 600 specimens, demonstrating the kit's reliability in identifying syphilis infection. However, the study's limitations include its reliance on historical samples and the need for further validation in diverse populations.
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 Syphilis Bio-EnzaBead Kit used for?
It is used for detecting treponemal antibodies in patients suspected of having syphilis.
What specialties typically use this device?
Infectious disease specialists, laboratory technicians, and sexual health clinicians typically use this device.
What are the FDA-cleared indications?
The kit is indicated for detecting treponemal antibodies in patients suspected of syphilis infection, aiding in diagnosis.
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.