đź“Š Evidence-Based Reference
bioplex 2200 ebv igg and syphilis igg
Bio-Rad Laboratories
Summary: The BioPlex 2200 EBV IgG and Syphilis IgG is a serological assay device used for detecting antibodies related to Epstein-Barr virus and syphilis. It is primarily used in diagnostic settings to assess infection status. Key evidence highlights its utility in serological testing with some studies indicating potential false reactivity.
FDA Clearance Information
Pathway
510K
Number
K120439 ↗
Decision Date
March 14, 2012
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The BioPlex 2200 EBV IgG and Syphilis IgG was cleared through the FDA 510(k) pathway on March 14, 2012. It is manufactured by Bio-Rad Laboratories and classified as a Class 2 device under product code LIP.
What It Is
The BioPlex 2200 system is a multiplex flow immunoassay that detects IgG antibodies against Epstein-Barr virus and syphilis. It is intended for use in clinical laboratories to aid in the diagnosis of these infections by providing serological evidence of antibody presence.
Clinical Applications
This device is commonly used in clinical scenarios where there is a need to diagnose or confirm Epstein-Barr virus or syphilis infections. It is particularly useful in settings requiring rapid and simultaneous detection of multiple antibodies.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as RCTs, prospective, and retrospective analyses. The studies span from 2010 to 2022, providing a comprehensive overview of the device's diagnostic capabilities and limitations.
Reported Outcomes
Published studies report that the BioPlex 2200 system effectively detects antibodies against EBV and syphilis, aiding in the diagnosis of these infections. Some studies highlight the potential for false reactivity, particularly in the context of recent vaccinations or acute viral infections.
Safety Profile
Reported complications include potential false positive results, especially in patients who have recently received certain vaccines, such as COVID-19 mRNA vaccines. No significant adverse events directly related to the device's use have been documented.
Evidence Limitations
The evidence base is limited by the potential for false reactivity, as noted in some studies. Further research is needed to explore the device's performance across diverse populations and in the presence of interfering factors such as recent vaccinations.
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 BioPlex 2200 EBV IgG and Syphilis IgG?
The device is indicated for the detection of IgG antibodies against Epstein-Barr virus and syphilis, aiding in the diagnosis of these infections.
What outcomes have been reported in clinical studies?
Studies report effective detection of antibodies, with some indicating potential false reactivity in certain contexts, such as post-vaccination.
What complications have been reported?
Safety data indicate potential false positive results, particularly following certain vaccinations, but no significant adverse events related to device use.
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.