đź“Š Evidence-Based Reference
bioplex 2200 syphilis total rpr bioplex 2200 syphilis total rpr calibrator set bioplex 2200 syphilis total rpr control set
Bio-Rad Laboratories
Summary: The BioPlex 2200 Syphilis Total RPR is an automated assay used for syphilis screening. It combines treponemal and nontreponemal testing in one step. Key evidence highlights its utility in clinical settings, with some concerns about false positives.
FDA Clearance Information
Pathway
510K
Number
K170413 ↗
Decision Date
May 11, 2017
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The BioPlex 2200 Syphilis Total RPR was cleared by the FDA through the 510(k) pathway on May 11, 2017. It is manufactured by Bio-Rad Laboratories and classified as a Class 2 device.
What It Is
The BioPlex 2200 Syphilis Total RPR is an automated diagnostic device that performs both treponemal and nontreponemal tests for syphilis. It is intended for use in clinical laboratories to aid in the diagnosis of syphilis infections.
Clinical Applications
This device is commonly used in clinical settings for syphilis screening, particularly in laboratories that require high-throughput testing. It is suitable for both pregnant and nonpregnant patients, providing a comprehensive serological assessment.
Evidence Summary
The available literature includes 9 studies, comprising retrospective and prospective analyses, published between 2020 and 2024. These studies evaluate the performance and reliability of the BioPlex 2200 Syphilis Total RPR in various clinical contexts.
Reported Outcomes
Published studies report that the BioPlex 2200 Syphilis Total RPR is effective in syphilis screening, with some studies noting a risk of false positives, particularly in individuals who have received COVID-19 vaccinations. The device's ability to perform dual testing in one step is highlighted as a significant advantage.
Safety Profile
Reported complications include a risk of false-positive results, which may be influenced by factors such as recent vaccinations. No severe adverse events have been directly linked to the use of the device in the reviewed studies.
Evidence Limitations
The evidence is limited by the potential for false positives, as noted in some studies. Further research is needed to fully understand the impact of recent vaccinations on test accuracy and to explore the device's performance 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 are the clinical indications for BioPlex 2200 Syphilis Total RPR?
The device is indicated for syphilis screening in clinical laboratories, suitable for both pregnant and nonpregnant patients.
What outcomes have been reported in clinical studies?
Studies report effective syphilis screening with some risk of false positives, especially post-COVID-19 vaccination.
What complications have been reported?
Safety data indicate a risk of false-positive results, with no severe adverse events directly attributed to the device.
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.