đź“Š Evidence-Based Reference
architect syphilis tp reagent architect syphilis tp calibrator architect syphilis tp control
Abbott Laboratories
Summary: The Architect Syphilis TP Reagent by Abbott Laboratories is a diagnostic tool for detecting Treponema pallidum. It is primarily used in syphilis screening. Key evidence highlights its high sensitivity in automated immunoassays.
FDA Clearance Information
Pathway
510K
Number
K153730 ↗
Decision Date
June 15, 2016
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The Architect Syphilis TP Reagent was cleared by the FDA through the 510(k) pathway on June 15, 2016. It is manufactured by Abbott Laboratories and classified as a Class 2 device.
What It Is
The Architect Syphilis TP Reagent is a chemiluminescent microparticle immunoassay used for the qualitative detection of Treponema pallidum antibodies in human serum and plasma. It is intended for use in clinical laboratories to aid in the diagnosis of syphilis.
Clinical Applications
This device is commonly used in clinical settings for the screening and diagnosis of syphilis, particularly in populations at risk for sexually transmitted infections. It is often employed in public health clinics and laboratories.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2019 to 2024, providing a comprehensive overview of the device's performance.
Reported Outcomes
Published studies report that the Architect Syphilis TP Reagent demonstrates high sensitivity and specificity in detecting Treponema pallidum antibodies. Comparative studies indicate that it performs well against other automated immunoassays. The reverse algorithm using this reagent shows improved detection rates for primary and secondary syphilis cases.
Safety Profile
Reported complications include potential interference from lipemia, which can affect test accuracy. However, high-speed centrifugation has been shown to mitigate this issue effectively. No significant adverse events have been reported in the literature.
Evidence Limitations
Some studies highlight the need for confirmatory testing due to the high sensitivity of automated assays, which may lead to false positives. Further research is needed to explore the long-term clinical outcomes and cost-effectiveness of using this reagent in various healthcare settings.
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 Architect Syphilis TP Reagent?
The device is indicated for the qualitative detection of Treponema pallidum antibodies in human serum and plasma, aiding in the diagnosis of syphilis.
What outcomes have been reported in clinical studies?
Studies report high sensitivity and specificity in syphilis detection, with improved detection rates for primary and secondary cases using the reverse algorithm.
What complications have been reported?
Safety data indicate potential interference from lipemia, though this can be mitigated with high-speed centrifugation. No significant adverse events have been noted.
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.