đź“Š Evidence-Based Reference
Trust Rpr Test for Syphilis in Serum or Plasma
Ampcor
Summary: The trust RPR test by Ampcor is a diagnostic device for syphilis detection in serum or plasma. It is primarily used for screening and diagnosis of syphilis. Key evidence includes studies on its diagnostic performance and clinical utility.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K880165 ↗
Decision Date ?
March 30, 1988
Product Code ?
GMQ
Device Class ?
Class 2
Evidence ?
419 studies
The trust RPR test for syphilis was cleared by the FDA via the 510(k) pathway on March 30, 1988. It is manufactured by Ampcor and classified as a Class 2 device under product code GMQ.
What It Is
The trust RPR test is a serological test designed to detect syphilis in serum or plasma samples. It operates by identifying reagin antibodies, which are indicative of a syphilis infection. This test is intended for use in clinical settings to aid in the diagnosis of syphilis.
FDA-Cleared Indications
- For the qualitative and quantitative detection of reagin antibodies in human serum or plasma.
- To aid in the diagnosis of syphilis when used with clinical findings and other laboratory test results.
Clinical Applications
- Screening patients for evidence of syphilis infection.
- Supporting the diagnosis of syphilis in patients with compatible symptoms or risk factors.
- Testing serum or plasma specimens for reagin antibodies.
- Providing a quantitative reagin result when indicated for clinical evaluation.
Evidence Summary
The available literature includes 11 studies, ranging from randomized controlled trials to observational studies, conducted between 2018 and 2024. These studies evaluate the diagnostic performance, clinical utility, and safety of syphilis testing methods.
Reported Outcomes
Published studies report that the trust RPR test is effective in detecting syphilis, with high sensitivity and specificity in various clinical settings. It is particularly useful in identifying active syphilis infections, as evidenced by high RPR titers in symptomatic patients.
Safety Profile
Reported complications include potential false-negative results in early syphilis cases, where serological tests may be non-reactive. No significant adverse events directly related to the test have been documented in the reviewed studies.
Evidence Limitations
Evidence gaps include the need for more studies on the test's performance in diverse populations and settings. Some studies are limited by small sample sizes and retrospective designs, highlighting the need for further prospective research.
Practical Considerations
- This is an in vitro diagnostic test, not an implantable or therapeutic device.
- It requires a properly collected and handled human serum or plasma specimen and laboratory testing according to the manufacturer's instructions.
- A reactive result does not by itself prove active syphilis; confirmatory treponemal testing and clinical evaluation are typically needed.
- Nonreactive results may occur during early infection or in other clinical circumstances; testing should be interpreted with symptoms, exposure history and timing.
- MRI safety, device sizing and vascular compatibility do not apply because the test is performed on a blood specimen outside the body.
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 trust RPR test for syphilis?
The trust RPR test is indicated for the screening and diagnosis of syphilis in individuals with suspected infection or those at high risk.
What outcomes have been reported in clinical studies?
Studies report high sensitivity and specificity for syphilis detection, particularly in symptomatic patients with active infection.
What complications have been reported?
Safety data indicate potential false negatives in early syphilis, but no significant adverse events have been associated with the test itself.
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.