đź“Š Evidence-Based Reference
Asi Automated Rpr Rapid Plasma Reagin Test for Syphilis for Use on the Asi Evolution Automated Syphilis Analyzer
Arlington Scientific, Inc. (Asi)
Summary: The ASI Automated RPR Test is used for syphilis diagnosis on the ASI Evolution Analyzer. Key evidence shows its performance in automated settings, with limited safety data.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K201438 ↗
Decision Date ?
October 21, 2020
Product Code ?
GMQ
Device Class ?
Class 2
Evidence ?
419 studies
The ASI Automated RPR Test was cleared by the FDA via the 510(k) pathway on October 21, 2020. It is manufactured by Arlington Scientific, Inc. and is classified as a Class 2 device.
What It Is
The ASI Automated RPR Test is an automated nontreponemal test designed for the detection of syphilis antibodies. It is intended for use on the ASI Evolution Automated Syphilis Analyzer, providing rapid results in clinical settings.
FDA-Cleared Indications
- For the qualitative and quantitative detection of reagin antibodies associated with syphilis in human serum or plasma.
- For use on the ASI Evolution Automated Syphilis Analyzer.
- For in vitro diagnostic use by trained laboratory professionals.
Clinical Applications
- Automated laboratory testing of patient serum or plasma for syphilis-associated reagin antibodies.
- Qualitative screening for evidence of syphilis infection.
- Quantitative RPR testing when reported titers are needed for clinical evaluation or follow-up.
- High-throughput syphilis testing in clinical and public health laboratories.
Evidence Summary
The available literature includes two studies evaluating automated RPR tests, with publication years ranging from 2019 to 2023. These studies focus on the performance comparison of automated versus manual RPR assays.
Reported Outcomes
Published studies report that the ASI Automated RPR Test demonstrates comparable performance to manual RPR tests in detecting syphilis. The studies highlight its utility in high-volume laboratory settings, with consistent reactivity results.
Safety Profile
Reported complications include limited data on adverse events, as the studies primarily focus on analytical performance rather than safety outcomes. No significant safety concerns were highlighted in the available literature.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on analytical performance rather than clinical outcomes. Further research is needed to assess long-term safety and efficacy in diverse populations.
Practical Considerations
- This is an in vitro diagnostic reagent and does not involve placement in the body or a procedural access site.
- Testing requires the ASI Evolution Automated Syphilis Analyzer and compatible laboratory supplies; it is not intended for use as a stand-alone visual RPR test.
- Results should be interpreted with the clinical history and, when appropriate, treponemal testing because nontreponemal tests can produce false-positive or false-negative results.
- The test is not an imaging device, implant, or therapeutic device and has no MRI-safety classification.
- Specimen collection, storage, handling, quality control, and result interpretation should follow the manufacturer's instructions and applicable laboratory requirements.
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 ASI Automated RPR Test?
The ASI Automated RPR Test is indicated for the diagnosis of syphilis in clinical laboratory settings, particularly where automated testing is required.
What outcomes have been reported in clinical studies?
Studies report that the ASI Automated RPR Test has comparable performance to manual RPR tests, with consistent reactivity results in syphilis detection.
What complications have been reported?
Safety data from the evidence is limited, with no significant complications reported in the available studies.
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.