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stanbio syphilis rpr test no 1170
Stanbio Laboratory
Summary: The Stanbio Syphilis RPR Test No 1170 is a diagnostic tool used for the detection of syphilis. It is primarily used by laboratory technicians and healthcare providers in clinical settings to screen for syphilis infection.
FDA Clearance Information
Pathway
510K
Number
K880144 ↗
Decision Date
May 23, 1988
Product Code
GMQ
Device Class
Class 2
Evidence
419 studies
The Stanbio Syphilis RPR Test No 1170 was cleared through the FDA 510(k) pathway on May 23, 1988. It is manufactured by Stanbio Laboratory and is classified as a Class 2 device under product code GMQ.
What It Is
The Stanbio Syphilis RPR Test No 1170 is a rapid plasma reagin (RPR) test used to detect non-treponemal antibodies in the blood, indicative of a syphilis infection. The test involves mixing a patient's serum or plasma with a reagent containing carbon particles. If antibodies are present, they cause the particles to clump, indicating a positive result. This test is commonly used for initial syphilis screening due to its simplicity and rapid results.
Clinical Applications
This test is commonly used in clinical laboratories and public health settings for the screening of syphilis, particularly in sexually transmitted infection (STI) clinics. It is utilized by healthcare providers such as infectious disease specialists, general practitioners, and obstetricians, especially in prenatal care to prevent congenital syphilis. The test is suitable for use in both symptomatic and asymptomatic patients who are at risk of syphilis infection.
Indications for Use
The FDA indications for this test are for the qualitative detection of reagin antibodies in human serum or plasma. It is used to screen individuals for syphilis infection, particularly in populations at higher risk for STIs.
Practical Considerations
The Stanbio Syphilis RPR Test is typically available in kit form, compatible with standard laboratory equipment. It requires careful handling of reagents and samples to avoid cross-contamination. The test is relatively quick, providing results within minutes, making it practical for high-volume screening 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 is the Stanbio Syphilis RPR Test No 1170 used for?
It is used for the detection of syphilis by identifying non-treponemal antibodies in the blood.
What specialties typically use this device?
Infectious disease specialists, general practitioners, and obstetricians, particularly in STI clinics and prenatal care settings.
What are the FDA-cleared indications?
The test is indicated for the qualitative detection of reagin antibodies in human serum or plasma to screen for syphilis infection.
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.