Develops, manufactures, and　Distributes various types of in-vitro diagnostics and plastic vacuum blood collection tubes. Diagnostics Business of SEKISUI MEDICAL.

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Diagnostic Reagent for Syphilis
Mediace®RPR

*Read carefully the package insert before use.

INDEX

Syphilis is a disease caused by the spirochete Treponema pallidum (Nichols strain, TP). Currently, two methods are available for serological tests for syphilis: a method using lipid antigens, such as cardiolipin (STS); and a method using TP antigens. Because test results differ between these two methods according to the stage, both are used in order to detect infection or to diagnose the state of the disease.

SEKISUI　MEDICAL's "Mediace®TPLA®" and "Mediace®RPR" are the world's first diagnostic reagents for syphilis that allow a fully automated system. These reagents are used to rapidly measure serum anti-TP antibodies and syphilitic antilipid antibodies using artificial carrier latex particles with a measurement principle based on the latex turbidimetry.

Features

Non-treponema Lipid Antibody Kit Mediace®RPR

  • Marketing Approval Number: 21200AMZ00424000
  • Insurance: Pursuant to a Syphilis Lipid Antigen test, quantitative. Applicable as "Qualitative/Quantitative" as in the case with the RPR card test or the slide precipitation test
  • Measurement unit: R.U. (RPR UNITS) for the reagent, which is based on the WHO international standard
  • 1 R.U. corresponds to one reciprocal titer of the RPR card test

Package

Name Package Shelf-life Storage
Mediace®RPR (A) Buffer solution 18mL×2 6 months 2-8°C
Latex suspension 12mL×1
Mediace®RPR (M) Buffer solution 60mL×1 6 months 2-8°C
Latex suspension 20mL×1
Mediace®RPR (H) Buffer solution 180mL×1 6 months 2-8°C
Latex suspension 60mL×1
RPR Standard serum
(5 concentrations)*		 RPR positive human serum 1mL×5 conc.×1 6 months 2-8°C
RPR Control* RPR positive human serum 1mL×positive×2 6 months 2-8°C
RPR negative human serum 1mL×negative×2

*Not for in vitro diagnostic use.

Basic Performance Data
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We prepared this page for medical staff (doctors, dentists, pharmacists, clinical laboratory technicians, nurses, etc.) in Japan to ensure the correct use of our products. You should be aware that the information provided is not intended for overseas medical staff and the general public.