US FDA Registered Establishment #1641328 EVALUATION KITS RPR Card Test for Syphilis ASI’s nontreponemal RPR (Rapid Plasma Reagin) test screens for syphilis; a sexually transmitted disease caused by the bacterium Treponema pallidum (a spirochete bacteria). The disease is found worldwide and is easily treated if detected early. If left untreated it can be fatal and facilitate the transmission and acquisition of HIV.1 This test is FDA cleared for use in diagnostic screening. Nontreponemal tests, such as the ASI RPR Card Test, are more reliable indicators of untreated syphilis infections and are used to monitor response to treatment or to indicate new infections.2 Features A CDC recommended primary screening test Simple and economical to use Easy to interpret All testing materials provided Available without controls 3 levels of liquid controls included (reactive, weak reactive, nonreactive) Color-coded dropper vials Warp resistant coated test cards Screw cap vials (No glass ampules) Up to 24 month shelf life (from date of manufacture) Proven results (CAP, AAB, API surveys) 10, 15, 30 well test cards available 1. https://www.cdc.gov/std/stats18/syphilis.htm 2. https://www.cdc.gov/mmwr Certifications CPT Code 86592 (Screening) CPT Code 86593 (Titers) FDA 510(k) K851504 Sensitivity & Specificity Sensitivity: >98% Specificity: >99% Test Kit Sizes 25 test kit #900025 100 test kit #900100 500 test kit #900500 5,000 test kit #9005000-30 with controls 5,000 test kit #987530 without controls 10,000 test kit #90010000-30 with controls 10,000 test kit #987X30 without controls DOCUMENTATION SAFETY DATA SHEET SAFETY DATA SHEET (FRENCH) CLSI CARBON ANTIGEN (SDS) (PDF) PROCEDURE & INTERPRETATION MATERIALS PROVIDED (PDF) PRODUCT INSERT (PDF) SYPHILIS INFORMATION WHY NONTREPONEMAL COMPONENTS CONTACT US ABOUT US NEWS & EVENTS POLICIES 1840 North Technology Drive Springville, UT 84663 800-654-0146, 801-489-8911 info@arlingtonscientific.com Copyright © 2021- All rights reserved.