Syphilis Screening - Nontreponemal (RPR)

Test Code: 30806

A special account is required to order pre-transplant testing. Contact Client Services or your account executive to set up a pre-transplant account to order this assay. Specimens should not be collected until after account has been created.

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Clinical and Procedure

Clinical Utility

The ASI Automated RPR (rapid plasma reagin) Test For Syphilis for use on the ASI Evolution, is a qualitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis.

The ASI Evolution is intended to be used as a fully automated analyzer to objectively interpret the results of the ASI Automated RPR Test For Syphilis. The ASI Evolution is designed to provide standardized test interpretation and to provide for storage, retrieval, and transmittal of the test results.

The ASI Automated RPR Test For Syphilis for use on the ASI Evolution is for professional use only. The test is intended to be used for blood donor screening and for cadaveric (non-heart beating) donor specimens for tissue donation. This test is not intended for diagnostic use.

About Syphilis

Treponema pallidum, the etiological agent of syphilis, induces the production of at least two types of antibodies in human infection: anti-treponemal antibodies that can be detected by FTA-ABS antigen¹, and anti-nontreponemal antibodies (reagin) that can be detected by RPR antigen².

Procedure

The ASI Automated RPR Test for Syphilis for use on the ASI Evolution is an automated macroscopic nontreponemal flocculation test to be used for the detection of reagin. This test kit is intended to be used with the ASI Evolution Automated Syphilis Analyzer. The ASI Evolution instrument automates the dispensing of serum or plasma samples and the dispensing of carbon antigen reagent. The microparticulate carbon RPR antigen enhances the visual discrimination between reactive and nonreactive results. The reagin-type antibody binds with the antigen that is composed of a complex of cardiolipin, lecithin and cholesterol particles with activated charcoal. The result of this antigen-antibody reaction is macroscopic flocculation. The ASI Evolution uses and internal camera an image processing algorithm to read the RPR agglutination reaction and report a reactive or non-reactive result.

Test performed by Eurofins DPT, 6933 S. Revere Parkway, Centennial, CO 80112. This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

See package insert for more information.

Turnaround Time

Within 24 hours from receipt of specimen.

Specimen Information

Specimen Type	Order Code	CPT Code	NY Approved	Volume	Assay Range	Special Instructions
Plasma (1)	30806	86592	Yes	200 µL (100 µL min.)	Qualitative	Collect whole blood in an EDTA, lavender top tube. Whole blood in Lithium or Sodium Heparin, and Sodium Citrate are also accepted. Do not freeze whole blood or plasma. Sample sent in original vacutainer tube can be shipped at ambient or refrigerated temperature, must be received within 5 days. If not shipping in original container, centrifuge and transfer 200 µL (min 100 µL) plasma to screw top tube. Plasma shipped at ambient or refrigerated temperature must be received within 5 days of collection.
Serum (1)	30806	86592	Yes	200 µL (100 µL min.)	Qualitative	Collect whole blood in an gold, red, or red/gray tiger top tube. Do not freeze whole blood. Sample sent in original vacutainer tube can be shipped at ambient or refrigerated temperature, must be received within 5 days. If not shipping in original container, centrifuge and transfer 200 µL (min 100 µL) serum to screw top tube. Serum shipped at ambient or refrigerated temperature must be received within 5 days of collection or frozen.

Shipping

All specimens must be labeled with patient's name and collection date. A Eurofins Viracor/DPT Pre-Transplant test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Eurofins DPT, 6933 S. Revere Parkway, Centennial, CO 80112.

Causes for Rejection

Whole blood frozen, plasma samples frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Eurofins DPT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins DPT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

1. Hunter EF, Deacon WE, Myer PE. 1964. Public Health Reports, 79:410-412.
2. Larsen SA, Hunter EF, Kraus SJ (ed.). 1990. Manual of Tests for Syphilis, Public Health Service, Washington, D.C.