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Axis-Shield RPR
Table of contents
1
Product details
2
Introduction
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1
Product details
Manufacturer:
Intended use:
Intended user:
Use by:
Storage:
Special
precautions:
For technical assistance or additional product information, contact your local Axis-Shield Diagnostics
representative.
2
Serologic tests are important as an aid in the clinical diagnosis of syphilis. Individuals infected with the
spirochete Treponema pallidum (T. pallidum) produce a number of different antibodies.
Syphilitic infection caused by Treponema pallidum leads to the appearance of antibodies called
reagins. The detection of reagin has been the basis for the development of a reagent utilising extracts
of various tissue components namely cardiolipin, lecithin and cholesterol. This is the classic VDRL
Antigen. The antigen used in this kit is a modification of VDRL Antigen that contains microparticulate
Axis-Shield Diagnostics Ltd.
Technology Park, Dundee DD2 1XA, UK
In vitro diagnostic medical device. Axis-Shield RPR is a slide flocculation test
for the qualitative and semi-quantitative determination of antibodies to VDRL
antigen (a presumptive diagnosis for syphilis) in human serum or plasma.
Axis-Shield RPR can be used:
• for the screening of donated blood;
• for the rapid screening of patients suspected of having syphilis;
• to monitor the immunological response to treatment;
• for use in programs for the screening of healthy individuals or
population groups.
Skilled professionals (within the intended use environment) are intended to
use this product in accordance with local legislation.
Use before the end of the indicated month. See labels for the expiry date of
individual kit components (date = YYYY-MM-DD).
Store between +2 and +8 °C.
This kit contains substances of both human and animal origin.
All such materials should be handled with caution and treated as
being potentially infectious.
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