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The Macro-Vue™ RPR Card Test Control Cards are dehydrated control specimens of predetermined reactivity for quality-control testing of antigen before use in performing the Macro-Vue RPR Card Tests for the serologic detection of syphilis.

Macro-Vue RPR Card Test Control Cards were designed for routine, daily use as check-test specimens to determine the acceptable reactivity of RPR Card antigen suspension. RPR Card antigen is a cardiolipin type antigen, which detects "reagin", an antibody-like substance present in serums from syphilitic persons, and occasionally in serums of persons with other acute and chronic conditions.^1-4

Quality control requirements must be performed is accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent NCCLS guidance and CLIA regulations for appropriate Quality Control practices.

The RPR 18 mm Circle Card Test Control Card consists of three circles designated as: Reactive, Reactive minimal-to-moderate and Nonreactive. The labelled areas on this card contain graded reactivity specimens. The specimen material is human plasma purchased from licensed blood banks as Reactive or Nonreactive for syphilis.

For in vitro Diagnostic Use.

Before proceeding, review "Procedure" and "Warnings and Precautions" in the package insert supplied in all Macro-Vue RPR Card Test Kits.

The plasma used on the control cards is derived from human blood tested by an FDA (U.S. Food and Drug Administration)-approved method for the presence of the antibody to HIV (human immunodeficiency virus) and HBsAg (hepatitis B surface antigen) and found to be nonreactive.

Controls and RPR Card antigen suspension should be at room temperature (23 to 29°C) when used.

If the established reactivity pattern is not obtained, delay routine testing until the optimal reactivity is obtained by rechecking antigen suspension, test procedures, room temperature and equipment (including use of a rotator with humidifying cover). Non-acceptable results invalidate tests on individual specimens.

Once the dehydrated specimens on the control card are reconstituted, the specimen solutions should be tested immediately using the RPR Card Test procedure. Delay in testing may allow evaporation to affect the reactivity pattern.

Prolonged storage at cool room temperatures (21 to 25°C) and at elevated temperatures (above 27°C) causes deterioration of the specimens, showing a decrease in reactivity and difficulty in reconstituting the card. Once the sealed envelope is opened, the card should be used immediately.

Reconstitution of Control Card: Each test area of the control card should be reconstituted with 0.05 mL of deionized/distilled water.