ORASURE Diagnostics Direct Syphilis Controls

Description

 

Regulatory Status: CLIA Waived for Oral Fluid Whole Blood

Contents: (1) Syphilis positive control, (1) Syphilis Negative Control, (1) IFU

Determinations: Terponemal Antibody (Syphilis)

Storage Requirements: 2° – 8° C (35°-46° F)

Syphilis-Flyer

Syphilis Health Check PI

 

ORASURE Diagnostics Direct Syphilis Controls:

The Positive and Negative Controls, which are sold separately by the manufacturer, should be run according to the

laboratory requirements. These controls should be run like an unknown patient specimen, and as required by your

laboratory’s standard QC procedures or Medical / Lab Director selected from any of the following examples:

• Each new lot

• Each new shipment (even if from the same lot previously received)

• Each new operator (an individual who has not run the tests for at least two weeks)

• Monthly, as a continued check on storage conditions

• Whenever problems (storage, operator, or other) are identified

NOTE: If the controls do not give expected results (Positive or Negative), patient results must not be reported, and the test should be re-run.  If your local or state regulations require more frequent testing of quality control material, quality control must be performed in compliance with those regulations. If the test does not show any Control or Test line in the window or a smudged or partial line, the test cassette should be discarded. Do not report the results. Run the test again with a new cassette and follow the procedure exactly. If the second test does not show lines, please contact Technical Services at 866-358-9282. For any other concerns regarding Syphilis Health Check please call 866-358-9282 8am -6pm EST. Problems may also be reported using the MedWatch reporting system at http://www.fda.gov/Safety/MedWatch/HowToReport/ or calling 1-800-FDA-1088 (1-800-332-1088).

 

Orasure Syphilis Test

Syphilis Health Check is a rapid qualitative screening test for detection of human antibodies to TP in serum, plasma or

whole blood. The method employs a unique combination of anti-human immunoglobulins gold conjugate and highly purified TP recombinant proteins to specifically detect anti-TP antibodies.

As the samples flow through the absorbent device, the anti-human immunoglobulins/protein A dye conjugate binds to the

human immunoglobulins forming an antigen-antibody complex. This complex binds to the recombinant protein in the

positive reaction zone and produces a pink-rose colored band. In the absence of anti TP antibodies, there is no line in the

positive reaction zone. The reaction mixture continues flowing through the absorbent device past the reaction and control

zones. Unbound conjugate binds to the reagents in the control zone producing a pink-rose color band, demonstrating that the reagents are functioning correctly.