Syphilis Test, BLUE SCREEN

Description

Simple Procedure
Rapid Result
Easy to Read
Economical
for Vitro Diagnostic use

The Blue Screen Syphilis Ultra Rapid Test Strip (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema pallidum (TP) in whole blood, serum, or plasma to aid in the diagnosis of Syphilis.

The Blue Screen Syphilis Ultra Rapid Test Strip (Whole Blood/Serum/Plasma) utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on the membrane to detect TP antibodies (IgG and IgM) qualitatively and selectively in whole blood, serum, or plasma.

DIRECTION FOR USE:
Allow test device, specimen, and/or controls to reach room temperature (15o – 30oC) prior to testing.
1. Remove the test strip from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2. Peel off the tape from the test card, and stick the test strip in the middle of the test card with arrows pointing downwards.

For Serum or Plasma Specimens: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 µl) onto the specimen pad of the test strip, then add 1 drop of buffer (approximately 40 µl) and start the timer.
For Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 2 drops of venipuncture whole blood (approximately 50 µl) onto the specimen pad of the test strip, then add 1 drop of buffer (approximately 40 µl) and start the timer.
For Fingerstick Whole Blood specimens: (A) To use a capillary tube: Fill the capillary tube and transfer approximately 50 µl of fingerstick whole blood specimen onto the specimen pad of the test strip, then add 1 drop of buffer (approximately 40 µl) and start the timer. (B) To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 500 µl) to fall onto the specimen pad of the test strip, then add 1 drop buffer (approximately 100 µl) and start the timer.

3. Wait for the colored line(s) to appear. Read results at 10 minutes. DO NOT INTERPRET RESULTS AFTER 30 MINUTES.

INTERPRETATION OF RESULT:
POSITIVE: Two distinct colored lines appear. One line should be in the control line region (C) and another line should be in the test line region (T).

**NOTE: The shade of color in the test line region (T) may vary, but it should be considered positive whenever there is even a faint colored line.

NEGATIVE: One colored line appears in the control line region (C). No apparent colored line appears in the test line region (T).

INVALID: Control line (C) fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.