HIV Syphilis Assay System : A Research Study

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It is a research study that investigate whether a device, or treatment is safe and effective for human. The clinical trial that I was involved in is about test device was developed to detect the HIV and syphilis at the same time. The product’s name is DPP® HIV Syphilis Assay System, which is an in vitro qualitative, single-use Dual Path Platform (DPP) lateral flow immunoassay for the simultaneous identification of HIV antibodies and Treponema pallidum in three samples type: venous whole blood, plasma, and finger stick whole blood.
The test was created by adding an additional T. pallidum antibody test line to the previous DPP HIV 1/2 Assay which has been approved by FDA in December 2012. By combining these two analytes into a new multiplex …show more content…

On-site monitoring carried out as-needed basis, as determined by review of the data forms supplied during the clinical study and review of the Nextrials PRISM Database.

To run the test, a whole blood (finger stick or venous whole blood) or plasma specimen (a sample loop of approximately 10 µL) is mixed with pre-measured buffer in a DPP® SampleTainer® Bottle for 10 seconds. Two drops of the sample-buffer mixture are placed into Sample+Buffer Well #1 of the test device. The sample migrates along a nitrocellulose-coated strip to the test and control areas of a second strip, where specific HIV and T. Pallidum antigens (test areas) and non-specific IgG capture proteins (control area) are immobilized. Five minutes later, the sample migration is complete and soluble colored dyes on the test and control lines are washed away, indicating successful sample addition. HIV and/or treponemal antibodies, if present in the sample, bind to the immobilized HIV and treponemal antigens on the test lines, and non-specific IgG in the sample binds to the control line.

After Five minutes of adding the sample, four drops of Running Buffer are added to Buffer Well #2. The buffer hydrates the dried antibody-binding colored conjugates, which migrate to the test and control areas and bind to any HIV and/or treponemal antibodies present, and also bind to the control antibodies, producing one or more colored lines. Result

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