Intended Use
The Syphilis Rapid Test Strip (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Treponema Pallidum in whole blood, serum or plasma.proteins.
DIRECTIONS FOR USE
Materials Provided
·Test strips
·Disposable specimen droppers
·Buffer (for whole blood only)
·Test cards
·Package insert
Materials Required But Not Provided
·Specimen collection containers
·Lancets (for fingerstick whole blood only)
·Disposable heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
·Centrifuge (for plasma only)
·Timer
Allow the test strip, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1.Remove the test strip from the sealed foil pouch and use it as soon as possible. When the room temperature is over 30 °C or the environment is humid, please use the strip as soon as you open the seal. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2.Place the test strip on a clean and level surface.
Cassette: For Venipuncture Whole Blood/Serum/Plasma specimen: Hold the dropper vertically and transfer 2 bubble-free drops of specimen into the sample well (S), and immediately add 1 drop of buffer into the well too, as shown in Figure 1 below.
Strip: For Venipuncture Whole Blood/Serum/Plasma specimen: Hold the dropper vertically and transfer 2 bubble-free drops of specimen into the specimen area, and immediately add 1 drop of buffer into the area too, as shown in Figure 2 below.
3.Wait for the red line(s) to appear. The result should be read at 10-15 minutes. Do not interpret the result after 15 minutes.