INTENDED USE
PocTell® Syphilis Rapid Test Device (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. For professional in vitro diagnostic use only..
Ordering Information
|
Test Item |
Format |
Specimen |
Reaction Time |
Shelf life |
Kit Size |
|
Syphilis |
Cassette |
S / P / WB |
10 mins |
24 months |
25 T/Kit |
TEST PRINCIPLE
PocTell® Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative membrane based immunoassay for the detection of TP antibodies (IgG and IgM) in whole blood, serum or plasma. In this test procedure, recombinant Syphilis antigen is immobilized in the test line region of the test. After specimen is added to the specimen well of the device, it reacts with Syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the test and interacts with the immobilized Syphilis antigen. The double antigen test format can detect both IgG and IgM in specimens. If the specimen contains TP antibodies, a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain TP antibodies, a colored line will not appear in this region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred..
DIRECTIONS FOR USE
Bring the specimen and test components to room temperature Mix the specimen well prior to assay once thawed. Place the test device on a clean, flat surface.
1.Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2.Place the test device on a clean and level surface.
3.Hold the dropper vertically and transfer 2 drops of sample (or approximately 50 μl) to the specimen well (S) of the test device, then add 1 drop of buffer (or approximately 40 μl) and start the timer.
Wait for the red line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes. .
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