DE Medical Technology Jiangsu Co.,Ltd

IVD Infections diseases Syphilis diagnostic rapid test cassette Syphilis rapid test kit CE certificate

Intended Use of Syphilis Rapid Test Device

TheSyphilis Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of IgM and IgG antibodies to Treponema Pallidum (TP) in human Whole Blood, serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of syphilis.

Principle of Syphilis Rapid Test Device

TheSyphilis Rapid Test Device (Whole Blood/Serum/Plasma) detects IgM and IgG antibodies toTreponema Pallidum (TP) through visual interpretation of color development on the internal strip. Specific recombinant TP antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with recombinant TP-specific antigen conjugated to colored particles and precoated onto the sample pad of the test.The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane.If there are sufficient antibodies to Treponema Pallidum (TP) in the specimen,a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicatingthat the proper volume of specimen has been added and membrane wicking has occurred.

Procedure and Result Reading of Syphilis Rapid Test Device

Strip

1. Allow the sealed Anti-Syphilis test strip, serum specimens and control solution to reach room temperature (18-30°C).

2. Remove the test strip from the sealed pouch.

3. Immerse the strip into the serum with the arrow end pointing towards the serum. Do not immerse past the marker line. Take the strip out after 5 -10 seconds and lay the strip flat on a clean, dry, non-absorbent surface (e.g., mouth of the serum container).

4. Wait 10-15 minutes and read results. Do not read results after 20 minutes.

Cassette

1.To begin testing; open the sealed pouch by tearing

along the notch.. Remove the test form the pouch.

2.lay the cassette flat on a clean, dry, nonabsorbent surface ,draw about 30ul whole blood into the sample pad.

3.Then draw one drop of Sodium Chloride(about 20ul)into the sample well as well.

4.Wait for colored bands to appear.Read results within 15 minutes. Do not read results after 20 minutes

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