Syphilis (SYP) Antibody Rapid Test Kit

Instruction for Use
A lateral flow immunochromatographic assay f for the qualitative detection of antibodies including IgG, IgM, and IgA to Treponema pallidum (Tp) in human whole blood, serum or plasma.

Precautions

• For professional and IN VITRO diagnostic use only.
• The test should remain in the sealed pouch until use.
• Do not use the kit if the foil pouch is punctured or not well sealed.
• Do not reuse or use kits after the expiration date.
• Do not mix components from kits with different lot number.
• Avoid microbial contamination of reagents.
• Wear gloves during the whole process and avoid reagents or specimen spilling-out. Wash hands thoroughly afterwards.
• Handle all specimens as if they contain infectious agents. When the assay procedure is completed, dispose of specimens carefully after autoclaving for at least one hour. Alternatively, treat with a 0.5 or 1% solution of sodium hypochlorite for one hour before disposal.
• Dispose the used kit after decontamination of all liquids or solid wastes by following the local law or laboratory rule.

Assay Procedure

Test device, patient’s samples, and controls should be brought to room temperature (15-30℃) prior to testing. Do not open pouches until ready to perform the assay.

• Remove the test cassette from the foil pouch. Place it on a clean and level surface. Be sure to label it with specimen’s ID number.
• For Serum or Plasma specimen:

Hold the dropper vertically and transfer 1 drop (about 30μL) of serum or plasma into the specimen well of the test cassette, then add 2 drop of buffer (approximately 80μL) and start the timer. See illustration below.

For venipuncture whole blood specimen:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 60μL) to the specimen well, then add 1 drop of buffer (approximately 40μL), and start the timer. See illustration below.

For Fingerstick whole blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen well of the test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration below.

To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 60μL) to fall into the specimen well of the test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration below.

• Wait for colored lines to appear and read results at 10 minutes. Don’t read result after 30 minutes.

Interpretation of Assay Result