Infection Disease Chlamydia Rapid Test with CE certificate Test Device

For professional in vitro diagnostic use only.

PRINCIPLE

The Chlamydia Rapid Test Device is a qualitative, lateral flow immunoassay for the detection of Chlamydia antigen from clinical specimens.

In this test, antibody specific to the Chlamydia antigen is coated on the test line region of the strip. During testing, the extracted antigen solution reacts with an antibody to Chlamydia that is coated onto particles. The mixture migrates up to react with the antibody to Chlamydia on the membrane and generate a red line in the test region. The presence of this red line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a red line will always appear in the control region indicating that proper volume of specimen has been added and membrane wicking has occurred.

MATERIALS

Materials Provided

• Test devices
• Test tubes
• Dropper tips
• Sterile polyester tipped applicator

(Sterile female cervical swabs)

• Reagent A
• Reagent B
• Workstation
• Package insert

Materials Required But Not Provided

• Timer
• Sterile male cervical swabs
• Positive control
• Negative control
• Urine Cup(for male urine specimens only)
• Centrifuge tube(for male urine specimens only)

PRECAUTIONS

• For professional in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens and kits are handled.
• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results.
• Use only sterile swabs to obtain endocervical specimens.
• Tindazole vaginal effervescent tablets and Confort Pessaries with negative specimens may cause very weak interference effect.