Chlamydia Home Test Kit (Male or Female) – Rapid Test Kit. Results in 15 mins

Chlamydia Antigen Rapid Test Kit (Colloidal Gold Method)

Product Overview:

• Intended Use: This kit is for in vitro qualitative detection of Chlamydia antigens in female cervical and male urethral swabs. It is used for the auxiliary diagnosis of Chlamydia infection and is intended for professional in vitro diagnostic use only.

Principle of the Test:
The kit utilises a double-antibody sandwich method. If Chlamydia antigen is present in the sample, it reacts with colloidal gold-labeled CHL monoclonal antibody 1 on the conjugate pad to form a labeled antibody-antigen complex. This complex migrates upwards via capillary action, where it is captured by the CHL monoclonal antibody 2 on the T-line, producing a visible red band. The C-line serves as a control, capturing chicken IgY with goat anti-chicken IgY antibody.

Specimen Collection and Storage:

• Types: Female cervical swabs and male urethral swabs.
• Female Cervical Sample Collection: Remove mucus from the cervix, insert the sterile swab into the cervical canal, and rotate for 15-20 seconds.
• Male Urethral Sample Collection: Patient should avoid urination for at least 1 hour. Insert the swab 2-4 cm into the urethra, rotate for 5-10 seconds, then remove.
• Storage: Samples should be tested promptly. If storage is needed, they can be kept in a dry tube at room temperature for up to 6 hours or refrigerated at 2-8°C for up to 72 hours. Do not freeze.

Test Procedure:

1. Preparation: Ensure the kit is at room temperature and all components are intact.
2. Sample Processing: Add 6 drops (300 μL) of lysis buffer A, rotate and squeeze the swab on the tube wall for 15 repetitions. Let it stand for 2 minutes. Add 6 drops of lysis buffer B, rotate, squeeze, and repeat for 15 repetitions. Let stand for 1 minute, remove the swab, and discard in a medical waste bag.
3. Testing: Place the test card on a clean surface, add the processed sample, and begin timing.
4. Reading Results: Read the result within 15-30 minutes. Results are invalid after 30 minutes.

Interpretation of Results:

• Positive: Red bands appear on both T and C lines, indicating the presence of Chlamydia antigen.
• Negative: Only the C line shows a red band, indicating no detectable Chlamydia antigen.
• Invalid: No red band on the C line, regardless of T line result. Retest recommended.

Components and Storage Conditions:

• Test pad: Coated with CHL monoclonal antibodies on T and C lines, with colloidal gold-chicken IgY-CHL monoclonal antibody 1 on the conjugate pad.
• Lysis Buffers: Contains specific reagents to optimize antigen extraction.
• Storage: Store between 2-30°C, avoiding high temperatures, humidity, and direct sunlight. Valid for 24 months.

Precautions:

1. This test is for in vitro use only.
2. Results are for clinical reference only and should be interpreted along with other clinical information.
3. False negatives may occur due to improper sample handling or patient medication. Nucleic acid testing is recommended to confirm doubtful results.
4. Do not freeze samples.
5. Dispose of all used materials according to medical waste regulations.

Specifications:

• Negative Reference Rate: 100% on CHL-negative reference products.
• Positive Reference Rate: 100% on CHL-positive reference products.
• Sensitivity: Able to detect specific thresholds for Chlamydia.
• Specificity: Not affected by whole blood, cervical mucus, common vaginal medications, or other substances.

Contact Information:

• Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd., Nanjing, China
• Distributor (EU): Lotus NL B.V., The Hague, Netherlands