Chlamydia Antigen Rapid Test Cassette

INTENDED USE

The Chlamydia Antigen Rapid Test Cassette is designed as a rapid, qualitative immunoassay for the detection of Chlamydia trachomatis antigen in female cervical swab, male urethral swab, or male urine samples. It aids in diagnosing Chlamydia trachomatis infection effectively and quickly.

SUMMARY

Chlamydia trachomatis is a leading cause of sexually transmitted infections globally. It exists in two forms: elementary bodies (infectious) and reticulate bodies (replicative). Known for its high prevalence and asymptomatic cases, it frequently leads to serious health complications. In women, it can cause cervicitis, urethritis, endometritis, pelvic inflammatory disease (PID), and increase the risk of ectopic pregnancies and infertility. Neonates exposed during childbirth may develop conjunctivitis or pneumonia. In men, chlamydia can lead to urethritis and epididymitis, with approximately 40% of non-gonococcal urethritis cases being chlamydia-related. Up to 70% of women and 50% of men with infections are asymptomatic, making screening essential.

Traditional testing through tissue culture methods, while highly sensitive, is complex, time-consuming, and often impractical. The Chlamydia Antigen Rapid Test Cassette offers a quick, simple alternative, providing results within 15 minutes.

PRINCIPLE

The Chlamydia Antigen Rapid Test Cassette is a membrane-based immunoassay. Anti-chlamydia antibodies are immobilized on the test line of the cassette. When a specimen is applied, it interacts with anti-chlamydia antibody-coated particles. The mixture migrates along the test strip, interacting with immobilized antibodies. A positive result displays a colored line in the test region, while a control line indicates a successful test process.

WARNINGS AND PRECAUTIONS

  • For in vitro diagnostic use only.
  • Do not use expired kits.
  • Avoid eating, drinking, or smoking in testing areas.
  • Treat all specimens as potentially infectious.
  • Follow standard biosafety protocols and dispose of specimens responsibly.
  • Wear protective attire (gloves, lab coat, eye protection) during specimen handling.

COMPOSITION

  • Membrane strip with anti-chlamydia antibody on the test line and goat anti-mouse antibody on the control line
  • Dye pad with colloidal gold-coated anti-chlamydia antibody

Materials Provided:

  • Test cassette
  • Sterile swab (for sample collection)
  • Reagent A
  • Reagent B
  • Extraction tube
  • Urine cup (for male urine specimens)

STORAGE AND STABILITY

Store in a sealed pouch at 4-30°C (40-86°F). Do not use beyond the printed expiration date. Once opened, use the test within one hour to avoid deterioration.

SPECIMEN COLLECTION

Female Cervical Swab Specimen Collection

  1. Use the provided swab, removing excess mucus from the cervix with a cotton ball.
  2. Insert the swab past the squamocolumnar junction, rotating it 360° for 15 seconds. Avoid contamination with exocervical or vaginal cells.
  3. Place the swab into the extraction tube immediately if testing right away.

Male Urethral Swab Specimen Collection

  1. Use a sterile swab; ensure the patient has not urinated for at least one hour prior.
  2. Insert swab 2-4 cm into the urethra, rotating it 360° for 10 seconds. Avoid any treatment with 0.9% saline prior to collection.

Male Urine Specimen Collection

  1. Collect 15-30 mL of first morning urine in a sterile cup for higher antigen concentration.
  2. Transfer 10 mL to a centrifuge tube, add 10 mL of distilled water, and centrifuge at 3,000 rpm for 15 minutes. Remove the supernatant carefully and follow Directions for Use.

EXTRACTION PROCEDURE

For Female Cervical or Male Urethral Swab Specimen:

  1. Add 5 drops of Reagent A (approx. 300 µL) to the extraction tube. Insert the swab, compress the tube bottom, and rotate the swab 15 times. Let stand for 2 minutes.
  2. Add 5 drops of Reagent B (approx. 250 µL), rotate the swab again until the solution becomes clear with a slight green/blue tint. Let stand for 1 minute.
  3. Remove the swab, squeezing the tube to retain liquid. Cover with the dropper cap.

For Male Urine Specimen:

  1. Add 5 drops of Reagent B to the urine pellet, shake until homogeneous.
  2. Transfer to an extraction tube, let stand for 1 minute, add 5 drops of Reagent A, and mix by tapping the tube. Let stand for 2 minutes.
  3. Cover the extraction tube with the dropper cap.

TEST PROCEDURE

  1. Ensure the test cassette and specimen are at room temperature (15-30°C or 59-86°F) prior to testing.
  2. Remove the test cassette from its sealed pouch and place it on a clean, level surface.
  3. Reverse the specimen extraction tube, then hold it upright and transfer 3 drops (approximately 100 μL) into the specimen well (S) of the test cassette. Start the timer immediately after adding the specimen.
  4. Wait for the colored line(s) to appear. Read results at 15 minutes; do not interpret results after 20 minutes.

INTERPRETATION OF RESULTS

  • Positive: Two colored lines appear—one in the control region (C) and another in the test region (T), indicating the presence of Chlamydia antigen.
  • Negative: A single colored line appears in the control region (C) only, indicating the absence or undetectable level of Chlamydia antigen.
  • Invalid: If no line appears in the control region (C), the test is invalid due to possible procedural errors or insufficient specimen volume. Repeat the test with a new cassette. If the problem persists, stop using the current lot and contact the distributor.

QUALITY CONTROL

  • A procedural control is integrated into the test: the appearance of a line in the control region (C) confirms sufficient specimen volume, adequate membrane wicking, and correct procedural technique.
  • Positive and negative control standards are not supplied with the kit but are recommended for verifying test accuracy as part of good laboratory practice.

LIMITATIONS

  • This test is for in vitro diagnostic use only, intended for detecting Chlamydia trachomatis antigen in cervix swab, penis swab, or male urine specimens.
  • It provides qualitative results only and should not be used as the sole diagnostic tool. All results should be interpreted in the context of clinical information.
  • A negative result does not rule out Chlamydial infection. Additional testing may be warranted if symptoms persist.

PERFORMANCE CHARACTERISTICS

  • Accuracy: In a comparison study with commercially available Chlamydia antigen tests across 1,234 clinical specimens, the Chlamydia Antigen Rapid Test demonstrated an agreement rate of 97.95% for positive specimens and 97.98% for negative specimens.
  • Reproducibility: Studies at three physician office laboratories demonstrated 100% intra-assay and inter-site agreement, indicating strong reproducibility across various clinical settings.

CROSS-REACTIVITY AND INTERFERENCE

  1. Cross-reactivity with other organisms (e.g., Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus) was tested and found negative with the Chlamydia Antigen Rapid Test.
  2. Potentially cross-reactive substances like lipids, hemoglobin, and bilirubin were spiked into positive and negative specimens and showed no interference.

BIBLIOGRAPHY

  1. Ryan, K.J., & Ray, C.G. (2004). Sherris Medical Microbiology (4th ed.). McGraw Hill.
  2. Euzeby, J.P. “Chlamydia.” List of Prokaryotic Names with Standing in Nomenclature.

 

Instructions for use