Monkeypox Virus Antigen Rapid Test Kit

Product Overview

• Product Name: Monkeypox Virus Antigen Rapid Test Kit

Intended Use

• This product is intended for in vitro qualitative detection of monkeypox virus antigen in human skin lesion swabs.
• For professional use only.

Test Principle

• The test employs a double-antibody sandwich principle utilizing colloidal gold immunochromatography to detect monkeypox virus antigen in skin lesion swabs.
• The process involves:
  1. Reaction of monkeypox virus antigen in the sample with colloidal gold-chicken IgY-anti-mouse monkeypox virus antibody conjugate.
  2. Formation of a labeled antibody-antigen complex that moves via capillary action.
  3. Capture of the complex at the test line (T) by anti-mouse monkeypox virus antibody 2, resulting in a red band.
  4. A control line (C) is also developed, indicating the validity of the test regardless of the sample’s status.

Notes

• Incorrect sampling may affect results; follow instructions carefully.
• Swabs are to be used with the provided diluent only, and mixing of samples is prohibited.
• Test immediately after sampling to avoid contamination.

Sample Storage

• Test samples within one hour of collection.
• If delayed, store samples at:
  • 2-8°C for no more than 7 days
  • -20°C for up to 60 days
  • Below -70°C for long-term (>60 days)
• Frozen samples must be completely thawed and mixed before use, with a maximum of 3 freeze-thaw cycles.

Test Method

Preparation Before Testing

1. Read instructions thoroughly.
2. Ensure kit is within validity and components are intact.
3. Allow kits and samples to reach room temperature.
4. Wash/disinfect hands.

Testing Procedure

1. Open the aluminum foil bag and place the test pad on a clean, flat surface.
2. Follow the instructions for sample extraction and application.
3. Read results between 10-30 minutes; results are invalid after 30 minutes.
4. Dispose of used materials as medical waste according to local regulations.
5. Wash/disinfect hands after testing.

Note on Sample Size

• Insufficient sample size may lead to false negative or invalid results. Always interpret results within the specified timeframe.

Main Components

• Test Pad: Composed of nitrocellulose membrane, sample pad, conjugate pad, and contains the specific antibodies for the test.
• Sample Extraction Tube with Sample Diluent
• Instructions for Use
• Medical Waste Bag (optional)
• Swab (optional)

Sample Requirements

• Type: Human skin lesion swab (from rash, pustule surface, or exudate).
• Swab Specifications: Plastic swab with nylon flocking/absorbent cotton/polyester fiber/foam tip.

Sample Collection Procedure

1. Collect a sufficient sample from the lesion.
2. Insert swab into the sample extraction tube with diluent.
3. Rotate the swab for at least 30 seconds and squeeze the tip to mix.
4. Dispose of the swab in a medical waste bag.

Interpretation of Test Results

• Positive Result: Red bands appear at both T and C lines; monkeypox virus antigen is detected.
• Negative Result: Only C line is red; no monkeypox virus antigen detected.
• Invalid Result: No C line appears; retesting is recommended.

Limitations

• For in vitro qualitative diagnosis only.
• Results are for reference and should not be used alone for clinical diagnosis.
• Accuracy is affected by sampling methods and contamination during processing.
• Follow-up testing may be necessary.

Performance Characteristics

1. Positive Reference Agreement Rate: All positive with enterprise positive reference products.
2. Negative Reference Agreement Rate: All negative with enterprise negative reference products.
3. Analytical Sensitivity: Defined outcomes with reference products.
4. Repeatability: Consistent positive results with reference products.
5. Analytical Specificity: No cross-reactivity with specified substances.

Precautions

1. Use only for in vitro diagnosis; adhere to expiration dates.
2. Read and follow instructions strictly.
3. Product is for single use; do not use if the package is damaged.
4. Ensure samples reach room temperature before testing.
5. Handle swabs carefully to avoid breakage.
6. Follow safety precautions for sample diluent and waste disposal.