INTENDED USE

This kit is used for in vitro qualitative detection of the monkeypox virus F3L gene in samples of skin lesions (skin rash surface or exudate swabs) from suspected cases of monkeypox, other persons requiring diagnosis or differential diagnosis of monkeypox virus infection, and throat swabs. The test results of this kit are for clinical reference only and should not be used as the sole standard for clinical diagnosis. It is recommended to make a comprehensive analysis of the disease in combination with the patient’s clinical manifestations and other laboratory tests.

Principles of the Procedure

This kit uses polymerase chain reaction combined with Taqman technology to perform Real-Time PCR detection of specific nucleic acid fragments of monkeypox virus.

Storage and Stability

The reagents should be stored at or below -20°C and kept in a shaded area. The shelf life is 12 months. Do not freeze and thaw this product more than five times.

Applicable Instrument

Fluorescence quantitative PCR instrument: ABI 7500 fluorescence PCR instrument , ABI Quantstudio5, Gentier 96R, SLAN-96P automatic medical PCR analysis system.

Sample Requirements

1. Applicable Sample
(1) Rash exudate: Use a sterile swab to collect the exudate from the rash. Place the swab in a sterile tube containing 1 mL of virus preservation solution. Ensure the sample is kept in airtight conditions and send it for testing immediately.
(2) Oropharyngeal swab: Firmly wipe the swab back and forth on both sides of the recipient’s tonsils at least three times. Then, wipe up and down along the posterior pharyngeal wall at least three times. Afterward, immerse the swab head in a tube containing virus preservation solution and securely tighten the tube lid.
2. Sample Shipping and Storage
Strictly adhere to the relevant guidelines for “specimen preservation” and “specimen submission for inspection” of clinical specimens.
Sample Storage: If nucleic acid extraction can be performed immediately, proceed with testing. If testing will occur within 24 hours, store the sample at 2–8°C. For samples that cannot be tested within 24 hours, store them at -20°C or below, and try to avoid repeated freezing and thawing to prevent false negatives. Sample Shipping: Use low-temperature transportation methods. Ensure that sample transportation complies with national biosafety regulations for handling second-category pathogenic microorganisms.