Monkeypox virue Ab/Ag antigen/antibody rapid test kit MPXV Monkeypox Virus

INTENDED USE

The Monkeypox Virus Antigen Rapid Test Kit is an immune-chromato- graphic test system for the rapid, qualitative detection of monkeypox virus (MPXV) antigen in human throat swab, Lesion exudate swab (rash exudate, vesicle /acne scab focus), can be used for diagnosis of monkeypox virus infection disease in vitro. The Monkeypox Virus Antigen Rapid Test Kit provides preliminary test results, with negative results don’t preclude monkeypox virus infection. Cannot be used as the sole basis for treatment or other management decision. For professional use only.

Features:

• Product Name: Monkeypox virue Ab/Ag antigen/antibody rapid test
• Application: Clinical/ Hospital/ Laboratory/ Home
• Package: 20 Tests/kit
• Format: Cassette
• Sample Type: Lesion exudate swab (rash exudate, vesicle /acne scab focus)
• Reading Time: 5-15 Minutes
• Can be used as a Home test
• serum,plasma or whole blood

Technical Parameters:

PRINCIPLE

This kit is based on the principle of highly specific antibody-antigen reaction and colloidal gold labeling immunochromatographic analysis technology. The reagent contains mouse anti-monkeypox monoclonal antibody prefixed in the test area (T) on the membrane and the mouse anti-MPXV monoclonal antibody coated on the label pad-colloidal gold mixture. The sample is dripped into the sample well and reacts with the mouse anti-MPXV monoclonal antibody which is bound to the pre-coated colloidal gold particles when testing. Then the mixture is chromatographed upwards with capillary effects. If it is positive, the antibody labeled by colloidal gold particles will first bind to the monkeypox virus antigen in the sample during chromatography. Then the conjugates are bound by the mouse anti-MPXV monoclonal antibody fixed on the membrane, and a red line appears in the test area (T). If it is negative, there's no red line in the test area (T). Whether the sample contains monkeypox virus antigen or not, a red line will appear in the quality control area (C). The red line appearing in the quality control area (C) is the standard for judging whether there are enough samples and whether the chromatographic process is normal, and it also serves as the internal control standard for the reagen

COMPONENTS

Components of the test strip in the cassette:

Sample pad: contains buffered salts and detergents.

Label pad: contains gold-labeled mouse anti-MPXV monoclonal antibody. Nitrocellulose membran

Control area: contains goat anti-mouse IgG polyclonal antibody and buffer.

Test area: contains mouse anti-MPXV monoclonal antibody and buffer.

Absorbent pad: made of highly absorbent paper.

WARNINGS AND PRECAUTIO

1. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.

2. This product is a single-use in vitro diagnostic reagent. Do not reuse it. Do not use it if it is expired.

3. Each component of the kit cannot be used in batches.

4. Do not use a test device beyond the expiration date imprinted on the outside of the foil pouch.

5. It is recommended to use fresh samples, do not use repeatedly freeze-thaw samples.

6. The components of the kit and the waste produced by the test are treated as infectious pollutants.

7. Too much or too little sample size can bias the results.

8. The extraction buffer is not edible. When opening the extraction buffer, please ensure that the extraction buffer does not splash into the eyes or mouth.If the extraction solution comes into contact with your skin, wash the affected area with plenty of water. If irritation is found, contact your doctor

STORAGE AND SHELF LIFE AFTER FIRST OPENING

1. Store at 2℃ to 30℃ in the sealed pouch up to the expiration date (24 months).

2. Keep away from sunlight, moisture and heat.

3. DO NOT FREEZE

4. When the humidity is below 60%, use it within 1 hour after opening. When the humidity is above 60%, use it immediately after opening. Production date, expiry date will be in the lab