10Min Monkeypox Home Test Kit with desiccant, monkeypox antigen test kit

【SUMMARY】

Monkeypox virus is an orthopoxvirus, causing a zoonotic disease of monkeypox and a smallpox-like disease in human. The number of human monkeypox cases has been increasing since the 1970s, with the most dramatic increases occurring in the Democratic Republic of the Congo. The median age of the patients has increased from 4 (1970s) to 21 years (2010–2019). An overall case fatality rate was 8.7%, with a significant difference between clades—Central African 10.6% (95% CI: 8.4%– 13.3%) vs. West African 3.6% (95% CI: 1.7%– 6.8%). Import- and travel-related appearance of outbreaks beyond Africa highlights the global relevance of the disease. The cessation of smallpox vaccination may be just causing the disease to resurge. Detection of monkeypox cases is essential tool for understanding this resurging disease and clinical diagnosis of the disease. This kit is mainly used for the auxiliary diagnosis of monkeypox disease caused by monkey virus infection, and cannot be used alone as a basis for confirming or excluding cases. Clinical diagnosis and treatment of patients should be combined with other symptoms and other laboratory test results.

【PRINCIPLE】

The Monkeypox Virus Antigen Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of Monkeypox Virus in lesion exudate, plasma or serum. After addition of a sample, Monkeypox Virus will bind with a colloidal gold-labeled antibody on the conjugate release pad. The resulting complex overflows a nitrocellulose membrane where a specific capture antibody to Monkeypox Virus is pre-coated and a red line can be seen at a test zone (T). Unreacted colloidal gold-labeled antibody in the sample is captured at control zone(C).

【MAIN CONTENTS】

• Rapid test cassette with desiccant

• Extraction Tube with Buffer

• Sampling Swab

• Disposable pipettes

• Package insert

【STORAGE AND STABILITY】

• Store at 2 ~ 30 º C in the sealed pouch for 24 months.

• Keep away from direct sunlight, moisture and heat.

• DO NOT FREEZE

【DIRECTION OF USE】

Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.

1. Remove a test cassette from the foil pouch by tearing at the notch and place it on a flat surface.

2. Testing Lesion Exudate Sample:

a. Collect the lesion exudate sample by swab according to above instruction.

b. Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube.

c. Leave the swab into the extraction tube for 1 minute.

d. Squeeze the tube by fingers from outside of the tube to immerse the swab. Remove the swab. The extracted solution will be used as test sample.

e. Put the tip on the tube and tighten up.

f. Add 2~3 drops of the mixed sample to the cassette.

Whole blood/Serum/Plasma Sample: Transfer 1 drop of specimen to the specimen well (S) of the device with the provided disposable pipette, then add 1~2 drop of buffer and start the timer.

3. Wait for the colored band(s) to appear. The result should be read within 15 minutes. Do not interpret the result after 20 minutes.