Audited Supplier
MPAG-DS02
IVD Reagent
Rapid Test + Extraction Tube + Swab
Lesion Material
Within 15 Mins
2~30 º C
Immunochromatography
18 Months
CE
Professional Used
Dewei
40tests/Box
1000tests/Carton
China
Product Description
INTENDED USE
The Monkeypox Virus Antigen Rapid Test is an immuno-chromatographic test for in vitro qualitative determination of Monkeypox in human lesion exudate samples.
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. 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
• 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.
SAMPLE COLLECTION
1. It is better for lesion exudate than serum, plasma or whole blood samples.
2. Samples should be collected according to routine clinical methods and avoid hemolysis.
3. Use Swab to scrape the skin lesion position, collect more than one skin lesion in case there is insufficient sample.
Bring tests, specimens, buffer and/or controls to room temperature (15~30°C) before use.
| Storage | 2~30 º C |
| Specimen | Lesion Exudate |
| Component | Rapid Test + Extraction Buffer + Swab |
| Principle | Colloidal gold rapid tests |
| Reading | Within 15mins |
| Package | 40tests/box |
| Trademark | Dewei |
| Origin | China |
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. 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
• 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.
SAMPLE COLLECTION
1. It is better for lesion exudate than serum, plasma or whole blood samples.
2. Samples should be collected according to routine clinical methods and avoid hemolysis.
3. Use Swab to scrape the skin lesion position, collect more than one skin lesion in case there is insufficient sample.
4. Test the sample immediately right after collection, lesion exudate sample can be refrigerated at 2ºC~8ºC for 5 days, whole blood sample can be refrigerated at 2ºC~8ºC for 1 day, at -20ºC for longer time.
5. Transportation of the samples should be sealed ice cup with ice or sealed foam box with ice.
OPERATION 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
1) Collect the lesion exudate sample by swab according to above instruction.
2) Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube.
3) Leave the swab into the extraction tube for 1 minute.
4) 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.
5) Put the tip on the tube and tighten up.
6) Add 2~3 drops of the mixed sample to the cassette.
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.
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