Dewei Monkeypox Virus Antigen Test Kit (Colloidal Gold) is a lateral flow immunoassay for the qualitative detection of monkeypox virus antigen in human lesion exudate sample. It is intended to be used as a screening test for early diagnosis and management of patients related to infection with Monkeypox.
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 releasepad. 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 Contains
• Rapid test cassette with desiccant
• Extraction Tube with Buffer
• Sampling Swab
• Disposable pipettes
• Package insert
Features
Specification: 25 Tests/Kit
- Rapid detection of monkeypox virus antigen
- Reliable test result
- 10-15 min rapid test cassette
- Easy-to-operate
- No need of any equipment
Precautions
• For professional in vitro diagnostic use only.
• Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge ofthe origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g.,do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to testing.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents.Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as
laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded according to local regulations.
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.
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 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 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.
For further operation or performance details, please refer to final instruction manual.
Your message must be between 20-3,000 characters!