INTENDED USE

The PocTell^® Monkeypox Antigen Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of monkeypox virus antigen in human rash exudates and blood samples..

MonkeyPox Antigen Rapid Test

Ordering Information

Test Item	Format	Specimen	Reaction Time	Shelf life	Kit Size
Monkeypox Antigen	Cassette	Swab, S/P/WB	15 mins	24 months	25 T/Kit

TEST PRINCIPLE

The PocTell^® Monkeypox Antigen Rapid Test Device detects Monkeypox Virus antigens through visual interpretation of color development on the strip. Anti- Monkeypox Virus antibodies are immobilized on the test region of the membrane respectively. During testing, the extracted specimen reacts with anti- Monkeypox Virus antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient Monkeypox Virus antigens in the specimen, colored band will form at the according test region of the membrane. The presence of a colored band in the test region indicates a positive result for the particular viral antigens, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred. .

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DIRECTIONS FOR USE

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

For Plasma/Serum/Whole Blood:

1. When ready to test, open the pouch at the notch and remove the test cassette. Place the test cassette on a clean, flat surface.

2. Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 1 drop (about 25 μL) of specimen into the sample well, making sure there are no air bubbles.

3. Immediately add 1 drop (about 35-50 μL) of buffer into the sample well.

For Rash Exudate:

1. Reverse the sample extraction tube and add 3 drops (about 100~120 μL) sample by squeezing the extracted solution tube into the sample window.

Wait for colored line(s) to appear. Interpret the test results in 15 minutes. Do not read results after 20 minutes..

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