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Product details

Intended Use:

The Monkeypox Virus Antigen Rapid Test Kit is used for the qualitative detection of Monkeypox antigen in human serum, lesion exudate or scab samples. It is intended for in vitro diagnostic use only.

Test Principles:

When the specimen is processed and added to the sample well, monkeypox virus antigens in the sample interact with the monkeypox virus antibody-labeled conjugate forming antigen-antibody color particle

complexes. The complexes migrate on the nitrocellulose membrane via capillary action until the test line, where they are captured by the mouse monoclonal anti-monkeypox virus antibodies. A colored test line is visible in the result window if monkeypox virus antigens are present in the specimen and the intensity depends upon the amount of monkeypox virus antigen. When the monkeypox virus antigens in the specimen does not exist or is below the detection limit, there is not a visible colored band in the test line of the device. This indicates a negative result. Neither the test line nor control line are visible in the result window prior to applying the specimen. A visible control line is required to indicate the result is valid.

Main Contents

Components provided are listed in the table.

Operation Flow

Read the instructions thoroughly before testing and bring the cassette and specimen to room temperature. When ready to test, open the pouch at the notch and remove the device. Place the test device on a clean, flat surface.

The Monkeypox Virus Antigen Rapid Test Kit can be performed on serum, lesion exudate or scab samples

For Serum samples:

1. Test serum samples as soon as possible after collecting. Store serum samples at 2°C-8°C if not tested immediately. 2°C -8°C: for up to 5 days, -20°C for longer storage.

2. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clear by centrifugation before testing.

3. Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 50-60µL of serum into the sample extraction solution tube.

4. Mix the sample and solution by gently turning the tube upside down, let stand for a minute.Squeeze the tube to add 3 drops (about 100 μL) to the sampe well of the test cassette.

5. Visually read the result after 15-20 minutes. The result is invalid after 20 minutes.

Note:  Avoid multiple freeze-thaw cycles and do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

For Lesion exudate or scab samples:

1. Wipe the lesion exudate or scab samples with swab.
2. Insert the swab into the sample extraction solution tube and plunge the swab up and down in the fluid for a minimum of 15 seconds, then hold the swab against the bottom of the tube and rotate it 5 times.
3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. Press the nozzle cap firmly onto the solution tube containing the processed sample. Mix thoroughly by swirling or flicking the bottom of the tube.
4. Mix the sample by gently turning the tube upside down, squeeze the tube to add 3 drops (about 100 μL) to the sample well of the test cassette, and start counting.
5. Visually read the result after 15-20 minutes. The result is invalid after 20 minutes.

Interpreting the results

Order Information

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