Monkeypox virus IgG/IgM Test Kit

(Immunochromatography)

[Intended use]

Monkeypox virus IgG/IgM Test Kit (Immunochromatography) is a solid phase immunochromatographic assay for the rapid, qualitative detection of IgG/IgM antibody to Monkeypox virus in human blood. This test provides only a preliminary test result. Therefore, any reactive specimen with the Monkeypox virus IgG/IgM Test Kit (Immunochromatography) must be confirmed with alternative testing method(s) and clinical findings.

[Materials Supplied]

Each sealed pouches contains a test cassette, a desiccant, a dropper, Buffer, Package insert

[Packaging specifications]

1 test/box, 5 tests/box, 20 tests/box

[Storage conditions and validity period]

The test kit should be stored in a sealed aluminum foil bag at 4ºC~30ºC, and the validity period is 24 months. After the foil bag is opened, the validity period is 1 hour.

[Test method]

Allow test cassette, specimen, buffer and/or controls to equilibrate to room temperature prior to testing.

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay
is performed within one hour.

2. Place the test device on a clean and level surface.
For Serum or Plasma Specimens:

With the provided dropper, draw serum/plasma specimen and then add 1 drop serum/plasma specimen into the sample well(S).
Then add 2 drops of buffer to the sample well(S) immediately. Avoid air bubbles.

For Whole Blood Specimen:

With the provided dropper and transfer 1 drop of whole blood to the sample well(S) of the test device, then add 2 drops of buffer
to the sample well(S) immediately. Avoid air bubbles.

Wait for the colored line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 15 minutes.

 

[Interpretation of results]

NEGATIVE: If only the C band is present, the absence of any burgundy color in the both T bands (IgG and IgM) indicates that no anti-Monkeypox antibodies are detected in the specimen. The result is negative.

IgM POSITIVE:

In addition to the presence of C band, if only IgM band is developed, the test indicates for the presence of IgM anti-Monkeypox in the specimen. The result is IgM anti-Monkeypox positive.

IgG POSITIVE:

In addition to the presence of C band, if only IgG band is developed, the test indicates for the presence of IgG anti-Monkeypox in the specimen. The result is IgG anti-Monkeypox positive.

IgG and IgM POSITIVE:

In addition to the presence of C band, both IgG and IgM bands are developed, the test indicates for the presence of both IgG and IgM anti-Monkeypox in the specimen. The result is IgG and IgM anti-Monkeypox positive.

INVALID:

Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

[Warning]

1. For in vitro use only.

2. For professional use only.

3. Test is for single use only. Do not re-use under any circumstance.

4. All specimens should be considered potentially hazardous and handle in the same way as an infectious material. Wear protective clothing such as laboratory coats, disposable gloves.

5. The used testing materials should be discarded in accordance with local, state and or federal regulations.

6. In case of any serious incident related to the device, it shall be reported to the manufacturer, distributor, EU authorised representative, notified body and the competent authority.