Monkeypox Virus IgG/gM Antibody Test Kit (Colloidal Gold) --- Professional

Intended use

The Monkeypox Virus IgG/IgM Antibody Test Kit (Colloidal Gold) is a rapid chromatographic

immunoassay for the qualitative detected IgG/IgM antibody of Monkeypox Virus in Serum, Plasma or Whole Blood.

Test principle

The Monkeypox Virus IgG/IgM Antibody Test Kit (Colloidal Gold) is a qualitative, membrane-based immunoassay for detecting Monkeypox Virus antibody in Serum, Plasma or Whole Blood.

Materials and Components

1.Test Device

2.Instruction

3.Dropper

4.Buffer

1.Specimen collection containers

2.Lancets (for fingerstick whole blood only)

3.Centrifuge

4.Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)

Specimen Collection and Preparation

1.Whole Blood (Venipuncture Whole Blood specimen)

Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by venipuncture.

（1）Have a certified phlebotomist collect whole blood into a purple, blue orgreen top collection tube (containing EDTA, citrate or heparin, respectively) by venipuncture.

（2）Separate the plasma by centrifugation.

Allow test device extraction reagent and specimens to equilibrate to room temperature(15 ~ 30 ℃） prior to testing.Please keep the temperature at 15 ~ 30 ℃ and the humidity at 20%-80% during the whole test.

1. Remove the test device from the 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.

3. Add the sample to the specimen well:

• Whole Blood specimen (Venipuncture Whole Blood specimen)

Hold the dropper vertically, transfer 1 drop of the specimen to the specimen well, then add 1 drop of buffer and start the timer.

• Plasma or Serum specimen

Transfer 2 drops of serum/plasma to the specime well of the strip with a dropper in the kit,and then start the timer.

4.Test Results

Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 30 minutes.

Interpretation of Result