MPXV Monkeypox Virus IgG/IgM Antibody Rapid Test For Professional Use Only IVD

PRIMARY SAMPLE COLLECTION, HANDING AND STORAG

1. According to the routine method, the serum specimen must be collected from vein. Plasma samples are recommended for anticoagulation with heparin, EDTA, or sodium citrate anticoagulants. Different anticoagulants (EDTA, heparin, sodium citrate) commonly used clinical doses have no effect on the test results of the samples, the specific concentration: EDTA is 1.4-1.6g/L in blood; Heparin is 10.0-12.5 IU/mL in blood; Solutions with sodium citrate concentration of 0.129mol /L (3.8%) and blood are used 1: 9.

2. Serum or plasma samples can be stored at 2-8°C for testing within 5 days, and stored at -20°C for testing longer than 5 days. When the samples need to be frozen and thawed repeatedly, the number of freeze-thaw cycles should not exceed 3 times.

3. It is recommended to test whole blood samples within 3 days. Store the samples at 2-8°C. Do not freeze.

4. Refrigerated or frozen samples should be returned to room temperature and thoroughly mixed before testing to avoid repeated freeze-thaw cycles.

5. For samples containing suspended fibrin or polymer, it is recommended to take the supernatant for testing after centrifugation. Hemolysis samples cannot be tested.

6. There should be no other microbial contamination in the sample to be tested.

7. Specimen transfer boxes should be specially marked. After removing the specimen from the sealed bag, it should be disinfected by UV or 75% ethanol spray.

8. Please equilibrate the samples to be tested at room temperature for more than 30 minutes before use. Mix the frozen samples before testing

Technical Parameters:

TEST PROCEDURE

1.Bring the sample, test cassette and other controls to equilibrate to room temperature prior to testing.

2. Open a pouch containing a test cassette. Place the test cassette on a dry, horizontal work surface.

3. Use a micro-pipettor or dropper to add 10 μL of serum or plasma samples to the sample well of the test cassette (add 20 μL of whole blood).

4. Add 2 drops of samp (70 to 100 μL) to the sample well.

5. Set the timer /clock.

6. Read results within 10-15 minutes. Do not read results after 15 minutes.

INTERPRETATION OF RESULTS

Negative: If only the C band is present, the absence of any pink-rose color in the T1(IgG) and T2(IgM) bands indicates that no anti-2019-nCoV antibodies are detected. The result is negative.

Positive:

1. In addition to the presence of C band, if only T1(IgG) band is developed, the test indicates for the presence of anti-MPXV IgG. The result is positive.

2. In addition to the presence of C band, if only T2(IgM) band is developed, the test indicates for the presence of anti-MPXV IgM. The result is positive.

3. In addition to the presence of C band, both T1(IgG) and T2(IgM) bands are developed, this indicates for the presence of anti-MPXV IgG and IgM. The result is also positive. Invalid: If no C band is developed, the test is invalid regardless of any pink-rose color in the T1(IgG) and T2(IgM) bands as indicated below. Repeat the test with a new kit. If the problem persists, stop using this lot number immediately and contact your local supplier