Rapid Test for Monkeypox (MXG)

Rapid test for the detection of monkeypox.

Intended Use:

The rapid antigen test for monkeypox virus is a rapid chromatographic immunoassay intended for the qualitative detection of A29L
monkeypox virus antigen in fingerstick blood, rash specimens, and throat swab specimens. It is intended
for use as an aid in the diagnosis of monkeypox virus infection. The results indicate the presence of
monkeypox virus antigen. Positive results indicate the presence of monkeypox virus antigen.

Directions for Use:

STORAGE AND STABILITY
· Store in a sealed pouch at room temperature or in a refrigerator (2–30°C).
· The test is stable until the expiration date printed on the sealed package.
· The test must remain in the sealed package until use.
· DO NOT FREEZE.
· Do not use after the expiration date.
· Testing must be performed immediately after sample collection. Do not leave samples at room temperature for extended periods. Serum and plasma samples may be stored at 2–8°C for up to 10 days. For long-term storage, they must be stored at -20°C or below. Whole blood samples must be stored at 2–8°C if the test is to be performed within 3 days of collection. Do not freeze whole blood samples.
· Allow samples to reach room temperature before testing. Frozen samples must be completely thawed and mixed thoroughly before testing. Samples should not be frozen and thawed repeatedly.
· If samples need to be shipped, they must be packaged in accordance with local regulations governing the transport of infectious agents.
· EDTA-K2, sodium heparin, sodium citrate, and potassium oxalate may be used as anticoagulants for specimen collection.

For a rash specimen or throat swab specimen:
1. Remove the cap from the extraction buffer tube and place the tube in the workstation.
2. For a rash exudate, swab the rash exudate 5 times with a sterile swab. For a throat swab, place the swab in the back of the pharynx and on the tonsils. Swab the two pillars of the tonsils and the back of the oropharynx 5 times, taking care to avoid touching the tongue, teeth, and gums.
3. Place the swab into the extraction tube. Rotate the swab for 10–15 seconds while pressing the swab head against the inside of the tube to release the antigen from the swab.
4. Remove the swab while pressing its tip against the inside of the extraction tube as you pull it out to squeeze as much fluid as possible from it. Dispose of the swab in accordance with your protocol for disposing of biohazardous waste.
5. Replace the tube cap or close the lid, then invert the extraction tube and add 3 drops of the sample (approximately 75 μL) into the sample well (S), and then start the timer.
6. Wait for the color lines to appear. Read the results after 15 minutes. Do not interpret the result after 20 minutes.

Fingerstick blood
1. For a serum or plasma sample:
● Use a dropper: Hold the dropper vertically and transfer 1 full drop (approximately 25 μL) of serum or plasma into the sample well (S). Then add 1 drop of buffer (approximately 25 μL) to the sample well (S) and start the timer.
● Use a pipette: Transfer 25 μL of serum or plasma into the sample well (S), then add 1 drop of buffer (approximately 25 μL) to the sample well (S) and start the timer.
For a whole blood sample:
● Use a dropper: Hold the dropper vertically, transfer 2 full drops (approximately 50 μL) of whole blood into the sample well (S). Then add 2 drops of buffer (approximately 50 μL) to the sample well (S) and start the timer.
● Use a pipette: Transfer 50 μL of whole blood into the sample well (S), then add 2 drops of buffer (approximately 50 μL) to the sample well (S) and start the timer.
2. Wait for the color lines to appear. Read the results after 15 minutes. Do not interpret the result after 20 minutes.
Note: It is recommended that you do not use the buffer more than 6 months after opening the vial.

INTERPRETING THE RESULTS

Interpret the result after 10 minutes:

• POSITIVE: Two colored lines appear. One colored line must be in the control region (C), and the other colored line must be in the test region (T). A positive result in the test area indicates that monkeypox virus antigen has been detected in the sample.

• NEGATIVE: A colored line appears in the control region (C). No colored line appears in the test region (T).

• INVALID—if a control line (C) does not appear in a given sector, regardless of whether a test line (T) has appeared:

The test is invalid only in the sector where no control line appears. Reasons for an invalid test: insufficient sample volume or improper storage of the test. Repeat the test with a new kit.

Contents:

• Test cassette
• Lancet
• Buffer
• Disinfectant wipe
• Instructions in Bulgarian

Original instructions for use and complete technical specifications.