Monkeypox Virus Antigen Rapid Test Immunochromatography

Product Description

Intended Use
The test is intended for in vitro qualitative detection of monkeypox virus (MPXV) antigen in human oropharyngeal swab, whole blood or skin lesion materials, including lesion exudate, lesion roofs, lesion crusts.
The test is used for monkeypox virus antigen test of monkeypox suspected populations. Positive result of the antigen test can be used for early triage and rapid management of suspected populations, but it cannot be used as diagnosis basis of monkeypox infection. Negative results do not rule out monkeypox infection and should not be used as the sole basis for treatment or patient management decisions. Further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative.
The test is only for professional use, not suitable for family test. The test result is only for clinical reference and it is recommended to conduct comprehensive analysis of the disease condition in combination with clinical manifestations of patients and other laboratory tests.
Components
Test cassette: The test line and the control line are coated MPXV mAb 2 and goat anti-mouse IgG antibody respectively. Gold conjugate pad is labeled with MPXV mAb 1.
This product provides three different packaging forms, the packaging form 1, 2 or 3 can be selected according to the demands.
Packaging form 1 and 2 ( testing oropharyngeal swab, lesion exudate swab, lesion roofs and lesion crusts)
Extraction Reagent: Tris (hydroxymethyl)methyl aminomethane buffer with surfactant. The quantity of each bottle is 0.3ml.
Swab
Note: The difference of packaging form 1 and 2 is the type of the two extraction reagent tubes.
Packaging form 3 (testing whole blood)
Blood diluent: Phosphate containing buffer.
Disposable plastic strawSample Requirement
The test can be used for human oropharyngeal swab, whole blood or skin lesion materials, including lesion exudate, lesion roofs, lesion crusts. The sample is recommended to be tested immediately after collection.
1. Oropharyngeal swab, lesion exudate swab, lesion roofs and lesion crusts:
After collection, the sample shall be placed in the extraction reagent provided as soon as possible for elution, and should be tested within 1 hour. 
If the sample cannot be tested immediately, it can be stored at 2-8°C for 3 days prior to assay. If testing is delayed more than 3 days, the sample should be stored at -20°C or lower. Longer term sample storage (>60 days from collection) is recommended at -70°C. Repeat freeze and thaw for no more than 3 times.      
2. Whole Blood:
Whole blood sample with anticoagulation may be stored at 2-8°C for 3 days, and should be used immediately without anticoagulation. DO NOT FREEZE.
Sample Collection

1. Oropharyngeal swab

Across the root of the tongue and wipe the pharyngeal tonsils on both sides of the person by the swab for at least 3 times, and then wipe the posterior pharyngeal wall up and down for at least 3 times. Swab the sample vigorously, to ensure adequate monkeypox antigen is collected. Avoid touching your tongue, cheeks or teeth when sampling.

1. Lesion exudate swab

Wipe more than one lesion exudate from different locations on the body and which differ in appearance by the swab. Swab the sample vigorously, to ensure adequate monkeypox antigen is collected.

1. Lesion roofs, Lesion crusts

Take more than one lesion roofs or lesion crusts from different locations on the body and which differ in appearance. 

1. Whole blood

The whole blood sample must be collected in a clean and dry container.
Sample Treatment
Package form 1
1. Oropharyngeal swab, Lesion exudate swab

1. Take out the cap of the extraction tube.
2. Insert the swab after sampling into the extraction tube, and rotate vigorously against the inner wall of the tube to squeeze the swab for 10 times to make the sample dissolve in the solution as much as possible.
3. Squeeze the swab head along the inner wall of the extraction tube to keep the liquid in the tube as much as possible.
4. Cover the cap and unscrew the drip cap at the top for testing.

2. Lesion roofs, Lesion crusts
1) Take out the cap of the extraction tube.
2) Put the lesion roofs or lesion crusts into the extraction tube.
3) Squeeze the treatment tube 15 times to make the sample dissolve in the solution as much as possible.
4) Cover the cap and unscrew the drip cap at the top for testing.
Package form 2

1. Oropharyngeal swab, Lesion exudate swab

1) Open the sealing foil of the extraction tube.
2) Insert the swab after sampling into the extraction tube, and rotate vigorously against the inner wall of the tube to squeeze the swab for 10 times to make the sample dissolve in the solution as much as possible.
3) Squeeze the swab head along the inner wall of the extraction tube to keep the liquid in the tube as much as possible.
4) Cover the cap for testing.
2. Lesion roofs, Lesion crusts
1) Open the sealing foil of the extraction tube.

1. Put the lesion roofs or lesion crusts into the extraction tube.
2. Squeeze the treatment tube 15 times to make the sample dissolve in the solution as much as possible. The twisted liquid is taken as the sample to be tested.
3. Cover the cap for testing.

Test Procedure
Instructions must be read entirely before taking the test. Leave the reagent and sample at room temperature for 30 minutes before use. Return to room temperature. Do not open the inner packing until it is ready. Use it as soon as possible after opening the inner packing.
Packaging form 1 and 2 (testing oropharyngeal swab, lesion exudate swab, lesion roofs, lesion crusts)

1. Open the aluminum foil bag, take out the test cassette and lay it flat.

2) Add 2-3 drops (60μL-80μL) treated sample in extraction tube vertically into the sample well of the test, making sure there are no air bubbles.
3) The result is observed after 15 minutes and the result is invalid after 20 minutes.
Packaging form 3 (testing whole blood)
1) Open the aluminum foil bag, take out the test cassette and lay it flat.
2) Add 2 drops (about 50μL) whole blood by disposable plastic straw into the sample well of the test, and immediately add 2 drop (about 80μL) of blood diluent vertically.
3) The result is observed after 15 minutes and the result is invalid after 20 minutes.
Interpretation of Result
POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and the other line should be in the test region (T).
NEGATIVE: One red line appears in the control region(C). No red line appears in the test region (T).
INVALID: Control line fails to appear, indicating that the operation error or reagent failure.
Limitation

1. The result of the reagent should not be taken as a confirmed diagnosis, for clinical reference only. Judgement should be made along with RT-PCR results, clinical symptoms, epidemic condition and further clinical data.
2. In different stages of infection, samples of different viral load may have different coincidence rates with nucleic acid test results.
3. As the duration of the disease increases, the amount of antigen in the sample may decrease.
4. If the virus antigen level in the sample is lower than the detection limit, the test result may be negative.

5. The test can only qualitatively detect MPXV antigen in samples. It cannot determine the certain antigen content in samples.
6. It is optimum to use the matched sample extraction or diluent solution. Using other buffers may result in wrong results.
7. The extraction reagent and test cassettes must be equilibrated to room temperature (10°C-30°C) before used, otherwise the result may be incorrect.
8. Due to the limitation of the detection method, the negative result cannot exclude the possibility of infection. The positive result should not be taken as a confirmed diagnosis. Judgement should be made along with clinical symptoms and further diagnosis methods.
9. Analysis the possibility of false negative result:
Inappropriate sample collection, using other non-matching buffer, sample transfer time is too long, non-standardized elution operation, low virus titer in the sample, these may all lead to false negative result.
10. Analysis the possibility of false positive result:
1) Inappropriate sample collection, using other non-matching buffer, non- standardized elution operation, these may all lead to false positive result.
2) Cross-contamination of samples may lead to false positive result.
11. Analysis the possibility of invalid result:
1) If the sample volume is not enough or excessive, the chromatography cannot be carried out successfully.
2) The test would invalid if the package was broken. The packaging status must be carefully checked before use.