High Accuracy Monkeypox Virus Igg/Igm Antibody Rapid Test

Product Description

Intended Use
The test is intended for in vitro qualitative detection of monkeypox IgM and IgG antibodies in human serum, plasma, whole blood or fingerstick whole blood sample qualitatively.
This product is to be used as an aid in the diagnosis of monkeypox infection disease, which is caused by monkeypox virus. The test provides preliminary test results. Positive result can be used for early triage and rapid management of suspected populations, but it cannot be used as diagnosis basis of monkeypox infection. Negative result do not rule out monkeypox virus infection and should not be used as the sole basis for treatment or patient management decisions. Further detection should be carried out for suspected population whose test result is positive or negative.  
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 casstte: The test line are coated with mouse anti-human IgG mAb (T1 line) and mouse anti-human IgM mAb (T2 line) respectively. The control line is coated with streptavidin-conjugated IgG . Gold conjugate pad is labeled with MPXV recombinant antigen and Biotinylated BSA. 
Sample diluent: Phosphate containing buffer.
Disposable plastic straw
Sample Treatment
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.
For Serum/Plasma

1. Open the aluminum foil bag, take out the test cassette and lay it flat.
2. Add 1 drop serum or plasma (25μL) vertically into the sample well of the test, and immediately add 2 drops (80-100μL) sample diluent vertically.
3. Observe the test result immediately within 15-20 minutes, the result is invalid over 20 minutes.

For Whole Blood

1. Open the aluminum foil bag, take out the test cassette and lay it flat.
2. Add 2 drops whole blood (50μL) into the sample well of the test, and immediately add 2 drops (80-100μL) sample diluent vertically.
3. Observe the test result immediately within 15-20 minutes, the result is invalid over 20 minutes.

For Fingerstick Whole Blood
1. Wash the patient's hand with soap and warm water or clean with an alcohol
pad. Allow to dry.
2. Massage the hand without touching the puncture site by rubbing down the
hand towards the fingertip of the middle or ring finger.
3. Puncture the skin with a lancet. Wipe away the first sign of blood.
4. Gently rub the hand from wrist to palm to finger to form a rounded drop of
blood over the puncture site. Using a capillary pipette to draw sufficient fingerstick Whole Blood.
5. Add 2 full drops fingerstick whole blood (50μL) vertically into the sample well. Avoid air bubbles.
6. Add all the sample buffer in the sample diluent bottle into the sample well.
7. Observe the test result immediately within 15-20 minutes, the result is invalid over 20 minutes.
Interpretation of Result
POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the T1 test region (T1), indicating the IgG positive.
POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the T2 test region (T2), indicating the IgM positive.
POSITIVE: Three distinct red lines appear. One line should be in the control region (C), the T1 test region (T1) and the T2 test region (T2), indicating the IgG and IgM positive.
NEGATIVE: One red line appears in the control region(C). No red or pink line appears in the test region (T).
INVALID: No red lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.
Limitation
1. The result of the product 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. If the virus antibody level in the sample is lower than the detection limit, the test result may be negative.
3. 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.
4. This reagent can only qualitatively detect monkeypox virus IgG and IgM antibody in human serum, plasma, whole blood or fingerstick whole blood sample. It cannot determine the certain antibody content in the samples.
5. Improper sample transportation and storage or freezing and thawing of the sample will affect the test results.
6. The solution and test cassettes must be equilibrated to room temperature (10°C-30°C) before used, otherwise the results may be incorrect.
7. It is optimum to use the matched sample diluent. Using other diluent may result in wrong results.
PERFORMANCE CHARACTERISTICS

1. Cross-reactivity

By testing 13 virus antibodies, there were no effect on the test results.

Name	Results
SA*RS-Co*V-2 virus IgG Ab	Negative
SA*RS-Co*V-2 virus IgM Ab	Negative
Herpes simplex virus 1 IgG Ab	Negative
Herpes simplex virus 2 IgG Ab	Negative
Varicella zoster virus IgG Ab	Negative
Enterovirus A IgM Ab	Negative
Enterovirus B IgM Ab	Negative
Enterovirus C IgM Ab	Negative
Enterovirus D IgM Ab	Negative
Human cytomegalovirus IgG Ab	Negative
EB virus IgM Ab	Negative
Measles virus IgM Ab	Negative
Ectromelia virus IgG Ab	Negative

1. 2. Interference

There were no interference with rheumatoid factors, antinuclear antibodies, antimitochondrial antibodies, and the substances in listed concentrations:

Substance	Concentration
Cholesterol	≤ 7.7mmol/L
Triglyceride	≤ 6mmol/L
Bilirubin	≤ 1000μmol/L