PRINCIPLE
The MPOX virus Antigen Rapid Test is a qualitative membrane strip based on immunoassay for the detection of Monkeypox virus antigen in human whole blood, serum, plasma or rash exudate. After the whole blood, serum, plasma or rash exudate specimen is added in the specimen well, it reacts with precoated Monkeypox virus Antigen in the test . If the specimen contains Monkeypox virus antigen, a colored line will appear in the test line region indicating a positive result . If the specimen does not contain Monkeypox virus antigen, a colored line will not appear in this region indicating a negative result . To serve as a procedural control, a colored line indicating that proper volume of specimen has been added and membrane wicking has occurred.
SPECIMEN
Monkeypox Virus Antigen Rapid Test can be performed using either whole blood, serum, plasma or rash exudate. Separate the serum or plasma from blood as soon as possible to avoid haemolysis. Only clear, non haemolysed specimens can be used.Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Serum or plasma specimens may be stored at 2 - 8 °C for up to 5 days. For long term storage, serum or plasma specimens should be kept below -20°C. Bring specimens to room temperature prior to testing . Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly. Frozen whole blood can not be used. If specimens are to be shipped, they should be packed in compliance with federal, state or local regulations for the transportation of etiologic agents.
COMPOSITION
Materials Provided
1. Monkeypox Virus Antigen Rapid Test Device 2. Dropper 3. Buffer 4. Sterilized swab 5. Package Insert
Materials Required But Not Provided
1 . Timer
2. Specimen collection containers
SPECIMENPREPARATION
Plasma:
1 . Collect blood s o a lavender, blue or green top collection tube (containing EDTA,
citrate or heparin, respectively, in Vacutainer® ) by venipuncture.
2 . Separate the plasma by centrifugation.
3 . Carefully withdraw the plasma into a new pre- labeled tube.
Serum:
1 . Collect blood specimen into a red top collection tube (containing no anticoagulants in
Vacutainer® ) by venipuncture.
2 . Allow the blood to clot.
3 . Separate the serum by centrifugation.
4 . Carefully withdraw the serum into a new pre- labeled tube.
Test specimens as soon as possible after collecting. Store specimens at 2 °C-8 °C if not tested
immediately. Specimens can be stored at 2 ° C - 8 °C for up to 5 days. The specimens should be frozen
at -20 °C for longer storage.
Avoid multiple freeze- thaw cycles. Prior to testing, bring frozen specimens to room temperature
slowly and mix gently. Specimens containing visible particulate matter should be clarified by
centrifugation before using the Monkeypox Virus Antigen Rapid Test.
Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid
interference on result interpretation.
Blood:
Drops of whole blood can be obtained by either finger tip puncture or venipuncture.
Whole blood specimens should be stored in refrigeration ( 2 ° C- 8 ° C) , if not tested immediately. The
specimens must be tested within 2 4 hours of collection.
Rash Exudate:
1 . Wipe the rash exudate with a sterile swab;
2 . lnsert the swab into the extraction tube with buffer;
3 . Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction
tube.
4 . Leave the swab in the extraction tube for 1 minute.
5 . Squeeze the tube several times with fi ngers from outside of the tube to immerse the swab. Remove
the swab. The extracted solution will be used as test sample of Monkeypox Virus Antigen Rapid Test.
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