Monkeypox Virus Antigen Rapid Test

SUMMARY

Monkeypox is used to be a viral zoonosis with symptoms very similar to those in smallpox patients, caused by by infection with Monkeypox virus. It is an enveloped double-stranded DNA virus that belongs to the Orthopoxvirus genus of the Poxviridae family. Human monkeypox was first identified in humans in 1970 in the Democratic Republic of the Congo. Recently in 2022, the monkeypox virus is spreading across the world, with reports of cases in the U.K., Spain, Portugal, the U.S and some more countries. In humans, the symptoms of monkeypox are similar to but milder than the symptoms of smallpox. Monkeypox begins with fever, headache, muscle aches, and exhaustion. The incubation period (time from infection to symptoms) for monkeypox is usually 7−14 days but can range from 5−21 days. The virus enters the body through broken skin (even if not visible), respiratory tract, or the mucous membranes (eyes, nose, or mouth). Animal-to-human transmission may occur by bite or scratch, bush meat preparation, direct contact with body fluids or lesion material, or indirect contact with lesion material, such as through contaminated bedding. Human-to-human transmission is thought to occur primarily through large respiratory droplets. Respiratory droplets generally cannot travel more than a few feet, so prolonged face-to-face contact is required. Other human-to-human methods of transmission include direct contact with body fluids or lesion material, and indirect contact with lesion material, such as through contaminated clothing or linens.

The Monkeypox Virus Antigen Rapid Test is designed as a simple tool in detection of Monkeypox for regular clinical diagnosis.

TEST PROCEDURE

Allow the rapid test, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. 1. Bring the pouch to room temperature before opening. Remove the rapid test cassette from the sealed pouch and use it as soon as possible.
2. 2. Place the test device on a clean and horizontal surface.Suck the treated sample extraction from the assay buffer tube and place 3 drops into the specimen well (S) of the test cassette. Start the timer.  
3. 3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

4. INTERPRETATION OF RESULTS
   
   

   POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

   NEGATIVE: Only one colored band appears in the control region (C). No colored band appears in the test region (T).

   INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

   NOTE:

   1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
   2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

   3. LIMITATIONS

      1. The Monkeypox Virus Antigen Rapid Test is for in vitro diagnostic use only. This test should be used for the detection of Monkeypox antigens in human skin lesion swab, and mucous membrane swab 

      1. specimen. If negative found but symptoms likeMonkeypox, it is suggested to repeat the assay or send the specimen to a testing center/station/laboratory for PCR testing.
      2. 2. The Monkeypox Virus Antigen Rapid Testwill only indicate the presence to Monkeypox in the specimen and should not be used as the sole criteria for the diagnosis of the 

         infections.

      3. 3. If the symptom persists, while the result from the Rapid Test is negative or non-reactive result, it is recommended to re-sample the patient few days lateror test with PCR.
      4. 4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
      5. 5. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of flu infection.
      6. 6. The potential impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated in the test.
      7. 7. Due to inherent differences between methodologies, it is highly recommended that, prior to switching from one technology to the next, method correlation studies are undertaken to qualify technology differences. 8. One hundred percent agreement between the results should not be expected due to differences between technologies.
      8. 9. Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay.
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