Monkeypox Virus Antigen Rapid Test

タイトルまたは説明

INTENDED USE
TheMonkeypox Virus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection ofMonkeypox antigen in humanskin lesionswab, ormucous membraneswab specimen inindividuals who are suspected ofmonkeypox-like symptoms or recent contact with monkeypox infected patients. 
  SPECIMEN COLLECTION AND PREPARATION
TheMonkeypox Virus Antigen Rapid Test can be performed usingskin lesion ormucous membrane swab.

Skin lesion Swab: Place the sterile swab onto the skin lesion site, especially the part with vesicles. Gently scrape the lesion to collect the fluid for 5~8 times with the swab.

Mucous membrane Swab:Placethe head of sterile swab into thedeepthroat, or the nasal cavities, or onto the eye conjunctiva. Gently scrape themucous membrane with the swab for 5~8 times.

Take out of an assay buffer tube, and tear off theseal of the tube. Insert the swab into the tube and squeeze the flexible tube for 8~*0 times to extrude the specimen from the head of the swab. Make the specimen resolved in the assay buffer sufficiently. Add the tip onto the assay buffer tube.

The assay should be performed immediately in 2 hours after the specimen preparation. If the assay could not be carried immediately, the prepared specimen should be kept no more than *4 hours at **8°C or 7 days at **0°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 for more than two times.

If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.
  TEST PROCEDURE
Allow the rapid test, specimen, buffer, and/or controls to equilibrate to room temperature (****0°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove therapid test cassettefrom the sealed pouch and use it as soon as possible.

2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.

3. Wait for the colored line(s) to appear. Read results at *0 minutes. Do not interpret the result after *5 minutes.
  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.