Monkeypox Virus Antigen Rapid Test , Rash Exudate Swab, Infectious Disease Testing
PRECAUTIONS
1. This package insert must be read completely before performing the test. Failure to follow directions in package insert may yield inaccurate test results.
2. For professional in vitro diagnostic use only. Do not use after the expiration date.
3. Do not eat, drink or smoke in the area where the specimens or kits are handled.
4. Do not use the test if the pouch is damaged.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the collection, handling, storage and disposal of patient samples and the disposal of used kit contents.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Wash hands thoroughly after testing.
8. Please ensure that appropriate amounts of samples are used for testing. Too much or too little may lead to deviation of results.
9. The used test should be discarded according to local regulations.
10.Humidity and temperature can adversely affect results.
11.Where use of a centrifuge is required for a procedure, safety cups or sealed rotors should be used.
SPECIMEN COLLECTION AND PREPARATION
Rash Exudate Swab or Throat Swab
For rash exudate, wipe the rash exudate 5 laps with a sterile swab. For throat swab, insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsilla illarsand posterior oropharynx 5 laps and avoid touching the tongue, teeth, and gums.
Swab specimens should be tested as soon as possible after collection If swabs are not been processed immediately, it is highly recommended the swab sample is placed into a dry, sterile and tightly sealed plastic tube for storage. The swab specimen in dry and sterile condition is stable for up to 24 hours at 2-8°C.
Whole Blood, Serum or Plasma
Collect whole blood specimen into a collection tube (with specified anticoagulant, namely EDTA K2, heparin sodium, sodium citrate or potassium oxalate) according to standard venous blood sampling process. Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzed 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 and plasma specimens may be stored at 2-8°C for up to 10 days. For long term storage, they should be kept below -20°C. Whole blood specimens should be stored at 2-8°C if the test is to be run within 3 days after collection. Do not freeze whole blood specimens.
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.
If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents. EDTA-K2, Heparin sodium, Citrate sodium and Potassium Oxalate can be used as
the anticoagulant for collecting the specimen.
DIRECTIONS FOR USE
Allow the test, specimen and buffer equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test on a flat and clean surface, and run test as below for different specimen.
Rash Exudate Swab or Throat Swab
For Rash Exudate or Throat Swab specimen:
1. Remove the cover of the tube with extraction buffer and place the tube in the workstation.
2. For rash exudate, wipe the rash exudate 5 laps with a sterile swab. For throat swab, insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsillar pillarsand posterior oropharynx 5 laps and avoid touching the tongue, teeth,
and gums.
3. Place the swab into the extraction tube. Rotate the swab for 10-15 seconds while pressing the head against the inside of the tube to release the antigen in the swab.
4. Remove the swab while squeezing the swab head against the inside of the extraction tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol.
5. Fit the tube tip or close the cap onto the tube, then invert the extraction tube and add 2 drops of specimen (approximately 50 μL) into the specimen well (S) and then start the timer.
6. Wait for the colored line (s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
Whole Blood, Serum or Plasma
1. For Serum or Plasma specimen:
Use a dropper: Hold the dropper vertically, transfer 2 full drops (approximately 50 μL) of Serum or Plasma to the Specimen well (S). Start the timer.
Use a pipette: Transfer 50 μL of Serum or Plasma to the Specimen well(S).Start the timer.
For Whole blood specimen:
Use a dropper: Hold the dropper vertically, transfer 3 full drops (approximately 75 μL) of Whole blood to the Specimen well (S). Then add 2 drops of buffer (approximately 50 μL) to the Specimen well (S), and start the timer.
Use a pipette: Transfer 75 μL of Whole blood to the Specimen well(S), then add 2 drops of buffer (approximately 50 μL) to the Specimen well (S), and start the timer.
2. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer beyond 6 months after opening the vial.
INTERPRETATION OF RESULTS
POSITIVE:* Two colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T). Positive result in the test region indicates monkeypox virus antigen was detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of monkeypox virus antigen present in the sample. So any shade of color in the test region (T) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No colored line appears in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
