DIRECTIONS FOR USE
Allow the test, specimen, buffer and/or controls to reach room temperature (15- 30°C) prior to testing.
1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Place the cassette on a clean and level surface. For Serum or Plasma specimen:
To use a dropper: Hold the dropper vertically, draw the specimen to the fill line (approximately 10uL), and transfer the specimen to the specimen well (S), then add 2 drops of buffer (approximately 80uL), and start the timer.
To use a pipette: To transfer 10 uL of specimen to the specimen well(S), then add 2 drops of buffer (approximately 80 uL), and start the timer
For Venipuncture Whole Blood specimen:
To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx. 20μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 uL) and start the timer.
To use a pipette: To transfer 20 uL of whole blood to the specimen well(S), then add 2 drops of buffer (approximately 80 uL), and start the timer
For Fingerstick Whole Blood specimen:
To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx. 20μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80uL) and start the timer.
To use a capillary tube: Fill the capillary tube and transfer approximately 20uL of fingerstick whole blood specimen to the specimen well (S) of test cassette, then add 2 drops of buffer (approximately 80 L) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
PRECAUTIONS
1. This package insert must be read completely before performing the test. Failure to follow directions in insert may yield inaccurate test results.
2. For professional in vitro diagnostic use only. Do not use after expiration date.
3. Do not eat, drink or smoke in the area where the specimens or kits are handled.
4. Do not use test if pouch is damaged.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Please ensure that an appropriate amount of samples are used for testing. Too much or too little sample size may lead to deviation of results.
8. The used test should be discarded according to local regulations.
9. Humidity and temperature can adversely affect results.
SPECIMEN COLLECTION AND PREPARATION
- The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick), serum or plasma.
- To collect Fingerstick Whole Blood Specimens:
- Wash the patient’s hand with soap and warm water or clean with an alcohol pad. Allow to dry.
- Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
- Puncture the skin with a lancet. Wipe away the first sign of blood.
- Gently rub the hand from wrist to palm to finger to form a rounded drop of blood
INTERPRETATION OF RESULTS
IgG POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgG line region.
IgM POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgM line region.
IgG and IgM POSITIVE:* Three colored lines appear. One colored line should always appear in the control line region (C) and two test lines should be in the IgG line region and IgM line region.
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of 2019-nCoV antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the IgG region and IgM region.
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.
QUALITY CONTROL
Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance
