【INTENDED USE】

Testsealabs®COVID-19 IgG/IgM Antibody Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to COVID-19 in human whole blood, serum or plasma specimen.

【Specification】

20pc/box (20 test devices+ 20 tubes+1buffer+1 product insert)

【MATERIALS PROVIDED】

1.Test Devices
2.Buffer
3.Droppers
4.Product Insert

【SPECIMENS COLLECTION】

SARS-CoV2（COVID-19）IgG/IgM AntibodyTest Cassette (Whole Blood/Serum/ Plasma) can be performed usinghole blood (from venipuncture or fingerstick), serum or plasma.

1.To collect Fingerstick Whole Blood Specimens:
2.Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
3.Massage the hand without touching the puncture site by rubbing down the hand towardsthe fingertip of the middle or ring finger.
4.Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
5.Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
6.Add the Fingerstick Whole Blood specimen to the test by using a capillary tube:
7.Touch the end of the capillary tube to the blood until filled to approximately 10mL. Avoid air bubbles.
8.Separate serum or plasma from blood as soon as possible to avoid  hemolysis. Use only  clear non- hemolyzed specimens.

【HOW TO TEST】

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

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.
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 10mL), and transfer the specimen to the specimen well (S), then add 2 drops of buffer (approximately 80 mL), and start the timer.
• To use a pipette: To transfer 10 mL of specimen to the specimen well(S), then add 2 drops of buffer (approximately 80 mL), 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. 10μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 mL) and start the timer.
• To use a pipette: To transfer 10 mL of whole blood to the specimen well(S), then add 2 drops of buffer (approximately 80 mL), 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. 10μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 mL) and start the timer.
• To use a capillary tube: Fill the capillary tube and transfer approximately 10mL of fingerstick whole blood specimen to the specimen well (S) of test cassette, then add 2 drops of buffer (approximately 80 mL) and start the timer. See illustration below.
• 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】

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 lineregion.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of COVID-19 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 an test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.