S-RBD IgG Ab Test (Fluorescence Immunoassay Analyzer)

【INTENDED USE】
TestsealabsBCOVID-19 lgGIgM Antibody Test Cassette is a lateral flow chromatographic immunoassay for the

qualitative detection of lgG and lgM antibodies to COVID-19 in human whole blood, serum or plasma specimen.
【 SPECIFICATION】
20pc/box (20 test devices+ 20 tubes+1buffer+1 product insert)

【SPECIMENS COLLECTION】

SARS-Cov2 (COVID-19) lIgGIgM AntibodyTest Cassette (Whole BloodlSerum/ Plasma) can be performed usingholeblood 

(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 orring 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- hemolyzedspecimens.

【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 isperformed 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 thespecimen 

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 80mL), 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.10uL) of specimen 

to the sample wel(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 80mL), 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 fil line and transfer 1 full drop(approx.10uL) of specimen 

to the sample wel(S). Then add 2 drops of buffer (approximately 80 mL) and start the timer.To use a capillary tube: Fil the capilary tube and transfer 

approximately 10mL of fingerstick whole blood specimen to thespecimen well (S) of test cassette, then add 2 drops of buffer (approximately 80 mL) 

and start the timer. See illustrationbelow.
Wait for the colored line(s) to appear.Read results at 15 minutes. Do not interpret the result after 20 minutes.
Note: lt is suggested not to use the buffer, beyond 6 months after opening the vial.

【INTERPRETATION OF RESULTS】

lgG POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region(C) andanother 

line should be in the lgG line region.
IgM POSITIVE:* Two colored lines appear.One colored line should always appear in the control line region (C) andanother 

line should be in the lgM line region.
lgG and lgM 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 lgG line region and lgM 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 lgG region and lgM region.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most l

ikelyreasons for control line failure.Review the procedure an test with a new test. If the problem persists, discontinue 

usingthe Test kit immediately and contact your local distributor.