Novel Coronavirus IgG/IgM Rapid Test Kit (CE Certified)
Quark Biotechnology's COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma.
This Rapid Test Kit facilitates patient treatment decisions quickly because of the fast 2 - 10 minutes results. This product is simple, time-saving procedure that contains all the necessary reagents. COVID-19 Rapid Test Kit is also high sensitive and specific.
Results In 10 Minutes
Easy To Use
Covid-19 IgG/IgM Rapid Test
Procedure & Explanation
Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
Be sure to label the device with specimen’s ID number.
For whole blood sample:
Fill the dropper with the specimen then add 1 dropper of specimen into the sample well. The volume is around 10µL. Making sure that there are no air bubbles. Then add 2 drops (about 60-100 µL) of Sample Diluent immediately into the sample well.
Note: Practice a few times prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimen by a pipette capable to deliver 10µL of volume.
For Plasma/ Serum sample:
Fill the dropper with the specimen not to exceed the specimen line. The volume of the specimen is around 10µL. Dispense the entire specimen into the center of the sample well making sure that there are no air bubbles.
Then add 2 drops (about 60-100 µL) of Sample Diluent immediately into the sample well.
Note: Practice a few times prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimen by a pipette capable to deliver 5µL of volume.
Set up a timer.
Step 6: Read the result at 15 minutes.
Don’t read result after 30 minutes. To avoid confusion, discard the test device after interpreting the result.
INTERPRETATION OF ASSAY RESULT
IgG POSITIVE:* The colored line in the control line region (C) appears and a colored line appears in test line region 1 (T1). The result is positive for Covid-19 virus specific-IgG and is probably indicative of secondary Covid-19 infection.
IgM POSITIVE:* The colored line in the control line region (C) appears and a colored line appears in test line region 2 (T2). The result is positive for Covid-19 virus specific-IgM antibodies and is indicative of primary Covid-19 infection.
IgG AND IgM POSITIVE:* The colored line in the control line region (C) appears and two colored lines should appear in test line regions 1 and 2 (T1 and T2). The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies and is indicative of secondary Covid-19 infection.
*NOTE: The intensity of the color in the test line region(s) (T1 and/or T2) will vary depending on
the concentration of Covid-19 antibodies in the specimen. Therefore, any shade of color in the test
line region(s) (T1 and/or T2) should be considered positive.
The colored line in the control line region (C) appears. No line appears in test line regions 1 or 2 (T1 or T2).
Control line (C) falls to appear. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
REAGENTS AND MATERIALS PROVIDED
1. Each foil pouch contains with three items inside:
a. One cassette device: the functional unit of the test which holds the immunoassay strip inside.
b. One plastic dropper: used to transfer the samples to the specimen well.
c. One desiccant.
2. Sample diluent: added to the specimen well to facilitate the test.
3. One blood lancets (for fingerstick whole blood only)
4. 75% Ethyl alcohol pad.
5. One package insert (instruction for use).
MATERIALS REQUIRED BUT NOT PROVIDED
1. Specimen collection containers: used to hold samples after collection.
2. Centrifuge (for plasma only).
3. Clock or Timer.