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1.Negative: ONLY one band in the control line (C). No COVID-19-specific IgM and IgG were detected. Re-test in 3-5 days if COVID-19 is suspected.
2.IgM Positive: two bands appear in the test line (T) and control line (C) in the left side of device.
3.IgG Positive: two bands appear in the test line (T) and control line (C) in the right side of device.
4.IgG and IgM Positive: each two bands appear in the test line (T) and control line (C) in both side of device.
5.Invalid result: If at 10 minutes, the red band does not appear in the control line (C), the result is considered invalid. If the test is invalid, a new test should be performed with a new patient specimen and a new test device.
GenBody COVID-19 IgM/IgG kit contains the following components:
1.Test device individually foil-pouched with a desiccant
2.Assay solution in dropping bottle
3.Capillary tube for sample loading
4.Instructions for Use
1.Specimen collection container
2.Micropipette
3.Disposable pipette tips
4.Lancets (for finger prick whole blood only)
5.Centrifuge (for plasma only)
6.Watch or timer
GenBody COVID-19 IgM/IgG is designed for the primary screening of IgM and IgG antibodies against COVID-19. This kit can provide a fast and simple results but, do not completely exclude the possibilities of false positive or false negative results caused by various factors. For confirmation, please make a final decision with clinical symptoms, other testing results, and doctor's assessment, collectively.
[Use quantitative analyzer]
•Using Confiscope G20 is optional.
Please refer to instructions for Use in the analyzer package
1.GenBody COVID-19 IgM/IgG kit should be stored between 2 to 30 °C (35.6 to 86 °F).
2.Expiration date of this kit is 24 months after its manufacture date.
1.The presence of humidity may decrease the stability of the reagents. Thus, please carry out the test immediately after removing the device from the foil pouch.
2.Do not use the kit after the expiration date. Do not freeze the kit.
3.For in vitro diagnostic use only. Do not re-use the test device.
4.Wear protective gloves while handling samples and wash hands thoroughly after the test.
5.Dispose gloves, swabs, test tubes, and the used strips properly after the test, in accordance with GLP.
6.Do not eat or smoke while handing specimens.
7.Decontaminate and dispose of all specimens, in a biohazard container.
1.Specimen to be tested should be obtained and handled by standard methods for their collections.
2.Serum: Allow the blood to clot, then centrifuge to separate the serum.
3.Plasma: Collect the whole blood into the tube containing anticoagulants such as heparin, citrate, or EDTA. Centrifuge the blood and separate the plasma.
4.Whole blood: whole blood should be collected over heparin, citrate, or EDTA. Mix the blood by inversion and use it to the test. If fingertip blood is used to the test, prick the finger and collect the blood by a capillary tube. And then, load the blood onto the sample well (S) of the test device.
5.All specimens should be tested as soon as early they are prepared. If necessary, they may be stored at 2-8°C for up to 24 hours or at -20°C for longer periods.
1.Place all specimens, test devices, and assay solution at room temperature prior to testing (15~30min).
2.[Capillary tube use] Using a capillary tube, add 10 μl of serum/plasma or load 20 μl of whole blood up to black line into the sample well (S).
[Micropipette use] Add 10 μl of serum/plasma or load 20 μl of whole blood into the sample well
(S) directly. Add 3 drops (approx. 100 μl) of assay solution into the buffer well (S) in the device.
3.After 10 minutes, interpret the test results.
Please do not read the results after 10 minutes of this testing.
CERTIFICATIONS
NOTE: Factory produce by the order of buyer's confirm
