Sugentech SGTi-flex COVID-19 IgG

Sugentech SGTi-flex COVID-19 IgG is the qualitative test kit which is designed to detect immunoglobulin G antibodies against SARS-CoV-2 in serum, plasma, and venous whole blood.

The Sugentech SGTi-flex COVID-19 IgG is a gold nanoparticle-based immunochromatographic test kit for qualitative determination of COVID-19’s IgG antibodies in human whole blood, serum or plasma. The kits are accurate and easy to use and results can be observed with the naked eye within 10 minutes. The test detects the presence of antibodies, which are specific proteins made in response to infections. Antibodies can be found in the blood of those who are tested after infection. The antibodies detected by this test indicate that a person had an immune response to COVID-19, whether symptoms developed from infection or the infection was asymptomatic.

Antibody test results are important in detecting infections with few or no symptoms. As there is no medicine or vaccine, the best way to combat this infection is isolation. A lot of people don’t have symptoms. Because of that, quick diagnostics are very important. SGTi-flex COVID-19 IgG enables to help for community to identify infection and isolate people without symptoms but suspected COVID-19.

Package contents :

• Test Cassette x 25
• Sample Buffer x 1 (4.5 mL/tube)
• Instructions for Use x1

Storage and stability :
• The test kit can be stored at 2-8 °C for 9 months or at room temperature for 3 months. DO NOT FREEZE. The test is stable through the expiration data printed on the sealed pouch. Do not use after the expiration date.
• SGTi-flex COVID-19 IgG Test Cassette and Sample Buffer should be brought to room temperature for 30 minutes before testing.
• Do not open the pouch of Test Cassette until ready to use. After opening aluminum pouch, Test Cassette should be
used immediately.
• Keep away from direct sunlight.

Sample collection and preparation :
SGTi-flex COVID-19 IgG can be performed with venous whole blood, plasma or serum.
1. Venous whole blood
1.1 The anticoagulants sodium heparin, lithium heparin, sodium citrate, and tripotassium EDTA have been tested and may beused with this assay. The correct specimen type must be used in the assay.
1.2 If venipuncture whole blood is not tested immediately, store at 2-8°C for up to 5 days.

2. Serum and Plasma
2.1 Serum : Collect the blood specimen obtained by venipuncture into a tube without anticoagulant and allow to clot for about 30 minutes. Separate serum from the supernatant by centrifugation.
2.2 Plasma : Collect the blood specimen obtained by venipuncture into a tube containing anticoagulant (sodium heparin, lithium heparin, sodium citrate and tripotassium EDTA), and separate plasma from the supernatant by
centrifugation.

3. Whole blood, Serum and Plasma Stability
If specimens are not tested immediately, store at 2-8°C for up to 5 days.
For serum and plasma, the specimens should be frozen at -70°C for longer storage. For frozen samples, avoid repeated
freezing/thawing cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently.

Manufacturer :
Sugentech, Inc., South Korea

Approvals :
US FDA EUA, CE-IVD