COVID-19 IgG/IgM Rapid Test CE | CTK-R0180C

The OnSite COVID-19 IgG/IgM Rapid Test is a single use lateral flow immunoassay rapid test intended for qualitative detection and differentiation of anti-SARS-CoV-2 IgG and IgM antibodies in human serum and plasma or whole blood containing EDTA, heparin or citrate anti-coagulants. The OnSite COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. For prescription use only. For in vitro diagnostic use only.

Currently, the laboratory method for detecting SARS-CoV-2 infection is RT-PCR. However, this method requires sophisticated equipment and highly trained laboratory technicians. Moreover, viral load decreases rapidly 9 or 10 days after onset of symptoms. During the acute phase of infection, the titer of IgM to SARS-CoV-2 rises rapidly and peaks around 2-3 weeks after the infection. SARS-CoV-2 specific IgG antibodies appear shortly after IgM and persist for months. It is unknown if SARS-CoV-2 infection leads to lifetime immunity or if a 2nd infection is possible. Nevertheless, the SARS-CoV-2 specific antibodies are useful markers for immune response and epidemiologic survey.

Product Features:

• The OnSite COVID-19 IgG/IgM Rapid Test is designed to detect anti-SARS-CoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within 15 minutes.

• This test is easy-to-use, with basic equipment needs.

• The OnSite COVID-19 IgG/IgM Rapid Test has 97.1% sensitivity and 97.8% specificity, making it one of the most effective tests for detecting previous exposure to anti-SARS-CoV-2 virus.

• Finger prick specimen allows testing at point-of-care, saving crucial time.

• Complementary to PCR by detecting immune response

• Compatible with CTK Rapid Test Reader (RTR-1)

• 200 tests per hour in batch mode

• Capable of connecting to Laboratory Information System (LIS)

• Built-in barcode reader provides faster test setup

• Stores up to 1,000 results, presented on screen, via printout, or uploaded to database

Product Specification:

Reagents and Materials provided: 1. Individually sealed foil pouches containing:

• One cassette device

• One desiccant 2. Disposable capillary tubes, marked for 10 µL and 20 µL 3. Detection buffer (tris-based buffered solution with preservatives) 4. Instructions for Use Materials Required but not provided: 1. Clock, watch or other timing device 2. Pipettor capable of delivering 10-20 μL of sample, that can be used instead of the disposable capillary tube for greater accuracy 3. Sterile lancets, sterile gauze and wipes for fingerstick whole blood specimens 4. Collection devices for venous whole blood, serum, plasma 5. Disposable gloves, biohazard disposal container