COVID-19 Rapid Point of Care (POC) Tests

The Cellex qSARS-CoV-2 IgG/IgM Rapid Test lateral flow chromatographic immunoassay which can detect antibodies against the SARS-CoV-2 virus. It is intended for rapid and qualitative detection of antibodies indicative of SARS-CoV-2 infection and is used as an aid for the diagnosis of SARS-CoV-2 infection.

Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test CE IVD

• Sensitivity: 94%
• Specificity: 97%

The Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test consists of: 1) a burgundy colored conjugate pad containing SARS-CoV-2 recombinant antigens conjugated with colloidal gold (SARS-CoV-2 conjugates) and rabbit IgG-gold conjugates; 2) a nitrocellulose membrane strip containing an IgG line (G Line) coated with anti-human IgG, an IgM line (M Line) coated with anti-human IgM, and the C line (C Line) coated with goat anti-rabbit IgG. The Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test is a lateral flow immunoassay for qualitative detection of antibodies to 2019 novel coronavirus (SARS-CoV-2) in serum, plasma, or whole blood specimens. For more information on the Cellex qSARS-CoV-2 IgG/IgM Rapid Test click here.

The Getein COVID-19 Rapid Point-of-Care CE-IVD Test is a lateral flow immunoassay. A lateral flow immunoassay is a way to qualitatively assess the presence of an analyte from a patient sample or specimen. In this case, the analytes being detected are IgG and IgM antibodies specific for SARS-CoV-2. The IgG/IgM test cassette is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to 2019-nCoV in whole blood, serum or plasma specimens. The principle of this test is similar to that of a hCG pregnancy test, which also uses a rapid chromatographic immunoassay for qualitative detection of a human glycoprotein.

Getein COVID-19 Rapid POC CE-IVD Test (25 tests)

• Sensitivity: 94.1%
• Specificity: 95.1%

The test detects the presence of patient-generated antibodies against SARS-CoV-2, the virus which causes the disease COVID-19. The test can detect two types of antibody isotypes: IgG and IgM. IgM antibodies are the first antibodies to appear in response to a novel antigen. They imply a more recently initiated infection. IgG antibodies have a higher affinity for the target antigen, meaning they are more specifically able to bind the substance which caused the immune response. IgG antibodies are generated later in the course of infection. IgM and IgG antibodies can both be present in a sample. This implies that the conversion from a primarily IgM to IgG humoral response is underway. A sample can be positive if there are IgM, IgG, or both IgM and IgG antibodies present.