What is Instant-view PLUS Covid-19 IgG/IgM rapid Test?

Test results in 3 – 7 minutes

• Technology: Driven Flow®

• Specimen: Whole Blood, Serum and Plasma

• Format: Single Cassette

• Sensitivity: 98.2%

The Instant-view® PLUS COVID-19 IgG/IgM Antibody Test is a rapid, qualitative immunechromatographic in vitro assay intended for the detection and/or differentiation of IgG and/or IgM antibodies to SARS-COV-2 in human serum, plasma or whole blood samples.

This assay only provides a preliminary result.

• A positive result does not necessarily mean a current infection, but represents a different stage of the disease after infection. IgM positive or IgM/IgG both positive suggest recent exposure, while IgG positive suggests previous infection, or latent infection. Current infection should be confirmed by Real-Time Reverse Transcriptase (RT-PCR) or viral gene sequencing.
• Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

This test is intended for use by trained laboratory personnel or healthcare professionals for laboratory use only and/or for Point of Care testing.

This assay is not intended for home testing (or self-testing).

• Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
• Negative results must be combined with clinical observations, patient history, and epidemiological information.
• False negative results can occur in elderly and immunocompromised patients.
• False positive results for IgM and IgG antibodies may occur due to cross-reactivity from preexisting antibodies or other possible causes.

This device is a chromatographic immunoassay. A progressive compression structure is built into the device to accelerate the reaction between antigen and antibody.
This device detects anti-SARS-CoV-2 IgG and IgM antibody through visual interpretation of colored lines.
Each device has a strip of nitrocellulose membrane coated with anti-human IgG as the test line G; and anti-human IgM as the test line M, respectively.

The strip is also coated with Goat anti-Mouse IgG, acting as an internal Control, the C line.
The other critical component is a conjugate pad with Colloidal gold-labeled COVID-19 protein. Once the specimen is applied to the device, the COVID-19 proteins will bind to anti-COVID-19 IgG and/or IgM antibody, if present, forming an antibody-antigen complex; and then move across the membrane via progressive compression force within the device.
If anti-COVID-19 IgG and/or IgM antibody is present in the specimen, the test line (G and/or M) will bind to the antibody-antigen complex and the line(s) will appear in burgundy color. If there is no anti-COVID-19 IgG and/or IgM antibody in the specimen, no test line of G and/or M will appear. The control line C should always be visible after the reaction as a confirmation that the test is working properly.
The progressive structure progressively forces the specimen to mix, thoroughly, with conjugated compounds, then flow onto the membrane which mobilizes the colored antibody conjugates.

The reaction time can be as quick as in three to seven (3–7) minutes.

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