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Registration Date 11 Apr 2020
Revision Date 11 Apr 2020
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COVID-19 Rapid Test Cassette

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Medicine Medical Supplies

Detection Kit

Nanomaterials

Manufacturer Asserted

Gold

Au Nanoparticle /Nanopowder CAS Number : 7440-57-5

Applications

The IgG that the test detects is specific to COVID-19, so a positive result would indicate COVID-19 infection. Although the IgM is a more generalised antibody, its presence, combined with IgG and/or the common symptoms of COVID-19, would also indicate infection with the novel SARS-CoV-2 virus. The test can be used for primary and secondary diagnosis of COVID-19.
Coronavirus detection COVID-19 detection

Properties

Significant time and cost saving over lab methods icon Significant time and cost saving over lab methods Results within 10 minutes icon Results within 10 minutes Identifies infection even in mild or asymptomatic cases icon Identifies infection even in mild or asymptomatic cases Assists in the control of viral transmission icon Assists in the control of viral transmission Screen anywhere icon Screen anywhere Ideal as a triage and screening tool icon Ideal as a triage and screening tool Accuracy of 97.8% (IgM) and 99.6% (IgG) icon Accuracy of 97.8% (IgM) and 99.6% (IgG) Easy to use and read, with no specialist equipment required icon Easy to use and read, with no specialist equipment required

Rapid detection Finger-prick test

Manufacturer's Description

This test is CE marked for Professional use only. SureScreen's COVID-19 rapid test identifies the body's response to coronavirus after the onset of infection, and gives a qualitative yes/no result within 10 minutes. Implementing rapid screening for COVID-19 has huge time and cost savings when compared to laboratory screening, and will help to control the spread of the virus by identifying infection rapidly and accurately. The test cassette is easy to use, needing only a finger-prick sample to function, much like a blood glucose test. As well as whole blood, the cassette can also be run with serum or plasma samples.

The test is a lateral flow immunoassay test and operates in a similar way to a pregnancy test. Embedded into the test strip are antibodies that bind to a COVID-19 specific biomarker, Immunoglobulin G (IgG), and another infection biomarker, Immunoglobulin M (IgM). When a sample (blood, serum or plasma) is added to one end of the test, it flows along the test strip and interacts with these antibodies. If the patient has contracted COVID-19, the biomarkers in their blood will bind to the antibodies on the test strip, leaving a visible test line. If the patient doesn’t have COVID-19, no biomarkers should be present in their blood and no test line will be visible. There are separate test lines for IgG and IgM and only one needs to be visible for a positive result.