Rapid test for coronavirus

Results can be interpreted at 10~15 minutes after sample and buffer are combined in the cassette sample well.

The test strip uses a colloidal gold recombinant novel coronavirus antigen and a quality control antibody colloidal gold marker. The strip has the follow detection lines:

IgM – is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody.

IgG – is fixed with monoclonal antihuman IgG antibody for detecting the novel coronavirus IgG antibody.

C- The quality control antibody is fixed on the C (Control) line.

The clinical sensitivity is 97.5% and clinical specificity is 100% when compared to RT-PCR. The relative accuracy rate is 99.2%.

The device should never be frozen. If refrigerated, allow the buffer, specimen and device to reach room temperature before use. The advised storage is 2-30⁰C / 36-86⁰F.

IgM presumptive positive = Indication of an early adaptive immune response to SARS-CoV-2 infection.

IgG/IgM presumptive positive = Indication of an adaptive immune response to SARS-CoV-2 infection that has been ongoing for more than 10~14 days.

IgG presumptive positive= Indication of later-stage or recovered SARS-CoV-2 infection.

Positive = All positive results should be confirmed with a secondary laboratory based serological antibody test.

Negative = A medical professional should observe symptoms and epidemiology of patients to rule out the possibility of a false-negative result. Retesting should be considered if symptoms appear or persist.

The Covid-19 IgM/IgG Rapid Test can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of this test should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.

Urgency – The Covid-19 IgM/IgG Rapid Test can provide presumptive qualitative results onsite in a matter of minutes. Providing healthcare workers with more information at critical moments in the patient’s care.

Volume – Low-cost fast turn-around screening of asymptomatic/recovered individuals for antibodies to SARS-CoV-2.

Adaptive Immune Response Screening – Asymptomatic or recovered individuals can be screened with the Covid-19 IgM/IgG Rapid Test in conjunction with approved nucleic acid tests or laboratory-based serology tests to confirm recovery and the existence of infection fighting IgG antibodies in the bloodstream.