One Step Test for 

Novel Coronavirus (2019-nCoV) IgM/IgG Antibody

(Colloidal Gold)

Intended Use

One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold) is intended for the qualitative detection of 2019-Novel Coronavirus IgM and IgG antibody in serum, plasma or whole blood samples from patients suspected of COVID-19 infection by a healthcare provider.

About 2019-nCoV

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Contents

A kit contains:

Package specifications: 25 tests/box

1) Getein Novel Coronavirus (2019-nCoV) IgM/IgG antibody test card in a sealed pouch with desiccant

2) Sample diluent: 2 bottles/box

3) User manual: 1 piece/box

Note: Do not mix or interchange different batches of kits.

Specifications

Operation

Test Results

1. Valid Test

Positive (+):

(1) Three bands appear, one at the control area (C) and two at the test lines (M, G). The result indicates the presence of 2019-nCoV IgM and IgG antibody. The result is IgG and IgM positive or reactive, suggesting current or recent 2019-nCoV infection.

(2) Two bands appear, one at the control area (C) and one at the test line (M). The test indicates the presence of 2019-nCoV IgM antibody. The result is IgM positive or reactive, consistent with an acute or recent 2019-nCoV infection.

(3) Two bands appear, one at the control area (C) and one at the test line (G). The test indicates the presence of 2019-nCoV IgG antibody. The result is IgG positive or reactive, consistent with a recent or previous infection.

Negative (-):

A single band appears at the control area (C) and no other band at test lines. The result indicates that the sample does not contain 2019-nCoV IgM or IgG antibody. Negative results do not exclude 2019-nCoV infection, particularly for patients who have been in contact with known infected persons or in areas with high prevalence of active infection.

Note: Results from serological testing should not be used as the sole basis to diagnose or exclude 2019-nCoV infection. False positive results may occur due to cross-reacting antibodies from previous infections, such as other coronaviruses, or from other causes. Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a diagnostic determination is made.

2. Invalid Test

If no band appears in the control area (C), the test result is invalid. The test should be repeated with a new test card and if the same situation reappears, please stop using this batch of products and contact your supplier.

Clinical Application

1. This test is an aid in the diagnosis of patients with suspected 2019-nCoV infection in conjunction with clinical presentation and the results of other laboratory tests.

2. This test is only intended for professional and laboratory use, not for home testing.

3. Results from the test should not be used as the sole basis for diagnosis and exclusion of 2019-nCoV infection.

4. As it is a novel disease diagnosis of which are being explored, please refer to the latest guidelines for diagnosis and treatment of COVID-19.