【Package Contents】

· Pouch contents: Test Cassette, Desiccant.

· 100 capillary tubes (20 µl) for 100 tests.

· 12 ml sample buffer for 100 tests.

· Test instruction. 

【Packing】

25pouches/box, box demension 15*14*6.5cm，the weight of the box is 150g.

100boxes/carton, carton dimension 72*62*36cm，22KGS.

【Product Show】

【Intended Use】

Coronavirus Diseases 2019 (COVID-19) IgM/IgG Antibody Test is a rapid, qualitative and convenient immunochromatographic in vitro assay for the differential detection of IgM & IgG antibodies to COVID-19 virus in human serum, plasma or whole blood samples obtained from patient with COVID-19 infection. The device is designed to aid in the determination of recent or previous exposure to COVID-19 virus tracking the status of the disease after COVID-19 Virus infection.

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. The test is intended for professional use. 

【Principle Of The Assay】

The principle of Artron COVID-19 IgM/IgG Antibody Test i s an antibody-capture immunochromatographic assay for the simultaneous detection and differentiation of IgM & IgG antibodies to COVID-19 virus in human serum, plasma, or whole blood samples. COVID-19 virus-

specific antigens are conjugated to a colloidal gold and deposited on the conjugate pad. Monoclonal anti-human IgM and monoclonal anti-human IgG are immobilized on two individual test lines (T2 and T1) of the nitrocellulose membrane. The IgM line (T2) is closer to the sample well and followed by the IgG line (T1). When the sample is added, the gold-antigen conjugate is rehydrated and the COVID-19 IgM and/or IgG antibodies, if any in the sample, will interact with the gold conjugated antigen. The immunocomplex will migrate towards the test window until the test zone (T1 & T2) where they will be captured by the relevant anti-human IgM (T2) and/or anti- human IgG (T1), forming a visible pink line, indicating positive results. If COVID-19 antibodies are absent in the

sample, no pink line will appear in the test lines (T1 & T2), indicating a negative result.

To serve as an internal process control, a control line should always appear at Control Zone (C) after the test is completed. Absence of a pink control line in the Control Zone is an indication of an invalid result. 

【Test Proceduces】

Remove the testing device from the sealed pouch by tearing at

the notch and place the testing device on a flat, dry surface.

For fingerstick whole blood:

Using a capillary tube, collect the fingerstick whole blood till the black line.

For venous whole blood:

Using a pipette or a capillary tube, collect the venous whole blood (20µl).

For serum/plasma:

Using a pipette, collect the serum/plasma (10µl).

1. Add the collected serum/plasma/whole blood to upper rea (close to test window) of sample well on the test device without air bubbles (hold the capillary tube/ pipette vertically and gently touch the end against the pad within the sample well for transferring).
2. Wait for 20-30 seconds; add 2 drops (around 90µl) of the sample buffer to the sample well of the test device.
3. Read the results after 15-20 minutes. Strong positive specimens may produce positive result in as little as 1 minute.

DO NOT INTERPRET RESULTS AFTER 30 MINUTES.

【Result Interpretations】

Negative

A pink colored band appears only at the control region (C), indicating a negative result for COVID-19 infection.

Positive

Pink colored bands appear at the control region (C) and T1 and /or T2 region.

1)IgM and IgG positive, visible bands at T2 and T1, indicating positive result for a possible COVID-19 infection.

2)IgM positive, a visible band at T2 region, indicating positive result for a possible COVID-19 infection.

3)IgG positive, a visible band at T1 region, indicating a positive result for a possible COVID-19 infection.

Invalid

No visible band at the control region (C). Repeat with a new test device. If test still fails, please contact the distributor with the lot number.

【Workshop Show】

【Certificate】

CE