Kits de teste rápido de detecção do COVID-19

Packaging specifications

• 1 test/kit
• 20 tests/kit
• 40 tests/kit
• 100tests/kit

Product features

(1) Test samples: serum and plasma;
(2) Rapid screening of coronavirus within 15 minutes;
(3) No equipment, suitable for on-site screening;
(4) Reduce the risk of individual infection in hospital;
(5) Early diagnosis, early treatment, shorten the course of disease;
(6) Reduce the workload of designated hospitals.

Expected Usage

This Kit is suitable for qualitative detection of novel coronavirus (SARS-CoV-2) IgM and IgG antibodies in human Serum, plasma, and whole blood in vitro. Common signs of a person infected with a coronavirus include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome (SARS), kidney failure, and even death. Coronavirus can be excreted through respiratory secretions or transmitted through oral fluids, sneezing, physical contact, and through air droplets.

Detection Principle

This kit uses the principle of immunochromatography: the separation of components in mixture through a medium using capillary force and the specific and rapid binding of an antibody to its antigen. Inside the box is a dry culture medium, coated from top to bottom control antibody (“C” control line) (Figure 1) and mouse anti-human IgG monoclonal antibody (“IgG” test line), mouse anti-human IgM monoclonal antibody (“IgM” test line) . The novel coronavirus recombinant antigen (NCRA) is in the release pad section. Once diluted serum, plasma, or whole blood is applied to the release pad section, the NCRA will bind to coronavirus IgM/IgG antibodies if they are present, forming an    NCRA-IgM/IgG complex. The sample and antibodies will then move across the cassette’s medium via capillary action. If coronavirus IgM antibody is present in the sample, the test Line (T) will be bound by the IgM-IgM or IgG-IgG complex and develop color. If there is no coronavirus IgM/IgG antibody in the sample, free NCRA will not bind to the test line (T) and no color will develop. The free NCRA will bind to the control line ( C ), the control line should be visible after the detection step as this confirms that the kit is working properly.

Sample Requirements

1.Human serum, plasma or whole blood samples, other liquids and samples may not yield accurate results.
2.Sediment and suspended matter in the sample may affect the test result, and should be removed by centrifugation.
3.The samples shall not be placed at room temperature for more than 8 hours after collection and treatment; If the test is not conducted within 8 hours, the samples should be placed in a refrigerator at 2℃~8℃. If it takes more than 48 hours to store or transport, it should be frozen below -20℃. The whole blood sample shall not be frozen, store at 2℃~8℃ for no more than 2 day. Avoid heating and inactivating samples. Haemolytic samples should be discarded.
4.The samples must be balanced to room temperature before testing, and the freeze-preserved samples should avoid repeated freeze-thaw.

Assay Procedure

1.Sample Preparation:
Before the test, the test card, sample and sample diluent should be restored to room temperature (20℃~30℃). It is recommended to open the test card after restoring the room temperature, and use it within one hour as soon as possible to prevent the test card from getting damp.
2.Testing Method:
Place the test card on the test bench, use the pipette to absorb 20 μL of samples to be tested, drop them into the test card sample hole, and then add 2 drops of sample diluent to the test card sample hole with the drop bottle.
3.Observing Results:
Read the results in 15 minutes. To ensure the accuracy of the results, do not read the results after 15 minutes.

Interpretation of Test Results

1.IgM antibody positive: Clear purplish red bands appear at IgM and C of the IgM antibody detection reagent interpretation window, which is positive for novel coronavirus IgM antibody;
2.IgG antibody positive: Clear purplish red bands appear at IgG and C of the IgG antibody detection reagent interpretation window, which is positive for novel coronavirus IgG antibody;
3.Negative: a clear purplish red band appeared in the interpretation window only at position C, which is negative for new coronavirus antibodies;
4.Invalid: the test is invalid if there is no red strip at the position of window C, regardless of whether there is a red strip at the position of IgG,IgM.

Range of application

It can be used for outpatient and emergency treatment and ward testing, especially for early screening and early diagnosis of outpatient and emergency treatment in community health service centers, primary hospitals, senior hospitals, and fever clinics. Government employees and employees of private enterprises shall undergo physical examination and screening before taking up their posts.