COVID19 AG AUTOTEST NEWGENE

COVID-19 Antigen Detection Kit NEWGENE - Nasal swab

Immunochromatographic membrane assay using highly sensitive monoclonal antibodies to detect the nucleocapsid protein from SARS-CoV-2.
The test strip consists of the following parts: sample pad, reagent pad, reaction membrane and absorbent pad. The reagent pad contains colloidal gold conjugated with the monoclonal antibody against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains secondary antibodies for the SARS-CoV-2 nucleocapsid protein. The entire strip is fixed inside a plastic device.
When the sample is added to the sample well, the conjugates absorbed in the reagent buffer are dissolved and migrate with the sample.
If SARS-CoV-2 antigen is present in the sample, the SARS-CoV-2 antibody conjugate complex and the virus will be captured by the specific anti-SARS-CoV-2 monoclonal antibodies coated on the test line (T) region .
The absence of the T line suggests a negative result.
To serve as a procedural control, a red line will always appear in the control line region (C) indicating that an appropriate volume of sample has been added and the membrane adsorption effect has occurred.
The test is suitable for people with COVID-19-like symptoms, such as cough, fever, fatigue, etc., to assist in the early diagnosis of SARS-CoV-2 infection. It can also be used to screen people without COVID-19 symptoms to regularly monitor their health status.

How to use

Preparation before the test
Place the test kit components at room temperature (15-30°C).
Blow your nose to clear the nasal passages. Wash your hands and keep them dry.
Read the instructions for use carefully.
Check the expiry date on the packaging. Do not use expired tests.

Testing procedure

Open the sampling buffer package. Do not touch the tip of the swab.
Gently insert the tip of the swab into a nasal cavity, to a depth of 2-3 cm. Gently rotate the swab 5 times for 20 seconds to collect the nasal secretion.
Do not force the swab to avoid hurting your nose.
Gently insert the same swab into the other nasal cavity and repeat the same procedure.

Remove the seal from the extraction tube and insert the swab into the extraction tube. Mix the buffer into the solution at least 5 times.
Squeeze the tube with your fingers. Move the swab up and down at least 3 times to expel any sample solution from the swab.
Take out the swab. Insert the cap firmly onto the extraction tube. Gently squeeze the tube 3 times to mix the sample solution. Let the tube sit for 1 minute.

Open the foil pouch containing the test card and place it on a table.
Invert the extraction tube and add 3 drops of sample solution to the loading well (S) on the test card.
Read the result after 15 minutes. The result is considered inaccurate and invalid after 30 minutes.
Do not refill sample solution onto a used test card.

After interpretation of results, use household bleach spray or 70-75% alcohol spray to disinfect used product components. Place the used components in a plastic bag. Close the bag and place it in another plastic bag. Dispose of the bag with household waste.
Wash your hands thoroughly.

Interpretation of results

Positive (+): Red bands appear on both the T and C lines in 15 to 30 minutes. A white band on the T-line should be considered a negative result.
There is currently a suspicion of COVID-19 infection. Contact a doctor/GP or local health authority immediately and follow local self-isolation guidelines. Perform a confirmatory PCR test.

Negative (-): A red band appears on the C line while no red band appears on the T line in 15-30 minutes after sample loading.
A negative result cannot completely exclude the possibility of viral infection. Continue to comply with all applicable rules that relate to contact with others and protective measures; there may be an ongoing infection even if the test results are negative. If suspected, repeat the test after 1-2 days because the coronavirus cannot be detected precisely at all stages of the infection.

Invalid: No red band appears on the C line. Repeat the test with another test card.
An invalid result may be caused by incorrect test performance. It is recommended to test again. If the results continue to be invalid, contact a doctor or COVID-19 testing center.

Warnings

The test is intended for self-test diagnosis of COVID-19 only. The final diagnosis should not be determined solely on the result of a single test, but should be determined by a professional doctor after evaluating the clinical signs and results of other tests.
Persons who are unable to perform the test themselves should be examined by their legal guardians.
This test is applicable to nasal swab specimens. Using other sample types may cause inaccurate or invalid test results.
Test within two hours of sample collection. Stale samples can give inaccurate results.
Make sure an appropriate amount of test sample is added. Too much or too little sample can cause inaccurate results.
Wait 15 to 30 minutes after loading the sample, then read the test results. Incorrect waiting time can cause inaccurate results.
If the test line or control line is outside the test window, do not use the test card. The result is invalid. Re-examine the sample with another Covid-19 Rapid Antigen Test newgene self-diagnostic qualitative determination of sars-cov-2 antigens in nasal swabs by immunochromatography test card.
This product is disposable. Do not recycle used components.
Disinfect used products, specimens, and other consumables with household bleach spray or a 70-75% alcohol spray.
Wash your hands thoroughly before and after the test.
Read the instructions carefully before use.
Children under 15 years of age must take the test under adult supervision.
For people who have had recent nasal trauma or surgery, or who have severe coagulopathy, a gentle nasal swab collection operation is necessary to avoid injury to the nose.
Use the components provided in the test kit. Do not use components from other kits.
Perform the test in a location with sufficient light to accurately interpret the results.
A negative result indicates that there is no virus present in the sample or that the viral load is below the detection limit of the test. The possibility of viral infection of the patient cannot be completely excluded. Testing too early after exposure to the virus can also give a negative result. Please repeat the test after a few days if you suspect a virus infection.
A positive result indicates that the sample tested has a viral load above the detection limit of the test. However, the color intensity of the test line may not correlate with the severity of the infection or the progression of the patient's disease.
Strictly follow the instructions when storing and using the test. False negative results can also be caused by abnormal storage conditions or incorrect sampling.
Do not use the test if the packaging is damaged. The test may generate an inaccurate result.
Specimens collected from asymptomatic individuals may generate false negative results if a sufficient quantity of specimen is not collected.
The amount of viral antigens in the sample will decrease as the disease lasts. Samples taken one week after the onset of symptoms are more prone to false negative results.

storage

Store at temperatures between 2°C and 30°C.
Validity with intact packaging: 24 months.

Format

The kit contains:
- 1 test card;
- 1 sample extraction tube with tube cap;
- 1 sampling swab;
- 1 instruction for use.