Covid-19 Ag Test Kit Wesail 1 Piece

Covid-19 Ag Test Kit Wesail - Self-Test

The COVID-19 Ag Test Kit is designed for self-testing of the SARS-Cov-2 nucleocapsid protein. This test is authorized for self-sampling from the anterior nostril (AN) by swab from Individuals suspected of COVID-19 infection, enters the first seven (7) days of symptom onset. Individuals under the age of 18 must complete aided blood collection and testing procedure.
The COVID-19 Ag Test Kit is based on the principle of lateral flow oro-colloidal immunoassay, which is intended for the qualitative detection of the nuclapsid protein from SARS-Cov-2 in anterior nasal (AN) samples, collected by swab , from individuals suspected of having COVID-19 infection within the first seven (7) days of symptom onset. When the sample is added to the well, the nucleocapsid protein in the sample reacts with the "gold-labeled" antibody. It forms an immune complex that flows on the nitro-cellulosic membrane. When the immune complex reaches the T line (Test band). It reacts with the COVID-19 antibody labeled on the nitrocellulose membrane, then develops the T-line stains (Test band), which indicates a positive result. Regardless of whether the sample contains nucleocapsid proteins, the gold-labeled QC antigen will bind to the antibody coated on the C-band and develop color.
Sensitivity: 82.4%
Specificity: 99.7%
Overall percentage agreement: 95%
LoD: 8x102 TCID50 / ml

How to use

Sample collection
Take a swab from the bag. Carefully insert the swab into the patient's nostril approximately 2-3 cm. Slowly scrape the nasal wall 5 times. Repeat this process in the other nostril using the same swab to ensure that an adequate sample is collected from both nasal passages. Then slowly withdraw the collection swab from the nostril. It is recommended that you hold your breath when doing the nasal swab. Analyze the tubes immediately after collection for optimal test performance. Inadequate collection or improper handling / storage / transport of specimens may give erroneous results.
Take a collection swab from the sachet.
Carefully insert the swab into the patient's nostril for 2-3 cm.
Slowly rub the nasal walls 5 times. Repeat this in the other nostril using the same swab to ensure that adequate sampling is taken from both nasal passages.
Then slowly pull the swab out of the nostril. It is recommended to hold your breath when swabbing.

Procedure

Please read the kit information leaflet carefully. Before starting the test wash your hands, use hand sanitizer.
Pierce the sealing membrane of the extraction tube with the tip of the nozzle cap.
Detach the nozzle cap from the hose and place it on the workbench with the protective cap facing down. Be careful not to touch the nozzle tip to avoid contamination. Insert the swab into the extraction tube. Squeeze the tube and mix the buffer 5 times.
Continue to squeeze the tube and remove the swab. Make sure all liquid from the swab is removed.
Install the nozzle cap with the protective cover facing up. Mix the tube by gently shaking 10 times. Leave to rest for 1 minute.
Remove the protective cover. Vertically add three drops to the sample and let it rest for 15 minutes.
Read the results immediately. The results read after 30 minutes will no longer be considered valid.
Keep the COVID-19 Ag Test Cassette in a sealed pouch before use. In humidity conditions of 45-65% and 15-25 ° C, the cassette should be used within 30 minutes once the pouch film is opened. If the temperature is 30 ° C or in conditions of high ambient humidity, the test must be used within 5 minutes of opening the pouch.
Interpretation of the results
Positive: colored bands appear on both bands: test (T) and control (C).
Negative: A colored band appears only on the control band (C).
Invalid: No visible colored bands appear on the control. The test procedures may not have been followed correctly or the cassette has deteriorated. It is recommended to repeat the sample test.
Note: The color intensity of the test band (T) may vary depending on the antigen concentration in the sample. The lower the concentration, the lower the intensity. The determination of a positive result should be based on the presence of the test band (T) and the control band (C), regardless of whether the test band (T) is weaker than the control band (C). If the test result is positive, isolate yourself from other people. Don't visit or invite others, don't go to the store, wear masks around the house, and follow social distancing rules. Contact your family doctor and / or health service immediately for further instructions. The positive test must be confirmed by a PCR test. As a precaution. Please inform your contacts about the potential infection. Even if the test result is negative, infection prevention rules must be followed.

Warnings

This kit is for in vitro diagnostic use. If you are not sure how to proceed. Scan the QR code to watch the video of the procedure or contact the Technical Support, contact information is present in the package. Do not use cassettes that are damaged or have an unclear label or have expired. Incorrect collection, storage and transport of specimens may give false results. When collecting an anterior nasal (AN) swab sample, use the original swab provided in the kit. Using alternative swabs may result in incorrect test results. Samples showing invalid results should be repeated. The cassette can be used only once. The used test cassette, used swab, used nozzle cap with protective cap, and used sample collection swab should be treated as potentially biohazardous materials. Do not eat the desiccant in the paper bag. Do not reuse the test cassette, reagent, nozzle, and sample collection buffer. Do not interchange or mix components from different kit lots. Wash hands thoroughly with hand sanitizer or soap before and after handling. After the test, dispose of the used test cassette, swab, nozzle cap with protective cap, and sample collection swab in the medical waste bag. When the test result is close to the critical value and the user is unable to determine the test result, it is recommended to go to the hospital for professional diagnosis. Interpretation of the critical value: when the operation is correct, the color of the control band is normal, and the color of the test band is very faint, which leads to the unavailability of a correct interpretation by the layman. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is required to determine infection status. The agent identified may not be the definitive cause of the disease. People who test positive should self-isolate and seek follow-up care with their doctor or health care provider as further testing and reporting to public health authorities may be required. Negative results should be treated as suspected and do not rule out SARS-CoV-2 infection and should not be used as the sole basis for patient treatment or management decisions, including infection control decisions. Negative results should be considered in the context of a patient's recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19 and confirmed with a molecular examination if necessary for patient management.
The results of this test are for diagnostic indications only and cannot be used as the sole basis for confirming or ruling out the diagnosis. To make the diagnosis, the results should always be evaluated in combination with the clinical examination, history and other laboratory data. This product is used only for the qualitative detection of SARS-CoV-2 nucleocapsid protein in human anterior nasal swab, but not for quantitative detection. This product is for the initial screening test only. Diagnosis of the disease should be made in conjunction with clinical observations, patient history, epidemiological information and other laboratory tests. Subject to the limitations of the test methodology, the results must be verified by RT-PCR. Positive test results do not rule out co-infections with other pathogens. The cross-reaction between SARS-coronavirus Tor2 and the human coronavirus HKUl can give positive results. Incorrect results can occur if a sample is improperly collected, transported and handled. False-negative results can occur if the level of an antigen in a sample is below the detection limit of the test. False-positive results may occur, particularly in individuals without symptoms of COVID-19 and / or individuals living in areas with low numbers of COVID-19 infections and with no known exposure to COVID-19. Negative results should be considered presumed and, if necessary, confirmed with another SARS-CoV-2 test. A faint visible band is to be interpreted as positive. Samples and kits should be treated as potential sources of infection. Positive test results do not differentiate between SARS-coronavirus Tor2 and SARS-CoV-2. Positive test results do not distinguish between human coronavirus HKUl and SARS-CoV-2. The prevalence of infection will affect the predictive values of the test. Positive and negative predictive values are highly dependent on prevalence. False negative test results are more likely during peak activity when disease prevalence is high. False positive test results are more likely during periods of low SARS-CoV-2 activity when the prevalence is moderate to low. To ensure validity of the assay, C-band was added as a quality control band.

storage

Store at room temperature (2-30 ° C) in a shady and dry place. Avoid exposure to direct sunlight.
Validity in unopened package: 18 months.

Format

1 piece box.
Contains:
1 test cassette;
1 swab for sample collection;
1 reagent (0.6 ml per tube);
1 nozzle cap with protective cover;
1 package insert;
1 sanitary waste bag;
1 quick start guide.