Rapid antigen test covid-19 realy self-diagnostic qualitative determination of sars-cov-2/influenza a+b antigens in nasal swabs by immunochromatography

Description
In vitro diagnostic test for the qualitative detection of novel coronavirus antigens and influenza A and B antigens in nasal swabs from individuals with or without symptoms, using the rapid immunochromatographic method.
It is used for self-diagnosis.
This kit is intended for home use by a non-expert individual in a non-laboratory environment (for example, in a person's residence or in some non-traditional locations such as offices, sporting events, airports, schools, etc.) The test results of this kit are for clinical reference only. It is recommended to perform a complete disease analysis based on the clinical manifestations of the patients and other laboratory tests.
The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test is a membrane-based immunochromatographic assay that uses highly sensitive monoclonal antibodies to the Novel Coronavirus. The test device consists of the following three parts: sample swab, reagent swab and reaction membrane. The entire strip is fixed inside a plastic device. The reaction membrane contains colloidal gold conjugated with monoclonal antibodies against Novel Coronavirus; the reaction membrane contains secondary antibodies for Novel Coronavirus and polyclonal antibodies against mouse globulin, pre-immobilized on the membrane. When the sample is added to the sampling window, the dried conjugates in the reagent buffer dissolve and migrate along with the sample. If the Novel Coronavirus is present in the sample, the complex formed between the anti-Novel Coronavirus conjugate and the virus will be captured by the specific anti-Novel Coronavirus monoclonal coated in the T region. Regardless of whether the sample contains the virus or not, the solution continues to migrate to meet another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thus producing a red line in the C region.
The Influenza A/B Rapid Test Cassette is a qualitative lateral flow immunoassay for the detection of Influenza A and Influenza B nucleoproteins in nasal swab. In this test, antibodies specific for Influenza A and Influenza B nucleoproteins are coated separately on the test regions of the test device. During testing, the extracted sample reacts with the Influenza A and/or Influenza B antibody that are coated on particles. The mixture migrates up the membrane to react with the Influenza A and/or Influenza B antibody on the membrane and generate one or two colored lines in the test regions. The presence of this colored line in one or both test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test was performed correctly.

How to use
Sample collection and preparation
1. Sample collection*
a) Wash or clean your hands for at least 20 seconds and make sure they are dry before starting the test.
b) It is applicable to the diagnosis of Novel Coronavirus or Influenza A/B virus from nasal swab specimens. For optimal test performance, use freshly collected specimens. Improper collection or improper handling of the specimen may result in a false-negative result.
c) Unpack the swab. Caution: Do not touch the soft end of the swab and the swab must not come into contact with any other object, otherwise the result may be false.
d) Tilt your head back slightly. Insert the swab approximately 2 cm, at least with the entire soft tip of the swab, into the left nostril. Gently rotate the swab at least five times against the nasal wall.
e) Insert the same swab about 2 cm, at least the entire tip of the soft swab, into the right nostril. Again, gently roll the swab at least five times against the nasal wall. Remove the swab from the second nostril.
2. Sample preparation
Insert the swab into the extraction tube containing the Sample Extraction Buffer. Rotate the swab inside the tube in a circular motion to roll the side of the extraction tube so that the liquid is expressed and reabsorbed.

How to use
Allow the test, specimen, swab and extraction buffer to reach room temperature (15-30°C) before testing.
1. Remove the test device from the sealed foil pouch and use it as soon as possible. Place the test cassette on a clean, flat surface. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Remove an extraction tube with the swab, peel off the sealed aluminum foil on the extraction tube, and place the extraction tube into the tube holder or box hole.
3. Place the sterilized swab sample into the sample extraction pad. Rotate the swab for approximately 10 seconds while pressing the head of the swab against the inside of the tube to release the antigen into the swab.
4. Remove the sterilized swab by squeezing the head of the sterilized swab against the inside of the swab to expel as much of the liquid as possible. Discard the sterilized swab in accordance with your biohazard disposal protocol.
5. Screw and tighten the Filter Nozzle onto the sample collection tube, then shake the sample collection tube vigorously to mix the sample and sample extraction buffer.
6. Add 3 drops of solution (about 80ul) to each sample well and start the timer. Read the result after 15-20 minutes. Do not interpret the result after 20 minutes.
7. Dispose of the test materials in a closed plastic bag with household waste. If there are local regulations, please follow them.
8. Wash your hands thoroughly after testing.

Interpretation of results
SARS-Cov-2 POSITIVE: Two red lines appear. One red line appears in the control area (C) and one red line in the test area (T).
Influenza A POSITIVE: Two distinct colored lines appear. One line should be in the Control Region (C) area and another line should be in the Influenza A (A) region. A positive result in the Influenza A region indicates that Influenza A antigen has been detected in the specimen.
Influenza B POSITIVE: Two distinct colored lines appear. One line should be in the Control Region (C) area and another line should be in the Influenza B (B) area. A positive result in the Influenza B region indicates that Influenza B antigen has been detected in the specimen.
Influenza A and Influenza B POSITIVE: Three distinct colored lines appear. One line should be in the Control Region (C) area and two additional lines should be in the Influenza A (A) and B (B) regions. A positive result in both the Influenza A region and the Influenza B region indicates that Influenza A antigen and Influenza B antigen have been detected in the specimen.
*NOTE: The color tone may vary, but should be considered positive whenever even a faint line appears.
If the test result is positive, it is recommended to maintain social distancing to avoid spreading the infection, following local social distancing guidelines.
NEGATIVE: Only one red line appears in the control zone (C), while no line appears in the test zone (T/A/B). If you have symptoms such as fever, cough and/or shortness of breath. It is recommended to repeat the test in 1-3 days. It is necessary to continue to follow the hygiene and distancing rules applicable even in the event of a negative result.
INVALID: No red line appears in the control region (C). The test is invalid even if a line is present in the control region (T/A/B). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device. If the problem persists, discontinue use of the test kit immediately and contact your local distributor.

Warnings
Precautions
- For in vitro diagnostic use only.
- Do not use after the expiry date.
- Make sure the bag containing the device is not damaged before opening it for use.
- Perform the test at room temperature from 15 to 30 °C.
- Wear gloves when taking samples, avoiding touching the reaction membrane and sample window.
- All used specimens and accessories must be treated as infectious and disposed of according to local regulations.
- Avoid using bloody samples.
- Children and people who are unable to perform the test alone must be tested by an adult or under their supervision.
- Avoid eating, drinking and smoking before taking the test.
- Use the right topical medications before the test.
- Use only the swab provided with the device and perform the test immediately after collecting the nasal swab material.

Limitations
- The test should be used for the detection of influenza A and/or B viruses and/or novel coronavirus antigens in nasal swab. This qualitative test is not able to determine either the quantitative value or the rate of increase in the concentration of influenza A and/or B viruses and/or novel coronavirus antigens.
- The Test is an acute phase screening test for qualitative detection. The sample taken may contain a concentration of antigens lower than the sensitivity threshold of the reagent, therefore a negative test result does not exclude infection.
- The test detects viable and non-viable antigen of influenza A and/or B virus and/or novel coronavirus. Test performance depends on the antigen load in the specimen and may not correlate with cell culture performed on the same specimen. A positive test does not rule out the possibility that other pathogens are present, so results should be compared with all other available clinical and laboratory information to make an accurate diagnosis.
- The performance of the test has not been established for monitoring antiviral treatment of the novel coronavirus.
- Positive test results do not exclude co-infection with other pathogens.
- Negative test results for the new coronavirus are not intended to rule out other coronavirus infections, except SARS-Cov-2.
- Children tend to shed the virus for longer periods of time than adults, which may lead to differences in susceptibility between the adult and child lists.
- A negative result may occur if the antigen concentration in a sample is below the detection limit of the test or if the sample was collected or transported improperly; therefore, a negative test result does not eliminate the possibility of infection and must be confirmed by viral culture or PCR.
- Excess blood or mucus on the swab specimen may interfere with the performance of the test and may produce a false positive result.
- Using over-the-counter and prescription nasal sprays at high concentrations may interfere with the results, leading to invalid or incorrect test results.
- Test results are most reliable when tested between 1 and 7 days after the onset of symptoms; testing after this time increases the possibility of false results. The test is more likely to give false results when testing asymptomatic cases.

Conservation
Store the Rapid Test Cassette at room temperature or in the refrigerator (2-30°C). Do not freeze. All reagents are stable until the expiration dates indicated on the outer packaging and buffer vial.

Format
Test device, sterilized timepiece, extraction tube with swab, biohazard sample bag, tube holder.

Cod. K751416D