VivaDiag SARS-COV-2 Ag RAPID TEST wellion 25 Test

VivaDiag SARS-COV-2 Ag RAPID TEST wellion

VivaDiag COVID-19 Antigenic Rapid Diagnostic Test
THE SALE OF THIS PRODUCT IS INTENDED ONLY TO PROFESSIONAL OPERATORS
PRINCIPLE AND INTENDED USE

The Wellion SARS-CoV-2 Antigen Rapid Diagnostic Test is used for the rapid and qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in human nasal, nasopharyngeal, or nasopharyngeal swab specimens. The test is for in vitro diagnostic use only. For professional use only. It is intended for clinical laboratories and for professional use in healthcare only for tests carried out in treatment centers. It is not intended for self-analysis. The SARS-CoV-2 Wellion Antigenic Rapid Diagnostic Test is based on immunoassay technology. Each test device consists of an anti-SARS-CoV-2 monoclonal antibody detection band (T-band) and an anti-rat IgG polyclonal antibody on the quality control band (C band). Once the collected sample is inserted into the well, it reacts with the labeled antibody to form a complex, the mixture then rises through the membrane by capillary action and interacts with the anti-SARS-CoV-2 monoclonal antibody it is coated with. the detection band. If the sample contains the SARS-CoV-2 antigen, the detection band will appear purplish-red indicating that the SARS-CoV-2 antigen is positive. Otherwise, the diagnostic test result will be negative. The test device also contains a quality control band C which will appear purplish-red for all valid tests. If the quality control band C does not appear, the test result will be invalid even if the detection band is displayed.

STORAGE AND HANDLING

- Store the diagnostic test kit in a cool, dry place between 2-30 ° C. Keep away from light. Exposure to temperature and / or humidity outside the specified conditions may cause inaccurate results.
- Do not freeze or refrigerate. Use the test kit at temperatures between 15-30 ° C.
- Use the test kit with humidity between 10 and 90%.
- Do not use the test kit beyond the expiration date (printed on the pouch and box).

WARNINGS, PRECAUTIONS AND LIMITS OF USE

- SARS-CoV-2 Rapid Antigen Diagnostic Test results should not be used as the sole basis for diagnosing or ruling out SARS-CoV-2 infection or for information on infection status.
- Any negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Only a follow-up test with molecular diagnostics and / or a CT scan should be considered to rule out infection in these people.
- Positive results may be due to an infection present with SARS coronavirus strains, see „cross reactivity“ for details. Follow-up with molecular diagnostics and / or CT scan should be considered to confirm the test result.
- For in vitro diagnostic use only.
- Not for self-analysis.
- Further molecular diagnostics and / or CT scan is recommended to identify the actual physical situation.
- Do not open the foil pouch of the test device exposing it to the surrounding environment until immediately prior to use.
- Do not use any devices or materials from the test kit if they are damaged.
- Do not reuse the test device.
- Handle the solution with the reagent carefully, avoid contact with eyes or skin. In case of contact with eyes or skin, wash thoroughly with water.
- Do not use the test kit beyond the expiration date.
- Specific training or guidance is recommended if operators are inexperienced with specimen collection and use procedures.
- Use only nasal, oropharyngeal or nasopharyngeal swabs as a sample. Follow the package insert for accurate results.
- Wear protective equipment such as lab coats, disposable gloves, and protective eyewear when specimens are collected and evaluated.
- Wash hands thoroughly after use.
- All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from bloodborne pathogens, even after cleaning and disinfection have been performed. Follow appropriate precautions and all local regulations when disposing of used test kits.

COLLECTION OF SAMPLES AND HANDLING

1. Collection of samples
- Nasal swab sample (recommended) It is important to collect as much secretion as possible. Insert the sterile swab into one nostril. The tip of the swab should be inserted up to 2.5 cm (1 inch) from the edge of the nostril. Rotate the swab 5 times along the mucosa inside the nostril to ensure that both mucus and cells are collected. Repeat the same process for the other nostril to ensure that an adequate sample is taken from both nasal passages (use the same swab).
- Oropharyngeal swab sample (optional) It is important to collect as much secretion as possible. Insert the sterile swab into the throat where most of the secretion is present in the red area of the pharyngeal wall and maxillary tonsils to collect the throat swab sample. Gently rub along the tonsils in the throat and pharyngeal wall to take the sample. Do not touch your tongue when pulling out the swab.
- Nasopharyngeal swab sample (optional) It is important to collect as much secretion as possible. Insert the sterile swab into the nostril that presents the most secretion by visually checking. Hold the swab close to the nasal septum while gently pushing the swab towards the posterior nasopharynx. Rotate the swab 5 times and then remove it from the nasopharynx. Nasal Swab Oropharyngeal Swab Nasopharyngeal Swab 2. Specimen Processing Freshly collected specimens should be tested as soon as possible. Proper specimen collection and preparation procedures are essential.

PROCEDURE FOR CARRYING OUT THE RAPID DIAGNOSTIC TEST

The use of disposable gloves is recommended when performing the rapid diagnostic test and performing hand hygiene before and after testing with soap and water or hand sanitizer gel.

Allow the test devices and reagent solution to reach a temperature of 15-30 ° C before testing.
1. Hold the sealed sachet upright and allow all of the extraction solution to flow into the bulb. Break the end of the sachet and, pressing the bulb, pour all the solution into the extraction tube.
2. Refer to the Sample Collection section to collect the sample.
3. Insert the swab with the collected sample into the tube filled with reagent solution. Rotate the swab 5 times by pressing the swab head against the bottom and side of the reagent tube. Remove the swab by pressing it against the sides of the tube to extract the liquid. Try to get as much liquid out as possible. Dispose of the used swab as biohazard waste.
4. Put the cap on the tube. Connect the cap with the reagent.
5. Take the test device out of the sealed foil pouch and place it on a clean, flat surface.
6. Apply 3 drops (approximately 60 μL) of the collected sample to the sample well. Avoid bubbles forming during application.
7. Read the test result after 15 minutes. Do not read the result after 20 minutes have passed. 15 min Read the test result after 15 minutes, do not evaluate after more than 20 minutes.
Note:
- Do not interchange or mix the solution with reagents from different lots.
- Handle the solution with the reagent carefully, avoid contact with eyes or skin. In case of contact with eyes or skin, wash thoroughly with water.
- Follow local regulations for the disposal of used materials.

READING OF TEST RESULTS

1. Positive result: Both quality control band C and detection band T are displayed.
2. Negative result: Only the quality control band C is displayed, while no other bands appear on the detection band.
3. Invalid Result: The quality control band C does not appear indicating that the test is invalid, regardless of whether the detection band is displayed or not. Collect a new sample and perform another test with a new device.

Positive: Both the detection band (T) and the quality control band (C) appear red-purplish in the detection area.

Negative: Only the quality control band (C) appears in the detection area.

Invalid: No red-purplish quality control band (C) appears in the detection area, regardless of whether the detection band (T) is colored or not.

QUALITY CHECK

Internal procedural controls are included in the test. A colored band displayed in the control area (C) represents the internal procedural control. Confirm sufficient sample volume and successful procedure. Check standards are not provided with this kit; however, it is recommended that Positive and Negative Controls be run according to Good Laboratory Practice to confirm the test procedure and to verify correct performance.

FORMAT

Pack of 25 tests.