Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

The detected reagents may not be the definitive cause of disease. Negative results in patients who have had symptoms for more than 7 days should be treated as presumptive and, if necessary, confirmed with a molecular test for patient management. Negative results do not exclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of recent exposures and the patient's history, as well as the presence of clinical signs and symptoms consistent with COVID-19.

The SARS-CoV-2 antigen rapid test is intended for use by trained clinical laboratory personnel and professional healthcare providers. The SARS-CoV-2 antigen rapid test is intended to be used as an aid in diagnosing a SARS-CoV-2 infection.

Package contents:
Test cassette
Disposable swab
Extraction buffer tube
Instructions for use

Required but not included materials:
Personal protective equipment
Timer

Summary
The new coronaviruses belong to the beta genus. COVID-19 is an acute respiratory infectious disease. Humans are generally susceptible. Currently, patients infected with the new coronavirus are the main source of infection; asymptomatic infected individuals can also be a source of infection. Based on current epidemiological studies, the incubation period is 1 to 14 days. However, it is usually 3 to 7 days. The main symptoms include fever, fatigue, and dry cough. In some cases, there was also nasal congestion, runny nose, muscle pain, and diarrhoea.

PRINCIPLE
The rapid test for SARS-CoV-2 antigens is a qualitative membrane-based immunoassay for the qualitative detection of SARS-CoV-2 through nasal and nasopharyngeal samples.
When samples are processed and added to the test cassette, SARS-CoV-2 antigens, if present, react with the anti-SARS-CoV-2 antibody-coated particles that are pre-dispersed on the test strip. The mixture then migrates upwards by capillary action on the membrane. The antigen-conjugate complexes migrate across the test strip to the reaction area and are captured by a line of antibodies on the membrane.

Test results can be visually interpreted within 15-30 minutes based on the presence or absence of coloured lines.

To serve as a procedural control, a coloured line always appears in the control line region. This indicates that the correct sample volume has been added and membrane wicking has occurred.

REAGENTS
The test cassette contains anti-SARS-CoV-2 antibodies.

PRECAUTIONS
- For in vitro diagnostic use only. Do not use after the expiration date.
- No eating, drinking, or smoking in the area where samples or kits are handled.
- Do not use the test if the pouch is damaged.
- Treat all samples as if they contain infectious agents. Observe established precautions against biological hazards during testing and follow standard procedures for the proper disposal of samples.
Wear protective clothing, such as laboratory coats, disposable gloves, face and eye protection when samples are being tested.
- The used tests must be disposed of according to local regulations. The used tests should be considered potentially infectious and disposed of according to local regulations.
- Moisture and temperature can negatively affect results.
- The test line for a high viral load sample may become visible within 15 minutes, or as soon as the sample passes through the test line street.
- The test line for a low viral load sample may become visible within 30 seconds.

APPLICATION
A rapid test for the qualitative detection of SARS-CoV-2 through nasal and nasopharyngeal samples of antigens from the protein shell cells.
For professional in vitro diagnostic use only.

INSTRUCTIONS FOR USE
SAMPLE COLLECTION AND PREPARATION
- The test should be performed immediately after, or at least 1 (one) hour after sample collection, or at least 1 (one) hour after sample collection if stored at room temperature (15-30°C)
- A sample previously collected via the nose can be picked up by a healthcare professional or by someone collecting the sample themselves.
- Sample collection from children under 12 years must be done by a healthcare professional. Children between 12 and 17 must be accompanied by an adult when performing the test themselves. Adults over 18 may perform the test on themselves. Follow your local guidelines for sample collection by children.

Sample collection from the nose using a swab:
1. Insert a disposable swab, provided with your kit, into one of the nostrils. Rotate gently, pushing the swab inwards and leaving less than 2.5 cm (1 inch) space from the nostril.

2. Rotate the swab 5 times against the mucosa in the nostril to collect a sufficient sample.

3. Use the same swab and repeat this process in the other nostril to ensure that a sufficient sample is collected from both nostrils.

4. Withdraw the swab from the nostril. The sample can now be prepared with the extraction buffer tubes.

INSTRUCTIONS FOR USE
Allow the test and extraction buffer to reach room temperature (15-30°C) before performing the test.

1 Use an extraction buffer tube for each sample to be tested and label each tube appropriately
2 Remove the aluminium foil from the top of the tube for the buffer to be taken.
3 Place the swab in the tube and shake it for 30 seconds. Then rotate the swab at least 5 times while squeezing the sides of the tube. Ensure that the contents do not spray out of the tube.
4 Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
5 Attach the dropper to the extraction buffer tube with the swab. Mix thoroughly by shaking or tapping the bottom of the tube.
6 Remove the test cassette from the foil pouch and use it as soon as possible.
7. Place the test cassette on a flat and clean surface.
8 Then add the processed specimen to the sample, well away from the cassette.
- Turn the extraction buffer tube with the dropper downwards and hold it vertically.
- Gently squeeze the tube and transfer 4 drops of the processed sample into the opening of the test cassette.
9 Wait for the coloured line(s) to appear. The result can be read after 15-30 minutes. DO NOT READ THE RESULT AFTER 30 MINUTES!

INTERPRETATION OF RESULTS
NEGATIVE: Only 1 coloured test line appears in the control section. No distinctly coloured line appears in the test line section.
This means that no SARS-CoV-2 antigen is detected.

POSITIVE*: Two distinctly coloured lines appear. One line in the control line section and the other line in the test line section. This means that the presence of the SARS-CoV-2 antigen is detected

NOTE: Depending on the SARS-CoV-2 antigen present in the sample, the colour intensity of the test line may vary. Therefore, any shade of colour in the test line section should be considered positive.

INVALID: No control line appears. Insufficient sample volume or incorrect procedure are the most common reasons for a failed control line. Review the procedure and repeat the test with a new test cassette. If the problem persists, stop using the strips immediately and contact your local distributor.

QUALITY CONTROL
Internal procedural controls are included in the test. A coloured line appearing in the control line section is an internal procedural control. It confirms the presence of sufficient sample volume and correct procedural technique.
Control sticks are not included in the kit. However, it is recommended that positive and negative controls be tested according to good laboratory practices to ensure that the test cassette is functioning properly and that the test procedure is performed correctly.

LIMITATIONS
1 The rapid test for SARS-CoV-2 is for in vitro diagnostic use only.
2 The test is intended for the detection of SARS-CoV-2 antigens in nasal and nasopharyngeal samples. The intensity of the test line does not necessarily correlate with the viral titer of SARS-CoV-2 in the sample.
3 Samples should be tested as soon as possible after collection and no later than one hour after collection.
5 Use of viral transport media may result in reduced test sensitivity.

Read the instructions for use before testing.

WARNING
1 The rapid test for SARS-CoV-2 is for in vitro diagnostic use only.
2 The test is intended for the detection of SARS-CoV-2 antigens in nasal and nasopharyngeal samples. The intensity of the test line does not necessarily correlate with the viral titer of SARS-CoV-2 in the sample.
3 Samples should be tested as soon as possible after collection and no later than one hour after collection.
5 Use of viral transport media may result in reduced test sensitivity.

STORAGE ADVICE
The kit can be stored at temperatures between 2 and 30°C.
The test is stable until the expiration date on the sealed pouch.
The test should remain in the sealed pouch until use.
Do not freeze.

Do not use after the expiration date

Other information

EAN: (1 piece) 6921756492427

EAN: (5 pieces) 6921756492434