Flowflex Self-Test Covid-19 SARS-COV-2 Antigen 1 Piece
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Flowflex Self-Test Covid-19 SARS-COV-2 Antigen 1 Piece
Flowflex Self-Test Covid-19 SARS-COV-2 Antigen 1 Piece
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Flowflex Self-test Covid-19 SARS-COV-2 antigen
SARS-CoV-2 Antigen Rapid Test
The SARS-CoV-2 Antibody Rapid Test is a lateral flow chromatographic immunity test for the qualitative detection of SARS-CoV-2 in nasal and nasopharyngeal samples from people suspected by a physician of COVID-19 infection within the first seven days of symptom onset. The SARS-CoV-2 Antibody Rapid Test can also use samples from asymptomatic people.
The SARS-CoV-2 antigen rapid test does not distinguish between SARS-CoV and SARS-Cov-2.
Results are for the identification of SARS-CoV-2 neucleocapsid antigens. This antigen is most commonly observed in upper respiratory tract samples during acute infections.
Positive results indicate the presence of viral antigens, but to determine infection status, a clinical correlation with the patient's history and other diagnostic information is required. Positive results do not rule out bacterial infection or co-infection with other viruses.
The detected reagents may not be the definitive cause of illness. Negative results in patients with symptoms lasting longer than 7 days should be treated as suspected and, if necessary, confirmed with a molecular test for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used solely for treatment or patient management decisions, including decisions about infection control. Negative results should be considered in the context of the patient's recent exposures and 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 healthcare professionals. The SARS-CoV-2 antigen rapid test is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.
Summary
The novel coronaviruses belong to the beta genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, patients infected with the novel coronavirus are the main source of infection; infected people who are asymptomatic can also be a source of infection. Based on current
Epidemiological studies indicate that the incubation period is 1 to 14 days. However, it is usually 3 to 7 days. The main symptoms are fever, fatigue, and a dry cough. In some cases, nasal congestion, runny nose, muscle aches, and diarrhea were also present.
PRINCIPLE
The SARS-CoV-2 antigen rapid test is a qualitative membrane-based immunity test for the qualitative detection of SARS-CoV-2 using 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 pre-dispersed on the test strip. The mixture then migrates upward on the membrane by capillary action. The antigen-conjugate complexes migrate along 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 colored lines.
To serve as a procedural control, a colored line always appears in the control line region. This indicates that the correct sample volume has been added and membrane action 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 is allowed in the area where the samples or kits are used.
- 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 proper sample disposal.
Wear protective clothing such as lab coats, disposable gloves, face and eye protection when testing samples.
Used tests must be disposed of according to local regulations. Used tests should be considered potentially infectious and disposed of according to local regulations.
- Humidity and temperature can negatively affect results.
- The test line for a highly viral load sample can become visible within 15 minutes, or as soon as the sample passes through the test line lane.
- The test line for a low viral load sample can become visible within 30 seconds.
-
What is this medicine used for?
A rapid test for the qualitative detection of SARS-CoV-2 using a sample of antigens from the protein envelope cells collected from the nose and nasopharynx.
For professional in vitro diagnostic use only.
Directions for use
SAMPLE COLLECTION AND PREPARATION
- The test must 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 taken through the nose can be collected by a medical specialist or by someone who takes the sample from themselves.
- Sampling for children under 12 must be performed by a medical specialist. Children between 12 and 17 must be accompanied by an adult when performing the test themselves. Adults over 18 may self-test. Follow your local guidelines for sampling by children.
Taking a sample from the nose using a cotton swab:
1. Insert a disposable cotton swab, provided with your kit, into one of your nostrils. Gently rotate it, pushing the swab inward, leaving less than 2.5 cm (1 inch) of space from the nostril.
2. Rotate the swab 5 times against the mucous membranes in the nostril to collect a sufficient sample.
3. Use the same swab and repeat this process in the other nostril to ensure a sufficient sample has been 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 aluminum foil from the scrub side 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 five times while squeezing the sides of the tube. Be careful not to let the contents squirt out.
4 Remove the swab while squeezing the sides of the tube to extract the fluid from the swab.
5. Attach the dropper to the extraction buffer tube containing 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 cassettes on a flat, clean surface.
8 Next, add the processed specimen to the sample, well away from the cassette.
- Turn the extraction buffer house with the dripper 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 until the colored line(s) appear. The result can be read after 15-30 minutes. DO NOT READ THE RESULT AFTER 30 MINUTES!
INTERPRETATION OF THE RESULTS
NEGATIVE: Only one colored test line appears in the control section. No clearly visible colored line appears in the test line section.
This means that no SARS-CoV-2 antigen was observed.
POSITIVE*: Two distinct colored lines appear. One line is in the control line section and the other line is in the test line section. This means that the presence of the SARS-CoV-2 antigen has been detected.
NOTE: Depending on the SARS-CoV-2 antigen present in the sample, the color intensity of the test line may vary. Therefore, any color variation in the test line portion should be considered positive.
INVALID: No control line appears. Insufficient sample volume or incorrect operation are the most common reasons for a control line failure. Check the procedure and repeat the test with a new test cassette. If the problem persists, discontinue use of the strips immediately and contact your local dealer.
QUALITY CONTROL
Internal procedural controls are incorporated into the test. A colored line appearing in the control line section is an internal procedural control. It confirms the presence of sufficient sample volume and proper procedural technique.
Control swabs 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 good and that the test procedure has been performed correctly.
LIMITS
1 The rapid test for SARS-CoV-2 may only be used for in vitro diagnosis.
2. The test may only be used to detect SARS-CoV-2 antigens in nasal and nasopharyngeal samples. The intensity of the test line does not necessarily correspond to the SARS-CoV-2 viral titer in the sample.
3 Samples must be tested as soon as possible after sample collection and no later than one hour after collection.
5 Use of viral transport media may result in reduced test sensitivity.
Read the package leaflet before use.
Ingredients
Package contents: Test cassette Disposable swab Extraction buffer tube Package insert Required but not included materials: Personal protective equipment Timer
Warnings
1 The rapid test for SARS-CoV-2 may only be used for in vitro diagnosis.
2. The test may only be used to detect SARS-CoV-2 antigens in nasal and nasopharyngeal samples. The intensity of the test line does not necessarily correspond to the SARS-CoV-2 viral titer in the sample.
3 Samples must be tested as soon as possible after sample collection and no later than one hour after collection.
5 Use of viral transport media may result in reduced test sensitivity.
Storage advice
The set can be stored at temperatures between 2 and 30°C.
The test is stable until the expiry date on the sealed pouch.
The test must remain in the sealed pouch until use.
Do not freeze.
Do not use after the expiry date.
Other information
Medical device. Read the instructions for use before use.
Manufacturer / Distributor
Distributor, MedNet GmbH, Borkstrasse 10, 48163 Münster, Germany
SARS-CoV-2 Antigen Rapid Test
The SARS-CoV-2 Antibody Rapid Test is a lateral flow chromatographic immunity test for the qualitative detection of SARS-CoV-2 in nasal and nasopharyngeal samples from people suspected by a physician of COVID-19 infection within the first seven days of symptom onset. The SARS-CoV-2 Antibody Rapid Test can also use samples from asymptomatic people.
The SARS-CoV-2 antigen rapid test does not distinguish between SARS-CoV and SARS-Cov-2.
Results are for the identification of SARS-CoV-2 neucleocapsid antigens. This antigen is most commonly observed in upper respiratory tract samples during acute infections.
Positive results indicate the presence of viral antigens, but to determine infection status, a clinical correlation with the patient's history and other diagnostic information is required. Positive results do not rule out bacterial infection or co-infection with other viruses.
The detected reagents may not be the definitive cause of illness. Negative results in patients with symptoms lasting longer than 7 days should be treated as suspected and, if necessary, confirmed with a molecular test for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used solely for treatment or patient management decisions, including decisions about infection control. Negative results should be considered in the context of the patient's recent exposures and 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 healthcare professionals. The SARS-CoV-2 antigen rapid test is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.
Summary
The novel coronaviruses belong to the beta genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, patients infected with the novel coronavirus are the main source of infection; infected people who are asymptomatic can also be a source of infection. Based on current
Epidemiological studies indicate that the incubation period is 1 to 14 days. However, it is usually 3 to 7 days. The main symptoms are fever, fatigue, and a dry cough. In some cases, nasal congestion, runny nose, muscle aches, and diarrhea were also present.
PRINCIPLE
The SARS-CoV-2 antigen rapid test is a qualitative membrane-based immunity test for the qualitative detection of SARS-CoV-2 using 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 pre-dispersed on the test strip. The mixture then migrates upward on the membrane by capillary action. The antigen-conjugate complexes migrate along 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 colored lines.
To serve as a procedural control, a colored line always appears in the control line region. This indicates that the correct sample volume has been added and membrane action 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 is allowed in the area where the samples or kits are used.
- 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 proper sample disposal.
Wear protective clothing such as lab coats, disposable gloves, face and eye protection when testing samples.
Used tests must be disposed of according to local regulations. Used tests should be considered potentially infectious and disposed of according to local regulations.
- Humidity and temperature can negatively affect results.
- The test line for a highly viral load sample can become visible within 15 minutes, or as soon as the sample passes through the test line lane.
- The test line for a low viral load sample can become visible within 30 seconds.
-
What is this medicine used for?
A rapid test for the qualitative detection of SARS-CoV-2 using a sample of antigens from the protein envelope cells collected from the nose and nasopharynx.
For professional in vitro diagnostic use only.
Directions for use
SAMPLE COLLECTION AND PREPARATION
- The test must 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 taken through the nose can be collected by a medical specialist or by someone who takes the sample from themselves.
- Sampling for children under 12 must be performed by a medical specialist. Children between 12 and 17 must be accompanied by an adult when performing the test themselves. Adults over 18 may self-test. Follow your local guidelines for sampling by children.
Taking a sample from the nose using a cotton swab:
1. Insert a disposable cotton swab, provided with your kit, into one of your nostrils. Gently rotate it, pushing the swab inward, leaving less than 2.5 cm (1 inch) of space from the nostril.
2. Rotate the swab 5 times against the mucous membranes in the nostril to collect a sufficient sample.
3. Use the same swab and repeat this process in the other nostril to ensure a sufficient sample has been 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 aluminum foil from the scrub side 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 five times while squeezing the sides of the tube. Be careful not to let the contents squirt out.
4 Remove the swab while squeezing the sides of the tube to extract the fluid from the swab.
5. Attach the dropper to the extraction buffer tube containing 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 cassettes on a flat, clean surface.
8 Next, add the processed specimen to the sample, well away from the cassette.
- Turn the extraction buffer house with the dripper 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 until the colored line(s) appear. The result can be read after 15-30 minutes. DO NOT READ THE RESULT AFTER 30 MINUTES!
INTERPRETATION OF THE RESULTS
NEGATIVE: Only one colored test line appears in the control section. No clearly visible colored line appears in the test line section.
This means that no SARS-CoV-2 antigen was observed.
POSITIVE*: Two distinct colored lines appear. One line is in the control line section and the other line is in the test line section. This means that the presence of the SARS-CoV-2 antigen has been detected.
NOTE: Depending on the SARS-CoV-2 antigen present in the sample, the color intensity of the test line may vary. Therefore, any color variation in the test line portion should be considered positive.
INVALID: No control line appears. Insufficient sample volume or incorrect operation are the most common reasons for a control line failure. Check the procedure and repeat the test with a new test cassette. If the problem persists, discontinue use of the strips immediately and contact your local dealer.
QUALITY CONTROL
Internal procedural controls are incorporated into the test. A colored line appearing in the control line section is an internal procedural control. It confirms the presence of sufficient sample volume and proper procedural technique.
Control swabs 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 good and that the test procedure has been performed correctly.
LIMITS
1 The rapid test for SARS-CoV-2 may only be used for in vitro diagnosis.
2. The test may only be used to detect SARS-CoV-2 antigens in nasal and nasopharyngeal samples. The intensity of the test line does not necessarily correspond to the SARS-CoV-2 viral titer in the sample.
3 Samples must be tested as soon as possible after sample collection and no later than one hour after collection.
5 Use of viral transport media may result in reduced test sensitivity.
Read the package leaflet before use.
Ingredients
Package contents: Test cassette Disposable swab Extraction buffer tube Package insert Required but not included materials: Personal protective equipment Timer
Warnings
1 The rapid test for SARS-CoV-2 may only be used for in vitro diagnosis.
2. The test may only be used to detect SARS-CoV-2 antigens in nasal and nasopharyngeal samples. The intensity of the test line does not necessarily correspond to the SARS-CoV-2 viral titer in the sample.
3 Samples must be tested as soon as possible after sample collection and no later than one hour after collection.
5 Use of viral transport media may result in reduced test sensitivity.
Storage advice
The set can be stored at temperatures between 2 and 30°C.
The test is stable until the expiry date on the sealed pouch.
The test must remain in the sealed pouch until use.
Do not freeze.
Do not use after the expiry date.
Other information
Medical device. Read the instructions for use before use.
Manufacturer / Distributor
Distributor, MedNet GmbH, Borkstrasse 10, 48163 Münster, Germany
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