Flowflex Self-test Covid-19 SARS-COV-2 antigen 1.00 Piece

Flowflex Self-Test Covid-19 SARS-COV-2 Antigen

SARS-CoV-2 Antigen Rapid Test

The SARS-CoV-2 antigen rapid test is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 in nasal and nasopharyngeal swab samples from individuals suspected by their healthcare provider of being infected with COVID-19 within the first seven days of symptom onset. The SARS-CoV-2 Antigen Rapid Test can also include samples from individuals who are asymptomatic.
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 nucleocapsid antigens. This antigen is generally detectable in upper respiratory tract samples during the acute phase of infection.

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 agents may not be the definitive cause of illness. Negative results from patients with symptoms lasting longer than 7 days should be treated as presumptive 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 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 patient 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. Humans are generally susceptible. Currently, patients infected with the novel coronavirus are the main source of infection; asymptomatic infected individuals can also be a source of infection. Based on current epidemiological investigations, the incubation period is 1 to 14 days. However, it is usually 3 to 7 days. The main symptoms are fever, fatigue, and dry cough. In some cases, there was also nasal congestion, runny nose, muscle aches, and diarrhea.

PRINCIPLE
The SARS-CoV-2 antigen rapid test is a qualitative membrane-based immunoassay for the qualitative detection of SARS-CoV-2 in nasal and nasopharyngeal swab samples.
When samples are processed and added to the test cassette, if SARS-CoV-2 antigens are present, they 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 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 based on the presence or absence of colored lines within 15-30 minutes.

To serve as a procedural control, a colored line will always appear in the control line region. This indicates that the correct volume of sample 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.
- Do not eat, drink, or smoke in the area where samples or kits are handled.
- Do not use the test if the pouch is damaged.
- Handle all samples as if they contain infectious agents. Observe established biohazard precautions during testing and follow standard procedures for proper disposal of samples.
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 high-viral load sample may 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 may become visible within 30 seconds.

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

Instructions for Use
SPECIMEN 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 nasally can be collected by a medical specialist or by someone taking the sample themselves. - Sample collection for children under 12 years of age should be performed by a medical specialist. Children between 12 and 17 should be accompanied by an adult if performing the test themselves. Adults over 18 may perform the test on themselves. Follow your local guidelines for sample collection by children. Nasal swab sample collection: 1. Insert a disposable swab, included with your kit, into one of the nostrils. Gently rotate it, pushing the swab inward, leaving less than 2.5 cm (1 inch) space from the nostril.
2. Rotate the swab 5 times against the mucous membranes in the nostril to collect sufficient sample. 3. Using the same swab, repeat this process in the other nostril to ensure 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 one extraction buffer tube for each sample to be tested and label each tube appropriately 2 Remove the aluminum foil from the top of the tube for the buffer to be collected. 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. Make sure 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 by 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, well away from the cassette. - Invert the extraction buffer tube with the dropper facing downwards and hold it vertically. - Gently squeeze the tube and transfer 4 drops of the processed sample into the sample well of the test cassette. 9 Wait for the colored 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 colored test line appears in the control region. No distinct colored line appears in the test line region. This means that no SARS-CoV-2 antigen has been detected. POSITIVE*: Two distinct colored lines appear. One line in the control line region and the other line in the test line region. 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 shade of color in the test line region should be considered positive. INVALID: No control line appears. Insufficient sample volume or incorrect procedure are the most common reasons for a failing control line. Check the procedure and repeat the test with a new test cassette. If the problem persists, stop using the strips immediately and contact your local dealer. QUALITY CONTROL Internal procedural controls are included in the test. A colored line appearing in the control line region 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 the test cassette is working properly and the test procedure has been performed correctly. LIMITATIONS 1 The SARS-CoV-2 rapid test should only be used for in-vitro diagnosis. 2 The test should only be used for the detection of SARS-CoV-2 antigens in nasal and nasopharyngeal swab 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 decreased test sensitivity. Read the leaflet before use.

Warnings
1 The SARS-CoV-2 rapid test should only be used for in-vitro diagnosis.
2 The test should only be used for the detection of SARS-CoV-2 antigens in nasal and nasopharyngeal swab 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 decreased 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 must remain in the sealed pouch until use. Do not freeze. Do not use after the expiration date

Medical device. Read the leaflet before use.

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