Flowflex self testing
Intended Use: The Rapid Test for SARS-CoV-2 Antigen is a lateral flow assay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab samples directly from individuals suspected of COVID-19 within the first seven days of symptom onset. The test can be used to analyze samples from asymptomatic subjects. It does not distinguish between SARS-CoV and SARS-CoV-2.
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Intended use:
The results concern the identification of SARS-CoV-2 antigen. This antigen is generally found in samples taken from the upper respiratory tract during the acute phase of infection. Positive results indicate the presence of viral antigens, but history and other personal diagnostic data are required to determine infection status. Positive results do not rule out the presence of bacterial infection or simultaneous infection with other viruses. The pathogen detected may not be the exact cause of the disease.
Negative results obtained on subjects with symptoms that have appeared for more than seven days should be treated as probable negatives. If necessary, seek confirmation through molecular analysis. The negative results do not rule out SARS-CoV-2 infection. The rapid antigen test for SARSCoV-2 is intended for use as an aid in the diagnosis of SARS-CoV-2 infection.
The usability of stand-alone tests taken by subjects under the age of 18 was not determined. It is recommended that those under 18 years of age be tested by an adult.
Summary:
The new coronaviruses belong to the beta genus. COVID-19 is an acute infectious respiratory disease. Currently, the main source of infection is patients infected with the new coronavirus; even asymptomatic infected individuals can infect others. Based on current knowledge, the incubation period ranges from 1 to 14 days, which in most cases is reduced to the range of 3 to 7 days. The main symptoms include fever, fatigue and dry cough. In some cases, nasal congestion, runny nose, sore throat, myalgia, and diarrhea occur.
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Principle:
The Rapid Test for SARS-CoV-2 Anti gen is an assay for the detection of nucleocapsid antigen from SARS-CoV-2 in human anterior nasal swab samples. The test results are read visually in the next 15-30 minute interval, based on the presence or absence of colored lines.
A colored line with a procedural control function will always appear in the control line area to indicate that a sufficient volume of sample has been inserted and membrane uptake has occurred.
Reagents:
The test cassette contains. anti-SARS-CoV-2 antibodies. and lgG anti goat mouse. The extraction buffer tube contains detergent and tris buffer.
Precautions:
- Before performing the test, carefully read the package insert in the package of the Rapid Antigen Test for SARS-CoV-2. Failure to follow the directions may result in inaccurate test results.
- Do not use the test after the expiration date on the envelope.
- Do not eat, drink or smoke before and during the test.
- Do not use the test if the envelope is damaged.
- All used tests, samples and potentially contaminated material should be disposed of according to local regulations.
- Humidity and temperature can adversely affect the results.
- The test line related to a sample with high viral load could appear within 15 minutes or even earlier when the sample passes the test line area.
- The test line related to a sample with low viral load could appear within 30 minutes.
- Do not collect nasal swab specimen in case of nose bleeding.
- Wash hands thoroughly after use.
- If the extraction pad accidentally comes in contact with the skin or eyes, flush with large amounts of water and seek medical attention if necessary.
Preservation and stability:
- You can store the kit at a temperature between 2 and 30°C.
- The test is stable until the expiration date printed on the sealed envelope. Do not use after the expiration date.
- The test must remain in the sealed envelope until used.
- DO NOT FREEZE.
Limitations:
- The Rapid Test for SARS-CoV-2 antigen is for self-testing only. The test should be used only for the detection of nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab samples. The intensity of the test line does not necessarily correlate with the SARS-CoV-2 viral load in the sample.
- A false-negative test could be obtained if the antigen concentration in a sample was below the detection limit of the test or if the sample was collected incorrectly.
- The results of the analysis should be observed against other clinical data available to the physician.
- The positive results do not exclude the presence of co-infection caused by other pathogens.
- The positive results do not distinguish between SARS-CoV and SARS-CoV-2.
- Negative test results do not rule out the presence of other viral or bacterial infections.
- A negative result obtained on a subject with symptoms that have appeared for more than seven days should be treated as probable negative and, if necessary, verified by molecular analysis.
