FlowFlex
Flowflex SARS-CoV-2 Antigen Rapid Test 5pcs
Flowflex SARS-CoV-2 Antigen Rapid Test 5pcs
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Rapid antigen test for COVID-19 detection designed for self-testing. This is a fast, non-invasive and gentle method of testing, sampling from the edge of the nose. This is not a test from the nasopharynx. The swab is carried out by applying only 2.5 cm.
The rapid antigen test is a qualitative membrane chromatographic immunoassay for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in human nasal swab samples.
Clinical sensitivity, specificity and test accuracy: Relative sensitivity: 97.1% (93.1% - 98.9%)*Relative specificity: 99.5% (98.2%-99.9%)*Accuracy:
98.8% (97.6%-99.5%)** 95% confidence interval
Producer:
- SARS-CoV-2 Antigen Rapid Test (Self-Testing): ACON Biotech (Hangzhou) Co., Ltd. No.210 Zhenzhong Road, West Lake District, Hangzhou, P.R.China, 310030
- Disposable Bar: Jiangsu Changfeng Medical Industry Co., Ltd. Touqiao Town, Guangling District, Yangzhou 225109, Jiangsu, P.R China or Jiangsu HanHeng Medical Technology Co., Ltd. 16-B4, #1 North Qingyang Road, Tianning District, Changzhou, 213017 Jiangsu P.R. China
The set includes:
- test cassette 5 pcs,
- 5 pcs extraction buffer tube,
- disposable stick 5 pcs.,
- Package leaflet 1 pc.
After processing the samples and applying them to the test cartridge, the SARS-CoV-2 antigens, if present in the sample, will react with the particles coated with antibodies to SARS-CoV-2 that have been immobilized in the test strip. The mixture then travels through the membrane using capillary forces. The antigen-conjugate complexes travel through the test strip to the reaction area, where they are captured by a line of antibodies bound to the membrane. The results are interpreted visually after 15 minutes based on the presence or absence of visible colored lines. As an activity check, a colored line always appears in the area of the control line, which confirms the addition of the correct sample volume and that the membrane has become wet.
Interpretation of the result:
Negative: Only the control line (C) is displayed, and the test line (T) is not. This means that no SARS-CoV-2 antigen has been detected. A negative test result indicates that you probably don't currently have COVID-19. When in contact with others, continue to follow all appropriate rules and protective measures. You can have the infection even if the test is negative. If you suspect, repeat the test after 1-2 days, as coronavirus cannot be accurately detected at all stages of infection.
Positive: A control line (C) and a test line (T) are displayed. This means that the SARS-CoV-2 antigen has been detected. Note: Any weak line in the test line (T) area should be considered positive. A positive test result means that it is very likely that you currently have COVID-19.
Invalid: Control line (C) is not displayed. The probable reason for an invalid result is insufficient sample volume or incorrect procedure. Read the instructions again and test again with the new cartridge.
Notification
Only for professional in vitro diagnostic use.
Before performing the test, read carefully the package leaflet for the rapid test antigen SARS-CoV-2. Failure to follow the instructions may lead to inaccurate test results.
A nasal swab sample can be taken by an individual over the age of 18. For children under 18 years of age, this should be done by a parent or legal guardian. When taking samples from children, follow local instructions.
Do not use the test after the expiry date indicated on the sachet.
Do not eat, drink or smoke before and during the test.
If the sachet is damaged, do not use the test.
All used tests, samples and potentially contaminated materials should be disposed of in accordance with local regulations.
Humidity and temperature may adversely affect the results.
The test line for a sample with a high viral load can become visible within 15 minutes or as soon as the sample passes through the test line area.
The test line for a sample with a low viral load can be visible within 30 minutes.
If nosebleeds occur, do not collect nasal swab samples.