RightSign 1 Pack - COVID-19 Antigen Rapid Tests Lay Tests Self Test
RightSign 1 Pack - COVID-19 Antigen Rapid Tests Self-Tests for Laypeople
The COVID-19 Antigen Rapid Test Cassette (nasal swab) is a chromatographic rapid test for the qualitative detection of COVID-19 antigen in nasal swabs from symptomatic individuals. The detection is based on monoclonal antibodies that are specific for the nucleocapsid (N) protein of SARS-CoV-2. It is intended to aid in the rapid differential diagnosis of current COVID-19 infections.
✓ The manufacturer is on the "Common List of the EU".
✓ European recognition of results by listing in the European Commission's Common List
✓ FOR PRIVATE USE
No medical personnel required.
✓ NO EQUIPMENT REQUIRED
Simply and easily apply the tests.
✓ CE CERTIFICATION
Our tests are all CE certified and suitable for use on the European market.
✓ MONEY-BACK GUARANTEE
Our goal is your satisfaction with your purchase. If the purchased product does not meet your expectations, you can return it within the 14-day cancellation period and receive a refund of the purchase price.
Application of the RightSign COVID-19 Antigen Rapid Test for Laypersons
Technical Data
Package
1 Pack
Carton
800 pieces
Standards and Market Compliance
Self-test for laypersons
Approved in Germany
Certification: CE 1434
The manufacturer is on the "Common List of the EU".
93.2% sensitivity x 99.2% specificity
Product-Specific FAQ
Who is this test suitable for?
Individuals who are 18 years or older can perform the test independently. Adolescents between the ages of 13 and 17 can perform the test with the help of an adult. Children under the age of 13 should be tested by an adult. The study was conducted with a minimum age group of 3-13 years. No study was conducted with children under 3 years of age. Therefore, the use of this test in children under 3 years of age is not recommended. Discontinue the test if sampling is difficult in children.
How does the test cassette work?
The COVID-19 antigen rapid test cassette (nasal swab) is a chromatographic immunoassay for the qualitative detection of COVID-19 antigen in nasal swabs. It is intended to aid in the rapid differential diagnosis of COVID-19 infections.
How accurate is the test?
A clinical evaluation was conducted, in which the results obtained with the COVID-19 Antigen Rapid Test Cassette (nasal swab) were compared with those of PCR. Nasal swabs were taken and tested with the COVID-19 Antigen Rapid Test Cassette (nasal swab), and nasopharyngeal swabs were taken from the same person and tested for confirmation using RT-PCR. Samples were considered positive if the PCR showed a positive result. Of the 103 PCR-positive cases, 96 positive cases were tested with the COVID-19 Antigen Rapid Test Cassette (nasal swab). The relative sensitivity of the COVID-19 Antigen Rapid Test Cassette (nasal swab) is 93.2% (96/103), (95% CI: 86.5-97.2%). Of the 250 PCR-negative cases, 248 were negative cases with the COVID-19 Antigen Rapid Test Cassette (nasal swab), the relative specificity of COVID-19 Antigen Rapid Test Cassette (nasal swab) is 99.2% (248/250), (95% CI: 97.1% -99.9%)*. Out of 103 PCR-positive and 250 PCR-negative cases, 344 cases showed consistent PCR results with the COVID-19 Antigen Rapid Test Cassette (nasal swab), the relative accuracy of the COVID-19 Antigen Rapid Test Cassette (nasal swab) is 97.5% (344/353), (95%CI: 95.2%-98.8%)*.
Do other illnesses affect the result?
No cross-reactivity was detected in tests with the following common pathogens of the oropharyngeal respiratory tract: Influenza A virus, Influenza B virus, Adenovirus, Coxsackie virus, Parainfluenza virus type 1, Parainfluenza virus type 2, Parainfluenza virus type 3, Parainfluenza virus type 4a, Enterovirus, Mumps virus, Respiratory syncytial virus, Rhinovirus, Bordetella pertussis, Haemophilus parainfluenzae, Staphylococcus aureus, Streptococcus agalactiae, Neisseria meningitides, Streptococcus sp. group A, Streptococcus sp. group B, Streptococcus sp. group C, Candida albicans, Human metapneumovirus (hMPV), Legionella pneumophila, Mycobacterium tuberculosis, Mycoplasma pneumoniae, Pneumocystis jirovecii (PJP)-S cerevisiae recombinant, Pseudomonas aeruginosa, Staphylococcus epidermis, Streptococcus pneumoniae, Streptococcus pyogenes.
Do other interfering substances affect the result?
A clinical evaluation was conducted comparing the results obtained with the COVID-19 Antigen Rapid Test Cassette (nasal swab) to those obtained with PCR. Nasal swabs were collected and tested with the COVID-19 Antigen Rapid Test Cassette (nasal swab), and nasal/oropharyngeal swabs were collected from the same person and tested with RT-PCR for confirmation. Samples were considered positive if the PCR yielded a positive result. Of the 103 PCR-positive cases, 96 cases were tested positive with the COVID-19 Antigen Rapid Test Cassette (nasal swab). The relative sensitivity of the COVID-19 Antigen Rapid Test Cassette (nasal swab) is 93.2% (96/103), (95% CI: 86.5-97.2%). Of the 250 PCR-negative cases, 248 cases were tested negative with the COVID-19 Antigen Rapid Test Cassette (nasal swab), and the relative specificity of the COVID-19 Antigen Rapid Test Cassette (nasal swab) is 99.2% (248/250), (95% CI: 97.1%-99.9%)*. Of 103 PCR-positive and 250 PCR-negative cases, 344 cases showed concordant results with the COVID-19 Antigen Rapid Test Cassette (nasal swab), and the relative accuracy of the COVID-19 Antigen Rapid Test Cassette (nasal swab) is 97.5% (344/353), (95% CI: 95.2%-98.8%)*.
Does this test hurt?
No, the nasal swab is not sharp and should not hurt. Sometimes the swab may feel slightly uncomfortable or ticklish. If you experience pain, please discontinue the test and consult a physician. 7. I got a nosebleed after the nasal swab. What should I do?
How do I know if the test was performed correctly?
The test includes a procedural control. A colored line appearing in the control region (C) is considered an internal procedural control.
What should I do if the result is positive?
Please contact a qualified medical professional immediately and inform your immediate contacts whom you have had contact with in the past 24 hours. Measures should be taken according to local guidelines to prevent further spread of the infection. It is recommended to immediately perform a PCR test, self-isolate, and receive medical treatment based on the PCR test. A laboratory test using the PCR method is recommended to confirm a positive result.
What to do if the result is negative?
A negative result may require further testing to confirm your result. Please talk to your healthcare provider to see if you need further testing. It is likely that you were not infectious at the time of testing. However, a negative test result is not a guarantee that you are not infected with coronavirus. Please continue to follow social distancing rules and local regulations.
Can the RightSign COVID-19 antigen test detect different variants of COVID-19?
Yes, the test can detect different variants. A detailed list is available on request.
Who can use the tests?
These tests are intended for laypersons, i.e. private individuals, and can be found here
Where can I find more information about antigen tests?
For detailed information about antigen tests, you can visit our blog.
How reliable is a self-test?
It is advisable to perform a self-test that meets the minimum criteria set by the Paul Ehrlich Institute (PEI) together with the Robert Koch Institute. Reliable tests are usually identified by the presence of a CE marking with a four-digit identification number of the notified body and a German-language instruction manual.
Can the self-test also be used on children?
Yes, under adult supervision. For children, a nasal swab of 1-2 cm is sufficient.
General FAQs
How does Odem ensure high-quality at such a fair price?
The Better AG, founded in 2006 in Switzerland, has become the main supplier to thousands of companies in recent years.
The strategy:
- Purchasing in large volumes
- Tight quality control of goods
- Passing on the purchasing advantages to our customers
By offering the possibility to receive free samples, there are no risks to the customers.
What is the money-back guarantee?
If you are not satisfied with your purchase, you can return it within 14 days of receipt for a full refund.
What payment options are available?
We offer a convenient payment via invoice after receipt of goods to a German bank account.
Has the goods already been cleared by customs?
Yes, the goods have already been cleared by customs and will be delivered to you from our German warehouse. You will not incur any additional costs.
Product Sheet
Login
April 25, 2023 08:04
Genaue Ergebnisse
Die Ergebnisse dieses Produkts sind sehr genau