The test kit identifies the presence of SARS-CoV-2 (coronavirus) and gives a qualitative YES/NO result within 15 minutes. Implementing rapid screening for COVID-19 has huge time and cost savings when compared to laboratory screening, and will help to control the spread of the virus by identifying infection rapidly and accurately.
The test kit is CE marked for professional use only.
The test kit holds a Certificate of Free Sale issued by United Kingdom Medicines and Healthcare products Regulatory Agency.
The test utilises the nasopharyngeal swab samples.
We have all the answers
Wollerau Pharma Rapid CAT SARS-CoV-2 Rapid Antigen Test is a double antibody-sandwich, qualitative membrane-based immunoassay In-vitro diagnostic medical device. The kit is designed to detect nucleocapsid antigen from the SARS-CoV-2 in nasopharyngeal, oropharyngeal or nasal swab samples from patients who are suspected of being COVID-19 positive. The SARS-CoV-2 antigens present in the specimen react with anti- SARS-CoV-2 antibody-coated particles in the test cassette. The mixture then migrates upward on the membrane by capillary action and reacts with the pre-coated antibody in the test line region. If the specimen contains SARS-CoV-2 antigens, a coloured line will appear in the test line region. If the specimen does not contain SARS-CoV-2 antigens, no coloured line will appear in the test line region, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The SARS-CoV-2 anitgen that the test detects is the specific virus that causes the COVID-19 disease, so a positive result would indicate the presence of the virus that is to develop the infection. The test can be used for primary and secondary diagnosis of presence of SARS-CoV-2.
The test cassette will work with nasopharyngeal, oropharyngeal and nasal samples (Be aware, this version is supplied with Nasopharyngeal Swabs). The type of sample will affect the sensitivity, specificity or accuracy of the test.
The buffer solution has two functions. It acts as the carrier for the sample, allowing it to laterally flow along the test strip, and it maintains a constant sample pH as it flows, preventing degradation of the biomarkers and the antigen. We recommend that you only use the buffer solution provided with the test kits, as other ones may affect the accuracy of the test.
For the result, the window of accuracy is 15-30 minutes after you add the sample and buffer solution. If you forget to read the results after this time, the test may not be accurate and should be disposed in biological waste. You should retest with a new Rapid CAT.
The recommended storage temperature is 2 – 30°C, however, we do not recommend you store them in the fridge, unless there is a risk of them overheating. Do not freeze the test cassettes or buffer solution. Tests should be performed at room temperature (15 – 30°C), so if you have stored tests in the fridge, you should allow them to reach room temperature before performing a test.
Yes, the SARS-CoV-2 Rapid CAT is CE marked for professional use and is therefore a registered IVD device, according to the requirements in the In Vitro Diagnostic Medical Device Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998. The test kit holds a Certificate of Free Sale issued by United Kingdom Medicines and Healthcare products Regulatory Agency (UK Medical Devices Regulations 2002 S.I. No. 618, as amended) and therefore may be freely sold in all member states of the European Economic Area including the United Kingdom.
The COVID-19 test is CE marked for professional use and is therefore suitable and ready for use by a healthcare professional. In addition to our clinical evaluations already completed on the product, we are currently working with a number of independent laboratories and Departments of Health across Europe to further validate the product and gain best practice approvals.
We SHOW you how it's done!
Having issues/problems, watch the video here
The test kit identifies the presence of SARS-CoV-2 (coronavirus) and gives a qualitative YES/NO result within 15 minutes. Implementing rapid screening for COVID-19 has huge time and cost savings when compared to laboratory screening, and will help to control the spread of the virus by identifying infection rapidly and accurately.
The test kit is CE marked for professional use only.
The test kit holds a Certificate of Free Sale issued by United Kingdom Medicines and Healthcare products Regulatory Agency.
The test utilises the oropharyngeal swab samples.
We have all the answers
Wollerau Pharma Rapid CAT SARS-CoV-2 Rapid Antigen Test is a double antibody-sandwich, qualitative membrane-based immunoassay In-vitro diagnostic medical device. The kit is designed to detect nucleocapsid antigen from the SARS-CoV-2 in nasopharyngeal, oropharyngeal or nasal swab samples from patients who are suspected of being COVID-19 positive. The SARS-CoV-2 antigens present in the specimen react with anti- SARS-CoV-2 antibody-coated particles in the test cassette. The mixture then migrates upward on the membrane by capillary action and reacts with the pre-coated antibody in the test line region. If the specimen contains SARS-CoV-2 antigens, a coloured line will appear in the test line region. If the specimen does not contain SARS-CoV-2 antigens, no coloured line will appear in the test line region, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The SARS-CoV-2 anitgen that the test detects is the specific virus that causes the COVID-19 disease, so a positive result would indicate the presence of the virus that is to develop the infection. The test can be used for primary and secondary diagnosis of presence of SARS-CoV-2.
The test cassette will work with nasopharyngeal, oropharyngeal and nasal samples (Be aware, this version is supplied with Oropharyngeal Swabs). The type of sample will affect the sensitivity, specificity or accuracy of the test.
The buffer solution has two functions. It acts as the carrier for the sample, allowing it to laterally flow along the test strip, and it maintains a constant sample pH as it flows, preventing degradation of the biomarkers and the antigen. We recommend that you only use the buffer solution provided with the test kits, as other ones may affect the accuracy of the test.
For the result, the window of accuracy is 15-30 minutes after you add the sample and buffer solution. If you forget to read the results after this time, the test may not be accurate and should be disposed in biological waste. You should retest with a new Rapid CAT.
The recommended storage temperature is 2 – 30°C, however, we do not recommend you store them in the fridge, unless there is a risk of them overheating. Do not freeze the test cassettes or buffer solution. Tests should be performed at room temperature (15 – 30°C), so if you have stored tests in the fridge, you should allow them to reach room temperature before performing a test.
Yes, the SARS-CoV-2 Rapid CAT is CE marked for professional use and is therefore a registered IVD device, according to the requirements in the In Vitro Diagnostic Medical Device Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998. The test kit holds a Certificate of Free Sale issued by United Kingdom Medicines and Healthcare products Regulatory Agency (UK Medical Devices Regulations 2002 S.I. No. 618, as amended) and therefore may be freely sold in all member states of the European Economic Area including the United Kingdom.
The COVID-19 test is CE marked for professional use and is therefore suitable and ready for use by a healthcare professional. In addition to our clinical evaluations already completed on the product, we are currently working with a number of independent laboratories and Departments of Health across Europe to further validate the product and gain best practice approvals.
We SHOW you how it's done!
Having issues/problems, watch the video here
The test kit identifies the presence of SARS-CoV-2 (coronavirus) and gives a qualitative YES/NO result within 15 minutes. Implementing rapid screening for COVID-19 has huge time and cost savings when compared to laboratory screening, and will help to control the spread of the virus by identifying infection rapidly and accurately.
The test kit is CE marked for professional use only.
The test kit holds a Certificate of Free Sale issued by United Kingdom Medicines and Healthcare products Regulatory Agency.
The test utilises the nasal swab samples.
We have all the answers
Wollerau Pharma Rapid CAT SARS-CoV-2 Rapid Antigen Test is a double antibody-sandwich, qualitative membrane-based immunoassay In-vitro diagnostic medical device. The kit is designed to detect nucleocapsid antigen from the SARS-CoV-2 in nasopharyngeal, oropharyngeal or nasal swab samples from patients who are suspected of being COVID-19 positive. The SARS-CoV-2 antigens present in the specimen react with anti- SARS-CoV-2 antibody-coated particles in the test cassette. The mixture then migrates upward on the membrane by capillary action and reacts with the pre-coated antibody in the test line region. If the specimen contains SARS-CoV-2 antigens, a coloured line will appear in the test line region. If the specimen does not contain SARS-CoV-2 antigens, no coloured line will appear in the test line region, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The SARS-CoV-2 anitgen that the test detects is the specific virus that causes the COVID-19 disease, so a positive result would indicate the presence of the virus that is to develop the infection. The test can be used for primary and secondary diagnosis of presence of SARS-CoV-2.
The test cassette will work with nasopharyngeal, oropharyngeal and nasal samples (Be aware, this version is supplied with Nasal Swabs). The type of sample will affect the sensitivity, specificity or accuracy of the test.
The buffer solution has two functions. It acts as the carrier for the sample, allowing it to laterally flow along the test strip, and it maintains a constant sample pH as it flows, preventing degradation of the biomarkers and the antigen. We recommend that you only use the buffer solution provided with the test kits, as other ones may affect the accuracy of the test.
For the result, the window of accuracy is 15-30 minutes after you add the sample and buffer solution. If you forget to read the results after this time, the test may not be accurate and should be disposed in biological waste. You should retest with a new Rapid CAT.
The recommended storage temperature is 2 – 30°C, however, we do not recommend you store them in the fridge, unless there is a risk of them overheating. Do not freeze the test cassettes or buffer solution. Tests should be performed at room temperature (15 – 30°C), so if you have stored tests in the fridge, you should allow them to reach room temperature before performing a test.
Yes, the SARS-CoV-2 Rapid CAT is CE marked for professional use and is therefore a registered IVD device, according to the requirements in the In Vitro Diagnostic Medical Device Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998. The test kit holds a Certificate of Free Sale issued by United Kingdom Medicines and Healthcare products Regulatory Agency (UK Medical Devices Regulations 2002 S.I. No. 618, as amended) and therefore may be freely sold in all member states of the European Economic Area including the United Kingdom.
The COVID-19 test is CE marked for professional use and is therefore suitable and ready for use by a healthcare professional. In addition to our clinical evaluations already completed on the product, we are currently working with a number of independent laboratories and Departments of Health across Europe to further validate the product and gain best practice approvals.
We SHOW you how it's done!
Having issues/problems, watch the video here