The increasing spread of COVID-19 has made the need for effective testing methods more urgent than ever. In this context, rapid antigen tests are gaining in importance as they enable simple and rapid diagnoses. The CLUNGENE Corona rapid test offers a promising solution that is accessible to both private individuals and professionals.
The CLUNGENE test, available in a convenient 25-pack, offers high reliability and is designed to maximize ease of use. It combines modern testing technology with ease of use, making it a preferred choice for many. This article focuses on exactly how it works and how to interpret the results.
In the following sections, you will learn everything you need to know about how the CLUNGENE teststheir accuracy and the benefits they offer users both in healthcare and at home. Let's dive into the world of rapid coronavirus tests and find out how they can help fight the pandemic.
The Clungene COVID-19 antigen rapid test serves as a kit for in vitro diagnosis and is used for the qualitative detection of acute SARS-CoV-2 infection. This test is specially designed for professional use and therefore requires medical expertise. With a high sensitivity of up to 98.5% and a specificity of up to 100%, the Clungene tests provide reliable results. The test results can be read within 10 to 15 minutes, enabling a rapid diagnosis. The test is CE-certified and listed with the German BfArM, available in a pack of 25 test cassettes.
Available in professional and layman versions
The CLUNGENE COVID-19 Antigen Rapid Test is available in both professional and lay test versions. For healthcare professionals, there is a pack of 25 suitable for nasal and throat swabs. These more comprehensive kits are ideal for clinics or pharmacies that need to perform regular tests.
For home use, a kit of 5 is available which is specially designed for easy use by lay people. These lay tests are easily accessible and offer a user-friendly way to perform the tests at home. The high sensitivity of 95.50% and specificity of 100% guarantee reliable results.
The Clungene rapid test covers both professional and private use, which underlines its versatility. The availability of different pack sizes enables a flexible testing strategy for both healthcare professionals and end users.
The CLUNGENE Covid-19 Antigen Rapid Test is specially developed for professional use to detect acute SARS-CoV-2 infections. With an impressive sensitivity of 92.00% and a specificity of 99.70%, the test provides reliable results in just 10 to 15 minutes. It can be easily used by healthcare professionals at the point-of-care as it does not require any additional laboratory equipment.
Mechanism of action
The Clungene antigen rapid test for the diagnosis of acute SARS-CoV-2 infection identifies specific viral antigens in samples collected by nasal, nasopharyngeal or oropharyngeal swabs. This sample collection enables effective detection of the virus in the acute phase of the infection and ensures rapid diagnosis.
The test cassettes are individually sealed and offer increased user-friendliness thanks to easy-to-read results. Sterile disposable swabs are used for sampling to ensure hygienic and efficient sample collection. The extraction tubes are pre-filled and equipped with a dropper tip, which simplifies handling and speeds up the procedure.
The success of the test depends on correct application and timely performance. The exact results vary depending on the time of sampling during the course of the infection. Therefore, accurate handling is crucial for safe use.
Important points:
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Sample typesNasal, nasopharyngeal or oropharyngeal swabs.
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EquipmentSealed test cassettes, sterile disposable swabs, pre-filled extraction tubes.
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Success factors: Correct performance and timely sampling.
Test procedure
The Clungene Covid-19 Antigen Rapid Test uses a lateral flow immunoassay method for the qualitative determination of SARS-CoV-2 nucleocapsid antigens. The test is suitable for people aged seven years and older and provides rapid results within 15 minutes. Correct performance is crucial to obtain reliable results.
A nasal swab is used to perform the test. The sterile swab is inserted about 2.5 cm deep into the first nostril and rotated several times along the nasal mucosa. The procedure is then repeated in the other nostril. This ensures sufficient sample collection and prevents incorrect test results.
It is important to carry out the rapid test under certain storage conditions. It should be stored between 4 and 30 °C and the test should ideally be carried out at room temperature (15 - 30 °C). By following these simple steps, the Clungene antigen rapid test can be used effectively and safely.
Evaluation of the results
The correct implementation of the Clungene COVID-19 antigen rapid test is crucial for reliable results. With a sensitivity of 98.5% and a specificity of 100%, these tests provide accurate results if the user follows the instructions exactly. A false result can occur if the test is not performed properly or is used at a time of low viral load.
The Clungene 3in1 Rapid COVID-19 Antigen Test is able to detect the virus at different stages of infection. This is particularly important during the acute phase of the infection. Healthcare professionals should place the results in the context of the patient's clinical symptoms and medical history to ensure an informed diagnosis.
It is important to interpret the test results immediately after use in order to take prompt action. A positive result requires rapid isolation of the affected person to contain the spread. However, negative results should be followed by further clinical clarification if symptoms persist. Reliable use of the Clungene rapid tests effectively supports close-to-patient laboratory diagnostics.
Accuracy and efficacy
The Clungene antigen rapid test offers impressive accuracy with an overall sensitivity of 95.50% and a specificity of 100%. These values demonstrate the high reliability of the test in detecting COVID-19. In particular, the test shows a sensitivity of 98.5 % with a Ct value ≤33 and a specificity of 99.7 % in a nasopharyngeal swab, making it a reliable diagnostic tool.
The test has been extensively validated to ensure that it can detect all known corona variants, including Omikron (BA.1, BA.2, BA.4, BA.5). For the nasal swab, the sensitivity is 92.0% and the specificity is 99.4%, making it effective for nasal sampling as well. Test results are available within 15 to 20 minutes and enable a quick decision to be made on the necessary measures.
Performance compared to COVID-19 variants (including Omikron)
The Clungene COVID-19 antigen rapid tests are efficient in detecting all known corona variants, including Omikron (BA.1, BA.2, BA.4, BA.5). They achieve a specificity of 100% and an overall sensitivity of 95.50%, which underlines their high reliability. It is particularly noteworthy that the sensitivity for detecting an acute SARS-CoV-2 infection is 98.5%.
These tests are designed for use by healthcare professionals and allow nasal, nasopharyngeal and oropharyngeal swabs. The validity of the test results may vary depending on the time of testing, the stage of infection and the viral load. This means that they provide very accurate results if the viral load is high.
Here is an overview:
Specificity
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Overall sensitivity
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Sensitivity for acute infection
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100%
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95,50%
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98,5%
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The Clungene rapid tests thus offer a reliable and rapid way to safely identify COVID-19 at different stages of the infection.
Highlights of the clinical study
Clinical studies on the Clungene COVID-19 rapid antigen tests show impressive results. With a specificity of 100% and a sensitivity of 98.5%, the test offers high reliability. The test results are available within 15 minutes, enabling an immediate diagnosis.
The Clungene Antigen Rapid Test is capable of detecting different SARS-CoV-2 variants, including alpha, beta, gamma, delta and omicron. It has been evaluated by the Paul-Ehrlich-Institut and is on the European Commission's common list of COVID-19 rapid antigen tests.
Another advantage of these tests is that they show no cross-reactivity with influenza viruses, rhinoviruses or human coronaviruses. This increases the specificity of the test results and minimizes the likelihood of false alarms. Clung tests offer a reliable option for close-to-patient laboratory diagnostics, especially in the acute phase of infections.
Instructions for use and precautions
The Clungene COVID-19 Antigen Rapid Test is user-friendly and provides results in just 15 minutes. Test samples can be collected by nasal swab, nasopharyngeal swab or oropharyngeal swab. It has been specially developed for professional use and is supplied in packs of 25 test cassettes and accessories. For reliable results, it is important to maintain the storage temperature between 4 - 30 °C. Each test cassette is individually packaged and contains pre-filled extraction tubes with dropper tips for ease of use.
Step-by-step instructions for use
The CLUNGENE COVID-19 Antigen Rapid Test is specially designed for trained healthcare professionals. The sample can be taken using a nasal swab, a nasopharyngeal swab or an oropharyngeal swab.
After taking the sample, the swab must be carefully inserted in parallel into the solution before a few drops are added to the test cassette. The test result can usually be read after 15 minutes.
Each pack contains 25 tests with all the necessary materials, including a workstation and leaflet. Remember to store the tests at a temperature between 4 and 30 °C to ensure reliable results. Results should be evaluated by trained personnel and can often be communicated by email.
General precautions to ensure accurate results
In order to ensure accurate results when performing a Clungene COVID-19 antigen rapid test precise results, correct performance is essential. An error-free application significantly influences the reliability of the test results. It is therefore important to follow the test instructions carefully, especially when taking samples from the front of the nose.
The test should be carried out at an optimal time during the infection. The viral load fluctuates during the course of the infection, which influences the probability of a correct test result. It is therefore advisable to choose the test phase strategically.
The test material must always be brought to room temperature before use. This guarantees the accuracy of the results and maximizes the sensitivity (98.5%) and specificity (100%) of the test. Care should always be taken to maintain the required ambient temperature during storage and preparation.
In addition, it is advisable to strictly adhere to the manual when taking samples in order to avoid misunderstandings and misapplications. These measures make a decisive contribution to ensuring the effectiveness and safety of the Clungene antigen rapid tests tests.
The Clungene COVID-19 antigen rapid tests offer high reliability with an impressive overall sensitivity of 95.50% and specificity of 100%. The tests are particularly useful in the current epidemiological situation, as they detect all corona variants including Omikron (BA.1, BA.2, BA.4, BA.5). These tests are also available in individually sealed, easy-to-read test cassettes, which simplifies handling and reading the results. The rapid test results, which are available after just 10 to 15 minutes, enable fast diagnostics and shorten the response time in the event of a suspected infection.
Advantages for trained personnel
The Clungene Antigen Rapid Test offers significant advantages for trained medical personnel. With its high clinical specificity of 100% and sensitivity of 98.5%, it provides reliable results that are crucial for the accurate diagnosis and rapid isolation of COVID-19 cases. This enables effective containment of the pandemic.
Thanks to the ease of use of the test at the point-of-care, healthcare professionals can work directly on site without the need for additional laboratories and materials. The rapid provision of test results is particularly useful for quickly identifying and isolating infected individuals. The Clungene 3in1 antigen test is also able to detect the virus at different stages of infection, making it a versatile tool for pandemic response.
An important aspect is also the correct use by trained staff. Detailed instructions ensure that healthcare professionals obtain accurate results, ensuring safe and efficient medical care.
Frequently asked questions (FAQs) for professionals
The Clungene COVID-19 Antigen Rapid Test is specially designed for use by healthcare professionals. It can be performed accurately with a nasal swab or an oropharyngeal swab and is sensitive to all known corona variants, including Omikron. With a specificity of 100% and a sensitivity of 98.5%, the test offers high reliability in the detection of SARS-CoV-2. Instructions for correct performance are essential and are provided to ensure the validity of the test results.
Frequently asked questions about the test
The Clungene Corona Antigen Rapid Test is ideally performed by healthcare professionals or trained personnel. This ensures that all steps are carried out correctly to guarantee reliable results. A crucial step is correct sample collection: the patient should tilt their head back by 70° so that the swab can be placed correctly.
The swab should be guided parallel to the palate until slight resistance is felt. This optimizes the accuracy of the test, which achieves a sensitivity of 94.4% with a CT value of less than 25. Always use a sterile disposable swab suitable for nasal, nasopharyngeal or oropharyngeal swabs.
To achieve optimal test results, it is important to follow the instructions for use. A correctly performed drop test maximizes the sensitivity of the rapid test. If you have any questions about storage or performance, trained staff in pharmacies and medical facilities are available to ensure correct use.
Troubleshooting tips for test problems
When performing the Clungene COVID-19 antigen rapid test correct handling is crucial for reliable results. The most common sources of error include improper sample collection and inaccurate process steps. Make sure to insert the sterile swab carefully and parallel into the anterior nasal area to ensure accuracy.
Another important point is the timing of the test. Preferably perform it during the acute phase of the infection, as the probability of a positive result is higher at this time. The sensitivity of 98.5 % and the specificity of 100 % of the test underline the need for correct application to avoid dubious results.
Ensure that the test is stored at room temperature and that all components are undamaged before use. Because Clungene tests are suitable for different SARS-CoV-2 virus strains, all relevant variants can be reliably detected if performed correctly. Trained employees and medical professionals can provide assistance in case of uncertainties.
Product details
The CLUNGENE COVID-19 Antigen Rapid Test is a qualitative test that provides a result within 15 minutes. It is carried out using a nasal, nasopharyngeal or oropharyngeal swab. With a specificity of 99.7% and a sensitivity of 98.5% (at Ct value ≤33), the test guarantees a high level of reliability. It is registered with the German authorities and has been evaluated by the Paul Ehrlich Institute.
This rapid test can detect various virus mutations such as alpha, beta, gamma, delta and omicron (BA.1, BA.2, BA.4, BA.5). Each test kit contains 25 test cassettes, sterile disposable swabs and all the necessary materials to perform the test. The kit is intended for use by healthcare professionals only.
The Clungene COVID-19 Antigen Rapid Test Kits contain 25 test cassettes that are provided for reliable diagnostics in different environments. Each box is fully equipped and offers 25 extraction reagents packed in convenient ampoule bottles. These reagents are essential for the correct performance of the test procedure.
In addition, the box contains 25 disposable swabs, which are necessary for careful sampling. These swabs are ideal for nasal and nasopharyngeal swabs to ensure accurate results. For further processing, 25 extraction tubes and 25 drip tips are available to ensure clean handling.
In addition, each kit includes a practical workstation to facilitate the testing process and a leaflet detailing the correct application. This comprehensive kit enables easy and safe use by both healthcare professionals and trained laypersons. The tests offer rapid diagnostics within minutes and are suitable for use in near-patient laboratory diagnostics.
Source: istockphoto VioletaStoimenova
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