Clinical diagnostics testing has entered a new phase with the availability of various tools to diagnose health conditions for effective treatment.
Clinical tests such as in-vitro diagnostics (IVDs) are clinical tests that analyze the body conditions based on the samples taken from the human body. In contrast to other devices, IVDs include products used to collect specimens, prepare and examine models in serum, urine, blood, tissue samples, and spinal fluids removed from the human body.
The new EU IVD Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) introduces several changes for the modernization of the European regulatory system by bringing about sweeping changes to the information provided with IVD devices and their regulatory documentation. Typically, the documentation requires manufacturers to submit studies confirming the accuracy and usefulness in diagnosing a particular condition before bringing it to the market. In what follows, we analyze the commercial IVDs in terms of the processes and regulations are concerned.
Overview on the working of the IVD’s
IVDs are used to analyze human samples such as blood and saliva, either by measuring the concentration of specific substances or detecting the presence or absence of a given set of parameters such as genetic mutation or even response to an infection. The products may also be used to measure the analytes such as sodium and cholesterol using the samples in hand. Clinicians regularly use IVDs to diagnose conditions, take appropriate decisions to treat diseases, and mitigate any future possibilities of infections or diseases. A typical example here is screening tests that indicate a patient’s risk of developing a given condition in the future.
Clinical and regulatory validation
However, some of the critical standards are to be adopted to determine the effectiveness and accuracy of the tests. IVDs must demonstrate safety and efficacy through analytical and clinical validation, which are key standards in choosing a test’s accuracy.
The analytical validity of IVD implies that the test can measure a particular analyte by detecting and measuring the presence of a given chemical compound or a hormone or genetic marker. Analytical validation calls for high specificity and accuracy as they detect and reproduce the intended results.
<h3Clinical validation is the process for determining whether the test can accurately identify a particular clinical condition in a given patient. The test predicts the presence of or the risk of a given situation by conducting a genetic test and assessing genetic mutation either for particular cancer or any disease incidence.
Even as the Covid-19 continues to have a reverberating effect globally, and no specific vaccine or treatment is in sight for Covid-19, several clinical trials are evaluating potential treatment. Clinical findings can throw light into assess the prognosis of the disease and the further treatment that can be undertaken. Springhealthcare Services AG is a healthcare solutions provider from Switzerland having products that are designed for qualitative detection of antigens and identification of protein antigens, that are typically detectable in the upper respiratory specimens during the acute phase of infection. Whether it is the Covid-19 Rapid IGM/IgG Combined Antibody Assay, Sars-Cov-2 Antigen Rapid Test (Swab), Sars-Cov-2 Antigen Rapid Test (Saliva) and Sars-Cov-2 Antigen Rapid Test (Saliva Spit). While they are designed for robust, easily accessible, fast and cheap tool for diagnosis, and an effective one as well. Each of the products are marked with the CE mark to fulfill the EU regulatory compliances.
CE marking in EU
The CE process for IVDs is similar to medical devices and is required for all in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) and that the device may be legally commercialized in the EU. Europe’s new In Vitro Diagnostic Regulation (IVDR 2017/746) will come into force in 2022, ushering in substantial changes to the regulatory requirements for IVDs.
Therefore, it is vital that the IVD manufacturers to update their technical files to meet the requirements and comply with new, more stringent Regulations.
While the antigen tests are currently authorized to be performed only with nasal swab specimens placed directly into the extraction buffer or reagent, they are cheap, and reveal an active infection that is already present. Most of the currently authorized tests return results in approximately 15-30 mins. However, antigen tests do not amplify their protein signal and can get diluted when samples are mixed with liquid needed to enable the tests.
Antibody rapid test for COVID-19 lgG/lgM, on the other hand, is a combined test for IgG/IgM antibodies in serum, plasma and whole blood that does not require special equipment, storage, and transportation of samples gives accurate and reliable results in 10min compared to various other immunological tests.
About the Covid 19 Rapid Tester by Spring Health care
Typically, the tests show a 94.5% cross-assay agreement, up to 100% specificity and sensitivity where antibodies against both N and S domains are tested. This is useful for early diagnosis and early treatment of the virus.
The combined benefits of accuracy and prompt diagnosis are some of the benefits of Springhealthcare Covid 19 Rapid Tester kits. With proven accuracy of 98% the rapid one-step test kits for virus tracing has two-pronged benefits, which include: Rapid and effective diagnosis of Covid-19 infection and indication of a possibility of recent exposure to Covid-19 virus
Spring Healthcare makes it popular among healthcare specialists in Switzerland.