Product features: Preventis SmarTest Vitamin D Home For single use in-house application for the quantitative determination of 25(OH) vitamin D from capillary blood. Product description: Preventis SmartTest Vitamin D Home is a rapid test for the quantitative immunological determination of 25(OH) vitamin D in capillary blood. This value can be used to monitor vitamin D status and detect any excess or deficiency. The manual testing system consists of an antibody-based strip test, a so-called lateral flow test, including a smartphone app developed for its evaluation. The test is an in-vitro diagnostic and suitable for self-administration by laypersons aged 18 and over. The package contains materials for performing one test. The test is for single use only. General information: Preventis SmarTest Vitamin D Home is intended for in-vitro diagnostic use only, i.e., for use outside the body. One test kit contains materials to perform 1 test. Test components from different production units must not be mixed. All test components may only be used for the designated purpose and in combination with the components included in the kit. The prepared sample may only be used in combination with the corresponding test components. No special knowledge is required to take the test, and it can be done at home. Please allow at least 20 minutes to complete the test undisturbed. For persons under 18 years of age, the test can be carried out by a parent or guardian. The test must be performed at room temperature. Read the test instructions carefully before use. Set up the app, take samples, perform the test, and evaluate the results precisely according to the test instructions. Make sure your smartphone is sufficiently charged (battery level at least 20%). The SmarTest Vitamin D app requires an active internet connection at regular intervals, but at least every 48 hours, to load the latest calibration data. Do not turn off your phone or the ringtone/signal tones during use, as the timer uses a signal tone. Conduct device qualification and camera testing in the same location where you will later evaluate the rapid test, in order to incorporate the existing lighting conditions into the assessment. Ensure even lighting. Avoid shadows, side lighting, and direct sunlight. Ensure that the camera test card and test cassette are placed on a flat, dry and bright surface and remain horizontal at all times. After the 15-minute timer expires, you have 2 minutes to scan the test cassette with your smartphone. You will only receive a valid result if the test is evaluated within this time period. For the security of your data, it will only be transmitted in encrypted form. For detailed information, please refer to the corresponding Data Privacy Policy of Preventis GmbH, which can be found at www.preventis.com. Please use only the latest version of your original operating system provided by your smartphone manufacturer. A list of supported operating systems can be found at www.link.preventis.com/vitamin-d-home. Safety instructions: Do not drink the contents of the buffer tube; avoid direct contact with the liquid. Immediately and thoroughly wash any contaminated areas after skin contact. Keep all components out of reach of children. Should you experience any problems setting up the app, taking samples, performing the test or evaluating the results, please contact info@preventis.com or ask a third party, e.g. a family member, for help. Treat the sample as potentially infectious: do not eat, drink, or smoke during sample handling. It is recommended to always wash/disinfect your hands after the test. In case of serious incidents, please contact Preventis GmbH (info@preventis.com) and the relevant authorities immediately. Storage, stability and disposal: Store the test at room temperature or in the refrigerator (+4 to +30°C), do not freeze. The test is sensitive to humidity, direct sunlight, and high temperatures. Therefore, the test must be protected from heat and used immediately after opening the test cassette packaging (within 5 minutes). Do not use the test if the packaging or the supplied materials are damaged. Do not use the test after the expiry date. After use, dispose of all test components, including the camera test card and test instructions, in household waste. Medical background: Vitamin D refers to a group of molecules that perform many different important functions in the body. Unlike other vitamins, only a small portion of it is obtained through food. However, the body can produce vitamin D itself when exposed to sunlight. The storage form, 25(OH) vitamin D, is measured as a marker for vitamin D status. The majority of the total amount of vitamin D consists of this storage form. Vitamin D is able to bind to almost every cell in the body. Accordingly, the positive effects of vitamin D on the body are diverse. It is not only essential for bone formation but also extremely important for a healthy immune and nervous system, muscles, and the cardiovascular system. A vitamin D deficiency is also associated with the development of cancer, diabetes, high blood pressure, heart attacks, and autoimmune diseases. Regular monitoring of vitamin D status is particularly recommended for at-risk groups such as the elderly, people with dark skin, and those who spend little or no time outdoors. Test principle: Preventis SmarTest Vitamin D Home is an antibody-based strip test for the detection of 25(OH) vitamin D in capillary blood. The sample is taken using a specific sampling system and dissolved in a buffer solution. Three to four drops of the solution are then applied to the sample application window of the rapid test. Any 25(OH) vitamin D present reacts with gold-labeled anti-25(OH) vitamin D antibodies and, if performed correctly, becomes visible as a reddish test band within 15 minutes. The appearance of the control band also indicates whether the test has functioned correctly. Using the SmarTest Vitamin D app, the quantitative result is then evaluated based on the color intensity of the control and test bands. The sampling and processing of the sample before measurement, as well as the test procedure and evaluation, are described step by step in the package insert in the chapters on sampling, test procedure and evaluation. Distribution: Preventis GmbH Stubenwald-Allee 8a 64625 Bensheim, Germany Telephone: +49 6251 70711-0 Fax: +49 6251 70711-25 info@preventis.com www.preventis.com This patient information leaflet was last revised in December 2021. Source: https://preventis.com and information from the package leaflet As of May 2024