PRIMA Iron FER Home Test Self-test for detecting ferritin levels in whole blood samples Contents: 1 test IRON AND FERRITIN RESERVES Ferritin is the protein used to store iron in the body: the dosage of this protein is an excellent indicator of the amount of iron available. Iron is an essential trace element for our bodies, vital for oxygen transport in the blood, cell proliferation, and the building of tissues and organs. However, in excess, it is toxic. For this reason, our bodies have a system to absorb iron from external sources and store it in a controlled, non-toxic form within the cells. Low ferritin levels in the blood indicate a lack of iron in the bodys iron stores, a condition that precedes the development of anemia. WHO IS THE TEST FOR? The IRON FER TEST is useful for checking the bodys iron reserves. A decrease in ferritin levels in the blood can be caused by conditions and diseases such as anemia, pregnancy, bleeding, impaired iron absorption, and tuberculosis. TECHNICAL DATA IRON FER TEST is an immunochromatographic device that detects ferritin levels in the blood below the threshold of 30 ng/mL. Specificity 100% Sensitivity 85.2% Accuracy 96.6% CONTENTS - 1 test cassette - 1 dropper bottle containing the thinner - 2 sterile lancets - 1 pipette for blood collection - 1 antiseptic cleaning gauze - Instructions for use MISSION 1. Take a blood sample using the supplied sterile lancet; 2. Take the sample marked by the black line using the supplied capillary pipette; 3. Place the collected sample in the well (S) indicated on the cassette; 4. Add 2 drops of thinner and wait 5 minutes to read the result. INTERPRETATION OF THE RESULTS Negative: The ferritin level in the blood is above 30 ng/mL. Cases in which the ferritin concentration is just below this value (27 ng/mL-29 ng/mL) can lead to a similar result. Positive: Your ferritin level in your blood is lower than the upper limit. You need to consult your doctor. QUESTIONS & ANSWERS: What happens if the times for reading the results are not adhered to? The test was performed correctly if the instructions for use were followed, including the reading time and the interpretation of the results as specified in the INTERPRETATION OF RESULTS section of the instructions for use. How can you verify if the test worked correctly? A colored line appears in the control area (C) of the test device, indicating that the test was performed correctly. If this line is not present, the test should be repeated with a new device and a new sample. How should the test be interpreted if the control and test lines show different intensities? The color and intensity of the bands are not important for interpreting the result. The test is considered positive regardless of the intensity of the test line color (T).