INTENDED USE Vitassay FOB –Turbidimetric Assay- is a rapid Turbidimetric assay for the quantitative detection of human hemoglobin in human stool samples. Simple, non-invasive and highly sensitivity assay for the detection of human hemoglobin in feces that helps in the search for gastrointestinal bleeding problems. This product has been optimized for several automated analyzer. Rapid test for the quantitative detection of human hemoglobin in human stool samples. FOB Turbidimetric Assay is based on antigen-antibody agglutination reactions between the antigen contained in the sample and the antibodies anti-antigen coated on polystyrene latex particles. Such agglutination is measured as an increase in absorbance proportional to the quantity of antigen contained in the sample. The use of two external controls, Control 1 and Control 2, is used to verify that the test is working properly. Vitassay FOB –Turbidimetric Assay- is a quantitative turbidimetric assay for the detection of human hemoglobin in human solid stool samples. -Turbidimetric Assay- The increased amount of hemoglobin (hHb) in feces is the main symptoms of illnesses accompanied by hemorrhagic lesions in the digestive tract, particularly in the lower digestive tract. Therefore, measuring the amount of hemoglobin in feces is an effective method for the early detection and treatment of colon cancer and other diseases of the lower digestive tract that are accompanied by hemorrhaging. • Follow Good Laboratory Practices, wear protective clothing, use disposal gloves, goggles and mask. Do not use any other commercial kit component. • If measure range is exceeding, use the sample diluent to dilute the sample and repeat the assay again. • Read and follow up the instructions for use provided in the kit. • Prepare and adjust the analyzer before starting measurements. STORAGE AND STABILITY Store as packaged in the original primary container, the reagents should be preserved at refrigerated temperature (2-8ºC/35.646.4ºF), the sample diluent could be preserved refrigerated or at room temperature (2-30ºC/35.6-86ºF). • Components provided in the kit are approved for use with the Vitassay FOB-Turbidimetric Assay-. Do not use any other commercial component. For professional in vitro diagnostic use only. Professional trained in Turbidimetric techniques. The product is stable until the expiration date printed on the label, if they have been preserved under the recommended conditions. Do not freeze and keep away from the sunlight. MATERIALS MATERIAL REQUIRED BUT NOT PROVIDED MATERIAL PROVIDED Reagent R1 Reagent R2 Calibrator 0 Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 Control 1 Control 2 Vials with diluent for the sample dilution. ▪ Instruction for use. ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ Specimen collection container. Disposable gloves. Automated analyzer. Vortex. Microtubes (analyser vial). • For professional in vitro use only. SPECIMEN COLLECTION • Do not use after expiration date. Collect sufficient quantity of feces: 1-2 g or mL for liquid samples. Stool should be collected in clean and dry containers and must be kept away from the sunlight. Samples can be stored in the refrigerator (2-8ºC/35.6-46.4ºF) for 7 days prior to testing. For longer storage, maximum 6 months, the specimen must be kept frozen at -20ºC (-4ºF). Samples must be brought to room temperature before testing. Homogenize the sample as thoroughly as possible prior to preparation. • Do not use the test if its primary containers are damaged. • Specimens should be considered as potentially hazardous and handle in the same manner as an infectious agent. Avoid contamination errors, follow proper work procedure. • The reagents after use should be discarded in a proper biohazard container after testing. • Reagents contain preservatives. Avoid any contact with the skin or mucous membrane. Consult safety data sheet, available on request. Parque Tecnológico WALQA Ctra. N.330, Km.566 22197-Cuarte (Huesca, SPAIN) www.vitassay.com SPECIMEN PREPARATION

Analytical procedure 3. Use the stick to collect sufficient sample quantity. For solid stool, insert the stick in 4 different areas of the stool sample (figure 2), and add it into the vial with diluent for sample dilution. For liquid stool, take approx. 20 µL of the sample using a micropipette and transfer it into the vial for the sample dilution. Put the sample into the vial, close the vial and shake for a good dispersion of the samples (vortex until the sample is fully resuspended max.1 minute). 4.Close the cap of the vial with the diluent and sample, shake the vial in order to assure good...

• Patients should not collect samples during their menstrual period, if they have bleeding hemorrhoids, blood in urine or if they have strained during bowel movement. No cross reactivity was detected against other fecal markers that are occasionally present in feces: Human calprotectin Bovine haemoglobin Concentration than 1.9 µg/mL Human lactoferrin Concentration than 0.2 µg/mL ADAPTED EQUIPMENT Biolis i24 (Tokio Boeki) • All results must be interpreted along with the rest of the clinical information and other results obtained in the laboratory by a specialist doctor. EXPECTED VALUES The cut-off...

Parque Tecnológico WALQA Ctra. N.330, Km.566 22197-Cuarte (Huesca, SPAIN) www.vitassay.com