EquiChek™ Rapid Test Equine Inflammation and Infection Kit Components 1. Test Strips 3. Sample Applicators 4. Dropper Bottle 5. Instruction Manual surface of the blood. DO NOT IMMERSE SAMPLE APPLICATOR IN BL0OD TUBE. DO NOT SQUEEZE the sample applicator, blood will be drawn up automatically up to the black line on the sample applicator. 10 tests 10 1 x 4 ml 1 copy Test Unit Sample Port Test Window Figure 1: Sample is applied to the Sample Port and final test result is viewed in the Test Window Blood Samples The test is designed for use with freshly taken whole blood, but serum or plasma can also be used. For animal side application, a needle (no syringe attached) should be inserted into a vein. Once blood rises to the end of the needle, just touch the sample applicator to blood. Filling is automatic. Correct sample volume is indicated by a line on the applicator. Do not squeeze the applicator when drawing blood up. Alternatively, blood can be collected into a tube (EDTA or Heparin). Make sure there is enough blood in the tube so that the sample applicator provided with the kits can come into contact with the blood when inserted into the blood tube. Test Procedure Step 1: Remove test cassette from foil pouch Step 2: Remove cap from blood tube and insert sample applicator. Just touch sample applicator to Step 3: Apply sample to the sample port on the test strip. Touch sample applicator to the sample port and gently squeeze to expel blood into the test window. Step 4 : Add 3 drops of liquid from the dropper bottle into the sample port. Results will be visible in as little as 2-3 minutes but the test result can be read after 10 minutes. 5. The result can be seen in the Test Window (Figure 1). It is recommended that the test is read at 10 minutes after starting. However, a normal result can be seen within 2-3 minutes, i.e. 4 lines will be visible. Do not read after 15 minutes as lines may fade. inflammation. With clinically significant inflammation, only one line (the control line) will be visible. Interpretation of Results Note: Where inflammatory status is borderline, horses with evidence of low grade inflammation should be retested within 24 hours to establish inflammatory status. Note: the intensity of the colour on each line may vary depending on the level of SAA in the blood sample e.g. where the inflammation is progressing from intermediate to severe, test lines will begin to fade but may still be visible. Normal Storage and Stability Storage:Test strips can be stored at 6-25OC, avoid direct sunlight. Expiration date:12 months from manufacturing date. Expiry date is located on the outer box label. Mild Inflammation Note: Where inflammatory status is borderline, horses with evidence of low grade inflammation should be retested within 24 hours to establish inflammatory status. Limitations and Precautions Mild to Moderate Inflammation Clinically Significant Inflammation 1. As with all diagnostic tests, a definitive clinical diagnosis should not be based on a single result, but should only be made after all clinical and laboratory findings have been considered. 2. This product is intended only for detecting SAA in horse whole blood or Synovial Fluid. 3. Use only the sample diluent provided with the kit. 4. All specimens should be considered potentially hazardous and handled as an infectious agent. 5. Do not use this product beyond the expiration date located on the outer box. 6. Remove test strip from foil pouch just prior to use. Do not use the test strip if foil pouch is damaged or already opened. Liability Invalid Test The entire risk due to the performance of this product is assumed by the purchaser. The manufacture shall not be liable for any indirect special or consequential damages of any kind resulting from use of this product. Technical or Sales Inquiries Contact: Accuplex Diagnostics Ltd. Horses with normal or very low levels of SAA will give 4 lines in the test window. As the severity of inflammation increases so will the level of SAA. The test lines will get progressively weaker in colour so that only two lines become visible indicating that the horse has mild to moderate Tel: +353 1 6875055 Mobile: +00353 87 2823555 Email: info@accuplexdiagnostics.com Web: www.accuplexdiagnostics.com V210813 PATENT PENDING