1. Orion QuikRead ® Portable CRP Test Kit

2. Supplies QuikRead ® 101 instrument Magnetic calibrator card Blood Capillary tubes with plungers (20 uL) Cuvettes Waterproof marker Buffer with 1-mL dispenser CRP reagent caps

3. Intended Use QuikRead ® CRP is a quantitative test of CRP in whole blood, serum or plasma CRP is an acute phase protein associated with bacterial infection, inflammation or tissue destruction

4. Test Principle Immunoturbidimetric test based on microparticles coated with anti-human CRP F(ab) 2 CRP in sample reacts with the microparticles and increases solution turbidity, proportional to the CRP concentration

5. Steps Turn on QuikRead ® 101 instrument Lot-specific calibration curve, coded onto a magnetic card, is loaded into instrument Buffer is dispensed into cuvettes Blood (or serum or plasma) is added to buffer and mixed RBCs are lysed and blank is read

6. Steps (cont.) Pre-calibrated reagents are dispensed from caps Capped cuvettes are mixed by vigorous shaking Sample is read in instrument Result is recorded before removing cuvette Instrument performs self-check before next test

7. Measurement Range 5 – 180 mg/L

8. Analytical Precautions Make sure that the magnetic card and reagents have matching lot numbers Do not expose magnetic card to strong magnetic fields Do not touch the optical part (lower half) of the cuvettes Clean the dispenser regularly with deionized water

9. Analytical Precautions (cont.) Do not expose the reagent caps to moisture Check for air bubbles in buffer dispenser tube and cuvettes Do not splash liquid into the measuring well of the QuikRead ® 101 Results must be recorded before removing cuvette from instrument or else the result is lost

10. Calibration assumes a hematocrit of 40% Correction formula for different hematocrits 60 (plasma volume) 100 – actual hematocrit X CRP test result For example, 60 (plasma volume) 100 – 33 X 5 mg/L = 4.5 mg/L Alternatively, use table of correction factors provided with kit Hematocrit Correction