INTENDED USE

The Hemoglobin Test Strips are firm plastic strips onto which a multilayer dry reagent is affixed. A whole blood sample is drawn by capillary action into a reaction zone on the strip automatically that will achieve a stable sample volume. The test strips function by lysing erythrocytes and converting the released hemoglobin into methemoglobin and are intended to be read on the Hemoglobin Analysis Meter or Multi-function analyzer(hereinafter collectively referred to as analyzer). This test is for the quantitative determination of hemoglobin (Hb) and calculated hematocrit (HCT) in capillary and venous whole blood. The test strips are professional use only.

SUMMARY AND MEASUREMENT RANGE

Hemoglobin is the main component of red blood cells whose main function is to transport oxygen. The determination of hemoglobin concentration in whole blood is useful in the clinical diagnosis of diseases such as anemia and polycythemia.

Hemoglobin(Hb): 0-26 g/dL (0-260g/L, 0-16.1mmol/L)

PRINCIPLE

Erythrocytes in the specimen are lysed to release hemoglobin. The hemoglobin is converted to methemoglobin. The intensity of the color produced from this reaction is proportional to the hemoglobin concentration. Reference values are listed in the chart below:

Men: 13.0-17.0 g/dL(130-170 g/L, 8.1-10.5 mmol/L)

Women: 12.0-15.0 g/dL(120-150 g/L, 7.4-9.3 mmol/L)

Children: 11.0-14.0 g/dL(110-140 g/L, 6.8-8.7 mmol/L)