CE-marked

Sensitivity: 94.4%

Specificity: 98%

ISO:13485

WHO Pre-qualified

CE-marked

Sensitivity: 99.7%

Specificity: 99.8%

CE-marked

Sensitivity: 93.10%

Specificity: 100%

Specimen type: nasopharyngeal swabs

CE –marked

﹒BfArM Test-ID: AT981/21

﹒Specimen: Nasopharyngeal/nasal specimen

﹒Sensitivity(NP): 96.3%

﹒Specificity(NP): 100%

﹒Sensitivity(N): 95.5%

﹒Specificity(N): 99.6%

﹒Sensitivity: 93.64%

﹒Specificity: 100.00%

﹒Specimen: Nasal specimen

﹒ISO13485

Exclusive method

Solid-phase method

Accuracy rate: 100%

INTENDED USE

The kit is intended to qualitatively detect ABO blood group system A/B antigen and Rh blood group system D antigen in fresh finger prick blood/ anticoagulated venous whole blood.

Human blood contains a wide variety of blood groups, of which ABO and RhD are the most common. Blood group identification is a crucial test item prior to clinical blood transfusion, and has important clinical significance. When the blood group antigen on the surface of red blood cells comes in contact with the corresponding antibody, red blood cells will undergo agglutination reaction, which will eventually lead to hemolysis of red blood cells and endanger life. As a result, correct identification of ABO and RhD blood antigens is an essential prerequisite to ensure safe blood transfusion and avoid related diseases.