Newbio RPR

principle of the test

NewBio RPR (Rapid Plasma Reagin) utilises carbon particles coated with cardiolipin antigen to detect reagin antibodies present in serum or plasma of syphilitic persons.

Specimens that contain reagin cause aggregation of the carbon particles which appear as dark clumps against a white background. The aggregation can be read macroscopically. Non-reactive samples typically appear as a smooth non-aggregated pattern which may form buttons in the centre of the test area.

Specificity

A study with 1248 syphilis negative EDTA plasma samples showed 99.92% specificity (95% confidence interval 99.55-100.0%)

Sensitivity

A study with 158 syphilis positive samples (37 EDTA plasma and 121 sera) showed 98.73% sensitivity (95% confidence interval 95.50-99.85%)

Certification

This product is IVDR Certified.