NewBio pk TPHA is a passive particle agglutination assay for the qualitative and semi-quantitative detection of IgG and IgM antibodies to Treponema pallidum.
NewBio pk TPHA uses preserved avian erythrocytes coated with extracted antigens of T.pallidum (Nichols strain). Specific antibodies present in a sample of plasma or serum bind to these antigens when the sample is incubated with the particles. This causes the particles to agglutinate, then settle to form a characteristic pattern in the test well.
Non-specific reactions are eliminated by the use of absorbents. The assay can be run and interpreted manually or with an auto-analyser using an agglutination interpretation program.
A study on 300 donor serum showed 100% specificity. (95% confidence limits 98.8-100%)
A study on 300 donor EDTA plasma showed 100% specificity. (95% confidence limits 98.8-100%)
In-use study of over 1 million samples shows Initial reactive (IR) rate of 0.057% and Repeat Reactive (RR) Rate of 0.028%
A study on 100 syphilis positive samples showed 100% sensitivity. (95% confidence limits 99.6-100%)
NewBio pk TPHA has a sensitivity of between 0.1 and 0.025 IU/ml against the 1st IS for human syphilitic plasma IgG and IgM NIBSC code: 05/132
Quality Assured - 25 years experience
Ready to use stable liquid reagents
18 months shelf life
Up to 300 samples per hour
Results ready in 60 minutes
Automated reading
