engleski

Performance of the Alinity s Immunoassay for the Detection of Syphilis Antibodies

Background/Case Studies: Blood donations are commonly screened for Syphilis in order to detect the presence of antibodies to the bacterium Treponema pallidum. In addition, continued pressures on laboratory operations demand that the full panel of TTID assays perform on a single platform capable of increased walk away time and enhanced automation in areas of reagent management, retest options, and commodity/waste management. In response to those needs, we have evaluated a new automated immunoassay for the detection of antibodies to T. pallidum. Study Design/Method: Performance of the new automated chemiluminescence immunoassay for the detection of antibodies to Treponema pallidum was evaluated on the Alinity s System. Precision was assessed over 20 days using positive samples. Specificity was evaluated on samples obtained from 9, 101 blood and plasmapheresis donors from the United States and Europe and 200 diagnostic samples obtained from the United States. Sensitivity was evaluated using 514 preselected positive samples. Sensitivity and specificity samples were split across 3 reagent lots during testing. Confirmation of repeatedly reactive samples was done using a testing algorithm with 3 confirmatory assays, INNO-LIATM Syphilis Score, and Mikrogen recomLine Treponema IgG and IgM blots. Results/Finding: Imprecision was less than 6.0% CV for positive samples over 20 days. Clinical sensitivity was 100.00% (514/514) on preselected Syphilis positive samples. The specificity was 99.97% (9, 063/9, 066) for blood donor specimens and 100.00% (200/200) on diagnostic samples. Conclusion: These results indicate that the new automated Alinity s Syphilis assay provided good performance in precision, specificity and sensitivity in line with data found for the comparator assay.

Alinity s System ; Syphilis testing

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