Performance characteristics of the high sensitivity Alinity i & ARCHITECT HBsAg Next Qualitative/Confirmatory assays.

Despite improvement in vaccinations, Hepatitis B remains a major health concern due to the difficulty of prevention even in low endemic areas such as Europe. In this report we describe the performance characteristics of the new HBsAg Next Qualitative and HBsAg Next Confirmatory assays designed for blood screening and diagnostic purposes on the Alinity i and ARCHITECT fully automated systems. The new assays were evaluated in comparison to the ARCHITECT HBsAg Qualitative II and Confirmatory assays on seroconversion, analytical sensitivity, and mutant panels along with testing of over 400 clinical positive samples demonstrating excellent improvements in sensitivity.

Comparative evaluation of the new ARCHITECT EBV assays considering different testing algorithms.

In the current evaluation, Epstein-Barr virus (EBV) serology was performed on 1113 routine serum samples. Although the initial request for all samples from the general practitioner was EBV IgM testing, 80.9% were classified as past infections.

Evaluation of a new third-generation ARCHITECT rHTLV-I/II assay for blood screening and diagnosis.

In comparison to current on-market assays, the ARCHITECT rHTLV-I/II assay is the first fully automated assay that simultaneously detects human T-cell lymphotropic virus type I (HTLV-I) and type II (HTLV-II) in human serum and plasma. Specificity was assessed on 5646 blood donors and 692 clinical specimens. For sensitivity determination, 301 HTLV-I-positive and 105 HTLV-II-positive specimens were tested.