RESUMO
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. Additionally, specificity was shown to be improved with testing of over 6000 donors and 240 diagnostic specimens. Overall, the Alinity i & ARCHITECT HBsAg Next assays have taken a step forward in improving the detection of Hepatitis B virus.
Assuntos
Antígenos de Superfície da Hepatite B/sangue , Hepatite B/diagnóstico , Imunoensaio/métodos , Automação Laboratorial , Técnicas de Laboratório Clínico/métodos , DNA Viral/sangue , Hepatite B/sangue , Vírus da Hepatite B , Humanos , Programas de Rastreamento , Mutação , Kit de Reagentes para Diagnóstico , Sensibilidade e Especificidade , SoroconversãoRESUMO
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. The ARCHITECT(®) viral capsid antigen (VCA) IgM, VCA IgG, and EBV nuclear antigen (EBNA) 1 IgG assays showed good results for sensitivity and specificity, being 100.0%, 98.3%, and 100.0% and 99.9%, 95.4%, and 99.6%, respectively. Using an algorithm based on initial EBNA-1 IgG testing, followed by VCA IgG and IgM for samples that were not EBNA-1 IgG reactive, the number of tests per sample could be reduced to nearly 50% compared to parallel testing. The high sensitivity and specificity of the ARCHITECT(®) EBNA-1 IgG assay in combination with a low number of grayzone results are a precondition for the chosen test algorithm. Thus, the newly developed ARCHITECT(®) EBV panel is suitable for accurate and cost-efficient EBV serology in a routine clinical laboratory.
Assuntos
Anticorpos Antivirais/sangue , Testes Diagnósticos de Rotina/métodos , Infecções por Vírus Epstein-Barr/diagnóstico , Herpesvirus Humano 4/isolamento & purificação , Algoritmos , Antígenos Virais , Herpesvirus Humano 4/imunologia , Humanos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Sensibilidade e Especificidade , Testes Sorológicos/métodosRESUMO
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. Precision was between 3.98% and 4.31% coefficient of variation (CV) for specimens with 1 to 6 sample to cutoff. Specificity was 99.95% and 99.86% on specimens from blood donors and hospitalized patients, respectively. Sensitivity evaluation showed 100% detection on 301 HTLV-I and 105 HTLV-II specimens. HTLV-I and HTLV-II viruses are still circulating among general populations even in the low prevalence areas. To control the further spread of these retroviruses, we need to know that it is important to continue screening of blood. The performance evaluation data from this study demonstrate that the high throughput and fully automated ARCHITECT rHTLV-I/II chemiluminescence immunoassay effectively serves this purpose.