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Comparative evaluation of the new ARCHITECT EBV assays considering different testing algorithms
Eva Sickinger1, Mario Berth2, Angela Vockel1
1Abbott GmbH & Co. KG, Max-Planck-Ring 2, 65205 Wiesbaden-Delkenheim, Germany.
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.
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.
