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

Area of Science:

• Clinical diagnostics
• Virology
• Immunology

Background:

• Epstein-Barr virus (EBV) serology is crucial for diagnosing infections.
• Routine testing often involves multiple assays, impacting laboratory efficiency.
• Distinguishing past EBV infections from acute or recent ones requires specific serological markers.

Purpose of the Study:

• To evaluate the performance of the ARCHITECT(®) EBV assay panel for routine serology.
• To develop and assess a cost-efficient testing algorithm for EBV serology.
• To determine the sensitivity and specificity of ARCHITECT(®) VCA IgM, VCA IgG, and EBNA-1 IgG assays.

Main Methods:

• Performed EBV serology on 1113 routine serum samples using ARCHITECT(®) assays.
• Assessed sensitivity and specificity of VCA IgM, VCA IgG, and EBNA-1 IgG assays.
• Developed and validated a sequential testing algorithm starting with EBNA-1 IgG.

Main Results:

• 80.9% of samples indicated past EBV infections.
• ARCHITECT(®) assays demonstrated high sensitivity (98.3-100.0%) and specificity (95.4-99.9%).
• The proposed algorithm reduced the number of tests per sample by nearly 50% compared to parallel testing.

Conclusions:

• The ARCHITECT(®) EBV panel provides accurate and reliable EBV serology results.
• The developed algorithm enhances cost-efficiency by reducing redundant testing.
• This approach is suitable for routine clinical laboratories seeking efficient EBV diagnostics.