Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis

Area of Science:

• Clinical diagnostics
• Infectious disease research
• Immunological assays

Background:

• Syphilis, caused by Treponema pallidum (TP), is a global health issue with millions of new cases annually.
• Accurate diagnosis is challenging due to asymptomatic latent stages, requiring multiple testing methods.
• This study assesses a novel Mindray chemiluminescent immunoassay (CLIA) for TP antibody detection.

Purpose of the Study:

• To evaluate the diagnostic performance of the novel Mindray-TP assay.
• To compare Mindray-TP against established syphilis tests: Abbott ARCHITECT Syphilis Treponemal Test (Architect-TP), rapid plasma regain (RPR), and Fujiribio INNO-LIA® Syphilis Score line immunoassay (INNO-LIA-TP).

Main Methods:

• 180 samples with varying RPR and Architect-TP results were selected.
• Samples included concordant positive, discordant (RPR positive/Architect-TP negative), and concordant negative results.
• All selected samples were re-tested using the Mindray-TP and INNO-LIA-TP assays.

Main Results:

• Mindray-TP demonstrated 100% sensitivity and 100% specificity, with perfect agreement (κ=1.00) with INNO-LIA-TP.
• Mindray-TP showed excellent concordance with the Architect-TP assay.
• The RPR test exhibited a substantial false-positive rate (28.6%) when compared to INNO-LIA-TP.

Conclusions:

• The Mindray-TP assay exhibits high diagnostic accuracy for syphilis detection.
• Its performance aligns with gold-standard assays, making it a reliable tool for high-volume laboratories.
• Mindray-TP can optimize syphilis diagnostic workflows, enabling timely detection and improved patient management.