Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis

Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis

BackgroundSyphilis, caused by Treponema pallidum (TP), remains a significant global public health concern, with approximately 8 million new cases annually. Diagnosing syphilis is challenging due to its often-asymptomatic nature during latent stages, necessitating a combination of diagnostic methods....

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Main Author: Ahmed, Ismail (author)
Other Authors: Younes, Nadin (author), Ayoub, Houssein (author), Nasrallah, Dana F. (author), Al-Emadi, Jawaher A. (author), Khalid, Hadiya M. (author), Abouassali, Mazen Najib (author), Elshaikh, Manal (author), Karimeh, Ibrahim Wissam (author), Ibrahim, Mohammed Abdelfatah (author), Ali, Mutaz Mohamed (author), Shaar, Ibrahim Al (author), Younes, Salma (author), Zein, Nouran (author), Nizamuddin, Parveen Banu (author), Yassine, Hadi M. (author), Abu-Raddad, Laith J. (author), Nasrallah, Gheyath K. (author)
Format: article
Published: 2025
Subjects:
Treponema pallidum
Syphilis
Screening
STD
Mindray
CLIA
RPR
Online Access:http://dx.doi.org/10.1016/j.jiph.2025.102731
https://www.sciencedirect.com/science/article/pii/S1876034125000802
http://hdl.handle.net/10576/64006
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Summary:BackgroundSyphilis, caused by Treponema pallidum (TP), remains a significant global public health concern, with approximately 8 million new cases annually. Diagnosing syphilis is challenging due to its often-asymptomatic nature during latent stages, necessitating a combination of diagnostic methods. This study evaluates the performance of a novel chemiluminescent immunoassay (CLIA) developed by Mindray for detecting TP antibodies, comparing it to the widely used Abbott ARCHITECT Syphilis Treponemal Test (Architect-TP), the rapid plasma regain (RPR) test, and the Fujiribio INNO-LIA® Syphilis Score line immunoassay (INNO-LIA-TP). MethodsWe selected 180 samples that exhibited agreement or discrepancies between the RPR and Architect-TP assays. The selection included 40 cases that were RPR positive and Architect-TP positive, 40 cases that were RPR positive and Architect-TP negative, and 100 cases that were negative in both RPR and Architect-TP. All samples underwent re-testing using the Mindray-TP and INNO-LIA-TP assays. ResultsMindray-TP and Architect-TP exhibited excellent sensitivity of 100 % (95 % CI: 91–100) and specificity of 100 % (95 % CI: 97.4–100), with perfect agreement (κ= 1.00) compared to INNO-LIA-TP. Notably, 40 cases (28.6 %; 40/140) demonstrated false-positive results when using the RPR test compared to INNO-LIA-TP, indicating a substantial false-positive rate for the RPR assay. ConclusionThis study highlights the high diagnostic accuracy of the Mindray-TP assay, positioning it as a reliable and efficient tool for syphilis screening in high-volume laboratories. Given its operational efficiency and strong agreement with gold-standard assays, Mindray-TP can enhance diagnostic workflows, leading to timely syphilis detection and improved patient outcomes.

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