Journal of infection and public health · 2025
Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis.
СтатьяСравнительное исследованиеОценочное исследованиеНазвание и аннотация: Перевод в очереди
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Ismail Ahmed, Younes Nadin, Ayoub Houssein, Nasrallah Dana F, Al-Emadi Jawaher A, Khalid Hadiya M, Abouassali Mazen Najib, Elshaikh Manal, Karimeh Ibrahim Wissam, Ibrahim Mohammed Abdelfatah, Ali Mutaz Mohamed, Shaar Ibrahim Al, Younes Salma, Zein Nouran, Nizamuddin Parveen Banu, Yassine Hadi M, Abu-Raddad Laith J, Nasrallah Gheyath K
Аннотация
BACKGROUND: Syphilis, 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).
METHODS: We 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.
RESULTS: Mindray-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.
CONCLUSION: This 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.
METHODS: We 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.
RESULTS: Mindray-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.
CONCLUSION: This 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.