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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2025
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| 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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| _version_ | 1857415085057638400 |
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| author | Ahmed, Ismail |
| author2 | 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. |
| author2_role | author author author author author author author author author author author author author author author author author |
| author_facet | Ahmed, Ismail 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. |
| author_role | author |
| dc.creator.none.fl_str_mv | Ahmed, Ismail 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. |
| dc.date.none.fl_str_mv | 2025-03-27T06:59:25Z 2025-06-30 |
| dc.format.none.fl_str_mv | application/pdf |
| dc.identifier.none.fl_str_mv | http://dx.doi.org/10.1016/j.jiph.2025.102731 18760341 https://www.sciencedirect.com/science/article/pii/S1876034125000802 http://hdl.handle.net/10576/64006 6 18 1876-035X |
| dc.language.none.fl_str_mv | en |
| dc.publisher.none.fl_str_mv | Elsevier |
| dc.rights.none.fl_str_mv | http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess |
| dc.subject.none.fl_str_mv | Treponema pallidum Syphilis Screening STD Mindray CLIA RPR |
| dc.title.none.fl_str_mv | Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis |
| dc.type.none.fl_str_mv | Article info:eu-repo/semantics/publishedVersion info:eu-repo/semantics/article |
| description | 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. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | qu_e7c1f170a166588d3bdb6238b9c33513 |
| identifier_str_mv | 18760341 6 18 1876-035X |
| language_invalid_str_mv | en |
| network_acronym_str | qu |
| network_name_str | Qatar University repository |
| oai_identifier_str | oai:qspace.qu.edu.qa:10576/64006 |
| publishDate | 2025 |
| publisher.none.fl_str_mv | Elsevier |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| rights_invalid_str_mv | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| spelling | Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysisAhmed, IsmailYounes, NadinAyoub, HousseinNasrallah, Dana F.Al-Emadi, Jawaher A.Khalid, Hadiya M.Abouassali, Mazen NajibElshaikh, ManalKarimeh, Ibrahim WissamIbrahim, Mohammed AbdelfatahAli, Mutaz MohamedShaar, Ibrahim AlYounes, SalmaZein, NouranNizamuddin, Parveen BanuYassine, Hadi M.Abu-Raddad, Laith J.Nasrallah, Gheyath K.Treponema pallidumSyphilisScreeningSTDMindrayCLIARPRBackgroundSyphilis, 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.Elsevier2025-03-27T06:59:25Z2025-06-30Articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://dx.doi.org/10.1016/j.jiph.2025.10273118760341https://www.sciencedirect.com/science/article/pii/S1876034125000802http://hdl.handle.net/10576/640066181876-035Xenhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:qspace.qu.edu.qa:10576/640062025-03-27T19:05:55Z |
| spellingShingle | Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis Ahmed, Ismail Treponema pallidum Syphilis Screening STD Mindray CLIA RPR |
| status_str | publishedVersion |
| title | Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis |
| title_full | Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis |
| title_fullStr | Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis |
| title_full_unstemmed | Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis |
| title_short | Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis |
| title_sort | Evaluating chemiluminescent immunoassays for syphilis detection: A comparative analysis |
| topic | Treponema pallidum Syphilis Screening STD Mindray CLIA RPR |
| url | http://dx.doi.org/10.1016/j.jiph.2025.102731 https://www.sciencedirect.com/science/article/pii/S1876034125000802 http://hdl.handle.net/10576/64006 |