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. 2025 Jun 16;17(6):e86110.
doi: 10.7759/cureus.86110. eCollection 2025 Jun.

Testing Pooled Specimens With the Abbott Alinity m STI Assay: Four Years' Experience

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Testing Pooled Specimens With the Abbott Alinity m STI Assay: Four Years' Experience

Maria Angeles Argudín et al. Cureus. .

Abstract

Background: The Alinity m STI assay (Abbott Molecular, Des Plaines, IL, USA) is designed for the qualitative detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG), and Trichomonas vaginalis (TV) in individual collected samples. Pooled specimens are not recommended due to the high risk of inhibition.

Methods: We performed a two-part study, including a preliminary validation on 13 well-known positive samples before and after pooling, as well as a retrospective analysis of 5324 pooled specimens collected between 2021 and 2024. All samples were tested for CT/NG detection, and a subset (n = 277) for MG detection on the Alinity m STI system.

Results: The preliminary validation showed consistent results without inhibition. Out of 5324 specimens of the retrospective analysis for CT/NG detection, 966 pooled samples (18.1%) were positive: 363 (6.8%) for CT, 479 (9.0%) for NG, and 124 (2.3%) for both CT and NG. Only 95 (1.8%) tests were completely inhibited. A total of 277 specimens were additionally tested for MG. Pooled specimens also allowed MG detection (n = 195; 70.4%) with few inhibited results (n = 3; 1.0%).

Conclusions: This study proves that pooled specimens are rarely inhibited and can be helpful for laboratories where the number of specimens per patient is restricted.

Keywords: chlamydia trachomatis; inhibition; mycoplasma genitalium; neisseria gonorrhoeae; pooled specimens.

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Conflict of interest statement

Human subjects: Informed consent for treatment and open access publication was obtained or waived by all participants in this study. Comité d'Ethique Hospitalo-Facultaire Saint-Luc – UCL issued approval 2025/09MAR/104. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

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References

    1. Abbott Molecular Inc. Abbott Molecular Inc. Alinity m STI assay. Reference 09N17-090. Package insert 53-608076/R6. 2020. https://www.molecular.abbott/int/en/products/infectious-disease/alinity-... https://www.molecular.abbott/int/en/products/infectious-disease/alinity-...
    1. Abbott Molecular Inc. 2021. Abbott Molecular Inc. Alinity m STI assay. Reference 09N17-091. Package insert 53-608221/R1. 2021. https://www.molecular.abbott/int/en/products/infectious-disease/alinity-... https://www.molecular.abbott/int/en/products/infectious-disease/alinity-...
    1. Using pooled urogenital, anorectal and oropharyngeal specimens to detect Chlamydia trachomatis and Neisseria gonorrhoeae among men who have sex with men in China: a multisite diagnostic accuracy study. Jiang TT, Cao NX, Shi MQ, et al. BMJ Open. 2023;13:0. - PMC - PubMed
    1. The diagnostic accuracy of pooled testing from multiple individuals for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae: a systematic review. Xu Y, Aboud L, Chow EP, et al. Int J Infect Dis. 2022;118:183–193. - PubMed
    1. Abbott Molecular Inc. 2010. Abbott RealTime CT/NG. Abbott Molecular Inc. Abbott RealTime CT/NG. Reference 8L07-91. Package insert 51-608362/R1. 2010. https://www.molecular.abbott/content/dam/add/molecular/products/pdf-/ctn... https://www.molecular.abbott/content/dam/add/molecular/products/pdf-/ctn...

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