Evaluation of the Abbott Alinity m STI assay for diagnosis of the primary causes of sexually transmitted infections in the United States

Matysiak, Colette; Cheng, Annie; Kirby, James E.

doi:10.1016/j.plabm.2023.e00332

Practical Laboratory Medicine

2023

DOI: 10.1016/j.plabm.2023.e00332

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Evaluation of the Abbott Alinity m STI assay for diagnosis of the primary causes of sexually transmitted infections in the United States

Colette Matysiak,

Annie Cheng,

James E. Kirby

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2024

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Cited by 2 publications

(2 citation statements)

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“…The Alinity m STI assay (Abbott Laboratories, Des Plaines, IL) is an in vitro multiplex RT-PCR assay that is designed for qualitative and simultaneous detection of CT, NG, MG, and TV in various urogenital and extragenital specimens. Two groups have published results from their evaluation of the Abbott Alinity m STI assay compared with their standard-of-care (SOC) tests; both studies showed that the Alinity m STI assay displayed excellent performance characteristics with high concordance for all 4 targets 13,14 . The limits of detection in urine specimens were as follows: CT ≤5, NG ≤5, TV ≤0.5, and MG ≤500 genome copies/mL 13 …”

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confidence: 99%

“…Two groups have published results from their evaluation of the Abbott Alinity m STI assay compared with their standard-of-care (SOC) tests; both studies showed that the Alinity m STI assay displayed excellent performance characteristics with high concordance for all 4 targets 13,14 . The limits of detection in urine specimens were as follows: CT ≤5, NG ≤5, TV ≤0.5, and MG ≤500 genome copies/mL 13 …”

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confidence: 99%

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Clinical Evaluation of the Alinity m STI Multiplex PCR Assay

Lima,

Uy,

Kostera

et al. 2024

Sexual Trans Dis

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Background Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are routinely tested and reported; however, Trichomonas vaginalis (TV) is the most common STI in the US and the prevalence of Mycoplasma genitalium (MG) infections is likely higher than estimated. We examined the clinical performance of the Alinity m STI assay for detection and surveillance of CT/NG/TV/MG in urine specimens from patients at a large academic medical center. Methods Urine specimen from 198 patients were tested in this evaluation. Alinity m STI and Aptima Combo 2 CT/NG and TV assay (Panther System) results were compared, with discrepant results run on the cobas 6800 CT/NG, TV/MG assays. Analyzer turnaround times (TAT), time from loading the specimen on the analyzer to results reporting, were determined for Alinity m and Panther systems. Results Overall percent agreement of the Alinity m in comparison with the Aptima and cobas assays for CT, NG, TV, and MG were respectively: 99.5% (97.2, 99.9%), 99.5% (97.2, 99.9%), 98.4% (95.5, 99.5%), and 86.4% (66.7, 95.3). There were 5 discrepant samples (CT = 1, NG = 1, TV = 3) between the Alinity m and the Aptima assays, and 3 MG discrepant samples between the Alinity m STI and cobas 6800. Two of the five Aptima and Alinity m discrepant samples were resolved as they yielded similar results on both Alinity m and cobas 6800. TV and MG infections comprised 54% of the positive samples and were more often asymptomatic than CT and NG infections. Analyzer TAT was 3 hours 25 minutes for the Aptima CT/NG, 3 hours 25 minutes for Aptima TV, and 1 hour 55 minutes for Alinity m STI assay. Conclusions The Alinity m STI assay allows for fast and simultaneous detection of the four major STI pathogens, which can facilitate surveillance and provide accurate results to help clinicians diagnose for initiation of appropriate treatment.

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confidence: 99%

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confidence: 99%

Clinical Evaluation of the Alinity m STI Multiplex PCR Assay

Lima,

Uy,

Kostera

et al. 2024

Sexual Trans Dis

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The Past, Present, and Future in the Diagnosis of a Neglected Sexually Transmitted Infection: Trichomoniasis

Ibáñez-Escribano,

Nogal-Ruiz

2024

Pathogens

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More than one million curable sexually transmitted infections occur every day. Trichomonas vaginalis is one of the main infections responsible for these epidemiological data; however, the diagnosis of this protozoan is still mainly based on microscopic and culture identification. The commercialization of immunological tests and the development of molecular techniques have improved the sensitivity of classical methods. Nevertheless, the fact that trichomoniasis is a neglected parasitic infection hinders the development of novel techniques and their implementation in routine diagnosis. This review article shows the different methods developed to identify T. vaginalis in population and the difficulties in diagnosing male and asymptomatic patients. The importance of including this parasite in routine gynecological screening, especially in pregnant women, and the importance of considering T. vaginalis as an indicator of high-risk sexual behavior are also discussed.

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Evaluation of the Abbott Alinity m STI assay for diagnosis of the primary causes of sexually transmitted infections in the United States

Cited by 2 publications

References 8 publications

Clinical Evaluation of the Alinity m STI Multiplex PCR Assay

Clinical Evaluation of the Alinity m STI Multiplex PCR Assay

The Past, Present, and Future in the Diagnosis of a Neglected Sexually Transmitted Infection: Trichomoniasis

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