Alinity m STI 多重 PCR 检测试剂盒的临床评估。

Clinical Evaluation of the Alinity m STI Multiplex PCR Assay.

机构信息

From the Tampa General Hospital, Tampa, FL.

Abbott Laboratories, Des Plaines, IL.

出版信息

Sex Transm Dis. 2024 Jul 1;51(7):480-485. doi: 10.1097/OLQ.0000000000001964. Epub 2024 Mar 4.

DOI:10.1097/OLQ.0000000000001964

PMID:38465972

Abstract

BACKGROUND

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are routinely tested and reported; however, Trichomonas vaginalis (TV) is the most common sexually transmitted infection (STI) in the United States 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 was 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, time from loading the specimen on the analyzer to results reporting, were determined for Alinity m and Panther systems.

RESULTS

Overall percent agreements of the Alinity m in comparison with the Aptima and cobas assays for CT, NG, TV, and MG were 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), respectively. 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 5 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 turnaround time 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 4 major STI pathogens, which can facilitate surveillance and provide accurate results to help clinicians diagnose for initiation of appropriate treatment.

摘要

背景

沙眼衣原体（CT）和淋病奈瑟菌（NG）通常进行检测和报告；然而，阴道毛滴虫（TV）是美国最常见的性传播感染（STI），且支原体生殖器感染（MG）的流行率可能高于估计。我们研究了在大型学术医疗中心的患者尿液标本中，使用 Alinity m STI 检测法对 CT/NG/TV/MG 的检测和监测的临床性能。

方法

在本评估中，对 198 例患者的尿液标本进行了检测。将 Alinity m STI 和 Aptima Combo 2 CT/NG 和 TV 检测法（ Panther 系统）的结果进行比较，对不相符的结果使用 cobas 6800 CT/NG、TV/MG 检测法进行检测。确定了 Alinity m 和 Panther 系统的分析仪周转时间，即从加载标本到报告结果的时间。

结果

与 Aptima 和 cobas 检测法相比，Alinity m 检测法对 CT、NG、TV 和 MG 的总符合率分别为 99.5%（97.2%，99.9%）、99.5%（97.2%，99.9%）、98.4%（95.5%，99.5%）和 86.4%（66.7%，95.3%）。Alinity m 与 Aptima 检测法之间有 5 个不相符的标本（CT，1 个；NG，1 个；TV，3 个），Alinity m STI 与 cobas 6800 之间有 3 个 MG 不相符的标本。5 个 Aptima 和 Alinity m 不相符的标本中有 2 个标本解决了，因为它们在 Alinity m 和 cobas 6800 上的结果相似。TV 和 MG 感染占阳性样本的 54%，且比 CT 和 NG 感染更常无症状。Aptima CT/NG 的分析仪周转时间为 3 小时 25 分钟，Aptima TV 的分析仪周转时间为 3 小时 25 分钟，Alinity m STI 检测法的分析仪周转时间为 1 小时 55 分钟。