TriVerity的分析性评估,这是一种在Myrna仪器上使用RT-LAMP进行的快速诊断和预后宿主基因表达测试。

IF 5.4 2区 医学 Q1 MICROBIOLOGY
Claudia Figueiredo-Pereira, Paul Fleming, Mikaela Nicole Alganes, Ran Bi, Ana Mafalda Cavaleiro, Diogo Cruz, Carlota Cunha-Matos, Margarita Davalos-Arias, Dana Farkas, Yehudit Hasin, Kevin Hu, Christos Kampouridis, Ragheb El Khaja, Graciano Leal, Jingyi Lu, Rita Madeira, Michael Mayhew, Breana McBryde, Daniela C Oliveira, Anna Passernig, Davion Pendleton, Elizabeth Popp, Shailee Rasania, Cristina Rebelo, Ana Santiago, Joshua R Shak, Vera P Silva, Ambika Srinath, Timothy E Sweeney, Rodrigo Vieira, Thang Vu, Chris Wilson, Boris Zybin, Natalie N Whitfield, Oliver Liesenfeld, Hjalmar R Bouma, Richard E Rothman, Edward A Michelson, Joao Fonseca
{"title":"TriVerity的分析性评估,这是一种在Myrna仪器上使用RT-LAMP进行的快速诊断和预后宿主基因表达测试。","authors":"Claudia Figueiredo-Pereira, Paul Fleming, Mikaela Nicole Alganes, Ran Bi, Ana Mafalda Cavaleiro, Diogo Cruz, Carlota Cunha-Matos, Margarita Davalos-Arias, Dana Farkas, Yehudit Hasin, Kevin Hu, Christos Kampouridis, Ragheb El Khaja, Graciano Leal, Jingyi Lu, Rita Madeira, Michael Mayhew, Breana McBryde, Daniela C Oliveira, Anna Passernig, Davion Pendleton, Elizabeth Popp, Shailee Rasania, Cristina Rebelo, Ana Santiago, Joshua R Shak, Vera P Silva, Ambika Srinath, Timothy E Sweeney, Rodrigo Vieira, Thang Vu, Chris Wilson, Boris Zybin, Natalie N Whitfield, Oliver Liesenfeld, Hjalmar R Bouma, Richard E Rothman, Edward A Michelson, Joao Fonseca","doi":"10.1128/jcm.00352-25","DOIUrl":null,"url":null,"abstract":"<p><p>We evaluated the analytical performance of the TriVerity test system, a benchtop system for rapid measurement and interpretation of host messenger RNAs (mRNAs) measured quantitatively from PAXgene Blood RNA specimens using the TriVerity cartridge on the Myrna instrument. In approximately 30 minutes, 3 scores are generated from 29 host mRNAs for the likelihood of a bacterial infection, a viral infection, and illness severity (7-day need for ICU-level care), each falling into 1 of 5 interpretation bands (very low, low, moderate, high, and very high). Reproducibility, precision, limit of detection, linearity, interference, and sample and cartridge stability were determined per Clinical Laboratory Standards Institute standards. An operator survey assessed TriVerity's ease of use. Reproducibility demonstrated SDs meeting the acceptance criteria of <5.5 score units. The lowest concentration at which 100% of replicates showed measurable amplification was 1 × 10<sup>6</sup> cp/mL of <i>in vitro</i> RNA transcripts; the limit of quantification and detection were equivalent to blood containing 500 leukocytes/µL. Interference was not observed for 17 potential interferents. The cartridge was stable at room temperature (RT) for 9 and 12 months using accelerated testing at 37°C. TriVerity results were equivalent using fresh and frozen PAXgene Blood RNA samples. All operators agreed or strongly agreed that the TriVerity test system was easy to use. In summary, the analytical performance presented here, along with diagnostic accuracy established in the SEPSIS-SHIELD trial, demonstrates that the TriVerity system is reliable and user friendly, assisting clinicians in managing patients with suspected acute infections and sepsis in acute care settings.</p><p><strong>Importance: </strong>The prompt diagnosis of acute infections and sepsis is critical for better patient outcomes. We introduce a groundbreaking messenger RNA-based test, the first of its kind, designed to diagnose the presence of infection and predict illness severity in adult patients with suspected acute infections or sepsis. Several key findings regarding the accuracy and robustness of the test system are presented, which will be relevant to laboratories or acute care settings implementing the test for patient care. Furthermore, these findings may assist clinical researchers in developing analytical trial protocols aimed at the combined evaluation of RNA-based multi-marker tests with both diagnostic and prognostic test characteristics.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0035225"},"PeriodicalIF":5.4000,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Analytical evaluation of TriVerity, a rapid diagnostic and prognostic host gene expression test performed on the Myrna instrument using RT-LAMP.\",\"authors\":\"Claudia Figueiredo-Pereira, Paul Fleming, Mikaela Nicole Alganes, Ran Bi, Ana Mafalda Cavaleiro, Diogo Cruz, Carlota Cunha-Matos, Margarita Davalos-Arias, Dana Farkas, Yehudit Hasin, Kevin Hu, Christos Kampouridis, Ragheb El Khaja, Graciano Leal, Jingyi Lu, Rita Madeira, Michael Mayhew, Breana McBryde, Daniela C Oliveira, Anna Passernig, Davion Pendleton, Elizabeth Popp, Shailee Rasania, Cristina Rebelo, Ana Santiago, Joshua R Shak, Vera P Silva, Ambika Srinath, Timothy E Sweeney, Rodrigo Vieira, Thang Vu, Chris Wilson, Boris Zybin, Natalie N Whitfield, Oliver Liesenfeld, Hjalmar R Bouma, Richard E Rothman, Edward A Michelson, Joao Fonseca\",\"doi\":\"10.1128/jcm.00352-25\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>We evaluated the analytical performance of the TriVerity test system, a benchtop system for rapid measurement and interpretation of host messenger RNAs (mRNAs) measured quantitatively from PAXgene Blood RNA specimens using the TriVerity cartridge on the Myrna instrument. In approximately 30 minutes, 3 scores are generated from 29 host mRNAs for the likelihood of a bacterial infection, a viral infection, and illness severity (7-day need for ICU-level care), each falling into 1 of 5 interpretation bands (very low, low, moderate, high, and very high). Reproducibility, precision, limit of detection, linearity, interference, and sample and cartridge stability were determined per Clinical Laboratory Standards Institute standards. An operator survey assessed TriVerity's ease of use. Reproducibility demonstrated SDs meeting the acceptance criteria of <5.5 score units. The lowest concentration at which 100% of replicates showed measurable amplification was 1 × 10<sup>6</sup> cp/mL of <i>in vitro</i> RNA transcripts; the limit of quantification and detection were equivalent to blood containing 500 leukocytes/µL. Interference was not observed for 17 potential interferents. The cartridge was stable at room temperature (RT) for 9 and 12 months using accelerated testing at 37°C. TriVerity results were equivalent using fresh and frozen PAXgene Blood RNA samples. All operators agreed or strongly agreed that the TriVerity test system was easy to use. In summary, the analytical performance presented here, along with diagnostic accuracy established in the SEPSIS-SHIELD trial, demonstrates that the TriVerity system is reliable and user friendly, assisting clinicians in managing patients with suspected acute infections and sepsis in acute care settings.</p><p><strong>Importance: </strong>The prompt diagnosis of acute infections and sepsis is critical for better patient outcomes. We introduce a groundbreaking messenger RNA-based test, the first of its kind, designed to diagnose the presence of infection and predict illness severity in adult patients with suspected acute infections or sepsis. Several key findings regarding the accuracy and robustness of the test system are presented, which will be relevant to laboratories or acute care settings implementing the test for patient care. Furthermore, these findings may assist clinical researchers in developing analytical trial protocols aimed at the combined evaluation of RNA-based multi-marker tests with both diagnostic and prognostic test characteristics.</p>\",\"PeriodicalId\":15511,\"journal\":{\"name\":\"Journal of Clinical Microbiology\",\"volume\":\" \",\"pages\":\"e0035225\"},\"PeriodicalIF\":5.4000,\"publicationDate\":\"2025-08-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Microbiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1128/jcm.00352-25\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MICROBIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Microbiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1128/jcm.00352-25","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MICROBIOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

我们评估了TriVerity测试系统的分析性能,TriVerity测试系统是一种台式系统,用于快速测量和解释宿主信使RNA (mrna),该系统使用Myrna仪器上的TriVerity试剂盒定量测量PAXgene血液RNA标本。在大约30分钟内,从29个宿主mrna中产生3个分数,分别是细菌感染的可能性、病毒感染的可能性和疾病严重程度(7天的重症监护需要),每个分数都属于5个解释波段中的1个(非常低、低、中等、高和非常高)。重复性、精密度、检出限、线性、干扰以及样品和药筒稳定性均按照临床实验室标准协会的标准进行测定。一项运营商调查评估了TriVerity的易用性。重复性表明SDs符合6 cp/mL体外RNA转录物的接受标准;定量和检测限相当于含有500个白细胞/µL的血液。17个潜在干扰未观察到干扰。使用37°C加速测试,墨盒在室温(RT)下稳定9个月和12个月。使用新鲜的和冷冻的PAXgene血液RNA样本的TriVerity结果相同。所有作业者都同意或强烈同意TriVerity测试系统易于使用。总之,本文的分析性能以及在败血症- shield试验中建立的诊断准确性表明,TriVerity系统可靠且用户友好,可帮助临床医生在急性护理环境中管理疑似急性感染和败血症患者。重要性:急性感染和败血症的及时诊断对于更好的患者预后至关重要。我们推出了一种开创性的基于信使rna的测试,这是同类测试中的第一个,旨在诊断感染的存在并预测疑似急性感染或败血症的成年患者的疾病严重程度。提出了关于测试系统的准确性和稳健性的几个关键发现,这将与实验室或急性护理机构实施患者护理测试相关。此外,这些发现可能有助于临床研究人员制定分析性试验方案,旨在对具有诊断和预后特征的基于rna的多标记试验进行综合评估。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical evaluation of TriVerity, a rapid diagnostic and prognostic host gene expression test performed on the Myrna instrument using RT-LAMP.

We evaluated the analytical performance of the TriVerity test system, a benchtop system for rapid measurement and interpretation of host messenger RNAs (mRNAs) measured quantitatively from PAXgene Blood RNA specimens using the TriVerity cartridge on the Myrna instrument. In approximately 30 minutes, 3 scores are generated from 29 host mRNAs for the likelihood of a bacterial infection, a viral infection, and illness severity (7-day need for ICU-level care), each falling into 1 of 5 interpretation bands (very low, low, moderate, high, and very high). Reproducibility, precision, limit of detection, linearity, interference, and sample and cartridge stability were determined per Clinical Laboratory Standards Institute standards. An operator survey assessed TriVerity's ease of use. Reproducibility demonstrated SDs meeting the acceptance criteria of <5.5 score units. The lowest concentration at which 100% of replicates showed measurable amplification was 1 × 106 cp/mL of in vitro RNA transcripts; the limit of quantification and detection were equivalent to blood containing 500 leukocytes/µL. Interference was not observed for 17 potential interferents. The cartridge was stable at room temperature (RT) for 9 and 12 months using accelerated testing at 37°C. TriVerity results were equivalent using fresh and frozen PAXgene Blood RNA samples. All operators agreed or strongly agreed that the TriVerity test system was easy to use. In summary, the analytical performance presented here, along with diagnostic accuracy established in the SEPSIS-SHIELD trial, demonstrates that the TriVerity system is reliable and user friendly, assisting clinicians in managing patients with suspected acute infections and sepsis in acute care settings.

Importance: The prompt diagnosis of acute infections and sepsis is critical for better patient outcomes. We introduce a groundbreaking messenger RNA-based test, the first of its kind, designed to diagnose the presence of infection and predict illness severity in adult patients with suspected acute infections or sepsis. Several key findings regarding the accuracy and robustness of the test system are presented, which will be relevant to laboratories or acute care settings implementing the test for patient care. Furthermore, these findings may assist clinical researchers in developing analytical trial protocols aimed at the combined evaluation of RNA-based multi-marker tests with both diagnostic and prognostic test characteristics.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Journal of Clinical Microbiology
Journal of Clinical Microbiology 医学-微生物学
CiteScore
17.10
自引率
4.30%
发文量
347
审稿时长
3 months
期刊介绍: The Journal of Clinical Microbiology® disseminates the latest research concerning the laboratory diagnosis of human and animal infections, along with the laboratory's role in epidemiology and the management of infectious diseases.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信