对疑似子痫前期妇女的血管生成比值与糖基化纤维连接蛋白的诊断性能进行制造商间评估。

IF 6.1 1区 医学 Q1 ACOUSTICS
Ultrasound in Obstetrics & Gynecology Pub Date : 2024-11-01 Epub Date: 2024-09-29 DOI:10.1002/uog.29107
I Y M Wah, D S Sahota, N K L Wong, N M W Lee, C J Liu, C S L Lau, H H Y Leung, L C Poon
{"title":"对疑似子痫前期妇女的血管生成比值与糖基化纤维连接蛋白的诊断性能进行制造商间评估。","authors":"I Y M Wah, D S Sahota, N K L Wong, N M W Lee, C J Liu, C S L Lau, H H Y Leung, L C Poon","doi":"10.1002/uog.29107","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To compare the diagnostic performance of different manufacturers' immunoassays for the soluble fms-like tyrosine kinase-1 (sFlt-1)-to-placental growth factor (PlGF) ratio with that of a point-of-care (PoC) test for glycosylated fibronectin (GlyFn) in women with suspected pre-eclampsia (PE).</p><p><strong>Methods: </strong>This was a prospective, single-center, double-blinded, non-interventional study of East Asian women with a singleton pregnancy who presented with hypertension with or without clinical features of PE after 20 weeks' gestation between January 2020 and March 2022. Maternal serum samples were collected at the time of presentation, and subsequent management followed the departmental protocol, based on gestational age, severity of hypertension, fetal condition and presence of severe PE features. Women diagnosed with PE at presentation were excluded. PE was diagnosed according to the 2018 International Society for the Study of Hypertension in Pregnancy classification. Levels of sFlt-1 and PlGF were measured using the Cobas e411 (Roche Diagnostics), BRAHMS KRYPTOR (ThermoFisher Scientific) and iMAGIN 1800 (Ningbo Aucheer) platforms. GlyFn levels were measured using the Lumella™ GlyFn PoC test (DiabetOmics Inc.). The predictive performance of each test to rule out PE within 7 days and rule in PE within 28 days from the date of presentation was assessed. Based on the PROGNOSIS study, a sFlt-1/PlGF ratio of ≤ 38 on the Roche platform was used to predict the absence of PE within 7 days. The sFlt-1/PlGF ratio was classified as high or low using platform-specific thresholds equivalent to a Roche sFlt-1/PlGF ratio of 38, which were derived using Passing-Bablok regression. GlyFn was categorized as high or low using two reported clinical management thresholds (263 μg/mL and 510 μg/mL).</p><p><strong>Results: </strong>Overall, 236 women with suspected PE were included, of whom 70 (29.7%) were diagnosed with PE; 36 (51.4%) and 70 (100%) developed PE within 7 days and 28 days, respectively. Eighty-eight (37.3%) women had a sFlt-1/PlGF ratio of > 38 on the Roche platform, 79 (33.5%) women had a sFlt-1/PlGF ratio of > 55 on the KRYPTOR platform and 96 (40.7%) women had a sFlt-1/PlGF ratio of > 40 on the iMAGIN 1800 platform. Furthermore, 62 (26.3%) and four (1.7%) women had a GlyFn level of > 263 μg/mL and > 510 μg/mL, respectively. The negative predictive value (NPV) of the sFlt-1/PlGF ratio measured on the Roche, KRYPTOR and iMAGIN 1800 platforms to rule out PE within 7 days after presentation was 83.3%, 82.0% and 82.9%, respectively, while that for GlyFn > 263 μg/mL and > 510 μg/mL was 82.6% and 70.4%, respectively. The corresponding positive predictive values (PPV) to rule in PE within 28 days after presentation were 50.5%, 52.3% and 46.7%, respectively, for the sFlt-1/PlGF ratio, and 35.4% and 50.0%, respectively, for GlyFn > 263 μg/mL and > 510 μg/mL.</p><p><strong>Conclusions: </strong>The predictive performance of different manufacturers' assays for the sFlt-1/PlGF ratio to rule in and rule out PE were similar once standardized to a common threshold. Our findings suggest that the sFlt-1/PlGF ratio and GlyFn using a cut-off of 263 μg/mL can both be utilized to rule out PE within 7 days after assessment, with a moderate NPV. The PPV for ruling in PE within 28 days remains poor. © 2024 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.</p>","PeriodicalId":23454,"journal":{"name":"Ultrasound in Obstetrics & Gynecology","volume":null,"pages":null},"PeriodicalIF":6.1000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Intermanufacturer assessment of diagnostic performance of angiogenic ratio vs glycosylated fibronectin in women with suspected pre-eclampsia.\",\"authors\":\"I Y M Wah, D S Sahota, N K L Wong, N M W Lee, C J Liu, C S L Lau, H H Y Leung, L C Poon\",\"doi\":\"10.1002/uog.29107\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To compare the diagnostic performance of different manufacturers' immunoassays for the soluble fms-like tyrosine kinase-1 (sFlt-1)-to-placental growth factor (PlGF) ratio with that of a point-of-care (PoC) test for glycosylated fibronectin (GlyFn) in women with suspected pre-eclampsia (PE).</p><p><strong>Methods: </strong>This was a prospective, single-center, double-blinded, non-interventional study of East Asian women with a singleton pregnancy who presented with hypertension with or without clinical features of PE after 20 weeks' gestation between January 2020 and March 2022. Maternal serum samples were collected at the time of presentation, and subsequent management followed the departmental protocol, based on gestational age, severity of hypertension, fetal condition and presence of severe PE features. Women diagnosed with PE at presentation were excluded. PE was diagnosed according to the 2018 International Society for the Study of Hypertension in Pregnancy classification. Levels of sFlt-1 and PlGF were measured using the Cobas e411 (Roche Diagnostics), BRAHMS KRYPTOR (ThermoFisher Scientific) and iMAGIN 1800 (Ningbo Aucheer) platforms. GlyFn levels were measured using the Lumella™ GlyFn PoC test (DiabetOmics Inc.). The predictive performance of each test to rule out PE within 7 days and rule in PE within 28 days from the date of presentation was assessed. Based on the PROGNOSIS study, a sFlt-1/PlGF ratio of ≤ 38 on the Roche platform was used to predict the absence of PE within 7 days. The sFlt-1/PlGF ratio was classified as high or low using platform-specific thresholds equivalent to a Roche sFlt-1/PlGF ratio of 38, which were derived using Passing-Bablok regression. GlyFn was categorized as high or low using two reported clinical management thresholds (263 μg/mL and 510 μg/mL).</p><p><strong>Results: </strong>Overall, 236 women with suspected PE were included, of whom 70 (29.7%) were diagnosed with PE; 36 (51.4%) and 70 (100%) developed PE within 7 days and 28 days, respectively. Eighty-eight (37.3%) women had a sFlt-1/PlGF ratio of > 38 on the Roche platform, 79 (33.5%) women had a sFlt-1/PlGF ratio of > 55 on the KRYPTOR platform and 96 (40.7%) women had a sFlt-1/PlGF ratio of > 40 on the iMAGIN 1800 platform. Furthermore, 62 (26.3%) and four (1.7%) women had a GlyFn level of > 263 μg/mL and > 510 μg/mL, respectively. The negative predictive value (NPV) of the sFlt-1/PlGF ratio measured on the Roche, KRYPTOR and iMAGIN 1800 platforms to rule out PE within 7 days after presentation was 83.3%, 82.0% and 82.9%, respectively, while that for GlyFn > 263 μg/mL and > 510 μg/mL was 82.6% and 70.4%, respectively. The corresponding positive predictive values (PPV) to rule in PE within 28 days after presentation were 50.5%, 52.3% and 46.7%, respectively, for the sFlt-1/PlGF ratio, and 35.4% and 50.0%, respectively, for GlyFn > 263 μg/mL and > 510 μg/mL.</p><p><strong>Conclusions: </strong>The predictive performance of different manufacturers' assays for the sFlt-1/PlGF ratio to rule in and rule out PE were similar once standardized to a common threshold. Our findings suggest that the sFlt-1/PlGF ratio and GlyFn using a cut-off of 263 μg/mL can both be utilized to rule out PE within 7 days after assessment, with a moderate NPV. The PPV for ruling in PE within 28 days remains poor. © 2024 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.</p>\",\"PeriodicalId\":23454,\"journal\":{\"name\":\"Ultrasound in Obstetrics & Gynecology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":6.1000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Ultrasound in Obstetrics & Gynecology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/uog.29107\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/9/29 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"ACOUSTICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Ultrasound in Obstetrics & Gynecology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/uog.29107","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/29 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ACOUSTICS","Score":null,"Total":0}
引用次数: 0

摘要

目的比较不同厂家生产的可溶性酪氨酸激酶-1(sFlt-1)-胎盘生长因子(PlGF)比值免疫测定与糖基化纤连蛋白(GlyFn)床旁检测对疑似子痫前期(PE)妇女的诊断效果:这是一项前瞻性、单中心、双盲、非干预性研究,研究对象为2020年1月至2022年3月期间妊娠20周后出现高血压并伴有或不伴有子痫临床特征的东亚单胎妊娠女性。研究人员在孕妇发病时采集其血清样本,并根据胎龄、高血压严重程度、胎儿状况和是否存在严重 PE 特征,按照科室方案进行后续处理。排除了发病时被诊断为 PE 的妇女。PE根据2018年国际妊娠高血压研究学会的分类进行诊断。使用 Cobas e411(罗氏诊断公司)、BRAHMS KRYPTOR(赛默飞世尔科技公司)和 iMAGIN 1800(宁波欧切尔)平台测量 sFlt-1 和 PlGF 的水平。使用 Lumella™ GlyFn PoC 检验(Diabetomics)测量 GlyFn 水平。评估了每项检测对自发病之日起 7 天内排除 PE 和 28 天内排除 PE 的预测性能。根据 PROGNOSIS 研究,罗氏平台上的 sFlt-1/PlGF 比值≤ 38 可用于预测 7 天内无 PE。使用相当于罗氏 sFlt-1/PlGF 比值 38 的平台特异性阈值将 sFlt-1/PlGF 比值分为高或低,该阈值通过 Passing-Bablok 回归法得出。使用两个已报告的临床管理阈值(263 μg/mL和510 μg/mL)将GlyFn分为高或低:共纳入 236 名疑似 PE 患者,其中 70 人(29.7%)被确诊为 PE;36 人(51.4%)和 70 人(100%)分别在 7 天和 28 天内发生 PE。88名(37.3%)妇女在罗氏平台上的sFlt-1/PlGF比值大于38,79名(33.5%)妇女在KRYPTOR平台上的sFlt-1/PlGF比值大于55,96名(40.7%)妇女在iMAGIN 1800平台上的sFlt-1/PlGF比值大于40。此外,分别有 62 名(26.3%)和 4 名(1.7%)妇女的 GlyFn 水平> 263 μg/mL 和> 510 μg/mL。在罗氏、KRYPTOR 和 iMAGIN 1800 平台上测量的 sFlt-1/PlGF 比值对排除发病后 7 天内 PE 的阴性预测值(NPV)分别为 83.3%、82.0% 和 82.9%,而 GlyFn > 263 μg/mL 和 > 510 μg/mL 的阴性预测值(NPV)分别为 82.6% 和 70.4%。在发病后 28 天内排除 PE 的相应阳性预测值(PPV)中,sFlt-1/PlGF 比率分别为 50.5%、52.3% 和 46.7%,GlyFn > 263 μg/mL 和 > 510 μg/mL 分别为 35.4% 和 50.0%:不同厂家生产的sFlt-1/PlGF比值检测试剂盒一旦标准化到一个共同的阈值,其预测PE发生和排除PE的性能是相似的。我们的研究结果表明,sFlt-1/PlGF 比值和以 263 μg/mL 为临界值的 GlyFn 均可用于排除评估后 7 天内的 PE,其 NPV 值适中。在 28 天内排除 PE 的 PPV 值仍然较低。© 2024 作者。妇产科超声》由 John Wiley & Sons Ltd 代表国际妇产科超声学会出版。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Intermanufacturer assessment of diagnostic performance of angiogenic ratio vs glycosylated fibronectin in women with suspected pre-eclampsia.

Objective: To compare the diagnostic performance of different manufacturers' immunoassays for the soluble fms-like tyrosine kinase-1 (sFlt-1)-to-placental growth factor (PlGF) ratio with that of a point-of-care (PoC) test for glycosylated fibronectin (GlyFn) in women with suspected pre-eclampsia (PE).

Methods: This was a prospective, single-center, double-blinded, non-interventional study of East Asian women with a singleton pregnancy who presented with hypertension with or without clinical features of PE after 20 weeks' gestation between January 2020 and March 2022. Maternal serum samples were collected at the time of presentation, and subsequent management followed the departmental protocol, based on gestational age, severity of hypertension, fetal condition and presence of severe PE features. Women diagnosed with PE at presentation were excluded. PE was diagnosed according to the 2018 International Society for the Study of Hypertension in Pregnancy classification. Levels of sFlt-1 and PlGF were measured using the Cobas e411 (Roche Diagnostics), BRAHMS KRYPTOR (ThermoFisher Scientific) and iMAGIN 1800 (Ningbo Aucheer) platforms. GlyFn levels were measured using the Lumella™ GlyFn PoC test (DiabetOmics Inc.). The predictive performance of each test to rule out PE within 7 days and rule in PE within 28 days from the date of presentation was assessed. Based on the PROGNOSIS study, a sFlt-1/PlGF ratio of ≤ 38 on the Roche platform was used to predict the absence of PE within 7 days. The sFlt-1/PlGF ratio was classified as high or low using platform-specific thresholds equivalent to a Roche sFlt-1/PlGF ratio of 38, which were derived using Passing-Bablok regression. GlyFn was categorized as high or low using two reported clinical management thresholds (263 μg/mL and 510 μg/mL).

Results: Overall, 236 women with suspected PE were included, of whom 70 (29.7%) were diagnosed with PE; 36 (51.4%) and 70 (100%) developed PE within 7 days and 28 days, respectively. Eighty-eight (37.3%) women had a sFlt-1/PlGF ratio of > 38 on the Roche platform, 79 (33.5%) women had a sFlt-1/PlGF ratio of > 55 on the KRYPTOR platform and 96 (40.7%) women had a sFlt-1/PlGF ratio of > 40 on the iMAGIN 1800 platform. Furthermore, 62 (26.3%) and four (1.7%) women had a GlyFn level of > 263 μg/mL and > 510 μg/mL, respectively. The negative predictive value (NPV) of the sFlt-1/PlGF ratio measured on the Roche, KRYPTOR and iMAGIN 1800 platforms to rule out PE within 7 days after presentation was 83.3%, 82.0% and 82.9%, respectively, while that for GlyFn > 263 μg/mL and > 510 μg/mL was 82.6% and 70.4%, respectively. The corresponding positive predictive values (PPV) to rule in PE within 28 days after presentation were 50.5%, 52.3% and 46.7%, respectively, for the sFlt-1/PlGF ratio, and 35.4% and 50.0%, respectively, for GlyFn > 263 μg/mL and > 510 μg/mL.

Conclusions: The predictive performance of different manufacturers' assays for the sFlt-1/PlGF ratio to rule in and rule out PE were similar once standardized to a common threshold. Our findings suggest that the sFlt-1/PlGF ratio and GlyFn using a cut-off of 263 μg/mL can both be utilized to rule out PE within 7 days after assessment, with a moderate NPV. The PPV for ruling in PE within 28 days remains poor. © 2024 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

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
CiteScore
12.30
自引率
14.10%
发文量
891
审稿时长
1 months
期刊介绍: Ultrasound in Obstetrics & Gynecology (UOG) is the official journal of the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and is considered the foremost international peer-reviewed journal in the field. It publishes cutting-edge research that is highly relevant to clinical practice, which includes guidelines, expert commentaries, consensus statements, original articles, and systematic reviews. UOG is widely recognized and included in prominent abstract and indexing databases such as Index Medicus and Current Contents.
×
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:481959085
Book学术官方微信