Erin Silliman, Esther H Chung, Elizabeth Fitzpatrick, Julie A Jolin, Michelle Brown, James Hotaling, Aaron K Styer, Anatte E Karmon
{"title":"评价家庭血清抗<s:1>勒氏杆菌激素测试:一个头对头的比较研究。","authors":"Erin Silliman, Esther H Chung, Elizabeth Fitzpatrick, Julie A Jolin, Michelle Brown, James Hotaling, Aaron K Styer, Anatte E Karmon","doi":"10.1186/s12958-022-01004-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>For optimal fertility testing, serum anti-Müllerian hormone levels are used in combination with other testing to provide reliable ovarian reserve evaluations. The use of the ADx 100 card is widely commercially available for at-home reproductive hormone testing, but data demonstrating that its results are reproducible outside of a clinical setting are limited, as well as comparisons of its performance with other newer blood collection techniques. This study aimed to evaluate the concordance of serum AMH levels found via standard venipuncture and self-administered blood collection using the TAP II device (TAP) and ADx card in women of reproductive age.</p><p><strong>Methods: </strong>This was a prospective, head-to-head-to-head within-person crossover comparison trial that included 41 women of reproductive age (20-39 years). It was hypothesized that the TAP device would be superior to the ADx card both in terms of agreement with venipuncture reference standard and patient experience. Each subject had their blood drawn using the three modalities (TAP, ADx, and venipuncture). We evaluated the concordance of AMH assays from samples obtained via the TAP device and ADx card with the gold standard being venipuncture. Two-sided 95% CIs were generated for each method to compare relative performance across all three modes. Patient preference for the TAP device versus the ADx card was based on self-reported pain and Net Promoter Score (NPS).</p><p><strong>Results: </strong>The TAP device was superior to the ADx card on all outcome measures. TAP R-squared with venipuncture was 0.99 (95% CI 0.99, > 0.99), significantly higher than the ADx card, which had an R-squared of 0.87 (95% CI 0.80, 0.94) under most favorable treatment. TAP sensitivity and specificity were both 100% (no clinical disagreement with venipuncture), versus 100 and 88%, respectively, for the ADx card. Average pain reported by users of the TAP device was significantly lower than the ADx card (0.75 versus 2.73, p < 0.01) and the NPS was significantly higher than the ADx card (+ 72 versus - 48, p < 0.01).</p><p><strong>Conclusions: </strong>The TAP was non-inferior to venipuncture and superior to the ADx card with respect to correlation and false positives. Moreover, the TAP was superior to both alternatives on patient experience.</p><p><strong>Trial registration: </strong>NCT04784325 (Mar 5, 2021).</p>","PeriodicalId":520764,"journal":{"name":"Reproductive biology and endocrinology : RB&E","volume":" ","pages":"131"},"PeriodicalIF":0.0000,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9434544/pdf/","citationCount":"4","resultStr":"{\"title\":\"Evaluation of at-home serum anti-Müllerian hormone testing: a head-to-head comparison study.\",\"authors\":\"Erin Silliman, Esther H Chung, Elizabeth Fitzpatrick, Julie A Jolin, Michelle Brown, James Hotaling, Aaron K Styer, Anatte E Karmon\",\"doi\":\"10.1186/s12958-022-01004-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>For optimal fertility testing, serum anti-Müllerian hormone levels are used in combination with other testing to provide reliable ovarian reserve evaluations. The use of the ADx 100 card is widely commercially available for at-home reproductive hormone testing, but data demonstrating that its results are reproducible outside of a clinical setting are limited, as well as comparisons of its performance with other newer blood collection techniques. This study aimed to evaluate the concordance of serum AMH levels found via standard venipuncture and self-administered blood collection using the TAP II device (TAP) and ADx card in women of reproductive age.</p><p><strong>Methods: </strong>This was a prospective, head-to-head-to-head within-person crossover comparison trial that included 41 women of reproductive age (20-39 years). It was hypothesized that the TAP device would be superior to the ADx card both in terms of agreement with venipuncture reference standard and patient experience. Each subject had their blood drawn using the three modalities (TAP, ADx, and venipuncture). We evaluated the concordance of AMH assays from samples obtained via the TAP device and ADx card with the gold standard being venipuncture. Two-sided 95% CIs were generated for each method to compare relative performance across all three modes. Patient preference for the TAP device versus the ADx card was based on self-reported pain and Net Promoter Score (NPS).</p><p><strong>Results: </strong>The TAP device was superior to the ADx card on all outcome measures. TAP R-squared with venipuncture was 0.99 (95% CI 0.99, > 0.99), significantly higher than the ADx card, which had an R-squared of 0.87 (95% CI 0.80, 0.94) under most favorable treatment. TAP sensitivity and specificity were both 100% (no clinical disagreement with venipuncture), versus 100 and 88%, respectively, for the ADx card. Average pain reported by users of the TAP device was significantly lower than the ADx card (0.75 versus 2.73, p < 0.01) and the NPS was significantly higher than the ADx card (+ 72 versus - 48, p < 0.01).</p><p><strong>Conclusions: </strong>The TAP was non-inferior to venipuncture and superior to the ADx card with respect to correlation and false positives. Moreover, the TAP was superior to both alternatives on patient experience.</p><p><strong>Trial registration: </strong>NCT04784325 (Mar 5, 2021).</p>\",\"PeriodicalId\":520764,\"journal\":{\"name\":\"Reproductive biology and endocrinology : RB&E\",\"volume\":\" \",\"pages\":\"131\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9434544/pdf/\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Reproductive biology and endocrinology : RB&E\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12958-022-01004-2\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Reproductive biology and endocrinology : RB&E","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12958-022-01004-2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 4
摘要
背景:为了优化生育能力检测，血清抗勒氏杆菌激素水平与其他检测相结合，以提供可靠的卵巢储备评估。ADx 100卡广泛用于家庭生殖激素测试，但证明其结果在临床环境之外可重复性的数据有限，其性能与其他较新的血液采集技术的比较也有限。本研究旨在评价育龄妇女通过标准静脉穿刺和使用TAP II装置(TAP)和ADx卡自行采血发现的血清AMH水平的一致性。方法:这是一项前瞻性、面对面的人内交叉比较试验，包括41名育龄妇女(20-39岁)。假设TAP设备在符合静脉穿刺参考标准和患者体验方面优于ADx卡。每位受试者采用三种方式(TAP、ADx和静脉穿刺)抽血。我们评估了通过TAP设备和ADx卡获得的样品的AMH测定的一致性，金标准是静脉穿刺。为每种方法生成双侧95% ci，以比较所有三种模式的相对性能。患者对TAP装置和ADx卡的偏好是基于自我报告的疼痛和净促进评分(NPS)。结果:TAP装置在所有结局指标上均优于ADx卡。TAP与静脉穿刺的r平方为0.99 (95% CI 0.99， > 0.99)，显著高于最有利治疗下的ADx卡的r平方为0.87 (95% CI 0.80, 0.94)。TAP的敏感性和特异性均为100%(与静脉穿刺无临床差异)，而ADx卡的敏感性和特异性分别为100%和88%。TAP装置使用者报告的平均疼痛明显低于ADx卡(0.75 vs 2.73, p)。结论:TAP在相关性和假阳性方面不逊于静脉穿刺，优于ADx卡。此外，在患者体验方面，TAP优于两种替代方案。试验注册:NCT04784325(2021年3月5日)。
Evaluation of at-home serum anti-Müllerian hormone testing: a head-to-head comparison study.
Background: For optimal fertility testing, serum anti-Müllerian hormone levels are used in combination with other testing to provide reliable ovarian reserve evaluations. The use of the ADx 100 card is widely commercially available for at-home reproductive hormone testing, but data demonstrating that its results are reproducible outside of a clinical setting are limited, as well as comparisons of its performance with other newer blood collection techniques. This study aimed to evaluate the concordance of serum AMH levels found via standard venipuncture and self-administered blood collection using the TAP II device (TAP) and ADx card in women of reproductive age.
Methods: This was a prospective, head-to-head-to-head within-person crossover comparison trial that included 41 women of reproductive age (20-39 years). It was hypothesized that the TAP device would be superior to the ADx card both in terms of agreement with venipuncture reference standard and patient experience. Each subject had their blood drawn using the three modalities (TAP, ADx, and venipuncture). We evaluated the concordance of AMH assays from samples obtained via the TAP device and ADx card with the gold standard being venipuncture. Two-sided 95% CIs were generated for each method to compare relative performance across all three modes. Patient preference for the TAP device versus the ADx card was based on self-reported pain and Net Promoter Score (NPS).
Results: The TAP device was superior to the ADx card on all outcome measures. TAP R-squared with venipuncture was 0.99 (95% CI 0.99, > 0.99), significantly higher than the ADx card, which had an R-squared of 0.87 (95% CI 0.80, 0.94) under most favorable treatment. TAP sensitivity and specificity were both 100% (no clinical disagreement with venipuncture), versus 100 and 88%, respectively, for the ADx card. Average pain reported by users of the TAP device was significantly lower than the ADx card (0.75 versus 2.73, p < 0.01) and the NPS was significantly higher than the ADx card (+ 72 versus - 48, p < 0.01).
Conclusions: The TAP was non-inferior to venipuncture and superior to the ADx card with respect to correlation and false positives. Moreover, the TAP was superior to both alternatives on patient experience.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
