{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T20:03:45Z","timestamp":1788379425047,"version":"build-2803163510"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Reprod Biol Endocrinol"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>For optimal fertility testing, serum anti-M\u00fcllerian 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This was a prospective, head-to-head-to-head within-person crossover comparison trial that included 41 women of reproductive age (20\u201339\u2009years). 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).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>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, &gt;\u20090.99), 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, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.01) and the NPS was significantly higher than the ADx card (+\u200972 versus \u2212\u200948, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.01).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>NCT04784325 (Mar 5, 2021).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12958-022-01004-2","type":"journal-article","created":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T11:03:06Z","timestamp":1662030186000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Evaluation of at-home serum anti-M\u00fcllerian hormone testing: a head-to-head comparison study"],"prefix":"10.1186","volume":"20","author":[{"given":"Erin","family":"Silliman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther H.","family":"Chung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Fitzpatrick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie A.","family":"Jolin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Brown","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Hotaling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron K.","family":"Styer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anatte E.","family":"Karmon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,9,1]]},"reference":[{"key":"1004_CR1","doi-asserted-by":"publisher","first-page":"299","DOI":"10.2146\/ajhp060565","volume":"65","author":"KL Scolaro","year":"2008","unstructured":"Scolaro KL, Lloyd KB, Helms KL. Devices for home evaluation of women\u2019s health concerns. Am J Health-Syst Pharm AJHP Off J Am Soc Health-Syst Pharm. 2008;65:299\u2013314.","journal-title":"Am J Health-Syst Pharm AJHP Off J Am Soc Health-Syst Pharm"},{"key":"1004_CR2","doi-asserted-by":"crossref","unstructured":"Delahaye L, Veenhof H, Koch BCP, Alffenaar J-WC, Linden R, Stove C. Alternative Sampling Devices to Collect Dried Blood Microsamples: State-of-the-Art. Ther Drug Monit. 2021; [cited 2022 Jul 5];Publish Ahead of Print. Available from: https:\/\/journals.lww.com\/10.1097\/FTD.0000000000000864.","DOI":"10.1097\/FTD.0000000000000864"},{"key":"1004_CR3","doi-asserted-by":"publisher","first-page":"343","DOI":"10.1097\/AOG.0000000000003066","volume":"133","author":"EE Burke","year":"2019","unstructured":"Burke EE, Beqaj S, Douglas NC, Luo R. Concordance of Fingerstick and venipuncture sampling for fertility hormones. Obstet Gynecol. 2019;133:343\u20138.","journal-title":"Obstet Gynecol"},{"key":"1004_CR4","doi-asserted-by":"publisher","first-page":"899","DOI":"10.1353\/dem.2007.0038","volume":"44","author":"TW McDade","year":"2007","unstructured":"McDade TW, Williams S, Snodgrass JJ. What a drop can do: dried blood spots as a minimally invasive method for integrating biomarkers into population-based research. Demography. 2007;44:899\u2013925.","journal-title":"Demography"},{"key":"1004_CR5","doi-asserted-by":"publisher","first-page":"2503","DOI":"10.1093\/humrep\/des194","volume":"27","author":"TW McDade","year":"2012","unstructured":"McDade TW, Woodruff TK, Huang Y, Funk WE, Prewitt M, Kondapalli L, et al. Quantification of anti-M\u00fcllerian hormone (AMH) in dried blood spots: validation of a minimally invasive method for assessing ovarian reserve. Hum Reprod Oxf Engl. 2012;27:2503\u20138.","journal-title":"Hum Reprod Oxf Engl."},{"key":"1004_CR6","doi-asserted-by":"publisher","first-page":"S20","DOI":"10.1017\/S0021932017000323","volume":"49","author":"T Sobotka","year":"2017","unstructured":"Sobotka T. Post-transitional fertility: the role of childbearing postponement in FUELLING the shift to low and unstable fertility levels. J Biosoc Sci. 2017;49:S20\u201345.","journal-title":"J Biosoc Sci"},{"key":"1004_CR7","doi-asserted-by":"publisher","first-page":"e110","DOI":"10.1016\/j.fertnstert.2021.07.308","volume":"116","author":"S Briggs","year":"2021","unstructured":"Briggs S, Worthington AK, Hershlag A. The impact of at-home anti-M\u00dcLLERIAN hormone test results on emotions and proactive fertility behaviors. Fertil Steril. 2021;116:e110.","journal-title":"Fertil Steril"},{"key":"1004_CR8","doi-asserted-by":"publisher","first-page":"50","DOI":"10.5653\/cerm.2019.46.2.50","volume":"46","author":"SR Oh","year":"2019","unstructured":"Oh SR, Choe SY, Cho YJ. Clinical application of serum anti-M\u00fcllerian hormone in women. Clin Exp Reprod Med. 2019;46:50\u20139.","journal-title":"Clin Exp Reprod Med"},{"key":"1004_CR9","doi-asserted-by":"publisher","first-page":"132","DOI":"10.1097\/POC.0000000000000176","volume":"17","author":"T Richards","year":"2018","unstructured":"Richards T, The TAP. Integrated capillary blood collection system. Point Care. 2018;17:132\u20135.","journal-title":"Point Care"},{"key":"1004_CR10","unstructured":"Ethical and Independent Review Services [Internet]. [cited 2022 Jul 5]. Available from: http:\/\/eandireview.com\/"},{"key":"1004_CR11","unstructured":"Turtle Health, Inc. AMH^2: Anti-M\u00fcllerian Hormone - At My Home [Internet]. clinicaltrials.gov; 2021 Jun. Report No.: NCT04784325. Available from: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04784325"},{"key":"1004_CR12","doi-asserted-by":"publisher","first-page":"561","DOI":"10.1097\/AOG.0000000000004698","volume":"139","author":"EH Chung","year":"2022","unstructured":"Chung EH, Petishnok LC, Conyers JM, Schimer DA, Vitek WS, Harris AL, et al. Virtual compared with in-clinic transvaginal ultrasonography for ovarian reserve assessment. Obstet Gynecol. 2022;139:561\u201370.","journal-title":"Obstet Gynecol"},{"key":"1004_CR13","unstructured":"Elecsys\u00ae AMH (Anti-Mullerian Hormone) [Internet]. Diagnostics. [cited 2022 Jul 5]. Available from: https:\/\/diagnostics.roche.com\/global\/en\/products\/params\/elecsys-amh-anti-mullerian-hormone.html"},{"key":"1004_CR14","volume-title":"Microsoft excel","author":"S Tingle","year":"2019","unstructured":"Tingle S. Microsoft excel; 2019."},{"key":"1004_CR15","doi-asserted-by":"publisher","first-page":"723","DOI":"10.1210\/jc.2013-3476","volume":"99","author":"O Rustamov","year":"2014","unstructured":"Rustamov O, Smith A, Roberts SA, Yates AP, Fitzgerald C, Krishnan M, et al. The measurement of anti-M\u00fcllerian hormone: a critical appraisal. J Clin Endocrinol Metab. 2014;99:723\u201332.","journal-title":"J Clin Endocrinol Metab"},{"key":"1004_CR16","doi-asserted-by":"publisher","first-page":"130","DOI":"10.1016\/j.rbmo.2012.11.005","volume":"26","author":"R Fleming","year":"2013","unstructured":"Fleming R, Fairbairn C, Blaney C, Lucas D, Gaudoin M. Stability of AMH measurement in blood and avoidance of proteolytic changes. Reprod Biomed Online Elsevier. 2013;26:130\u20132.","journal-title":"Reprod Biomed Online Elsevier"},{"key":"1004_CR17","doi-asserted-by":"publisher","first-page":"832","DOI":"10.1016\/j.fertnstert.2010.09.012","volume":"95","author":"O Shebl","year":"2011","unstructured":"Shebl O, Ebner T, Sir A, Schreier-Lechner E, Mayer RB, Tews G, et al. Age-related distribution of basal serum AMH level in women of reproductive age and a presumably healthy cohort. Fertil Steril. 2011;95:832\u20134.","journal-title":"Fertil Steril"},{"key":"1004_CR18","doi-asserted-by":"publisher","first-page":"591","DOI":"10.3109\/13697137.2014.912262","volume":"17","author":"FR Tehrani","year":"2014","unstructured":"Tehrani FR, Mansournia MA, Solaymani-Dodaran M, Azizi F. Age-specific serum anti-M\u00fcllerian hormone levels: estimates from a large population-based sample. Climacteric J Int Menopause Soc. 2014;17:591\u20137.","journal-title":"Climacteric J Int Menopause Soc"},{"key":"1004_CR19","doi-asserted-by":"publisher","first-page":"2364","DOI":"10.1093\/humrep\/dev197","volume":"30","author":"K Birch Petersen","year":"2015","unstructured":"Birch Petersen K, Hvidman HW, Forman JL, Pinborg A, Larsen EC, Macklon KT, et al. Ovarian reserve assessment in users of oral contraception seeking fertility advice on their reproductive lifespan. Hum Reprod Oxf Engl. 2015;30:2364\u201375.","journal-title":"Hum Reprod Oxf Engl"},{"key":"1004_CR20","unstructured":"0\u201310_Pain_Scale.pdf [Internet]. [cited 2022 Jul 5]. Available from: https:\/\/clusterheadachewarriors.org\/wp-content\/uploads\/2017\/03\/0-10_Pain_Scale.pdf"},{"key":"1004_CR21","unstructured":"Comparative Pain Scale [Internet]. [cited 2022 Jul 5]. Available from: https:\/\/www.thwink.org\/personal\/ComparativePainScale.htm"},{"key":"1004_CR22","unstructured":"NICE-Satmetrix-infographic-2018-b2c-nps-benchmarks-050418.pdf [Internet]. [cited 2022 Jul 5]. Available from: https:\/\/info.nice.com\/rs\/338-EJP-431\/images\/NICE-Satmetrix-infographic-2018-b2c-nps-benchmarks-050418.pdf"},{"key":"1004_CR23","unstructured":"Changing Faces of Greater Boston | Boston Indicators [Internet]. [cited 2022 Jul 5]. Available from: https:\/\/www.bostonindicators.org\/reports\/report-website-pages\/changing-faces-of-greater-boston"}],"container-title":["Reproductive Biology and Endocrinology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12958-022-01004-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12958-022-01004-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12958-022-01004-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T11:11:38Z","timestamp":1662030698000},"score":1,"resource":{"primary":{"URL":"https:\/\/rbej.biomedcentral.com\/articles\/10.1186\/s12958-022-01004-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,1]]},"references-count":23,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,12]]}},"alternative-id":["1004"],"URL":"https:\/\/doi.org\/10.1186\/s12958-022-01004-2","relation":{},"ISSN":["1477-7827"],"issn-type":[{"value":"1477-7827","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,1]]},"assertion":[{"value":"28 May 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 August 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 September 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Institutional research ethics board (IRB) approval was obtained from Ethical & Independent Review Services IRB, a third-party IRB accredited by the Association for the Accreditation of Human Research Protection Programs. All methods were carried out in accordance with relevant guidelines and regulations as outlined in the Declaration of Helsinki.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Dr. Chung, Dr. Jolin, Dr. Brown, Dr. Hotaling, Dr. Styer, and Dr. Karmon serve on the Clinical Advisory Board of Turtle Health. Their time for that work is compensated at fair market value, as was their time contributing to this study. Neither they, nor any other authors, own equity in Turtle Health, YourBio, or Accel Diagnostics. All other authors declare that they have no competing interests. Of note, Turtle Health made their supplier selection based on preliminary performance tests, resulting in a supply agreement with YourBio.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"131"}}