{"id":337,"title":"Preliminary laboratory analytical comparison of quantitative at-home urinary hormone monitoring systems using artificial urine","title_zh":"基于人工尿液的定量家用尿液激素监测系统实验室分析比较初步研究","url":"https://pubmed.ncbi.nlm.nih.gov/42974274","doi":"10.3389/fendo.2026.1947016","pmid":"42974274","journal":"Front Endocrinol (Lausanne)","kind":"paper","lang":"en","published_at":"2026-10-19T00:00:00+00:00","fetched_at":"2026-11-08T03:44:06+00:00","authors":["Bouchard TP","Yong PJ","Doyle-Baker PK"],"primary_topic":"repro-endo","topics":[{"slug":"repro-endo","score":5.0,"hits":["follicle-stimulating hormone","fsh","luteinizing hormone","ovulation","progesterone"]},{"slug":"oocyte","score":1.0,"hits":["follicle"]},{"slug":"art-clinical","score":1.0,"hits":["gonadotropin"]},{"slug":"contraception-health","score":1.0,"hits":["reproductive health"]}],"topic_score":5.0,"preference_score":0.0,"preference_labels":[],"llm_score":74.0,"final_score":74.0,"score_dims":{"novelty":70,"rigor":72,"impact":65,"relevance":78,"translation":70},"recommend_reason":"对家用激素监测设备的分析性能与hCG交叉反应风险提供了可比框架，适合生殖内分泌与生育监测研究者参考；但仅人工尿液、初步实验，临床结论有限。","keywords":["家用尿液激素监测","LH","hCG交叉反应","分析验证","排卵检测","人工尿液"],"selected":1,"story_id":370,"llm_provider":"deepseek","llm_model":"deepseek-flash","llm_effort":"low","source_key":"pubmed-core-journals","source_name":"PubMed · 核心期刊","source_tier":1,"mention_count":1,"has_interpretation":false,"journal_key":"front-endo","journal_tier":"standard","journal_if":3.9,"is_mock":false,"summary_zh":"该初步实验室研究依CLSI原则、用预注册框架，在人工尿液中比较4款家用定量尿液激素设备对LH、FSH、E3G、PDG的精密度、准确度、线性、检出限和交叉反应，并测试光照与摄像头影响。结果见设备/分析物差异，部分CV/RD近15%但可超50%；低浓度时光照影响摄像头试纸；100 mIU/mL hCG可致LH假阳性，LH-β亚单位设备可避免。结论：框架可用于研发，但排卵检测等需人尿纵向临床验证。","summary":"BACKGROUND: Quantitative at-home urinary hormone monitoring systems are increasingly used for reproductive health tracking, but their analytical behaviour requires systematic characterization. This preliminary laboratory comparison aimed to provide an analytical framework to compare multiple commercially available at-home urine hormone monitoring devices across key performance metrics under controlled artificial urine conditions. METHODS: Laboratory experiments were informed by Clinical and Laboratory Standards Institute's (CLSI) validation principles. Four urine hormone monitoring devices were evaluated using a pre-registered analytical framework for luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrone-3-glucuronide (E3G), and pregnanediol glucuronide (PDG). Metrics included coefficients of variation (CV, for precision), relative deviation (RD, for accuracy), linearity, limit of blank (LoB), limit of detection (LoD) for each device, using artificial urine samples with standard hormone concentrations. Cross-reactivity was tested with other hormones including human chorionic gonadotropin (hCG), cortisol, thyroid stimulating hormone (TSH) and progesterone subtypes. Device-specific evaluations, including the impact of ambient light and various camera systems, were also conducted for relevant devices. RESULTS: There were device- and analyte-specific differences in precision, accuracy, linearity and detection limits. Precision and accuracy ranged from CV/RD values near the 15% acceptability threshold to levels exceeding 50% at some concentrations. External lighting conditions affected camera-based strips at low hormone concentrations. False positive results for LH can occur in the presence of 100 mIU/mL hCG, which could lead to misinterpretation in the context of pregnancy. One device that measures the LH-beta subunit avoided this cross-reactivity. CONCLUSIONS: A preliminary analytical framework was applied to evaluate the performance of quantitative urinary hormone devices for at-home use. This framework can be used in future research and development of menstrual health monitoring technologies. Longitudinal clinical studies using human urine samples and appropriate ovulation reference standards are required before conclusions can be drawn regarding ovulation detection, fertile-window estimation or menstrual-phase classification.","interpretation_basis":null,"fulltext_status":null,"interpretation":null,"fulltext":{"available":false,"status":null,"reason":"尚未抓取全文（未入选、分数未达阈值，或还没跑 fulltext 步骤）","pmcid":null,"license":null,"chars":0,"source":null,"fetched_at":null}}