The study was conducted by researchers who analysed data generated by one manufacturer, Quanovate Tech Inc., in its facilities. Testing took place over four days with five operators and followed each manufacturer’s instructions. Four devices formed five evaluated configurations: three reader-based systems with controlled lighting and two strip-based systems that used smartphone imaging. Each device-and-strip combination underwent 208 test runs.

The researchers evaluated luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrone-3-glucuronide (E3G) and pregnanediol glucuronide (PDG). Artificial urine was prepared with standard concentrations of these hormones, and pH and specific gravity were checked for matrix consistency. Precision was assessed using coefficients of variation (CV), while accuracy was evaluated through relative deviation (RD) from the expected concentration. The researchers also examined linearity, limit of blank (LoB), limit of detection (LoD), ambient-light effects for the smartphone-based strips and responses to potentially interfering hormones.

The experiments were informed by Clinical and Laboratory Standards Institute validation principles but did not constitute full CLSI-compliant validation. The study used 10 replicate measurements at each concentration for several precision and accuracy tests, with five concentration levels for linearity and 20 replicates for blank and low-concentration samples. Because many replicates came from a single instrument or lot, the authors said the device comparisons should be interpreted as descriptive rather than as generalizable differences between devices. A full validation would also require between-day, between-run, lot-to-lot and instrument-to-instrument comparisons.

Performance varied by device and analyte. Across the tested concentrations, CV and RD values ranged from near the study’s 15% interpretation benchmark to levels exceeding 50% at some concentrations. For LH, the Device 2a and Device 2b configurations produced CV and RD values generally at or near, or below, 15% at most tested concentrations. Device 1, although also reader-based, exceeded the 15% threshold for LH and FSH at most concentrations; its FSH result was acceptable at the lowest tested concentration. Other systems also frequently exceeded the threshold. For E3G, Device 1 had low CV but marked systematic bias, with RD values of 97% to 322% relative to the spiked concentrations.

Linearity results also differed substantially. All five configurations had high coefficients of determination for LH, but Device 2a alone had a slope close to 1 and a maximum allowable deviation from linearity of 8.4%. For E3G, the coefficients of determination were 0.04 for Device 3 and 0.01 for Device 4, indicating little observed linear relationship between expected and measured concentrations in the tested range. Device 2a had the lowest E3G maximum allowable deviation, at 12.7%. For PDG, Device 1 and Device 2a had coefficients of determination of 0.93 and 0.90, respectively.

Detection limits also varied. For LH, Devices 1, 3 and 4 had LoB values of 0.00 to 0.10 mIU/mL, compared with 3.11 mIU/mL for Device 2a and 0.69 mIU/mL for Device 2b. Devices 1, 2a and 2b had near-zero LoB values for E3G, while the other systems produced higher blank readings. Against a 50 ng/mL clinical threshold for E3G, two devices had LoDs near or below that level, while the remaining devices exceeded it. For PDG, Devices 1 and 2 showed minimal blank noise, and the other configurations had progressively higher LoBs and LoDs.

Ambient lighting affected the two smartphone-based strip systems, particularly at lower hormone concentrations. Tests were conducted under regular ambient light, 50 lux and 300 lux. Device 3 showed significant deviations from ambient conditions only for low-concentration LH. Device 4 was more affected: LH results differed significantly under bright and dark conditions at 12.5 and 25 mIU/mL, while PDG readings showed pronounced light-dependent variability at lower concentrations.

Specificity testing identified the clearest cross-reactivity when LH channels were challenged with 100 mIU/mL hCG. All configurations except Device 4 showed significant LH cross-reactivity, indicating the possibility of a false LH result in the presence of hCG. Device 4, which measures the LH beta subunit, showed no detectable LH response at that concentration. Cross-reactivity involving thyroid-stimulating hormone, cortisol, pregnenolone, 17α-hydroxyprogesterone and progesterone was described as minimal and clinically inconsequential. The artificial-urine matrix did not reproduce all features of human urine, including variable pH, salts, proteins and hydration status. The findings therefore do not establish clinical validity, ovulation detection, fertile-window estimation or menstrual-phase classification. The authors call for independent replication, testing with human urine and longitudinal clinical studies with appropriate ovulation reference standards.

Subject of Research: Analytical performance of quantitative at-home urinary hormone monitoring systems tested in artificial urine

Article Title: Preliminary laboratory analytical comparison of quantitative at-home urinary hormone monitoring systems using artificial urine

Article References: Bouchard, T. P., Yong, P. J., & Doyle-Baker, P. K. (2026). Preliminary laboratory analytical comparison of quantitative at-home urinary hormone monitoring systems using artificial urine. Frontiers in Endocrinology, 17, Article 1947016. https://doi.org/10.3389/fendo.2026.1947016

Image Credits: AI Generated

DOI: 10.3389/fendo.2026.1947016

Keywords: at-home hormone monitoring, urinary hormone assays, analytical validation, artificial urine, precision and accuracy, luteinizing hormone, hCG cross-reactivity, fertility tracking, device comparison, Preliminary, laboratory, analytical