For Providers, Lab Trust is All in the Research

by Hilary Miller, ND

Patients and providers need lab results they can trust. Lab data can critically impact treatment plans and diagnoses, and the accuracy and validity of lab results reflect a provider’s commitment to their patients. Labs that develop their methods from peer-reviewed research provide accurate and trusted results that providers and patients can depend on.

Introducing

DUTCH Test Values Transparency

At Precision Analytical, creators of the DUTCH Test, we pursue opportunities to demonstrate our tests’ reliability. We do so by validating our methods and answering difficult clinical questions through peer-reviewed research.

The clinical validation process involves a thorough examination of testing methods and an in-depth understanding of method strengths and weaknesses. It’s a huge loss to healthcare when lab results are unreliable. Validating our methods against peer-reviewed research is what built our comprehensive hormone testing model as the foundation of DUTCH Trust.

DUTCH Test Validation Studies

Precision Analytical has published multiple peer-reviewed studies validating the DUTCH Test against conventional hormone testing methods.

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Evaluating Estrogen and Progesterone with Dried Urine

In 2019, Precision Analytical published a study showing that dried urine estrogen and progesterone results are comparable to serum. This not only means that urine is accurate, but that studies using serum to monitor and predict clinical outcomes can be compared to DUTCH Test results.

Providers might not realize the implications of this finding at first glance, but this is a broadly applicable finding and a real win for urine testing. Precision Analytical also tests saliva—although not for sex hormones, but for cortisol, where saliva is most reliable.

This same 2019 study further found that 4-spot urine testing was equivalent to 24-hour urine collection, showing that the DUTCH Test reports an average over the course of a day. This is important because hormones fluctuate naturally and collecting a single serum test can sometimes miss peak or trough results. Taking it one step further, patients on hormone replacement therapy (HRT) often take or apply their hormone once a day. The results of this study imply that urine could capture the average hormone level even with the variations in hormones while using HRT.

Dried Urine and Saliva Testing for Cortisol, Sex Hormones, and Organic Acids

In 2020 and 2021 Precision Analytical published two additional papers comparing the dried urine method against the previously validated method. This includes cortisol metabolites, the cortisol diurnal rhythm, organic acids, and sex hormone metabolites. The DUTCH Test showed excellent agreement with established testing methods.

Monitoring Estrogen Replacement Therapy (ERT)

Precision Analytical presented at North American Menopause Society (NAMS) with data showing the DUTCH Test can accurately monitor topical estrogen replacement therapies. The three method validation studies in 2019-2021 represent a strong foundation for launching into clinical questions that providers want to confidently investigate, such as how to monitor HRT. Precision Analytical has plans underway to continue publishing and presenting data, with the goal of continuous open inquiry into relevant provider questions and patient care.

In 2022, Mark Newman, et al. also published a study in Steroids showing the urine response to FDA-approved estradiol gel products. They found significant correlations between estrogen therapy and hormone concentrations in dried urine samples. They also concluded that dried urine has several benefits over saliva and serum for monitoring estrogen replacement therapy. Read more about this study in our recent blog post.

Reliable Testing Methods Build Trust

Putting trust in labs that cannot back up their claims can lead to inappropriate treatment plans and loss of patient trust. When providers use validated lab methods, they can treat their patients with confidence, and patients can trust their provider.

Precision Analytical is making a continual effort to provide robust clinical data on important questions. Using a validated lab shows our commitment to excellence and transparency.

Learn More About DUTCH Research and Submit a Research Inquiry

DUTCH Research

References Expand

1. Newman M, et al. Evaluating urinary estrogen and progesterone metabolites using dried filter paper samples and gas chromatography with tandem mass spectrometry (GC-MS/MS). BMC Chem. 2019;13(1):20.

2. Newman M, et al. Dried urine and salivary profiling for complete assessment of cortisol and cortisol metabolites. J Clin Transl Endocrinol. 2020;22:100243.

3. Newman M, et al. Reliability of a dried urine test for comprehensive assessment of urine hormones and metabolites. BMC Chem. 2021;15(1):18.