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Analytical and Clinical Validation

Precision Analytical’s testing methods go through a rigorous validation process to verify accuracy, recovery, and linearity. We pride ourselves in relentlessly pursuing the most accurate and precise techniques available for testing. See the data on the next page to support the analytical and clinical validation of this powerful new testing model.

The Easiest Patient Collection

Patients collect just four or five dried urine samples over a 24-hour period. Dried samples are stable for several weeks making them convenient to ship worldwide.

Effective HRT Monitoring

DUTCH testing was designed to be optimally effective for most forms of hormone replacement therapy. Unique methods are used for improved monitoring of oral progesterone and vaginal hormones.

DUTCH vs. Saliva Testing

While the free cortisol pattern in saliva has clinical value, there is a significant missing piece to surveying a patient’s HPA-Axis function with saliva testing – measuring cortisol metabolites. To properly characterize a patient’s cortisol status, free and metabolized cortisol should be measured to avoid misleading results when cortisol clearance is abnormally high or low. Likewise with sex hormones, measuring estrogen and androgen metabolites gives a fuller picture for more precise clinical diagnosis of hormonal imbalances and HRT monitoring.

DUTCH vs. Serum Testing

While the most universally accepted testing method (due to the availability of FDA-cleared analyzers that are reliable and inexpensive), serum testing is lacking in some areas. Adrenal hormones cannot be effectively tested in serum because free cortisol cannot be tested throughout the day. There is also a lack of extensive metabolite testing (especially for cortisol and estrogens).

DUTCH vs. 24-Hour Urine Testing

There are two primary drawbacks to 24-hour urine testing of hormones. First, the collection is cumbersome, and as many as 40% of those who collect, do so in error (Tanaka, 2002). Secondly, dysfunction in the diurnal pattern of cortisol cannot be ascertained from a 24-hour collection. Some providers add saliva for daily free cortisol. DUTCH eliminates the need for two tests.

Do values compare favorably to 24-hour collections? The DUTCH correlation to 24-hour collections is excellent (see graph, left). Because the dried samples span about 12-14 hours of the day (6-8 hours overnight plus 2 hours per day collection), they represent the entire day’s hormone production. A weighted average of the four samples is combined and measured forall hormones other than cortisol and cortisone. Values mustbe presented relative to creatinine (ng per mg of creatinine) to correct for hydration. This replaces the 24-hour value. The excellent correlation to 24-hour collections makes this model a very respectable alternative to 24-hour collections. With the addition of diurnal free cortisol, it becomes an improvement.Do dried samples compromise the analysis? Dried samples are accurate for hormone testing, and values correlate to liquid samples. Samples are stable once they are dried and easier to ship than liquid samples.Methods Used for TestingCortisol, cortisone, 8-OHdG, melatonin (6-OHMS), organic acid tests and metabolites related to cortisol are tested by LC-MS/MS. The remaining hormones are tested by GC-MS/MS. The most accurate methods available are used for all tests. These methods show increased accuracy over immunoassays used in typical serum and saliva testing.