Tuesday, 14 May 2019

How to asses Androgens in PCOS cases-relevance of Lab Tests-Accuracy??


Total testosterone levels because of the depression of SHBG levels that occurs concomitant with increasing androgen effects on the liver. Therefore, when moderate hyperandrogenism, characteristic of many functional hyperandrogenic states, occurs, elevations in total testosterone levels may remain within the normal range, and only free testosterone levels will reveal the hyperandrogenism. Severe hyperandrogenism, as occurs in virilization and that result from neoplastic production of testosterone, is reliably detected by measures of total testosterone.  Therefore, in practical clinical evaluation of the hyperandrogenic patient, determination of the total testosterone level in concert with clinical assessment is frequently sufficient for diagnosis and management. When more precise delineation of the degree of hyperandrogenism is desired, measurement or estimation of free testosterone levels can be undertaken and will more reliably reflect increases in testosterone production. These measurements are not necessary in evaluating the majority of patients, but they are common in clinical research studies and may be useful in some clinical settings.  Because many practitioners measure some form of testosterone level, they should understand the methods used and their accuracy. Although equilibrium dialysis is the gold standard for measuring free testosterone, it is expensive, complex, and usually limited to research settings, in a clinical setting; free testosterone levels can be estimated by assessment of testosterone binding to albumin and SHBG. Testosterone that is nonspecifically bound to albumin (AT), is linearly related to free testosterone (FT) by the equation:
AT=Ka [A] x FT,
Where AT is the albumin-bound testosterone, Ka is the association constant of albumin for testosterone, and [A] is the albumin concentration.
In many cases of hirsutism, albumin levels are within a narrow physiologic range and thus do not significantly affect the free testosterone concentration.
When physiologic albumin levels are present, the free testosterone level can be estimated by measuring the total testosterone and SHBG.
 In individuals with normal albumin levels, this method has reliable results compared with those of equilibrium dialysis. It provides a rapid, simple, and accurate determination of the total and calculated free testosterone level and the concentration of SHBG. The bioavailable testosterone level is based on the relationship of albumin and free testosterone and incorporates the actual albumin level with the total testosterone and SHBG. This combination of total testosterone, SHBG, and albumin level measurements can be applied to derive a more accurate estimate of available bioactive testosterone and thus the androgen effects derived from testosterone.  Bioactive testosterone determined in this manner provides a superior estimate of the effective androgen effect derived from testosterone. Pregnancy can alter the accuracy of measurements of bioavailable testosterone. During pregnancy, estradiol, which shares with testosterone a high affinity for SHBG, occupies a large proportion of SHBG binding sites, so that measurement of SHBG levels can overestimate the binding capacity of SHBG for testosterone.  Derived estimates of free testosterone, as opposed to direct measure by equilibrium dialysis, are therefore inaccurate during pregnancy. Testosterone measurements in pregnancy are primarily of interest when autonomous secretion by tumor or luteoma is in question, and for these, total testosterone determinations provide sufficient information for diagnosis. For testosterone to exert its biologic effects on target tissues, it must be converted into its active metabolite, DHT, by 5a-reductase (a cytosolic enzyme that reduces testosterone and androstenedione). Two isozymes of 5a-reductase exist; type 1, which predominates in the skin, and type 2, or acidic 5a-reductase, which is found in the liver, prostate, seminal vesicles, and genital skin.  The type 2 isozyme has a 20-fold higher affinity for testosterone than type 1. Both type 1 and 2 deficiencies in males result in ambiguous genitalia, and both isozymes may play a role in androgen effects on hair growth. vDihydrotestosterone is more potent than testosterone, primarily because of its higher affinity and slower dissociation from the androgen receptor. Although DHT is the key intracellular mediator of most androgen effects, measurements of circulating levels are not clinically useful. The relative androgenicity of androgens is as follows:
DHT=300
Testosterone=100
Androstenedione=10
DHEAS=5.
Until adrenarche, androgen levels remain low.
 Around 8 years of age, adrenarche is heralded by a marked increase in DHEA and DHEAS. The half-life of free DHEA is extremely short (about 30 minutes) but extends to several hours if DHEA is sulfated.  Although no clear role is identified for DHEAS, it is associated with stress and levels decline steadily throughout adult life. After menopause, ovarian estrogen secretion ceases, and DHEAS levels continue to decline, whereas testosterone levels are maintained or may even increase.
Although postmenopausal ovarian steroidogenesis contributes to testosterone production, testosterone levels retain diurnal variation, reflecting an ongoing and important adrenal contribution. Peripheral aromatization of androgens to estrogens increases with age, but because small fractions (2% to 10%) of androgens are metabolized in this fashion, such conversion is rarely of clinical significance.
Laboratory Evaluation
The 2008 Endocrine Society Clinical Practice Guidelines suggest testing for elevated androgen levels in women with moderate (Ferriman-Gallwey hirsutism score 9 or greater) or severe hirsutism or hirsutism of any degree when it is sudden in onset, rapidly progressive, or associated with other abnormalities such as menstrual dysfunction, infertility, significant acne, obesity, or clitoromegaly. These guidelines suggest against testing for elevated androgen levels in women with isolated mild hirsutism because the likelihood or identifying a medical disorder that would change management or outcome is estremely low.
 Medications that cause hirsutism are listed and should be considered When laboratory testing for the assessment of hirsutism is indicated, either a bioavailable testosterone level (includes a total testosterone, SHBG, and albumin level) or a calculated free testosterone level (if albumin levels are assumed to be normal) provides the most accurate assessment of the androgen effect derived from testosterone. In clinical situations requiring a testosterone evaluation, the addition of 17-hydroxyprogesterone will screen for adult onset adrenal hyperplasia, when indicated . When hirsutism is accompanied by absent or abnormal menstrual periods, assessment of prolactin and thyroid-stimulating hormone (TSH) values are required to diagnose an ovulatory disorder. Hypothyroidism and hyperprolavrinemia may result in reduced levels of SHBG and may increase the fraction of unbound testosterone levels, occasionally resulting in hirsutism. In cases of suspected Cushing syndrome, patients should undergo screening with a 24-hour urinary cortisol (most sensitive and specific) assessment or an overnight dexamethasone suppression test. For this test, the patient takes 1 mg of dexamethasone at 11 p.m, and a blood cortisol assessment is performed at 8 a.m. the next day. Cortisol levels of 2μg/dL or higher after overnight dexamethasone suppression require a further workup for evaluation of Cushing syndrome. Elevated 17-hydroxyprogesterone (17-OHP) levels identify patients who may have AOAH, found in 1% to 5% of hirsute women. The 17-OHP levels can vary significantly within the menstrual cycle, increasing in the periovulatory period and luteal phase, and may be modestly elevated in PCOS. Standardized testing requires early morning testing during the follicular phase.
According to the Endocrine Society clinical guideline, patients with morning follicular phase 17-OHP levels of less than 300 ng/dL (10 nmol/L) are likely unaffected .When levels are greater than 300 ng/dL but less than 10,000 ng/dL (300 nmol/L), ACTH testing should be performed to distinguish between PCOS and AOAH. Levels greater than 10,000 ng/dL (300 nmol/L) are virtually diagnostic of congenital adrenal hyperplasia.
Precocious pubarche precedes the diagnosis of adult onset congenital adrenal hyperplasia in 5% to 20% of cases. Measurement of 17-OHP should be performed in patients presenting with precocious pubarche, and a subsequent ACTH stimulation test is recommended if basal 17-OHP is greater than 200 ng/dL. A study using a 200 ng/dL threshold for basal 17-OHP plasma levels to prompt ACTH stimulation testing offered 100% (95 % confidence interval [CI], 69-100) sensitivity and 99% (95% CI, 96-100) specificity for the diagnosis of adult onset congenital adrenal hyperplasia within the cohort with precocious puberty .
Because increased testosterone production is not reliably reflected by total testosterone levels, the clinician may chose to rely on typical male pattern hirsutism as confirmation of its presence, or may elect measures that reflect levels of free or unbound testosterone (bioavailable or calculated free testosterone levels). Total testosterone does serve as a reliable marker for testosterone-producing neoplasms. Total testosterone levels greater than 200 ng/dL should prompt a workup for ovarian or adrenal tumors.
Although the ovary is the principal source of androgen excess in most of PCOS patients, 20% to 30% of patients with PCOS will demonstrate supranormal levels of DHEAS. Measuring circulating levels of DHEAS has limited diagnostic value, and overinterpretation of DHEAS levels should be avoided .
In the past, testing for androgen conjugates (e.g.,3a-androstenediol G [3a-diol G] and androsterone G [AOG] as markers for 5a-reductase activity in the skin) was advocated.

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