The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care

Kaul, Karen L.; Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Murata, Kazunori; Pessin, Melissa; Press, Richard D.; Thomson, Richard B.

Very sensitive measurements of serum androgens are important in adult and pediatric endocrinology and oncology. Very-low-level testosterone (Te) measurements are needed for adult women, whose values are routinely <50 ng/dL, in children, and men undergoing antiandrogen therapy whose values are usually <10 ng/dL. 149 The most commonly used methods for steroid analysis are FDA-approved immunoassays because they are rapid and sensitive enough for most routine applications involving healthy adult males. However, Te immunoassays lack the sensitivity requirements for chemically castrated males, women, and children. Many immunoassays also lack specificity and accuracy as immunoassays may show cross-reactivity with structurally similar compounds. [150] [151] [152] In addition, most immunoassays are not standardized against internationally recognized standards. For these reasons, a number of sensitive and specific assays using MS have been described for Te. [153] [154] [155] The lack of sufficient accuracy and standardization of Te assays is a major concern for the clinical and public health communities. 156 Several years ago, the Endocrine Society, in partnership with the CDC, convened a meeting with various relevant professional societies and industrial partners to create the Partnership for the Accurate Testing of Hormones (PATH) whose mission is to improve the accuracy and standardization of a variety of steroid hormone tests. [156] [157] [158] The PATH has worked with the CDC and begun to address this concern through its HoSt program, which provides laboratories with specimens spanning their analytical measurement range that have been previously analyzed using the CDC reference method. 155 Many assays using MS have been approved by the CDC HoST program, 159 however not a single FDA-approved immunoassay has met the performance requirements. Testosterone is a perfect example of an LDP that is indispensable for patient care and allows for accurate measurements to be made on children, women, and male patients with cancer receiving antiandrogen medication.