scholarly journals Translating pharmacodynamic biomarkers from bench to bedside: analytical validation and fit-for-purpose studies to qualify multiplex immunofluorescent assays for use on clinical core biopsy specimens

2016 ◽  
Vol 43 (4) ◽  
pp. 453-463 ◽  
Author(s):  
Allison Marrero ◽  
Scott Lawrence ◽  
Deborah Wilsker ◽  
Andrea Regier Voth ◽  
Robert J. Kinders
Keyword(s):  
Core Biopsy ◽  
Analytical Validation ◽  
Biopsy Specimens ◽  
Fit For Purpose ◽  
Pharmacodynamic Biomarkers

scholarly journals Analytical and physiological validation of an enzyme immunoassay to measure oxytocin in dog, wolf, and human urine samples

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
G. Wirobski ◽  
F. S. Schaebs ◽  
F. Range ◽  
S. Marshall-Pescini ◽  
T. Deschner
Keyword(s):  
Enzyme Immunoassay ◽  
Human Urine ◽  
Extraction Efficiency ◽  
Urine Samples ◽  
Antibody Specificity ◽  
Analytical Validation ◽  
Human Urine Samples ◽  
Assay Performance ◽  
Fit For Purpose ◽  
Commercial Enzyme Immunoassay

AbstractOxytocin (OT) promotes pro-sociality, bonding, and cooperation in a variety of species. Measuring oxytocin metabolite (OTM) concentrations in urine or saliva provides intriguing opportunities to study human and animal behaviour with minimal disturbance. However, a thorough validation of analytical methods and an assessment of the physiological significance of these measures are essential. We conducted an analytical validation of a commercial Enzyme Immunoassay (EIA; Arbor OT assay kit) to measure OTM concentrations in dog, wolf, and human urine samples. To test the assay’s ability to detect changes in OTM concentrations, we administered oxytocin intranasally to 14 dogs. Assay performance with regard to parallelism was acceptable. Assay accuracy and extraction efficiency for dog and wolf samples were comparable to a previously validated assay (Enzo OT assay kit) but variation was smaller for human samples. Binding sensitivity and antibody specificity were better in the Arbor assay. Average OTM concentrations were more than twice as high as in comparable samples measured with the Enzo assay, highlighting a lack of comparability of absolute values between different assays. Changes in OTM concentrations after intranasal treatment were detected reliably. The Arbor assay met requirements of a “fit-for-purpose” validation with improvement of several parameters compared to the Enzo assay.

Reflex Estrogen Receptor (ER) and Progesterone Receptor (PR) Analysis of Ductal Carcinoma In Situ (DCIS) in Breast Needle Core Biopsy Specimens

2016 ◽  
Vol 40 (8) ◽  
pp. 1090-1099 ◽  
Author(s):  
Christopher J. VandenBussche ◽  
Ashley Cimino-Mathews ◽  
Ben Ho Park ◽  
Leisha A. Emens ◽  
Theodore N. Tsangaris ◽  
...  
Keyword(s):  
Estrogen Receptor ◽  
Progesterone Receptor ◽  
Ductal Carcinoma In Situ ◽  
Core Biopsy ◽  
Carcinoma In Situ ◽  
Ductal Carcinoma ◽  
Needle Core Biopsy ◽  
Biopsy Specimens

SP3, a reliable alternative to HercepTest in determining HER-2/neu status in breast cancer patients

2013 ◽  
Vol 66 (5) ◽  
pp. 409-414 ◽  
Author(s):  
Timothy Michael D'Alfonso ◽  
Yi-Fang Liu ◽  
Zhengming Chen ◽  
Ying-Bei Chen ◽  
Ashley Cimino-Mathews ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Core Biopsy ◽  
In Situ Hybridisation ◽  
Excisional Biopsy ◽  
Needle Core Biopsy ◽  
Breast Cancer Patients ◽  
Biopsy Specimens ◽  
Her 2

Accurate assessment of HER-2/neu gene status in breast cancer patients has important prognostic and therapeutic implications. Overexpression/gene amplification of HER-2 is associated with a more aggressive clinical course and eligibility for targeted therapy with trastuzumab. A variety of immunohistochemical (IHC) antibodies and in situ hybridisation (ISH) methods have been employed to assess HER-2 status. SP3 is a rabbit monoclonal antibody that has been shown to have a high level of agreement with other anti-HER-2 antibodies and ISH methods. We assessed HER-2 status by SP3 and HercepTest IHC stains and by fluorescence in situ hybridisation (FISH) on invasive breast carcinomas from paired needle core biopsy and excisional biopsy specimens from 100 patients. We compared the two antibodies with respect to concordance rates with FISH, concordance rates between samples of the same tumour, and sensitivity and specificity using FISH as the reference test. Concordance between SP3 and FISH in needle core biopsy and excisional biopsy specimens was 96% (95% CI 91.9% to 99.7%) (κ=0.89 (95% CI 0.73 to 1.00)) and 97% (95% CI 90.3% to 99.3%) (κ=0.84 (95% CI 0.66 to 1.00)), respectively. Sensitivity and specificity of SP3 for detecting HER-2 overexpression/gene amplification were 78.3% and 100%, respectively, in needle core biopsy and excisional biopsy specimens. Concordance between SP3 results assessed on the needle core biopsy and excisional biopsy was 89% (95% CI 81.2% to 94.4%) (κ=0.62 (95% CI 0.42 to 0.82)). Concordance between SP3 and HercepTest antibodies, after excluding 2+ cases, was 97.6% (95% CI 94.0% to 99.3%) (κ=0.88 (95% CI 0.77 to 1.00)). SP3 is a reliable alternative to HercepTest in evaluating HER-2 status in breast cancer patients. Like other anti-HER-2 antibodies, SP3 may serve as a diagnostic tool in breast pathology and has potential utility as an IHC biomarker in non-mammary malignancies.

Myxoid Myofibroblastoma of the Breast With Atypical Cells

2019 ◽  
Vol 27 (4) ◽  
pp. 446-449 ◽  
Author(s):  
Julia A. Ross ◽  
John Reith ◽  
Jaya Ruth Asirvatham
Keyword(s):  
Differential Diagnosis ◽  
Adult Male ◽  
Core Biopsy ◽  
Myxoid Stroma ◽  
Biopsy Specimens ◽  
Female Breast ◽  
Atypical Cells ◽  
Anatomic Distribution ◽  
Morphological Variants ◽  
Exclusive Or

The differential diagnosis of myxoid lesions in the breast is broad and includes both benign and malignant entities. Assessment is particularly challenging on core biopsy specimens. Myofibroblastoma, initially thought to be more common in the adult male breast, is being recognized with increasing frequency in the female breast. The wider anatomic distribution of mammary-type myofibroblastoma has also become known, and many new morphological variants have been described. Though focal myxoid stroma may be noted in myofibroblastomas and occasional myofibroblastomas may contain atypical cells, there have been only 3 reports in the literature of myofibroblastomas with exclusive or predominantly myxoid stroma, and 2 of these contained atypical cells. We report another case of mammary myxoid myofibroblastoma with atypical cells in a 40-year-old woman and discuss the differential diagnoses of myxoid lesions in the breast.

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