| 摘要 |
Non-invasive methods are provided for obtained biological samples of mammary fluid or mammary fluid components from a patient using a breast pump device (10) incorporating or coupled with a solid phase sample collection medium (38). Use of the breast pump device stimulates expression of mammary fluid from patients, which provides for collection of diagnostic samples to evaluate breast disease, including cancer, in the patient. Methods for using the device optionally incorporate induction of mammary fluid expression by administration of oxytocin analog to the patient to stimulate myoepithelial contraction of the mammary alveolar glands. During or after mammary fluid expression, a biological sample is collected in the form of whole mammary fluid, whole cells or cellular components, other selected liquid or solid fractions of the mammary fluid, purified or bulk proteins, glycoproteins, peptides, nucleotides or other desired constituents of mammary fluid. Methods and kits are also provided for determining the presence or amount of a breast disease marker in biological samples of mammary fluid or mammary fluid components obtained according to the above sample collection methods. Also provided within the invention are novel breast pump and breast pump adapter devices that incorporate a solid phase sample collection medium integrated within the breast pump or adapter or otherwise fluidly connected therewith. These devices collect a sample of expressed breast fluid by contacting the fluid with a solid phase sample collection medium while the pump or adapter is applied to the breast. Yet additional methods, devices accessories, and material are provided for laboratory handling and processing of breast fluid samples and diagnostic methods related thereto. Among these are specially adapted fluid retaining reservoirs (30) for use within a breast fluid collection pump of the invention which are useful within a variety of mammary fluid collection, sample handling and sample processing methods. |
