Cytologic features of nipple aspirate fluid using an automated non-invasive collection device: a prospective observational study.

BACKGROUND: Detection of cytologic atypia in nipple aspirate fluid (NAF) has been shown to be a predictor of risk for development of breast carcinoma. Manual collection of NAF for cytologic evaluation varies widely in terms of efficacy, ease of use, and patient acceptance. We investigated a new automated device for the non-invasive collection of NAF in the office setting. METHODS: A multi-center prospective observational clinical trial involving asymptomatic women designed to assess fluid production, adequacy, safety and patient acceptance of the HALO NAF Collection System (NeoMatrix, Irvine, CA). Cytologic evaluation of all NAF samples was performed using previously described classification categories. RESULTS: 500 healthy women were successfully enrolled. Thirty-eight percent (190/500) produced fluid and 187 were available for cytologic analysis. Cytologic classification of fluid producers showed 50% (93/187) Category 0 (insufficient cellular material), 38% (71/187) Category I (benign non-hyperplastic ductal epithelial cells), 10% (18/187) Category II (benign hyperplastic ductal epithelial cells), 3% (5/187) Category III (atypical ductal epithelial cells) and none were Category IV (unequivocal malignancy). Overall, 19% of the subjects produced NAF with adequate cellularity and 1% were found to have cytologic atypia. CONCLUSION: The HALO system is a simple, safe, rapid, automated method for standardized collection of NAF which is acceptable to patients. Cytologic assessment of HALO-collected NAF showed the ability to detect benign and pre-neoplastic ductal epithelial cells from asymptomatic volunteers.

Gadolinium magnetic resonance contrast agents produce analytic interference in multiple serum assays.

Gadolinium magnetic resonance contrast agents are known to interfere with some clinical chemistry tests, particularly colorimetric assays for serum calcium. We studied the effects of 4 agents, gadodiamide, gadoversetamide, gadopentetate dimeglumine, and gadoteridol, for interference with multiple serum assays. Gadodiamide and gadoversetamide produced clinically significant negative interference with colorimetric assays for serum angiotensin-converting enzyme, calcium, and zinc. These agents produced clinically significant positive interference in magnesium and total iron binding capacity assays and both positive and negative interference in iron assays. Gadopentetate dimeglumine produced a negative interference with iron assays, and gadopentetate dimeglumine and gadoteridol produced negative interference with a colorimetric zinc assay. Caution should be exercised when using colorimetric assays for angiotensin-converting enzyme, calcium, iron, magnesium, total iron binding capacity, and zinc in serum samples from patients who have recently received magnetic resonance contrast agents. In general, gadodiamide and gadoversetamide are more likely to produce a clinically significant interference than gadopentetate dimeglumine and gadoteridol. Likewise, certain analytic methods are more prone to interference, while others not affected.