학술논문
Refining the serum miR-371a-3p test for viable germ cell tumor detection.
Document Type
Article
Author
Lafin, John T.; Scarpini, Cinzia G.; Amini, Armon; Konneh, Bendu; Howard, Jeffrey M.; Gerald, Thomas; Nuno, Michelle; Piao, Jin; Savelyeva, Anna; Wang, Zhaohui; Gagan, Jeffrey; Jia, Liwei; Lewis, Cheryl M.; Murray, Sarah; Sawa, Yun C.; Margulis, Vitaly; Woldu, Solomon L.; Strand, Douglas W.; Coleman, Nicholas; Amatruda, James F.
Source
Subject
*GERM cell tumors
*QUALITY control
*SERUM
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Language
ISSN
2045-2322
Abstract
Circulating miR-371a-3p has excellent performance in the detection of viable (non-teratoma) germ cell tumor (GCT) pre-orchiectomy; however, its ability to detect occult disease is understudied. To refine the serum miR-371a-3p assay in the minimal residual disease setting we compared performance of raw (Cq) and normalized (∆Cq, RQ) values from prior assays, and validated interlaboratory concordance by aliquot swapping. Revised assay performance was determined in a cohort of 32 patients suspected of occult retroperitoneal disease. Assay superiority was determined by comparing resulting receiver-operator characteristic (ROC) curves using the Delong method. Pairwise t-tests were used to test for interlaboratory concordance. Performance was comparable when thresholding based on raw Cq vs. normalized values. Interlaboratory concordance of miR-371a-3p was high, but reference genes miR-30b-5p and cel-miR-39-3p were discordant. Introduction of an indeterminate range of Cq 28–35 with a repeat run for any indeterminate improved assay accuracy from 0.84 to 0.92 in a group of patients suspected of occult GCT. We recommend that serum miR-371a-3p test protocols are updated to (a) utilize threshold-based approaches using raw Cq values, (b) continue to include an endogenous (e.g., miR-30b-5p) and exogenous non-human spike-in (e.g., cel-miR-39-3p) microRNA for quality control, and (c) to re-run any sample with an indeterminate result. [ABSTRACT FROM AUTHOR]