Whole Slide Imaging Versus Microscopy for Primary Diagnosis in Surgical Pathology: A Multicenter Blinded Randomized Noninferiority Study of 1992 Cases (Pivotal Study).

Most prior studies of primary diagnosis in surgical pathology using whole slide imaging (WSI) versus microscopy have focused on specific organ systems or included relatively few cases. The objective of this study was to demonstrate that WSI is noninferior to microscopy for primary diagnosis in surgical pathology. A blinded randomized noninferiority study was conducted across the entire range of surgical pathology cases (biopsies and resections, including hematoxylin and eosin, immunohistochemistry, and special stains) from 4 institutions using the original sign-out diagnosis (baseline diagnosis) as the reference standard. Cases were scanned, converted to WSI and randomized. Sixteen pathologists interpreted cases by microscopy or WSI, followed by a wash-out period of ≥4 weeks, after which cases were read by the same observers using the other modality. Major discordances were identified by an adjudication panel, and the differences between major discordance rates for both microscopy (against the reference standard) and WSI (against the reference standard) were calculated. A total of 1992 cases were included, resulting in 15,925 reads. The major discordance rate with the reference standard diagnosis was 4.9% for WSI and 4.6% for microscopy. The difference between major discordance rates for microscopy and WSI was 0.4% (95% confidence interval, -0.30% to 1.01%). The difference in major discordance rates for WSI and microscopy was highest in endocrine pathology (1.8%), neoplastic kidney pathology (1.5%), urinary bladder pathology (1.3%), and gynecologic pathology (1.2%). Detailed analysis of these cases revealed no instances where interpretation by WSI was consistently inaccurate compared with microscopy for multiple observers. We conclude that WSI is noninferior to microscopy for primary diagnosis in surgical pathology, including biopsies and resections stained with hematoxylin and eosin, immunohistochemistry and special stains. This conclusion is valid across a wide variety of organ systems and specimen types.

Clinical characteristics of nonradiographic axial spondyloarthritis in Korea: a comparison with ankylosing spondylitis.

AIM: To evaluate the clinical characteristics and outcomes of nonradiographic axial spondyloarthritis (nr-axSpA) in Korean patients. METHODS: A retrospective analysis evaluated 155 patients with nr-axSpA at a single tertiary hospital between January 2001 and January 2011. Baseline characteristics and clinical courses were reviewed and compared with those of patients with ankylosing spondylitis (AS). RESULTS: The mean age at disease onset was 29.5 ± 10.8 years and 52 (33.5%) patients were female. The mean age at symptom onset was older (29.5 ± 10.8 vs 25.9 ± 9.2, respectively, P < 0.001) and the male-to-female ratio was lower (2 : 1 vs 5 : 1, respectively, P = 0.001) in patients with nr-axSpA compared with patients with AS. The proportion of females was higher among patients with late onset SpA than early-onset nr-axSpA (55.0% vs 30.1%, respectively, P = 0.029). Among 74 patients with nr-axSpA, whose follow-up duration was more than 1.5 years, 29 (39.2%) patients progressed to AS during the follow-up period. The proportion of females was lower in progressors that that of non-progressors (13.8% vs 44.4%, respectively, P = 0.010). Presence of syndesmophyte and minimal X-ray changes at baseline were frequently observed in progressors compared with non-progressors (26.7% vs 0.0%, P = 0.006 and 69.0 vs 35.6%, P = 0.005, respectively). CONCLUSIONS: The predominance of male patients is more prominent among Korean patients with SpA compared with Caucasians. Female nr-axSpA patients had late symptom onset and less progression to AS. X-ray changes at baseline were associated with radiographic progression.

Purification and characterization of a 28-kDa major protein from ginseng root.

A major protein was isolated from ginseng root (Panax ginseng C.A. Meyer) using a combination of ammonium sulfate fractionation, gel filtration chromatography, ion-exchange FPLC, and fast performance liquid chromatofocusing. Electrophoretic and gel permeation chromatographic studies revealed that the major protein, GMP, is composed of two subunits of approximately 28 kDa. During purification, it was found that the elution profiles of GMP from gel filtration chromatography were significantly different, depending on the ionic strength of buffers used. GMP in a buffer of low ionic strength was isolated as a complex with carbohydrate, which could be only dissociated at high ionic strength. Carbohydrate composition in GMP detected by gas chromatography varied, depending on the isolation method of the protein from ginseng roots. These results suggest that carbohydrates are bound non-covalently to GMP whose amino acid composition analysis showed high amounts of acidic amino acids.