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Comments on Point of Care D-Dimer Testing in the Emergency Department: A Bioequivalence Study
Suzanne Ekelund,Eric Heilmann 대한진단검사의학회 2014 Annals of Laboratory Medicine Vol.34 No.1
Dear Editor We read with interest the article “Point of Care D-Dimer Testing in the Emergency Department: A Bioequivalence Study” by Per- veen et al. published in Ann Lab Med 2013;33:34-38 [1]. In this article, the authors compared the performance of the D-di- mer assays on the AQT90 FLEX analyzer (Radiometer Medical Aps, Åkandevej, Denmark) and the VIDAS analyzer (bioMérieux SA, RCS Lyon, France). The study had 2 objectives: 1. To determine any significant difference between the 2 assays in the time from sample draw until result. 2. To quantify the agreement between the results obtained by the 2 assays when performed on samples from the same sample draw. A pilot study determined that a minimum sample size of 100 patients was required for the first objective. The main study in- cluded 104 patients and revealed a significant difference be- tween the 2 assays in the time from sample draw until result. For the second objective, determining the agreement between the results obtained by the 2 assays, the pilot study did not de- termine a minimum sample size; however, the data from the 104 patients were used in this regard. Additionally, imaging re- sults were available for 40 patients in the study sample. Among these, 7 patients had positive imaging and 33 patients had negative imaging results. Only these 40 imaging results were used to calculate the sensitivity and the specificity for the 2 as-says. Therefore, we agree with the authors when they state that the sample size was not large enough to compare the clinical performance of both assays with respect to venous thrombo- embolism.
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Stefan Schwan,C. Ludtka,A. Friedmann,T. Mendel,H. J. Meisel,A. Heilmann,I. Kaden,F. Goehre 한국조직공학과 재생의학회 2017 조직공학과 재생의학 Vol.14 No.6
Autologous disc cell transplantation (ADCT) is a cell-based therapy aiming to initiate regeneration of intervertebral disc (IVD) tissue, but little is known about potential risks. This study aims to investigate the presence of structural phenomena accompanying the transformation process after ADCT treatment in IVD disease. Structural phenomena of ADCT-treated patients (Group 1, n = 10) with recurrent disc herniation were compared to conventionally-treated patients with recurrent herniation (Group 2, n = 10) and patients with a first-time herniation (Group 3, n = 10). For ethical reasons, a control group of ADCT patients who did not have a recurrent disc herniation was not possible. Tissue samples were obtained via micro-sequestrectomy after disc herniation and analyzed by micro-computed tomography, scanning electron microscopy, energy dispersive spectroscopy, and histology in terms of calcification zones, tissue structure, cell density, cell morphology, and elemental composition. The major differentiator between sample groups was calcium microcrystal formation in all ADCT samples, not found in any of the control group samples, which may indicate disc degradation. The incorporation of mineral particles provided clear contrast between the different materials and chemical analysis of a single particle indicated the presence of magnesium-containing calcium phosphate. As IVD calcification is a primary indicator of disc degeneration, further investigation of ADCT and detailed investigations assessing each patient’s Pfirrmann degeneration grade following herniation is warranted. Structural phenomena unique to ADCT herniation prompt further investigation of the therapy’s mechanisms and its effect on IVD tissue. However, the impossibility of a perfect control group limits the generalizable interpretation of the results.
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