Clinical utility of Abbott Alinity hq extended red blood cell parameters in differentiating ß-thalassemia trait and iron deficiency anemia.

INTRODUCTION: The objective of the study was to evaluate the performance of the Abbott Alinity hq advanced multi angle polarized scatter separation (MAPSSTM )-based optical RBC technology, for the differentiation between iron deficiency anemia (IDA) and ß-thalassemia carrier status. METHODS: Four hundred and sixty-four samples were analyzed. 228 were healthy controls, 30 were ß-thalassemia carriers, and 40 were IDA. Receiver operating characteristics analysis evaluated the performance of red cell parameters and mathematical formulas. RESULTS: RBC concentration was the most efficient discriminant (area under the curve; AUC of 0.963, Youden Index of 0.88) followed by red blood cell distribution width in size distribution (AUC of 0.960 and YI of 0.86), and red blood cell distribution width coefficient of variation (AUC of 0.924, and YI of 0.74). The absolute reticulocyte concentration showed good diagnostic efficiency, with AUC of 0.808. Hemoglobin distribution width, the %CV of directly measured cellular hemoglobin concentration, and CHCr, the average hemoglobin concentration of reticulocytes have emerged as novel discriminating parameters, with AUC of 0.749 and 0.785, respectively. The England and Fraser index was the best discriminating mathematical formula based on Youden Index of 0.91. The Ricerca, red blood cell distribution width index, Green and King, and Mentzner Index formulas also showed strong discriminative power. The Shine and Lal index, together with the recent mathematical formula M/H, (ratio of percent microcytic and hypochromic red blood cells) demonstrated moderate performance with AUC of 0.796 and 0.740, respectively. CONCLUSION: Extended red cell analysis delivered by the advanced optical technology on the Alinity hq hematology analyzer has efficient diagnostic utility in the initial discrimination of the two most common microcytic anemias: IDA and ß-thalassemia trait.

International Multicenter Validation Study of the SAGIT® Instrument in Acromegaly.

CONTEXT: The SAGIT® instrument (SAGIT) has been developed to enable accurate characterization of acromegaly disease activity. OBJECTIVE: We evaluated the ability of SAGIT to discriminate acromegaly disease control status. METHODS: This multicenter, noninterventional, prospective and retrospective, longitudinal study, conducted at academic and private clinical practice sites, included patients aged ≥ 18 years with a diagnosis of controlled (n = 109) or non-controlled (n = 105) acromegaly, assessed by clinical global evaluation of disease control (CGE-DC) questionnaire, investigator therapeutic decision, and international guidelines. Control status was not determined at baseline for 13 patients. Since 9 patients were enrolled retrospectively, all presented analyses are based on the prospective population (N = 227). Patients were assessed over a 2-year follow-up period. Classification and regression tree (CART) analyses were performed to investigate how SAGIT components at baseline (signs/symptoms [S], associated comorbidities [A], growth hormone levels [G], insulin-like growth factor 1 levels [I], tumor features [T]) discriminate between controlled and non-controlled acromegaly. RESULTS: Baseline mean subscores S, G, I, and T were significantly lower in patients with CGE-DC controlled vs CGE-DC non-controlled acromegaly. SAGIT components I and G for CGE-DC and S, A, G, I, and T for the clinician's therapeutic decision were retained by CART analyses. For international guidelines, only SAGIT component I was retained. The risk for undergoing ≥ 1 treatment change during the study was 3.44 times greater for CGE-DC non-controlled acromegaly relative to CGE-DC controlled acromegaly. CONCLUSION: The SAGIT instrument is a valid and sensitive tool to comprehensively and accurately assess acromegaly severity.

Machine Learning and Intelligent Diagnostics in Dental and Orofacial Pain Management: A Systematic Review.

Purpose: The study explored the clinical influence, effectiveness, limitations, and human comparison outcomes of machine learning in diagnosing (1) dental diseases, (2) periodontal diseases, (3) trauma and neuralgias, (4) cysts and tumors, (5) glandular disorders, and (6) bone and temporomandibular joint as possible causes of dental and orofacial pain. Method: Scopus, PubMed, and Web of Science (all databases) were searched by 2 reviewers until 29th October 2020. Articles were screened and narratively synthesized according to PRISMA-DTA guidelines based on predefined eligibility criteria. Articles that made direct reference test comparisons to human clinicians were evaluated using the MI-CLAIM checklist. The risk of bias was assessed by JBI-DTA critical appraisal, and certainty of the evidence was evaluated using the GRADE approach. Information regarding the quantification method of dental pain and disease, the conditional characteristics of both training and test data cohort in the machine learning, diagnostic outcomes, and diagnostic test comparisons with clinicians, where applicable, were extracted. Results: 34 eligible articles were found for data synthesis, of which 8 articles made direct reference comparisons to human clinicians. 7 papers scored over 13 (out of the evaluated 15 points) in the MI-CLAIM approach with all papers scoring 5+ (out of 7) in JBI-DTA appraisals. GRADE approach revealed serious risks of bias and inconsistencies with most studies containing more positive cases than their true prevalence in order to facilitate machine learning. Patient-perceived symptoms and clinical history were generally found to be less reliable than radiographs or histology for training accurate machine learning models. A low agreement level between clinicians training the models was suggested to have a negative impact on the prediction accuracy. Reference comparisons found nonspecialized clinicians with less than 3 years of experience to be disadvantaged against trained models. Conclusion: Machine learning in dental and orofacial healthcare has shown respectable results in diagnosing diseases with symptomatic pain and with improved future iterations and can be used as a diagnostic aid in the clinics. The current review did not internally analyze the machine learning models and their respective algorithms, nor consider the confounding variables and factors responsible for shaping the orofacial disorders responsible for eliciting pain.

Real-Time Diagnosis of Helicobacter pylori During Endoscopy by Gastric Juice Analysis.

EndoFaster is a high precision device for gastric juice analysis in real time during gastroscopy that enables detection of Helicobacter pylori infection and hypochlorhydric/achlorhydric conditions through the measurement of ammonium concentration and gastric pH. The high accuracy and feasibility of this technology enables a more accurate diagnosis and a reduced number of histologies, focusing the attention of the endoscopist on patients with high risk for cancer progression and limiting or avoiding biopsies on the low-risk ones while also saving costs and time.

Artificial intelligence in dermatopathology: Diagnosis, education, and research.

Artificial intelligence (AI) utilizes computer algorithms to carry out tasks with human-like intelligence. Convolutional neural networks, a type of deep learning AI, can classify basal cell carcinoma, seborrheic keratosis, and conventional nevi, highlighting the potential for deep learning algorithms to improve diagnostic workflow in dermatopathology of highly routine diagnoses. Additionally, convolutional neural networks can support the diagnosis of melanoma and may help predict disease outcomes. Capabilities of machine learning in dermatopathology can extend beyond clinical diagnosis to education and research. Intelligent tutoring systems can teach visual diagnoses in inflammatory dermatoses, with measurable cognitive effects on learners. Natural language interfaces can instruct dermatopathology trainees to produce diagnostic reports that capture relevant detail for diagnosis in compliance with guidelines. Furthermore, deep learning can power computation- and population-based research. However, there are many limitations of deep learning that need to be addressed before broad incorporation into clinical practice. The current potential of AI in dermatopathology is to supplement diagnosis, and dermatopathologist guidance is essential for the development of useful deep learning algorithms. Herein, the recent progress of AI in dermatopathology is reviewed with emphasis on how deep learning can influence diagnosis, education, and research.

Comparison among FLOTAC, Kato-Katz and formalin ether concentration techniques for diagnosis of intestinal parasitic infections in school children in an Egyptian rural setting.

The study aimed to compare the diagnostic performance of the Kato-Katz, formalin ether concentration method (FECM) and FLOTAC using Sheather's sugar solution (FS1), saturated sodium chloride (FS2) and zinc sulfate (FS7) for the diagnosis of intestinal parasites among school children, focusing on Schistosoma mansoni. Ninety fecal samples were examined using the above mentioned techniques. The overall infection rate was 87.7%. Concerning protozoa, FLOTAC (FS1 and FS2) and FECM detected nearly equal infection rates (43.3% and 44.4%, respectively) with very good agreement. Kato-Katz diagnosed the highest helminthic infection rate (57.8%) followed by FLOTAC FS7 (44.4%) and FECM showed the lowest helminthic infection rate (27.7%). As for S. mansoni, Kato-Katz showed an infection rate of 38.8% vs FLOTAC (22.2%) and FECM (11.1%). The three techniques detected the same infection rate (11.1%) with egg counts more than 72 eggs/gram of feces. The FLOTAC sensitivity and accuracy for the diagnosis of protozoa were 97% and 99%, respectively. Regarding helminths diagnosis, FLOTAC technique showed higher sensitivity (77%) and accuracy (87%) compared to FECM (48% sensitivity and 70% accuracy). Therefore, FLOTAC can be used synchronously or in replacement to other diagnostic techniques. This can strategically impact future control programmes of intestinal parasitic infections in limited resources settings.

[Use of « Reference change value ¼ in medical biology: about two examples: total PSA and hemoglobin]. / Utilisation de la « Reference change value ¼ en biologie médicale : à propos de deux exemples : PSA total et hémoglobine.

The interpretation of the variation between the results of two dosages performed on the same patient is generally quite empirical. It is usually based on the experience of the biologist or physician. Through two examples, total PSA and hemoglobin, we hoped to set up an indicator of the significance variation between results: The Reference change value or RCV to provide assistance to the validator biologist and prescriber based on measured statistical arguments. This article describes the methodology used for the RCV calculation, the formatting on analysis reports and the limitations of the system.

Continuous quality monitoring in the field: an evaluation of the performance of the Fio Deki Reader™ for rapid HIV testing in South Africa.

BACKGROUND: Rapid diagnostic tests (RDTs) are a cornerstone of HIV diagnosis and rely on good quality processing and interpretation, particularly in the era of test and treat. The Deki Reader (Fio Corporation®, Toronto, Ontario, Canada) is a portable device designed specifically for analysing RDTs and was selected for evaluation in South Africa in the context of HIV RDT analysis. METHODS: This study consisted of a laboratory evaluation and two-part field evaluation of the Deki Reader v100, covering two RDT testing algorithms, and an evaluation of the continuous quality monitoring through the Fionet™ web portal. Based on user feedback from the field evaluation, the device underwent hardware and software redesign, and the Deki Reader v200 was evaluated in the laboratory. Ethics approval for this evaluation was obtained from the University of the Witwatersrand Human Research Ethics Committee: M150160. RESULTS: The intra- and inter-device laboratory precision of the Deki Reader v100 were 98.3 and 99.2% respectively, and 99.3 and 100% for the Deki Reader v200. The laboratory concordances compared to standard-of-care reporting were 99.5 and 98.0% for the two respective models, while sensitivity and specificity were 99.5 and 99.4% for the Deki Reader V100 and 100 and 93.1% for the Deki Reader V200 respectively. Screening and confirmatory concordances in the field were 99.3 and 96.5% under algorithm 1 and 99.7 and 100% under algorithm 2. Sensitivity and specificity for the field evaluation were 99.8 and 97.7%. Overall robustness of the device was acceptable and continuous quality monitoring through Fionet™ was feasible. CONCLUSIONS: The Deki Reader provides an option for improved and reliable quality assessment for rapid diagnosis of HIV using RDTs to enhance the quality of healthcare at the point-of-care. However, the introduction of new RDTs and modification of current algorithms necessitates ongoing and agile RDT reader adjustments, which will require cost modelling to ensure sustainability of devices implemented into national HIV programs.

Clinical Accuracy of a New Rapid Assay for Fecal Calprotectin Measurement.

BACKGROUND: Fecal calprotectin is an excellent biomarker for distinguishing inflammatory bowel disease from irritable bowel syndrome and for evaluation of disease activity in Crohn's disease and ulcerative colitis. The aim of this work was to evaluate the analytical performance of a new flow immune chromatography assay by comparing it to our standardized laboratory gold standard system. METHODS: A total of 100 stool samples sent for routine calprotectin level measurements were analyzed by the Liaison XL system and the QuantOn Cal assay simultaneously using the same cutoff values for both assays. Performance of the QuantOn Cal assay was assessed by calculating sensitivity, specificity, and accuracy. RESULTS: Compared with the gold standard, the sensitivity, specificity, and accuracy of the QuantOn Cal assay were 98.7%, 76.2%, and 94.0%, respectively. Furthermore, linear correlation of calprotectin levels between the two assays were found to be significant by Pearson's correlation coefficient test (r = 0.82, p-values < 0.0001). CONCLUSIONS: The QuantOn Cal assay demonstrated good performance, both qualitative and quantitative when compared to the Liaison XL system. This novel and rapid assay is well suited for measuring fecal calprotectin as a point of care or home-based assay when laboratory services are limited or not available.

Photoacoustic imaging of cells in a three-dimensional microenvironment.

Imaging live cells in a three-dimensional (3D) culture system yields more accurate information and spatial visualization of the interplay of cells and the surrounding matrix components compared to using a two-dimensional (2D) cell culture system. However, the thickness of 3D cultures results in a high degree of scattering that makes it difficult for the light to penetrate deeply to allow clear optical imaging. Photoacoustic (PA) imaging is a powerful imaging modality that relies on a PA effect generated when light is absorbed by exogenous contrast agents or endogenous molecules in a medium. It combines a high optical contrast with a high acoustic spatiotemporal resolution, allowing the noninvasive visualization of 3D cellular scaffolds at considerable depths with a high resolution and no image distortion. Moreover, advances in targeted contrast agents have also made PA imaging capable of molecular and cellular characterization for use in preclinical personalized diagnostics or PA imaging-guided therapeutics. Here we review the applications and challenges of PA imaging in a 3D cellular microenvironment. Potential future developments of PA imaging in preclinical applications are also discussed.

Development of a Noninvasive Skin Evaluation Method for Lower Limb Lymphedema.

Background: The skin's condition is altered in lymphedema patients, and evaluating this change is important. Some noninvasive methods for evaluating skin condition have been reported, especially in upper limb lymphedema. However, evaluating the skin in lower limb lymphedema remains challenging and is often limited to palpation. We aimed to develop a noninvasive skin evaluation method for lower limb lymphedema patients. Methods and Results: Twenty-five lower limb lymphedema patients were included. Skin induration and elasticity were measured using Indentometer® IDM 400 and Cutometer® MPA580. The relationship between the properties of skin from the healthy forearm and thigh, those of the affected thigh, and age was analyzed. Predicted skin induration age (IA) and elasticity age (EA) were calculated from the forearm, whereas actual values were calculated from the thigh, and the differences (ΔIA and ΔEA) were assessed. Patients were classified according to the International Society of Lymphology clinical staging system, and the differences in ΔIA and ΔEA were analyzed among the three groups (healthy, stage I/IIa, and stage IIb/III). Skin biopsy was performed in five unilateral lower limb lymphedema patients, and the dermal elastic fiber area was determined using microscopy with Elastica van Gieson staining. ΔEA significantly increased with disease progression, but ΔIA did not change significantly. Microscopy revealed elastic fiber filamentous changes, with decreased elastic fiber areas in lymphedema-affected skin. Conclusion: To our knowledge, this is the first report to evaluate lower limb skin elasticity in lymphedema quantitatively and noninvasively. ΔEA is useful for evaluating skin condition progression in lymphedema patients.

Development of immunochromatographic device as a point-of-care tool for serodiagnosis of human strongyloidiasis cases.

Human strongyloidiasis is an important gastrointestinal disease with an estimated 30 to 100 million people infected. Prevalence is generally underestimated since many infections are asymptomatic, and traditional diagnostic tests based on parasitological examination of stool samples are not adequately sensitive. Serological tests are useful and supportive but are still only available in a reference research setting. We made an immunochromatographic test (ICT) kit for rapid serodiagnosis of human strongyloidiasis. The antigen used in the ICT kit was extracted from larvae of Strongyloides stercoralis. Diagnostic efficacy of the kit was evaluated using human serum samples from strongyloidiasis patients, healthy persons, and those with other parasitoses. When using a cutoff level of 0.5 or above, the diagnostic sensitivity, specificity, and positive and negative predictive values at the prevalence of infection of 34.4%, were 93.3%, 83.7%, 76.7%, and 95.6%, respectively. This ICT kit is easy to use at the point-of-care and a result can be obtained in 15 min. Sophisticated instruments and highly trained staff are not required. It can be used in several diagnostic and public-health settings, e.g., prevalence surveys in endemic areas, confirmation and monitoring of cure post-treatment, diagnosis and screening of infected but asymptomatic individuals, and populations "at risk" for hyperinfection syndrome or disseminated strongyloidiasis if they are given immunosuppressive treatment for other conditions.

Translating Immuno-oncology Biomarkers to Diagnostic Tests: A Regulatory Perspective.

The rapid development of effective immunotherapy using immune-checkpoint inhibitors (ICIs) against many different cancer types opened a new front in cancer treatment. Immunotherapy is undoubtedly one of the biggest breakthroughs in cancer therapy within the past decade. The identification of predictive biomarkers to select the patients most likely to respond to ICI monotherapies or emerging combination therapies remains one of the major unmet needs for the oncology community.This chapter provides an overview of existing and emerging biomarkers associated with ICI response. Additionally, using several case studies of FDA approved or authorized in vitro diagnostic oncology devices, this chapter also provides an overview of analytical and clinical validation considerations of diagnostic tests for immuno-oncology biomarkers.

An Evaluation of the Automated Cobas u 701 Microscopy Analyzer for the Routine Screening of Urine to Identify Negative Samples.

BACKGROUND: Urinalysis based on microbiological culture and manual microscopy requires expertise and is labor intensive. Automated screening could save time and improve patient management in clinical settings. METHODS: We evaluated the fully automated cobas u 701 analyzer for identifying infection-negative urine samples using 2,046 anonymized samples from a routine pathology laboratory. Samples containing ≥ 40 white blood cells (WBC)/µL and/or ≥ 100 bacteria/µL were considered positive. For microbiological cultures: pure growth of ≥ 108 colony-forming units (cfu)/L was considered significant; > 107 cfu/L was considered significant for pregnant women, children < 12 years, immune-compromised/critical care patients or patients with > 100 WBC/µL. RESULTS: The cobas u 701 analyzer identified 1,346 positive samples, giving a 65.7% culture rate. Sensitivity and negative predictive value were high (> 99%). Most replicates were within two standard deviations of the original measurement. CONCLUSIONS: The cobas u 701 analyzer is an effective screening tool for routine urinalysis and demonstrates rapid turnaround times, thus benefiting patients and clinicians.

Development and Evaluation of a New In Vivo Volume Measuring System in Mouse Tail Lymphedema Model.

Backgrounds: Secondary lymphedema is a common complication of parasitization and breast or gynecologic cancer therapy; however, options for the treatment of lymphedema are ineffective and limited. A mouse tail model is one of the most successful animal models for a lymphatic study. Lymphedema of the mouse tail is characterized by increases in the volume of the extremity caused by accumulation of tissue fluid, proliferation of fibroblasts and adipocytes, and excessive production of collagen. However, the study of lymphedema using mouse has been plagued with difficulty in directly assessing physiologic changes owing to limitations in the measurement of the mouse tail volume. Furthermore, the mouse tail volume cannot be obtained using the general in vivo measurement method such as volumetric water displacement. Methods and Results: Lymphatic researchers have used the truncated cone formula to approximate the volume as used in the numerical approximation of a cylindrical figure. Although this formula is simple and easy to use, it has difficulties of repeatability and accuracy because the measurement procedure is highly subjective and the accuracy depends on the number of divided segments on the tail. In this article, two novel volumetric measurement methods for the mouse tail model were introduced. The methods were evaluated and compared using three mice with surgically created lymphedema on the tails. Conclusions: The two continuous measuring methods showed a possibility to improve the conventional method by continuous measurement using visual and physical detecting methods. The proposed methods facilitate the extraction of longitudinal section-specific information, which can be an important clue in a lymphatic study.

Performance and usability evaluation of the INSTI HIV self-test in Kenya for qualitative detection of antibodies to HIV.

BACKGROUND: HIV testing is often undermined by lack of confidentiality, stigma, shortage of counselors and long distances to testing centers. Self-testing has the potential to circumvent these constraints. OBJECTIVE: To determine the performance and usability characteristics of the INSTI® HIV-1/HIV-2 Self-Test. METHODS: The performance evaluation was a cross sectional study and the usability a mixed methods study. For method comparison, Bioelisa HIV-1+2 Ag/Ab test was used as the reference test. When the test results were discrepant, results from Alere Determine™ HIV-1/2 and First Response HIV-1-2 Antibody tests were used for confirmation of status. RESULTS: Sensitivity of the INSTI HIV Self-Test was 98.99% (95% CI 96.05-99.75%), and specificity 98.15% (95% CI 95.63-99.23%). The concordance was therefore 97.27%. A total of 354 participants took part in the usability study. Of those, 343 (98.00%) found instructions for use easy to follow, 330 (94.29%) found the finger prick device easy to use, 303 (86.57%) were confident while performing the test, 342 (97.71%) felt result interpretation was easy, while 304 (86.86%) declared results within the recommended five minutes. Three hundred and forty two (342, 97.71%) were willing to use the test again while 344 (98.29%) would recommend the kit to a sexual partner. None of the 350 participants quit the process at any stage. Three hundred and eighteen (318, 91.12%) participants felt the test needed no further improvement. All 91 lay users correctly identified cartridges that showed positive, negative and invalid results. Only 31 (34.07%) participants correctly identified weak positive dummy test results. CONCLUSION: The excellent performance and usability characteristics of INSTI HIV-1/HIV-2 self-test make the kit a viable option for HIV self-testing. To improve the identification of weak positive results, the manufacturer should indicate on the IFU that even a faint test spot should be interpreted as positive.

Comparison of glucose-6 phosphate dehydrogenase status by fluorescent spot test and rapid diagnostic test in Lao PDR and Cambodia.

BACKGROUND: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common enzymopathy worldwide. Primaquine is the only licensed drug that effectively removes Plasmodium vivax hypnozoites from the human host and prevents relapse. While well tolerated by most recipients, primaquine can cause haemolysis in G6PD deficient individuals and is, therefore, underused. Rapid diagnostic tests (RDTs) could permit ascertainment of G6PD status outside of laboratory settings and hence safe treatment in remote areas. The performance of the fluorescent spot test (Trinity, Ireland; FST) and a G6PD RDT (Carestart, USA) against spectrophotometry were assessed. METHODS: Participants were enrolled during cross-sectional surveys in Laos and by purposive sampling in Cambodia. FST and RDT were performed during village surveys and 3 mL of venous blood was collected for subsequent G6PD measurement by spectrophotometry. RESULTS: A total of 757 participants were enrolled in Laos and 505 in Cambodia. FST and RDT performed best at 30% cut-off activity and performed significantly better in Laos than in Cambodia. When defining intermediate results as G6PD deficient, the FST had a sensitivity of 100% (95%CI 90-100) and specificity of 90% (95%CI 87.7-92.2) in Laos and sensitivity of 98% (94.1-99.6) and specificity of 71% (95%CI 66-76) in Cambodia (p < 0.001). The RDT had sensitivity and specificity of 100% (95%CI 90-100) and 99% (95%CI 97-99) in Laos and sensitivity and specificity of 91% (86-96) and 93% (90-95) in Cambodia (p < 0.001). The RDT performed significantly better (all p < 0.05) than the FST when intermediate FST results were defined as G6PD deficient. CONCLUSION: The interpretation of RDT results requires some training but is a good alternative to the FST. Trial registration clinicaltrials.gov; NCT01872702; 06/27/2013; https://clinicaltrials.gov/ct2/show/NCT01872702.

Effect of Serum Immunoglobulins on Routine Coagulation Tests: A Comparison of Coagulation Analyzers using Mechanical and Optical Clot Detection.

BACKGROUND: We previously showed that the prothrombin time (PT), but not activated partial thromboplastin time (APTT), is correlated with serum immunoglobulin level in patients with plasma cell neoplasms. METHODS: To determine if the observed effect of serum immunoglobulins on PT was reagent and/or method dependent, PT and APTT were measured in plasma samples obtained from patients referred to the Myeloma Institute using mechanical (STAR Evolution; Diagnostica Stago) and optical clot detection (ACL TOP 500 analyzer; Instrumentation Laboratory) and manufacturer provided reagents. RESULTS: A total of 97 patients were included in this study. Twelve patients had abnormal coagulation test results. An isolated prolonged PT was found in 8 patients and an isolated prolonged PTT was detected in 4 patients. CONCLUSION: The PT, but not APTT, was positively correlated with serum paraprotein level and this correlation was observed regardless of the reagents and instrumentation used to assess clot time.

Understanding of multi-level resistive switching mechanism in GeOx through redox reaction in H2O2/sarcosine prostate cancer biomarker detection.

Formation-free multi-level resistive switching characteristics by using 10 nm-thick polycrystalline GeOx film in a simple W/GeOx/W structure and understanding of switching mechanism through redox reaction in H2O2/sarcosine sensing (or changing Ge°/Ge4+ oxidation states under external bias) have been reported for the first time. Oxidation states of Ge0/Ge4+ are confirmed by both XPS and H2O2 sensing of GeOx membrane in electrolyte-insulator-semiconductor structure. Highly repeatable 1000 dc cycles and stable program/erase (P/E) endurance of >106 cycles at a small pulse width of 100 ns are achieved at a low operation current of 0.1 µA. The thickness of GeOx layer is found to be increased to 12.5 nm with the reduction of polycrystalline grain size of <7 nm after P/E of 106 cycles, which is observed by high-resolution TEM. The switching mechanism is explored through redox reaction in GeOx membrane by sensing 1 nM H2O2, which is owing to the change of oxidation states from Ge0 to Ge4+ because of the enhanced O2- ions migration in memory device under external bias. In addition, sarcosine as a prostate cancer biomarker with low concentration of 50 pM to 10 µM is also detected.

From XE-2100 to XN-9000, from SIS Standard to GFHC recommendations for slide review: potential impact on review rate and turnaround time.

In 2014, we moved from XE-2100 with Standard SIS rules to XN-9000 with GFHC recommendations for slide review. The aim of our study was to evaluate the potential impact of the new Sysmex® automation with implementation of GFHC rules on our review rate, turnaround time (TAT), workload and on CD34+ stem cells enumeration. We conducted a retrospective observational study from September 2013 through August 2014, in CHU Dinant Godinne UCL Namur. With the GFHC recommendations and the new Sysmex® automation, we significantly reduced our review rate by nearly 30% considering all units (35.8% vs 25.9%), and up to 73% when excluding oncology haematology department (17.5% vs 4.7%). We also noticed significantly shorter TAT for CBC measurement (median for routine samples: 76.4 vs 56.8 minutes, p < 0.0001; urgent samples: 18.9 vs 15.2 minutes, p = 0.023), slide review (median: 54.9 vs 36.4 minutes, p < 0.0001) and CD34+ enumeration performed on peripheral blood samples (p < 0.001) and on apheresis samples (p = 0.026). In conclusion, GFHC recommendations implemented on the new Sysmex® XN-9000 resulted in a significant reduction in review rate and in TAT. This is particularly of interest for the clinicians with subsequent potential faster patient management.