Diagnostic Instrument Research Articles

Taste Abnormalities Emerging during Anti-Myeloma Therapies Including GPRC5D x CD3 Bispecific Antibody Talquetamab

Background: Dysgeusia is a common, yet underexamined side-effect of anti-tumor therapy. In multiple myeloma (MM) it has received more attention recently with the introduction of talquetamab, a bispecific T-cell engaging antibody targeting GPRC5D. Although GPRC5D expression is mainly restricted to plasma cells, cornified tissues including some cells in the oral cavity also express GPRC5D. This expression could be associated with changes in taste perception in patients undergoing therapy with talquetamab. Abnormalities in taste perception can negatively affect patients' quality of life and nutritional status, and in some cases may even require treatment interruption with a potential negative impact on outcome. Our objective was to determine the quality and severity of dysgeusia and its impact on quality of life in MM patients treated with talquetamab. To take our findings into perspective, we compared these results to patients who received high-dose melphalan, a treatment which goes along with taste abnormalities frequently (positive controls) as well as with BCMA targeting bispecific antibodies for which taste abnormalities have not been reported thus far (negative controls). Methods: We used a validated diagnostic instrument, “Taste-Strips”, to objectively assess gustatory performance in all five qualities of taste (sour, sweet, bitter, salty and umami). Further, we used a validated diagnostic instrument, “Sniffin' Sticks Identification Test 16”, to identify possible changes in olfactory perception. In addition, we used a questionnaire to document subjectively perceived changes in taste perception, oropharyngeal symptoms, nutritional status, individual diet-related symptoms, therapy compliance and quality of life. Results: We enrolled 55 patients with MM in our study. Seven (13%) patients were treated with a GPRC5D bispecific. Twenty-one (38%) patients received a BCMA bispecific and 27 (49%) patients received melphalan. All patients receiving a GPRC5D bispecific responded to treatment but also reported a significantly impaired overall taste sensation. They were significantly more likely to report loss of appetite ( P<0.01; Fisher test), loss of bodyweight (GPRC5D bispecifics: -4.3kg (SD4.6); BCMA bispecifics: -0.3kg (SD2.0); melphalan: -2.8kg (SD2.8)) and dry mouth ( P<0.01; Fisher test). Futhermore, patients receiving a GPRC5D bispecific reported a severe to very severe subjectively perceived level of impairment in quality of life due to subjectively perceived changes in gustatory perception of sweet, bitter, umami, and salty flavors (in descending order; P<0.01; Fisher test) and dry mouth ( P<0.01; Fisher test) than patients receiving BCMA bispecifics or melphalan. Forty-eight% of patients on BCMA bispecifics and 59% of patients on melphalan reported some level of dysguesia, which was objectified by “Taste-strips”-testing, highlighting the overall underreported frequency of this side effect. Of note, melphalan patients reported nausea and vomiting significantly more frequently than the other groups ( P<0.01; Fisher test). Objective olfactory testing did not show significant differences in olfactory perception between patients who received GPRC5D bispecifics, BCMA bispecifics or melphalan. Conclusion: Our results demonstrate the importance of monitoring taste perception and quality of life changes caused by cancer therapies. The frequency of dysgeusia is underreported in MM patients receiving BCMA bispecifics and melphalan therapy. For optimal nutritional management, hospitals should consider patients' individual taste preferences.

Exploring the Potential of Convolutional Neural Networks in Healthcare Engineering for Skin Disease Identification

Skin disorders affect millions of individuals worldwide, underscoring the urgency of swift and accurate detection for optimal treatment outcomes. Convolutional Neural Networks (CNNs) have emerged as valuable assets for automating the identification of skin ailments. This paper conducts an exhaustive examination of the latest advancements in CNN-driven skin condition detection. Within dermatological applications, CNNs proficiently analyze intricate visual motifs and extricate distinctive features from skin imaging datasets. By undergoing training on extensive data repositories, CNNs proficiently classify an array of skin maladies such as melanoma, psoriasis, eczema, and acne. The paper spotlights pivotal progressions in CNN-centered skin ailment diagnosis, encompassing diverse CNN architectures, refinement methodologies, and data augmentation tactics. Moreover, the integration of transfer learning and ensemble approaches has further amplified the efficacy of CNN models. Despite their substantial potential, there exist pertinent challenges. The comprehensive portrayal of skin afflictions and the mitigation of biases mandate access to extensive and varied data pools. The quest for comprehending the decision-making processes propelling CNN models remains an ongoing endeavor. Ethical quandaries like algorithmic predisposition and data privacy also warrant significant consideration. By meticulously scrutinizing the evolutions, obstacles, and potential of CNN-oriented skin disorder diagnosis, this critique provides invaluable insights to researchers and medical professionals. It underscores the importance of precise and efficacious diagnostic instruments in ameliorating patient outcomes and curbing healthcare expenditures.

Effect of delayed cord clamping on cerebral hemodynamics in preterm infants

BackgroundUnstable cerebral hemodynamics is an important cause of intracranial hemorrhage in premature infants. The increased blood flow of delayed cord clamping (DCC) compared to immediate cord clamping (ICC) is equivalent to 1/3-1/4 of newborn blood volume. Our objective was to assess whether the increased blood flow causes fluctuations in cerebral blood flow and how. MethodsThis experiment was a prospective, observational study. Neonatologists selected preterm infants eligible for inclusion and exclusion, and divided them into DCC group and ICC group according to the way of umbilical cord ligation performed by obstetrics department, and matched them 1:1 according to gestational age. The peak systolic velocity （PSV) ，end diastolic velocity (EDV)，and resistance index (RI) of middle cerebral artery was measured by Mindray M9 color ultrasonic diagnostic instrument within 1 h, 24±1 h, 48±1 h, 72±1 h, respectively. ResultsThere was no significant difference in PSV, EDV and RI in middle cerebral artery between DCC group and ICC group (P > 0.05). There were no significant differences between groups and time (P > 0.05). The hemoglobin and hematocrit in DCC group were higher than those in ICC group within 2 h after birth (P < 0.05). (P > 0.05). ConclusionDCC can increase hemoglobin and hematocrit in preterm infants, but does not cause cerebral blood flow fluctuation within a certain range. DCC is a safe method of placental transfusion.

Medmont Meridia™: Much More Than a Corneal Topographer.

In recent years, advanced diagnostic instruments have become widely available in optometric practices, offering various functions that optimize clinical information gathering. This article focuses on the Medmont Meridia™, a state-of-the-art multipurpose diagnostic device with corneal topography and cutting-edge features. Corneal topography is pivotal in the early diagnosis of corneal disorders, determining baseline ocular surface assessment, helping in contact lens fitting, and monitoring ocular health over time. The Medmont Meridia boasts Placido-disc-based imaging with extensive corneal coverage. Furthermore, the Meridia accurately measures the horizontal visible iris diameter, pupil diameter, and palpebral fissure width, which assists in making contact lens parameter decisions. Additionally, it offers sagittal height data for scleral lens design and first lens selection, streamlining the fitting process. Beyond its topography capabilities, the Meridia excels as a comprehensive dry eye assessment tool. With features like tear meniscus height, tear film surface quality, and meibography capabilities, it aids in diagnosing dry eye and monitoring its progression. The device also provides customizable dry eye reports with integrated grading scales and questionnaires, making dry eye management, patient education, and compliance more accessible. In conclusion, the Medmont Meridia consolidates a multitude of examination tools in a single instrument, enhancing practice efficiency and elevating patient care and communication. Its versatility and accuracy make it an invaluable asset in optometric practices worldwide.

Development of a five-tier diagnostic test instrument to identify the level of understanding and misconceptions on the subject of equilibrium of rigid bodies at SMA Negeri 9 Jambi City

This research aims to identify students' misconceptions regarding website-based rigid body equilibrium material at SMA Negeri 9, Jambi City. This research focuses on developing a diagnostic paper-based test (PBT) in the form of a website. This research method is R&amp;D (Research and Development) development with the ADDIE (analysis, design, development, implementation, evaluation) development model. However, this research has only reached the implementation stage. The instruments used in the research were the results of media questionnaires, instrument validation, and student responses. The research results are as follows: First, Dreamweaver, MySQL, and HTML can be used in website development. Second, the results of this product development can be used because they have been validated by media experts, namely Validator One and Validator 2, to determine the feasibility of the product being developed. Thus, a five-tier diagnostic test in the form of a paper-based test has been successfully developed into a website with a suitable category for identifying misconceptions among students regarding the equilibrium of rigid bodies.

PENGEMBANGAN INSTRUMEN TES DIAGNOSTIK THREE-TIER PADA PEMBELAJARAN SISTEM EKSKRESI BERDIFERENSIASI

Diagnostic tests are strategies used in differentiated learning to adjust the course of learning based on students' existing learning needs. There are several types of diagnostic tests, including the three-tier diagnostic test. Explaining a three-tier diagnostic test instrument that is suitable for use in studying differentiated excretory systems is the aim of this research. The research method is research &amp; development with 4D as a development model. 33 students of class The instrument developed consisted of 20 questions which were then tested for content and empirical validity. Based on the results of validity testing, an average of 92% was obtained, which shows that the instrument is very valid. Empirical validity testing obtained 13 valid questions and 7 invalid questions. In addition, a value of 0.732 was obtained from the reliability testing results, which shows that the instrument developed is reliable. Based on the results of testing the level of difficulty of the questions, it was found that there were 3 easy questions, 10 medium ones, and 7 difficult ones, and from the results of testing the differentiating power of the questions it was found that the questions were not good because they had a negative value of 1, bad had 3, fair and good each had 7, respectively. and very well collected 2. Based on content and empirical validity testing, the results showed that only 13 questions could be used in the differentiated excretion learning system, while the other 7 questions could not be used.

Burns and posttraumatic stress disorder: What's being done

Burn injuries can be a life-shattering event causing significant physical impairment. Burn survivors suffer from changes in appearance and body function. The perception of burn injuries has transformed from permanent disability to now rehabilitative. Through ever-evolving technology coupled with enhanced clinical assessments, burn injuries are seen through the lens of being more than physical. This article aims to keep non-burn experts abreast of what is being done to address the psychological effects of burn injuries. This article discusses different screening and diagnostic instrumentation for assessing posttraumatic stress disorder as well as treatment options for clinicians encountering burn survivors. Early detection of posttraumatic stress disorder symptomology and aggressive treatment are essential in improving the quality of life of those who have suffered a burn trauma.

RETRACTED: Deep learning network (DL-Net) based classification and segmentation of multi-class retinal diseases using OCT scans

The most frequent cause of blindness in industrialized nations is age-related macular degeneration (AMD), particularly in persons over 60. In recent years in this field, three key factors have led to an increase in the workload of experts and the healthcare system: 1) population aging worldwide prevalence, 2) AMD's chronic nature, and 3) more widespread usage of the retinal optical coherence tomography (OCT) imaging technology. The establishment of fully automated diagnosis systems has recently been made possible by recent developments in the deep learning field. The main objective of the research is to develop a new deep learning-based model using OCT images. The performance for classification and segmentation of retinal diseases is improved by the proposed model through effectively capturing inter-scale features and combining these features using convolutional blocks. Then, we classify volumetric OCT images via a new deep learning-based model. For multi-class classification and segmentation of ocular diseases, the OCT scans of the human eye are used in this research to demonstrate a Deep Learning Network (DL-Net) model by automatically recognizing normal, diabetic macular edema (DME), choroidal neovascularization (CNV), AMD, and drusen images. This research introduces the Modified ResNet-50 approach and Image Processing for multiple OCT image classification. This research presents an efficient diagnostic technique for image segmentation based on a Bi-LSTM-based deep recurrent convolutional neural network (DRCNN). The modified SqueezeNet model analyzes the volumetric segmentation of OCT images. The volumetric publicly available datasets are used to analyze the proposed model. The proposed multi-scale structure model outperforms several well-known OCT classification and segmentation frameworks. 99.76% accuracy is achieved by the proposed model respectively. In healthcare settings, the proposed methodology can be used as a diagnostic instrument to help medical experts make better-diagnosing decisions, as shown by the encouraging proposed architecture's qualitative evaluations and quantitative results by generating a confusion matrix.

Computed tomography of intracranial hemorrhages in injured infants and little children aged from 0 months till 3 years

Introduction. The most common reason for young children to seek medical aid in hospitals is head injuries caused by falls from a small height. Currently, computed tomography (CT) of the head is a preferred method for rapid detection of bone fractures and brain injuries in children.Purpose. To investigate specific features of CT signs of intracranial hemorrhages in children with TBI under three years of age.Material and methods. 1334 children aged less than one month to 3 years with isolated TBI were examined at CT scanning. 128-slice scanner "Ingenuity CT" (Philips) was used for the examination. Scanning of the area of interest (head + cervical spine) was performed at the lowest possible values to reduce radiation exposure, including the O-MAR program, with step 0.75 mm at slice thickness 0.75 mm; reconstruction interval was 2 mm. The voltage applied to an X-ray tube during scanning (kV), current strength and time (mAS) were selected depending on patient's weight and age. The effective dose range was from 1.27 mSv to 1.91 mSv.Results. In 510 out of 1334 injured children (38.2%), there were traumatic injuries of various degree, from uncomplicated cephalohematomas and linear fractures to massive intracranial hematomas and total cerebral edema; the rest 61.8% (n=824) had concussion. The performed CT scanning revealed that 87.84% (448/510) children had skull fractures, of which only 18.3% (82/448) had “isolated skull fractures”; the others (366 = 81.7%) had accompanying intracranial injuries.Discussion. Pathological changes in children, aged 0 mon-3 years, after TBI are significantly different of those in children of other age groups. CT is the basic primary diagnostic instrument and should be used in all children with TBI no later than the first three hours. Radiation diagnostics play a key role in putting a correct diagnosis, if physicians use the information obtained at CT and know TBI mechanism in infants and little children.Conclusion. CT is an imaging method of choice for acute TBI in little children to accurately identify and therefore treat intracranial lesions. In addition, CT is an effective diagnostic tool in detecting secondary traumatic injuries.

Desenvolvimento de pronomes clíticos em produções escritas iniciais

This study investigates the development, in production, of clitic pronouns in the initial phases of writing by primary school children. Based on a corpus of 272 narrative texts produced by 136 children at the beginning of second grade and at the beginning of third grade, as part of a writing task which integrates the diagnostic instrument of the Preventive Intervention Project for Learning to Read and Write (PIPALE), the written production of clitics in each moment is compared. We conclude that there is development in clitic production between these two moments. The presence of clitics in the children’s written productions, as well as its distribution and function, can, thus, be taken as a developmental marker of competencies of writing composition.

Lab-on-a-chip – The advent of instantaneous diagnosis for a plethora of diseases

A lab-on-a-chip (LOC) is a device that facilitates the incorporation of a concatenation of various laboratory functions on a unique integrated circuit. The size of this instrument is merely a few millimeters to centimeters designed to attain automation and high-throughput screening. Microfluidic systems used in LOC devices allow the manufacture of millions of microchannels, each measuring mere micrometers. These microchannels enable control of fluids in infinitesimal quantities for a variety of diagnoses. Several labs on a chip have been commercialized in recent times for fundamental procedures, including glucose monitoring, human immunodeficiency virus, early tumor detection, and cardiac diagnostics. The LOC integrates microfluidics, nanosensors, micro-electrics, and biochemistry on one device. The advantages of the chip include its sustainability and cutback wastage. It expedites a decline in reagent costs and requires minimal sample volumes. The analysis and response are faster and the response is better controlled by equipping micro-channels. Countries with exiguous healthcare are in the face of adversity due to increased fatality rates from infectious diseases that are often curable in developed nations. In certain circumstances, impoverished healthcare clinics have the medications requisite to treat a specific condition but are in dearth of the diagnostic equipment needed to determine, in which individuals are in need of the medications. This is where the role of LOC as a potent novel diagnostic instrument would benefit humankind in the nearest future, according to eminent researchers. This article highlights the applications of LOC in a miscellany of fields, its advantages, feasible means to overcome the drawbacks, and the propitious prospects of this technology.

Creating patients: how technology and measurement approaches are misused in diagnosis and convert healthy individuals into TMD patients

The advances made in recent years regarding technological approaches to medical and dental diagnosis are impressive. However, while those tools, procedures, and instruments may produce an improved clinical diagnosis or discover a new disorder, they also can be misused and misinterpreted in various ways. In the field of temporomandibular disorders (TMDs), the very nature of those conditions is similar to common orthopedic problems elsewhere in the body. Yet, beyond imaging of the affected areas, there have been few important new technological approaches to augment the traditional history and examination for a sufficient diagnosis of such problems. The traditional approach is exemplified by the Diagnostic Criteria for Temporomandibular Disorders, which has high inter-examiner reliability and diagnostic validity; translations into over 20 languages allow for widespread use. In contrast and unfortunately, the TMD field is replete with a variety of so-called diagnostic instruments and procedures, which have not been tested for diagnostic validity; these instruments and procedures, through misuse, are capable of complicating a true diagnosis of patients who present with symptoms, while also creating new patients by finding so-called abnormalities in healthy subjects. This paper discusses those technological approaches and their misuse with respect to TMD diagnosis from a critical viewpoint, and the authors argue that there are significant risks for patients if their uncritical implementation becomes accepted and widespread. Therefore, dentists are encouraged to reject the proposed application of such technological approaches to diagnosis of the stomatognathic system.

Assessing limb apraxia after ischemic stroke: validation of the Chinese version of the diagnostic instrument for limb apraxia-short version (DILA-S) classic subtests

ABSTRACT Objective This study aimed to translate and validate the Chinese version of the Diagnostic Instrument for Limb Apraxia-Short Version (DILA-S) classic subtests in Chinese patients after ischemic stroke. Methods The DILA-S was translated and adapted for use in Mandarin-speaking Chinese patients. Internal consistency, test-retest reliability, dimensionality, convergent validity, divergent validity, and concurrent validity were tested. Results A total of 112 ischemic stroke patients were included. The internal consistency (Cronbach’s alpha 0.85 ~ 0.92) and test-retest reliability (ICC 0.88 ~ 0.93) were found satisfactory. Exploratory factor analysis obtained two factors for the imitation subtests and the execution scale of the pantomime of tool use. Convergent validity was supported by strong correlations (ρ > 0.7) between the scores of the DILA-S subtests and the LOTCA motor praxis subscale. Divergent validity was acceptable for weak to moderate correlations (ρ ranged from −0.25~ −0.41) between the scores of the DILA-S subtests and the NIHSS. Concurrent validity was supported by strong correlations (ρ > 0.7) between the scores of the DILA-S subtests and the MoCA, as well as strong correlations (ρ > 0.6 < 0.7) between the scores of the DILA-S subtests and the BI. Conclusion The Chinese version of the DILA-S classic subtests demonstrated satisfactory psychometric properties for assessing limb apraxia in Chinese patients after ischemic stroke.

Experiencing social tension in Ukrainian society: a diagnostic instrument

Introduction. Social tension is a condition that develops in a society as a result of an uncertain situation that changes the usual and comfortable life of people and has a real or imagined restrictive or threatening character. Experiencing social tension is an important factor in the social activity of individuals and social forces that are aimed at improving the current situation and harmonizing relations in society. The aim of the study was to develop a psychodiagnostic instrument for measuring the level of experiencing social tension in Ukrainian society. Methods. The Social Tension in Society (T. Mykhno, O. Savchenko) was proposed and the necessary measures were taken to check its validity, reliability and statements discrimination. To check convergent validity, standardized questionnaires "Personal Resources" (O. Savchenko, S. Sukach) and "Stability of Mental Health - Short Form (MHC-SF-UA)" (E. Nosenko, A. Chetveryk-Burchak) were used. Results. Psychological markers of social tension in society were determined. The validity of the scales for measuring experiences, high reliability-consistency and statements discrimination of the instrument were confirmed. The instrument scales standardization was conducted on a sample of young people (N=129) and its test norms were formed according to the stanine scale. Conclusions. The Social Tension in Society is a pilot project and the validation of its scales is well underway. It is planned to conduct a reliability-stability check according to the test-retest scheme and to form test norms for different age groups.

The latest developments of microwave diagnostics for high temperature plasma in ELVA-1 company

For nearly 30 years, we have been designing and supplying instruments for microwave diagnostics of high temperature plasma. This report provides a description of the mm-wave components we utilize to make diagnostics within the frequency range of 26–330 GHz. While most of these components are standard and readily available on the market, we have also developed a few specific devices that simplify the architecture of our instruments. The article includes descriptions of these devices: Backward Wave Oscillators (BWO), Impact Ionization Avalanche Transit-Time diode (IMPATT) sources, IMPATT Active Frequency Multipliers (AFM), Noise Sources, and Electronically Controlled Attenuators. Furthermore, we offer an overview of the microwave plasma diagnostics we have supplied, including ECE radiometers operating at 50–220 GHz, as well as heterodyne interferometers operating at fixed frequency 94 GHz, 140 GHz, or 300 GHz. We also discuss methods employed to ensure measurement stability and present the achieved results. The advent of the new era of modern Monolithic Microwave Integrated Circuit (MMIC) based devices has brought forth exciting possibilities. As an example, we discuss the upgrade of the low noise receiver for the Collective Thomson Scattering (CTS) diagnostic at Wendelstein 7-X, which enables ion temperature measurements in the plasma core [1]. Lastly, we provide a list of MMIC-based devices that are currently available and have garnered the attention of the plasma diagnostics community.

Development and validation of a nomogram-assisted tool to predict potentially reversible cognitive frailty in Chinese community-living older adults.

Cognitive frailty (CF) is a complex and heterogeneous clinical syndrome that indicates the onset of neurodegenerative processes and poor prognosis. In order to prevent the occurrence and development of CF in real world, we intended to develop and validate a simple and timely diagnostic instrument based on comprehensive geriatric assessment that will identify patients with potentially reversible CF (PRCF). 750 community-dwelling individuals aged over 60years were randomly allocated to either a training or validation set at a 4:1 ratio. We used the operator regression model offering the least absolute data dimension shrinkage and feature selection among candidate predictors. PRCF was defined as the presence of physical pre-frailty, frailty, and mild cognitive impairment (MCI) occurring simultaneously. Multivariate logistic regression was conducted to build a diagnostic tool to present data as a nomogram. The performance of the tool was assessed with respect to its calibration, discrimination, and clinical usefulness. PRCF was observed in 326 patients (43%). Predictors in the tool were educational background, coronary heart disease, handgrip strength, gait speed, instrumental activity of daily living (IADL) disability, subjective cognitive decline (SCD) and five-times-sit-to-stand test. The diagnostic nomogram-assisted tool exhibited good calibration and discrimination with a C-index of 0.805 and a higher C-index of 0.845 in internal validation. The calibration plots demonstrated strong agreement in both the training and validation sets, while decision curve analysis confirmed the nomogram's efficacy in clinical practice. This tool can effectively identify older adults at high risk for PRCF, enabling physicians to make informed clinical decisions and implement proper patient-centered individual interventions.

B-018 Compact all in one, Fully Automated Molecular Diagnostic System “ExiStation™ FA 96” in 100 minutes

Abstract Background Traditional PCR method’s instruments are discrete the processes of sample collection, nucleic acid(NA) extraction, and NA amplification. As human labor is required between the instruments, there is a risk of human error, infection and contamination. Biosafety facilities such as biosafety cabinet, level D protective clothing, and negative pressure facilities are required for ensuring safe testing. To improve the testing environment, the molecular diagnostic market has developed and started using automated instruments, though, which take up larger space and take longer time to test. As a result, it is necessary to develop instrument that takes up less space and reduces testing time to a minimum, so, space and time can be saved. Methods In this study, we developed an automated systematic genetic diagnostic instrument. In order to carry out the entire process within one integrated instrument, automatic mechanism of de-capping and re-capping of sample tube, sample aspiration, and sample transfer were developed. The system also includes integrated key steps of NA extraction and amplification (qPCR). We developed a primer/probe design technology that can accurately detect viruses with high accuracy in performing PCR tests using extracted genes, as well as precision temperature control algorithm and optimized real-time nucleic acid amplification using reverse transcription enzymes and gene amplification enzymes. In order to carry out all these functions within one device, we maximized user convenience by developing software for instrument operation, result analysis, and a Graphic User Interface for automation Results ExiStation™ FA 96 is largely composed of sample processing, gene extraction, and gene amplification (qPCR). (Photo to be in poster) Sample Processing automatically opens a cap of sample tube, then transfer a required quantity of sample to cartridge. While opening the cap, the barcode attached to sample tube is automatically identified and the information required for a test is entered. After sampling, the cap is automatically re-capped and placed back in the sample tube rack. When collecting samples, it measures the sample level in the tube and indirectly check the viscosity by detecting the pressure inside the tip, minimizing aspiration errors. The Extraction step performs the function of extracting genes. It consists of three modules of 32 wells, and the number of samples can even be adjusted in eight units, so the instrument can be operated flexibly upon the number of samples requested. Then, the qPCR step follows. The ExiStation™ FA 96 setup allows simultaneous testing of up to 20 targets for 94 samples in approximately 100 min. The instrument is equipped with a HEPA filter and UV lamp to maintain clean, and since the sample tubes are inserted directly on the instrument, it is no of necessity or save the costs such as of negative pressure rooms, biosafety cabinet, and level D protective clothing. Conclusion ExiStation™ FA 96 is a fully automated molecular diagnostic test instrument that can quickly and accurately process large amounts of samples, while greatly reducing user risks and shortening molecular diagnostic test time.

Dimensional profiling of psychopathology in children and adolescents based on the K-SADS-PL and an analysis of the construct validity of two ADHD symptom dimensions

Objectives The traditional view on psychiatric disorders as categorical and distinct is being challenged by perspectives emphasizing the relevance of dimensional and transdiagnostic assessment. However, most diagnostic instruments are based on a categorical view with a threshold-approach to disease classification. Methods We here describe algorithms for dimensionalizing the psychopathological ratings of the widely used diagnostic interview for children and adolescents, the Kiddie-Schedule for Affective Disorders and Schizophrenia – Present and Lifetime Version (K-SADS-PL). We further evaluate the criterion-related construct validity of the dimensionalized attention-deficit/hyperactivity disorder (ADHD) scales using Rasch models in a sample of 590 children (mean age 10.29 (.36), 49% girls). Results The algorithms generate scores of current symptom load, i.e., the sum of clinician-rated symptoms within each disorder assessed with the interview. We found support for counting symptoms of inattention and hyperactivity/impulsivity, respectively, but not for a single combined ADHD scale. Conclusions The algorithms constitute an initial step in creating a framework for clinician-rated dimensional analyses of symptoms derived from the K-SADS-PL, but future studies are needed to further evaluate the construct validity of the remaining scales and the reliability and clinical utility of the method. We believe that our proposed algorithms offer a novel method of dimensional psychopathological assessment, which can be applied in multiple branches of child and adolescent psychiatry.

A-049 Inter-assay Variation of Insulin-like Growth Factor-1 Remains an Issue

Abstract Background Human insulin-like growth factor-1 (IGF-1) is the main mediator of the somatotropic effects of growth hormone (GH). Accurate measurement of IGF-1 is required for the diagnosis and management of GH secretion disorders. Several commercial vendors and laboratories have standardized their IGF-1 assays to the WHO International Standard 02/254. This standardization does not prohibit the existence of significant inter-assay variability in IGF-1 measurements. Such concentration variance can lead to inaccurate patient case decision making. The IGF-1 testing performed in our laboratory was recently migrated from an Immulite 2000 platform to a CobasPro system. This shift in vendor necessitated an investigation of the inter-assay variability between these standardized tests. This relative variance was established through a validation of the analytical performance of the CobasPro IGF-1 assay. Methods Reportable range, intra-day precision and accuracy of IGF-1 measurements using the CobasPro (Roche Diagnostics) system were determined. Patient correlation studies between the CobasPro and an Immulite 2000 (Siemens Healthcare Diagnostics) instrument was also performed. The concentration of IGF-1 in a subset of these correlation study specimens was also quantified by liquid chromatography mass spectrometry (LC-MS) assays from two different reference laboratories. Results The CobasPro assay had a verified linear range of 7–1443 ng/mL (R2 = 0.9998, slope = 0.9915). At IGF-1 concentrations of 54 and 345 ng/mL the intra-day precision (%CV, N = 10) of the CobasPro assay did not exceed 0.9%. Patient specimen correlations between the CobasPro and Immulite 2000 assays showed significant bias (Deming regression: y = 1.543x − 48.61, N = 128, R = 0.9641). This method bias was exacerbated at Immulite 2000 derived IGF-1 concentrations &amp;gt;100 ng/mL (Deming regression: y = 1.662x − 84.29, N = 93, R = 0.9492, CobasPro range = 77–910 ng/mL, Immulite 2000 range = 103–539 ng/mL). Patient specimen correlations between the CobasPro and LC-MS assay from reference laboratory A showed a positive bias (Deming regression: y = 1.375x − 64.5, N = 19, R = 0.9210). An analogous correlation with reference laboratory B demonstrated a higher level of concordance (Deming regression: y = 1.005x + 10.2, N = 16, R = 0.9499). The CobasPro and Immulite 2000 assays both produced acceptable result when challenged by multiple external quality assurance (EQA) specimens provided by the College of American Pathologists (CAP). However, the observed relative trends in IGF-1 concentrations from these challenges were opposite to our observations with authentic patient specimens. The CobasPro assay consistently produced lower IGF-1 concentrations relative to the Immulite 2000 assay for these EQA specimens. Conclusion The CobasPro IGF-1 assay offered acceptable analytical performance. Although both assays were traceable to a reference standard, a significant positive concentration bias was observed between the CobasPro and Immulite 2000 assays. Standardization efforts have not eliminated inter-assay IGF-1 variability. A careful evaluation of the impact of this variance on the diagnosis and management of GH deficiency and acromegaly must be considered when IGF-1 testing platforms are changed.

The Protocol of Ultrasonic Backscatter Measurements of Musculoskeletal Properties.

This study aims to introduce the protocol for ultrasonic backscatter measurements of musculoskeletal properties based on a novel ultrasonic backscatter bone diagnostic (UBBD) instrument. Dual-energy X-ray absorptiometry (DXA) can be adopted to measure bone mineral density(BMD) in the hip, spine, legs and the whole body. The muscle and fat mass in the legs and the whole body can be also calculated by DXA body composition analysis. Based on the proposed protocol for backscatter measurements by UBBD, ultrasonic backscatter signals can be measured in vivo, deriving three backscatter parameters [apparent integral backscatter (AIB), backscatter signal peak amplitude (BSPA) and the corresponding arrival time (BSPT)]. AIB may provide important diagnostic information about bone properties. BSPA and BSPT may be important indicators of muscle and fat properties. The standardized backscatter measurement protocol of the UBBD instrument may have the potential to evaluate musculoskeletal characteristics, providing help for promoting the application of the backscatter technique in the clinical diagnosis of musculoskeletal disorders (MSDs), such as osteoporosis and muscular atrophy.