Role Of Clinical Laboratory Research Articles

B-117 Rapid Classification of Cleanliness Grades of Vaginal Discharge through Computational Analysis of SERS Spectra via Variational Auto-Encoder Model And Long Short-Term Memory Networks

Abstract Background Classification of cleanliness grades of vaginal discharge plays a pivotal role in clinical laboratories, serving as indicators for the presence of various vaginal infections such as bacterial vaginosis and candidal vulvovaginitis, etc. The conventional method for assessing vaginal discharge cleanliness involves manual microscopy, a technique susceptible to variations based on the examiner's expertise and subjective judgment, hindering the attainment of swift and accurate diagnoses. Methods This study introduces a novel approach by integrating Surface-Enhanced Raman Spectroscopy (SERS) with a deep learning algorithm for the rapid classification of vaginal discharge cleanliness grades. The proposed classification method combines the Variational Auto-Encoder (VAE) and Long Short-Term Memory (LSTM) to process SERS spectra. The quality of the training data is assessed using the signal-to-noise ratio (SNR) as a standard indicator. Results The application of the VAE-LSTM algorithm significantly enhances classification performance, providing swift and accurate results while reducing the required time. Comparative analyses with various classical machine learning algorithms and evaluation metrics reveal the superior predictive capability and time efficiency of the VAE-LSTM algorithm, demonstrating 100% accuracy and a fitting time of 2 seconds. Blind testing of SERS spectra collected from unknown patients further validates the reliability of the proposed method. Conclusions This study presents a promising and practical approach for the rapid classification of vaginal discharge cleanliness grades. The integration of the SERS technique with the VAE-LSTM algorithm not only ensures accuracy and efficiency in clinical diagnosis but also lays the foundation for advancements in non-invasive diagnostic technologies in gynecological healthcare.

A Review on High Performance Liquid Chromatography (HPLC)

High-performance liquid chromatography (HPLC) is an important qualitative and quantitative technique, generally used for the estimation of pharmaceutical and biological samples. It is the most versatile, safest, dependable, and fastest chromatographic technique for the quality control of drug components. This article was prepared with a review different aspects of HPLC, such as principle types, instrumentation, and application. High- Performance Liquid Chromatography has played a significant role in clinical laboratories for the separation and quantitation of biomarkers in different body fluids. The development of HPLC involves four basic steps; scouting, optimization, robustness testing, and validation. The technique is used to analyze drugs and medicines for their purity and to maintain the highest standards for pharmaceutical products with the end goal of helping patients with medical issues. Method of validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Validation High-Performance Liquid Chromatography method as per ICH guidelines covers all the performance characteristics of validation, like Accuracy, precision, specificity, linearity, range, limit of detection, limit of quantification, robustness, system suitability the testing. The limitation of High-Performance Liquid Chromatography methods of development, public health importance, and validation is the automated process becomes complicated, has low separation power, and is expensive but High-Performance Liquid Chromatography is the modern diagnostic technique is used in all sectors

Screening for Colorectal Cancer: The Role of Clinical Laboratories.

Colorectal cancer (CRC) is a leading cause of cancer incidence and mortality. Screening can result in reductions in incidence and mortality, but there are many challenges to uptake and follow-up. Here, we will review the changing epidemiology of CRC, including increasing trends for early and later onset CRC; evidence to support current and emerging screening strategies, including noninvasive stool and blood-based tests; key challenges to ensuring uptake and high-quality screening; and the critical role that clinical laboratories can have in supporting health system and public health efforts to reduce the burden of CRC on the population. Clinical laboratories have the opportunity to play a seminal role in optimizing early detection and prevention of CRC.

Symposium 11 - The role of clinical laboratory in kidney transplantation.

Symposium 11 - The role of clinical laboratory in kidney transplantation.

Correspondence: Role of clinical laboratories in reporting results of transgender individuals on hormonal therapy by Phiri-Ramongane and Khine

Correspondence: Role of clinical laboratories in reporting results of transgender individuals on hormonal therapy by Phiri-Ramongane and Khine

Role of clinical laboratories in reporting results of transgender individuals on hormonal therapy

Transgender individuals experience discordance between their gender identity and sex assigned at birth. To relieve the disconnection between their identity and their biological state, some may take hormonal therapy, which leads to notable changes in several laboratory results. As reference intervals in the clinical laboratory reports are mainly gender specific for biological male and female, the transgender population on hormonal therapy may end up with misinterpretation of their test results, which could lead to misdiagnosis or inappropriate medical decisions. The aim of this review is to highlight the challenges experienced by clinicians in this regard and some strategies used to interpret these results. Establishing reference intervals for transgender individuals will assist in correct interpretation of patients’ results and their management. This will also maximise their overall health, psychological well-being and self-actualisation.

The Role of Clinical Laboratories in Emerging Pathogens—Insights From the COVID-19 Pandemic

The Role of Clinical Laboratories in Emerging Pathogens—Insights From the COVID-19 Pandemic

Notification of biochemistry critical results and its clinical impact on outpatient care: experience in a Spanish tertiary hospital.

The communication of critical results (CR) is considered an essential role in clinical laboratories to ensure patient safety. This is especially relevant to outpatients, who are non-hospitalized and more difficult to locate. In our laboratory, there is a specific protocol for CR management that sets up the communication pathway to adequately provide these results to clinicians. The aim of this study is to evaluate the impact of CR reporting on outpatient care. This is a retrospective study focused on CR for biochemistry parameters in a clinical laboratory of a Spanish tertiary hospital during 2019. A total of 156 CR were determined and properly provided to clinicians. We collected CR, age, gender, and the requesting department. We also collected the medical action data resulting from the communication of the CR. Seventy-six outpatients (49%) were properly treated because of effective CR communication. Hypoglycemia was the most frequent event (33%), however, the greatest clinical impact was observed for patients with hyponatremia (100%), hyperkalemia (62%), hypokalemia (60%), and hypercalcemia (57%). Based on these findings, we evaluated new glucose alert thresholds depending on whether or not the outpatient was diabetic (1.7 and 2.2mmol/L, respectively). Based on these new thresholds, we established a CR reporting protocol with 69% effectiveness in outpatients. We demonstrate that CR communication in outpatients has a significant clinical impact. To increase the effectiveness of the CR reporting protocol, we propose to adjust alert thresholds according to pathology, department, and patient population.

Turnaround times and modes of reporting critical results in Asian laboratories.

Reporting critical results in a timely manner is a crucial role of clinical laboratories. Traditionally, these results were reported using the phone or fax system. However, there are now other modes of communication for this reporting. Quality improvement in any organization is driven by detection of errors and benchmarking against peers. In the case of critical result reporting, there are few current widely used Benchmarking schemes. The Roche Clinical Chemistry Benchmarking Survey in 2019 added questions about critical result reporting including the mode of communication and turnaround time key performance index. This survey includes over 1100 laboratories from 20 countries. The survey revealed a range of communication strategies with phone calls still the commonest followed by email. The key performance index for most laboratories was less than 10 min. Benchmarking can provide key information for quality improvement activities, particularly pre- and postanalytical.

SnackVar: An Open-Source Software for Sanger Sequencing Analysis Optimized for Clinical Use

Despite the wide application of next-generation sequencing, Sanger sequencing still plays a necessary role in clinical laboratories. However, recent developments in the field of bioinformatics have focused mostly on next-generation sequencing, while tools for Sanger sequencing have shown little progress. In this study, SnackVar (https://github.com/Young-gonKim/SnackVar, last accessed June 22, 2020), a novel graphical user interface-based software for Sanger sequencing, was developed. All types of variants, including heterozygous insertion/deletion variants, can be identified by SnackVar with minimal user effort. The featured reference sequences of all of the genes are prestored in SnackVar, allowing for detected variants to be precisely described based on coding DNA references according to the nomenclature of the Human Genome Variation Society. Among 88 previously reported variants from four insertion/deletion-rich genes (BRCA1, APC, CALR, and CEBPA), the result of SnackVar agreed with reported results in 87 variants [98.9% (93.0%; 99.9%)]. The cause of one incorrect variant calling was proven to be erroneous base callings from poor-quality trace files. Compared with commercial software, SnackVar required less than one-half of the time taken for the analysis of a selected set of test cases. We expect SnackVar to be a cost-effective option for clinical laboratories performing Sanger sequencing.

Molecular analysis of H&E- and Papanicolau-stained samples-systematic review.

Molecular pathology allows the identification of causative agents in infectious diseases and detection of biomarkers important for prediction of disease susceptibility, diagnosis and personalized therapy. Accordingly, nucleic acid-based methods have gained a special role in clinical laboratories particularly to evaluate solid and hematological tumors. Extraction of nucleic acids is commonly performed in microdissected formalin-fixed paraffin-embedded (FFPE) or cytological samples that had been previously evaluated through the use of hematoxylin and eosin (H&E) or Papanicolau (Pap) stains, respectively. Although the effect of both stains on nucleic acids integrity has been explored by several authors, the results are not consistent and require further examination. Accordingly, the goal of this review was to assess the influence of H&E and Pap stains on DNA and RNA integrity and to address the mechanism by which each staining compromises molecular based-analysis. The analyzed studies demonstrate that H&E- and Pap-staining result in low DNA recovery and some degree of DNA fragmentation. Additionally, it is concluded that hemalum inhibits PCR by interfering with DNA extraction, preventing DNA polymerase attachment and possibly by rescuing divalent cations. Accordingly, proper sample purification and adjustment of PCR conditions are of key importance to achieve satisfactory results by PCR in H&E- and Pap-stained samples. Furthermore, although H&E results in RNA fragmentation, it is possible to perform expression analysis in H&E-stained frozen sections, using RNase-free conditions, low amounts of hematoxylin and a rapid protocol from sample collection to RNA analysis. It The effect of Pap-staining on RNA integrity remains to be determined.

Development of Immunochromatographic Assays for the Selective Detection of Zika Virus or Dengue Virus Serotypes in Serum.

Immunoassays have long played an important role in clinical laboratories for the selective and sensitive detection of many analytes (1). Through the years, these methods have progressed from manual assays to automated systems that can be carried out in a routine fashion in a clinical setting. However, there are still situations in which simple manual immunoassays are desirable. For instance, it may be impractical to use expensive automated assays for the detection of infectious diseases and during point-of-care testing in regions of the world where adequate instrumentation or expertise is not available for carrying out these methods. According to the WHO, such an assay should ideally meet requirements that are described by the acronym ASSURED, in which the method is a ffordable, s ensitive, s pecific, u ser-friendly, r apid/ r obust, e quipment-free, and readily d eliverable to the final users (2, 3). One infectious agent for which such an assay would be valuable is the Zika virus (ZIKV)2 (3, 4). ZIKV was first isolated in 1947 from the sentinel monkey, and confirmed human infections have been noted since the early 1960s (4). This virus became of international interest in 2015 when thousands of individuals infected by ZIKV were identified in Brazil and the Americas, with subsequent reports of cases in pregnant women that were accompanied by the appearance of birth defects such as microcephaly (3, 4). In response to this situation, WHO declared in 2016 that ZIKV represented a global public health emergency. This declaration, in turn, led to a sudden need for new diagnostics for the rapid detection of infections by ZIKV (4). The development of rapid and simple tests for ZIKV, as well as serotypes of the related dengue virus (DENV), is the topic of a recent publication by Bosch …

Advances in Clinical Diagnosis and Management of Chikungunya Virus Infection

In this review, we attempt to give the reader an update on clinical diagnosis, management, and treatment of Chikungunya virus (CHIKV) infection regarding the course of the disease and the role of clinical laboratory. CHIKV infection evolves through three phases: acute, sub-acute, and chronic. Protocol for patient assessment and management should be in agreement with each phase requirements. Despite its benignity, CHIKV infection has shown an increase in severe cases during recent outbreaks. Among the most affected group are neonates, elderly population, and patients with co-morbidities. Furthermore, since CHIKV geographical distribution and clinical spectrum overlaps with other arboviruses, differential diagnosis becomes crucial for physicians to ensure good management and treatment for patients. In this review, we describe and compare the main symptoms, complications, and risk groups for CHIKV, Dengue (DENV), and Zika (ZIKV) infections, regarding key features will guide to an accurate diagnosis. CHIKV is an emergent and reemergent arbovirus that arrived in the Americas in 2014, causing thousands of infections. The acute febrile phase is similar to that of dengue but with a higher proportion of debilitating arthralgia that can persist for months or even years after infection. Severe forms of CHIKV infection can lead to chronic polyarthralgia, neurologic symptoms, or multiorgan failure. Treatment of CHIKV infection is mainly focused on supportive care, which includes the use of analgesic and anti-inflammatory medication, rehydration, and rest.

Internal Quality Control Practice of Thyroid Disease Related Tests and Imprecision Analysis in China

Internal quality control (IQC) has a long and well-established role in clinical laboratories and the quality of laboratories has achieved great improvement in China. However, the practice of IQC varies significantly between institutions and many problems still exists. Consequently, the Chinese National Center for Clinical Laboratories has been undertaking monthly nation-wide surveys of current IQC practice of tests since 2010 to monitor laboratory quality. Thyroid disease related tests were chosen for this research. Different numbers of laboratories in China participating national external quality assessment (EQA) schemes of Total Thyroxine (TT4), Total Triiodothyronine (TT3), Free Thyroxine (FT4) and Free Triiodothyronine (FT3) tests, and Thyroid Stimulating Hormone (TSH) measurements, were required to report the IQC information though the national external quality assessment (EQA) network platform. Survey data showed significant variability in all aspects of IQC practice. More than half of the laboratories are using a single concentration level of IQC material and up to 28.6% of the laboratories only use 1(2s) or 1(3s) to monitor IQC results for FT3, TT3, FT4, TT4, and TSH. The medians of the average time intervals of two control tests for FT3, TT3, FT4, TT4, and TSH are 33.6, 35.4, 33.6, 35.4, and 33.6 hours, respectively, more or less 1.4 days. When quality specifications based on biological variation are applied to imprecision evaluation, only 46.3%, 52.1%, 31.3%, 12.8%, and 5.86% laboratories meet the minimum performance for FT3, TT3, FT4, and TT4, 24.5%, 23.6%, 12.8%, and 5.86% of the all meet the desirable performance, and 4.4%, 3.9%, 2.5% and 3.0% of the all meet the optimal performance. While it shows a higher percentage of acceptable laboratories (98.1%, 87.9% and 39.0% meeting the minimum, desirable and optimal performance, respectively) for TSH. Not-well-designed IQC practices may affect the effectiveness of laboratory IQC and, thus, the adequacy of a laboratory to monitor system performance. Consequently, IQC practice should be designed according to performance of measure method and instrument. Both clinical laboratories and the government should make efforts to improve quality of clinical testing to ensure the patients' safety.

Genomic pathology: a disruptive innovation.

237 ISSN 1741-0541 10.2217/PME.12.5 © 2012 Future Medicine Ltd Personalized Medicine (2012) 9(3), 237–239 “...genomic pathology [is] founded on the premise that sequencing the human genome is rapidly becoming so routine and inexpensive that it will inevitably find its way into fundamental aspects of healthcare – not only in disease diagnosis and management, but also disease prevention, risk mitigation and health maintenance.”

A diagnostic conundrum: a case of acth heterophile antibody interference

Introduction Since the description of the first immunoassay in 1959 by Nobel Laureates Berson and Yalow, this technology has matured and taken on a major role in clinical laboratories. However it has been plagued by a fundamental weakness. The use of non-human antibodies can produce erroneous results with serious clinical consequences if one does not maintain constant vigilance. We describe a patient who underwent extensive investigations for the cause of her Cushing’s syndrome as a consequence of an erroneous laboratory result. Case A 60-year-old female was found to have incidental bilateral adrenal gland enlargement on abdominal CT scan. She was subsequently noted to have classic symptoms and signs of Cushing’s syndrome including weight gain, increased bruising and increased roundness of her face. A bone mineral density scan confirmed severe osteoporosis. Initial biochemistry was as follows: 24 h urine free corticoids, 2100 nmol/d (reference Scantibodies tubes have specific binders which inactivate hetero-philic antibodies. The use of Scantibodies led to a misleading increase in the ACTH value to 21.1 mol/L. Measurements of ACTH by the alternate method lead to the correct ACTH result of Conclusions We have described a patient with ACTH independent Cushing’s syndrome due to bilateral adrenal hyperplasia who underwent extensive investigation as a result of heterophile antibody interference in the ACTH assay with misleading interaction with Scantibodies.

Role of clinical laboratory in the follow-up of melanoma patients

Role of clinical laboratory in the follow-up of melanoma patients

Role of clinical laboratory in allergy testing

The clinical laboratory has a well defined role to play in the diagnosis and management of patients with allergy. Elevated serum levels of total IgE and/or allergen-specific IgE indicate that an IgE mediated event has occurred. Methods such as basophil degranulation and basophil or leukocyte histamine release can provide similar information. Sensitive and precise methods suitable for automation are available for quantitation of histamine in whole blood or plasma. Methyl histamine can be assayed in urine. Eosinophil cationic protein levels in serum can be used as an indicator of eosinophil activation in disorders such as asthma and atopic dermatitis. Similarly, serum mast cell tryptase levels can confirm or exclude an anaphylactic reaction both in life and as a cause of death. This review documents and compares commercially available methods for these assays and discusses their application to screening, diagnosis, and management of patients with allergy.