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Clinical Microbiology Reviews Jan 2019HIV diagnostics have played a central role in the remarkable progress in identifying, staging, initiating, and monitoring infected individuals on life-saving... (Review)
Review
HIV diagnostics have played a central role in the remarkable progress in identifying, staging, initiating, and monitoring infected individuals on life-saving antiretroviral therapy. They are also useful in surveillance and outbreak responses, allowing for assessment of disease burden and identification of vulnerable populations and transmission "hot spots," thus enabling planning, appropriate interventions, and allocation of appropriate funding. HIV diagnostics are critical in achieving epidemic control and require a hybrid of conventional laboratory-based diagnostic tests and new technologies, including point-of-care (POC) testing, to expand coverage, increase access, and positively impact patient management. In this review, we provide (i) a historical perspective on the evolution of HIV diagnostics (serologic and molecular) and their interplay with WHO normative guidelines, (ii) a description of the role of conventional and POC testing within the tiered laboratory diagnostic network, (iii) information on the evaluations and selection of appropriate diagnostics, (iv) a description of the quality management systems needed to ensure reliability of testing, and (v) strategies to increase access while reducing the time to return results to patients. Maintaining the central role of HIV diagnostics in programs requires periodic monitoring and optimization with quality assurance in order to inform adjustments or alignment to achieve epidemic control.
Topics: Diagnostic Tests, Routine; HIV; HIV Infections; History, 20th Century; History, 21st Century; Humans
PubMed: 30487166
DOI: 10.1128/CMR.00064-18 -
Clinical and Vaccine Immunology : CVI Apr 2016A concern during the early AIDS epidemic was the lack of a test to identify individuals who carried the virus. The first HIV antibody test, developed in 1985, was... (Review)
Review
A concern during the early AIDS epidemic was the lack of a test to identify individuals who carried the virus. The first HIV antibody test, developed in 1985, was designed to screen blood products, not to diagnose AIDS. The first-generation assays detected IgG antibody and became positive 6 to 12 weeks postinfection. False-positive results occurred; thus, a two-test algorithm was developed using a Western blot or immunofluorescence test as a confirmatory procedure. The second-generation HIV test added recombinant antigens, and the third-generation HIV tests included IgM detection, reducing the test-negative window to approximately 3 weeks postinfection. Fourth- and fifth-generation HIV assays added p24 antigen detection to the screening assay, reducing the test-negative window to 11 to 14 days. A new algorithm addressed the fourth-generation assay's ability to detect both antibody and antigen and yet not differentiate between them. The fifth-generation HIV assay provides separate antigen and antibody results and will require yet another algorithm. HIV infection may now be detected approximately 2 weeks postexposure, with a reduced number of false-positive results.
Topics: Diagnostic Tests, Routine; HIV; HIV Infections; Humans; Immunoassay
PubMed: 26936099
DOI: 10.1128/CVI.00053-16 -
Clinical Microbiology and Infection :... Mar 2019Parasitic diseases are one of the world's most devastating and prevalent infections, causing millions of morbidities and mortalities annually. In the past, many of these... (Review)
Review
BACKGROUND
Parasitic diseases are one of the world's most devastating and prevalent infections, causing millions of morbidities and mortalities annually. In the past, many of these infections have been linked predominantly to tropical or subtropical areas. Nowadays, however, climatic and vector ecology changes, a significant increase in international travel, armed conflicts, and migration of humans and animals have influenced the transmission of some parasitic diseases from 'book pages' to reality in developed countries. It has also been noted that many patients who have never travelled to endemic areas suffer from blood-borne infections caused by protozoa. In the light of existing knowledge, this new trend can be explained by the fact that in the process of migration a large number of asymptomatic carriers become a part of the blood bank donor and transplant donor populations. Accurate and rapid diagnosis represents the crucial weapon in the fight against parasitic infections.
AIMS
To review old and new approaches for rapid diagnosis of parasitic infections.
SOURCES
Data for this review were obtained through searches of PubMed using combinations of the following terms: parasitological diagnostics, microscopy, lateral flow assays, immunochromatographic assays, multiplex-PCR, and transplantation.
CONTENT
In this review, we provide a brief account of the advantages and limitations of rapid methods for diagnosis of parasitic diseases and focus our attention on current and future research in this area. The approximate costs associated with the use of different techniques and their applicability in endemic and non-endemic areas are also discussed.
IMPLICATIONS
Microscopy remains the cornerstone of parasitological diagnostics, especially in the field and low-resource settings, and provides epidemiological assessment of parasite burden. However, increased use and availability of point-of-care tests and molecular assays in modern era allow more rapid and accurate diagnoses and increased sensitivity in the identification of parasitic infections.
Topics: Animals; Diagnostic Tests, Routine; Humans; Microscopy; Molecular Diagnostic Techniques; Parasites; Parasitic Diseases; Parasitology; Point-of-Care Testing
PubMed: 29730224
DOI: 10.1016/j.cmi.2018.04.028 -
Archives of Razi Institute Jan 2021Toxoplasmosis is a widespread parasitic disease caused by a protozoan parasite Toxoplasma gondii. Currently, nanotechnology has been used for the diagnosis of many...
Toxoplasmosis is a widespread parasitic disease caused by a protozoan parasite Toxoplasma gondii. Currently, nanotechnology has been used for the diagnosis of many infectious diseases. It could be due to the fact that nanoparticles play an important role in accurate and fast diagnosis. The purpose of this study was to design a Nano-enzyme linked immunosorbent assay (Nano-ELISA) kit using excreted/secreted (E/S) antigens to have higher sensitivity and specificity than those reported for the designed enzyme-linked immunosorbent assay (ELISA) kit for the diagnosis of Toxoplasmosis in mice. Firstly, the serum samples were collected from 15 infected mice with T. gondii and 15 healthy ones. Then, E/S antigens were separated from parasite tachyzoites and used for designing an ELISA kit. In addition, the mice sera were evaluated using the designed ELISA kit. Finally, the serum samples were assessed by Nano-ELISA kits designed with E/S antigen and conjugate of gold nanoparticles. The obtained results of the present study showed that the sensitivity and specificity of the designed ELISA kit were reported as 80% and 86.66%, respectively, that both improved to 93.33% in these sera with the designed Nano-ELISA kit. This finding revealed the significant improvement of sensitivity and specificity using gold nanoparticles in designing the ELISA kit. Furthermore, according to the literature, the use of E/S antigens in designing recognizable ELISA kits has been always highlighted considering the presence of numerous antigens in T. gondii. The results of this study revealed that the use of E/S antigens in the preparation of an ELISA kit was very effective. This is very important, especially in the lower titers of antibody requiring a more accurate diagnosis. On the other hand, the Nano-ELISA method designed with E/S antigens can be more sensitive and specific than ELISA for the diagnosis of Toxoplasmosis and can be the basis for further studies in this regard.
Topics: Diagnostic Tests, Routine; Enzyme-Linked Immunosorbent Assay; Sensitivity and Specificity; Toxoplasmosis
PubMed: 33403837
DOI: 10.22092/ari.2018.123028.1236 -
Nature Reviews. Neurology Nov 2020Malformations of cortical development (MCDs) are neurodevelopmental disorders that result from abnormal development of the cerebral cortex in utero. MCDs place a... (Review)
Review
Malformations of cortical development (MCDs) are neurodevelopmental disorders that result from abnormal development of the cerebral cortex in utero. MCDs place a substantial burden on affected individuals, their families and societies worldwide, as these individuals can experience lifelong drug-resistant epilepsy, cerebral palsy, feeding difficulties, intellectual disability and other neurological and behavioural anomalies. The diagnostic pathway for MCDs is complex owing to wide variations in presentation and aetiology, thereby hampering timely and adequate management. In this article, the international MCD network Neuro-MIG provides consensus recommendations to aid both expert and non-expert clinicians in the diagnostic work-up of MCDs with the aim of improving patient management worldwide. We reviewed the literature on clinical presentation, aetiology and diagnostic approaches for the main MCD subtypes and collected data on current practices and recommendations from clinicians and diagnostic laboratories within Neuro-MIG. We reached consensus by 42 professionals from 20 countries, using expert discussions and a Delphi consensus process. We present a diagnostic workflow that can be applied to any individual with MCD and a comprehensive list of MCD-related genes with their associated phenotypes. The workflow is designed to maximize the diagnostic yield and increase the number of patients receiving personalized care and counselling on prognosis and recurrence risk.
Topics: Consensus; Delphi Technique; Diagnostic Tests, Routine; Humans; Internationality; Malformations of Cortical Development; Practice Guidelines as Topic
PubMed: 32895508
DOI: 10.1038/s41582-020-0395-6 -
Clinical Infectious Diseases : An... Jan 2016There are 4 families of viruses that cause viral hemorrhagic fever (VHF), including Filoviridae. Ebola virus is one virus within the family Filoviridae and the cause of... (Review)
Review
There are 4 families of viruses that cause viral hemorrhagic fever (VHF), including Filoviridae. Ebola virus is one virus within the family Filoviridae and the cause of the current outbreak of VHF in West Africa. VHF-endemic areas are found throughout the world, yet traditional diagnosis of VHF has been performed in large reference laboratories centered in Europe and the United States. The large amount of capital needed, as well as highly trained and skilled personnel, has limited the availability of diagnostics in endemic areas except in conjunction with governmental and nongovernmental entities. However, rapid diagnosis of VHF is essential to efforts that will limit outbreaks. In addition, increased global travel suggests VHF diagnoses may be made outside of the endemic areas. Thus, understanding how to diagnose VHF is imperative for laboratories worldwide. This article reviews traditional and current diagnostic modalities for VHF.
Topics: Diagnostic Tests, Routine; Global Health; Hemorrhagic Fevers, Viral; Humans
PubMed: 26354968
DOI: 10.1093/cid/civ792 -
Journal of Clinical Microbiology Sep 2019The timely and accurate diagnosis of respiratory virus infections has the potential to optimize downstream (posttesting) use of limited health care resources, including... (Comparative Study)
Comparative Study Review
The timely and accurate diagnosis of respiratory virus infections has the potential to optimize downstream (posttesting) use of limited health care resources, including antibiotics, antivirals, ancillary testing, and inpatient and emergency department beds. Cost-effective algorithms for respiratory virus testing must take into consideration numerous factors, including which patients should be tested, what testing should be performed (for example, antigen testing versus reverse transcription-PCR testing or influenza A/B testing versus testing with a comprehensive respiratory virus panel), and the turnaround time necessary to achieve the desired posttesting outcomes. Despite the clinical impact of respiratory virus infections, the cost-effectiveness of respiratory virus testing is incompletely understood. In this article, we review the literature pertaining to the cost-effectiveness of respiratory virus testing in pediatric and adult patient populations, in emergency department, outpatient, and inpatient clinical settings. Furthermore, we consider the cost-effectiveness of a variety of testing methods, including rapid antigen tests, direct fluorescent antibody assays, and nucleic acid amplification tests.
Topics: Cost-Benefit Analysis; Diagnostic Tests, Routine; Humans; Immunoassay; Molecular Diagnostic Techniques; Respiratory Tract Infections; Virus Diseases
PubMed: 31142607
DOI: 10.1128/JCM.00373-19 -
Clinical Microbiology and Infection :... Jul 2017Clinical microbiology is a field in constant evolution, with increasing technological opportunities and a growing emphasis on human and social issues. Maintaining... (Review)
Review
BACKGROUND
Clinical microbiology is a field in constant evolution, with increasing technological opportunities and a growing emphasis on human and social issues. Maintaining knowledge and skills and anticipating future changes is challenging both for laboratory managers and for all the co-workers. Training and succession preparation represents a unique opportunity to adapt/prepare future generations according to the evolutions of the field.
AIMS
The aim of this review is to provide to clinical microbiologists a reflection on ongoing technological and social changes in their field and a deepening of the central role of preparing future generations to these changes through a fruitful mentor-mentee relationship.
SOURCES
This narrative review relies on selected publications addressing mentor-mentee interactions in various academic fields, on interview with our colleagues and pairs, as well as on our personal experience.
CONTENT
From the qualities and aspects that emerged as necessary for a productive mentor-mentee interaction, we selected and discuss five of them for the mentor: the role and responsibility, the positioning, the vision, the scientific credibility, and the moral credibility, as well as five for the mentee: creativity, flexibility, energy, responsibility, and self evaluation.
IMPLICATIONS
This review emphasizes the importance of both the scientific and the ethical credibility of the mentor and the mentee as well as the importance of human and social values such as solidarity, equality, equity, respectfulness, and empathy, and might support mentor and mentee in the field of clinical microbiology and also in the field of infectious disease in their intent for a fruitful interaction.
Topics: Diagnostic Tests, Routine; Humans; Mentors; Microbiological Techniques; Professional Competence
PubMed: 28478239
DOI: 10.1016/j.cmi.2017.04.027 -
Journal of Clinical Microbiology Sep 2019Advanced microbiology technologies are rapidly changing our ability to diagnose infections, improve patient care, and enhance clinical workflow. These tools are... (Review)
Review
Advanced microbiology technologies are rapidly changing our ability to diagnose infections, improve patient care, and enhance clinical workflow. These tools are increasing the breadth, depth, and speed of diagnostic data generated per patient, and testing is being moved closer to the patient through rapid diagnostic technologies, including point-of-care (POC) technologies. While select stakeholders have an appreciation of the value/importance of improvements in the microbial diagnostic field, there remains a disconnect between clinicians and some payers and hospital administrators in terms of understanding the potential clinical utility of these novel technologies. Therefore, a key challenge for the clinical microbiology community is to clearly articulate the value proposition of these technologies to encourage payers to cover and hospitals to adopt advanced microbiology tests. Specific guidance on how to define and demonstrate clinical utility would be valuable. Addressing this challenge will require alignment on this topic, not just by microbiologists but also by primary care and emergency room (ER) physicians, infectious disease specialists, pharmacists, hospital administrators, and government entities with an interest in public health. In this article, we discuss how to best conduct clinical studies to demonstrate and communicate clinical utility to payers and to set reasonable expectations for what diagnostic manufacturers should be required to demonstrate to support reimbursement from commercial payers and utilization by hospital systems.
Topics: Communicable Diseases; Diagnostic Tests, Routine; Humans; Microbiological Techniques; Point-of-Care Systems
PubMed: 31217268
DOI: 10.1128/JCM.00495-19 -
Journal of Clinical Microbiology Jul 2017Malaria is a potentially life-threatening disease requiring rapid diagnosis and treatment. Although microscopic examination of thick and thin blood films remains the... (Review)
Review
Malaria is a potentially life-threatening disease requiring rapid diagnosis and treatment. Although microscopic examination of thick and thin blood films remains the gold standard for laboratory diagnosis, rapid antigen tests and nucleic acid amplification methods may also play a useful role in detection of acute infection. This review discusses the advantages and disadvantages of the commonly used diagnostic methods and provides important practice points for optimal malaria test utilization.
Topics: Chromatography, Affinity; Diagnostic Tests, Routine; Humans; Malaria; Microscopy; Nucleic Acid Amplification Techniques
PubMed: 28404673
DOI: 10.1128/JCM.02562-16