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Actas Dermo-sifiliograficas Nov 2020Sexually transmitted infections (STIs) are one of the most frequent and universal Public Health problems. Health professionals should be aware of the possibility of STIs... (Review)
Review
Sexually transmitted infections (STIs) are one of the most frequent and universal Public Health problems. Health professionals should be aware of the possibility of STIs due to their high morbidity and the presence of sequelae. The delay in the diagnosis is one of the factors that justifies the difficulty to infections control. Diagnostic tests allow the introduction of aetiological treatment and also lead to treating symptomatic and asymptomatic patients more effectively, as well as to interrupt the epidemiological transmission chain without delay. In this review we have made an update of the main existing diagnostic methods for the more important STIs.
Topics: Diagnostic Tests, Routine; Humans; Sexually Transmitted Diseases
PubMed: 32663448
DOI: 10.1016/j.ad.2019.05.008 -
Medical & Biological Engineering &... Apr 2022Since 1948, Shannon theoretic methods for modeling information have found a wide range of applications in several areas where information plays a key role, which goes... (Review)
Review
Since 1948, Shannon theoretic methods for modeling information have found a wide range of applications in several areas where information plays a key role, which goes well beyond the original scopes for which they have been conceived, namely data compression and error correction over a noisy channel. Among other uses, these methods have been applied in the broad field of medical diagnostics since the 1970s, to quantify diagnostic information, to evaluate diagnostic test performance, but also to be used as technical tools in image processing and registration. This review illustrates the main contributions in assessing the accuracy of diagnostic tests and the agreement between raters, focusing on diagnostic test performance measurements and paired agreement evaluation. This work also presents a recent unified, coherent, and hopefully, final information-theoretical approach to deal with the flows of information involved among the patient, the diagnostic test performed to appraise the state of disease, and the raters who are checking the test results. The approach is assessed by considering two case studies: the first one is related to evaluating extra-prostatic cancers; the second concerns the quality of rapid tests for COVID-19 detection.
Topics: COVID-19; Diagnostic Tests, Routine; Humans
PubMed: 35195818
DOI: 10.1007/s11517-021-02494-9 -
Revue Scientifique Et Technique... Jun 2021Before tools became available to consider diagnostic test validation studies where a 'gold-standard' is not available, new diagnostic tests were compared to a reference... (Review)
Review
Before tools became available to consider diagnostic test validation studies where a 'gold-standard' is not available, new diagnostic tests were compared to a reference standard assumed to be highly accurate if not perfect. This paper reviews such 'traditional' situations with examples and methods of study design and analysis. Three situations are described, two where a perfect reference is available for either positive or negative animals, and one where the reference is perfect for both. Thus, here the authors review circumstances to be considered when validating a diagnostic test with a credible reference standard. An appropriate study design requires an unbiased selection of animals from the population to which a new test will be applied. Examples for calculating sample size and data analysis are provided. Finally, the authors discuss situations where it may be appropriate to include influential variables ('covariates') in a diagnostic test validation study..
Topics: Animals; Diagnostic Tests, Routine; Reference Standards; Sensitivity and Specificity
PubMed: 34140725
DOI: 10.20506/rst.40.1.3223 -
European Radiology Jun 2021
Topics: COVID-19; Diagnostic Imaging; Diagnostic Tests, Routine; Humans; SARS-CoV-2
PubMed: 33372242
DOI: 10.1007/s00330-020-07465-6 -
PLoS Neglected Tropical Diseases Nov 2021As lymphatic filariasis (LF) programs move closer to established targets for validation elimination of LF as a public health problem, diagnostic tools capable of...
As lymphatic filariasis (LF) programs move closer to established targets for validation elimination of LF as a public health problem, diagnostic tools capable of supporting the needs of the programs are critical for success. Known limitations of existing diagnostic tools make it challenging to have confidence that program endpoints have been achieved. In 2019, the World Health Organization (WHO) established a Diagnostic Technical Advisory Group (DTAG) for Neglected Tropical Diseases tasked with prioritizing diagnostic needs including defining use-cases and target product profiles (TPPs) for needed tools. Subsequently, disease-specific DTAG subgroups, including one focused on LF, were established to develop TPPs and use-case analyses to be used by product developers. Here, we describe the development of two priority TPPs for LF diagnostics needed for making decisions for stopping mass drug administration (MDA) of a triple drug regimen and surveillance. Utilizing the WHO core TPP development process as the framework, the LF subgroup convened to discuss and determine attributes required for each use case. TPPs considered the following parameters: product use, design, performance, product configuration and cost, and access and equity. Version 1.0 TPPs for two use cases were published by WHO on 12 March 2021 within the WHO Global Observatory on Health Research and Development. A common TPP characteristic that emerged in both use cases was the need to identify new biomarkers that would allow for greater precision in program delivery. As LF diagnostic tests are rarely used for individual clinical diagnosis, it became apparent that reliance on population-based surveys for decision making requires consideration of test performance in the context of such surveys. In low prevalence settings, the number of false positive test results may lead to unnecessary continuation or resumption of MDA, thus wasting valuable resources and time. Therefore, highly specific diagnostic tools are paramount when used to measure low thresholds. The TPP process brought to the forefront the importance of linking use case, program platform and diagnostic performance characteristics when defining required criteria for diagnostic tools.
Topics: Diagnostic Tests, Routine; Elephantiasis, Filarial; Humans; Public Health; World Health Organization
PubMed: 34780503
DOI: 10.1371/journal.pntd.0009968 -
American Journal of Clinical Pathology Aug 2020Accurate hematologic test interpretation based on normative reference standards is critical to ensure appropriate clinical decision making. However, healthy pediatric...
OBJECTIVES
Accurate hematologic test interpretation based on normative reference standards is critical to ensure appropriate clinical decision making. However, healthy pediatric reference data for most hematology parameters are lacking. To address this gap, this study establishes age- and sex-specific hematologic reference standards in the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort of healthy children and adolescents.
METHODS
Fresh whole blood samples collected from a total of 566 healthy children and adolescents (birth to <21 years) with informed consent were analyzed for 47 hematologic parameters on the Beckman Coulter DxH 900. Age- and sex-specific reference standards were calculated based on the Clinical and Laboratory Standards Institute guidelines.
RESULTS
Reference value distributions for most hematology parameters demonstrated dynamic changes across the pediatric age range with significant age-specific differences observed for 39 of the 47 parameters examined. Sex-specific differences were also observed for eight hematologic parameters, primarily during and after puberty.
CONCLUSIONS
This study establishes a robust database of pediatric reference standards for 47 hematologic parameters in the CALIPER cohort for the first time. These comprehensive reference value data sets report potentially important and physiologically relevant trends in hematologic markers, clearly demonstrating the need for pediatric reference standards for hematologic test interpretation.
Topics: Adolescent; Biomarkers; Child; Child, Preschool; Clinical Laboratory Services; Databases, Factual; Diagnostic Tests, Routine; Female; Hematology; Humans; Infant; Infant, Newborn; Male; Reference Standards; Young Adult
PubMed: 32561916
DOI: 10.1093/ajcp/aqaa059 -
Genetics in Medicine : Official Journal... Jan 2021
Topics: Diagnostic Techniques and Procedures; Diagnostic Tests, Routine; Genetics, Medical; Genomics; Humans; Uniparental Disomy; United States
PubMed: 32814848
DOI: 10.1038/s41436-020-00940-x -
Clinical Chemistry Jan 2021
Topics: Cardiovascular Diseases; Cholesterol, LDL; Diagnostic Tests, Routine; Fasting; Humans; Triglycerides
PubMed: 33221866
DOI: 10.1093/clinchem/hvaa195 -
Research Synthesis Methods May 2021Comparative accuracy studies evaluate the relative performance of two or more diagnostic tests. As any other form of research, such studies should be reported in an... (Review)
Review
Comparative accuracy studies evaluate the relative performance of two or more diagnostic tests. As any other form of research, such studies should be reported in an informative manner, to allow replication and to be useful for decision-making. In this study we aimed to assess whether and how components of test comparisons were reported in comparative accuracy studies. We evaluated 100 comparative accuracy studies, published in 2015, 2016 or 2017, randomly sampled from 238 comparative accuracy systematic reviews. We extracted information on 20 reporting items, pertaining to the identification of the test comparison, its validity, and the actual results of the comparison. About a third of the studies (n = 36) did not report the comparison as a study objective or hypothesis. Although most studies (n = 86) reported how participants had been allocated to index tests, we could often not evaluate whether test interpreters had been blinded to the results of other index tests (n = 40; among 59 applicable studies), nor could we identify the sequence of index tests (n = 52; among 90 applicable studies) or the methods for comparing measures of accuracy (n = 59). Two-by-four table data (revealing the agreement between index tests) were only reported by 9 of 90 paired comparative studies. More than half of the studies (n = 64) did not provide measures of statistical imprecision for comparative accuracy. Our findings suggest that components of test comparisons are frequently missing or incompletely described in comparative accuracy studies included in systematic reviews. Explicit guidance for reporting comparative accuracy studies may facilitate the production of full and informative study reports.
Topics: Diagnostic Tests, Routine; Humans; Systematic Reviews as Topic
PubMed: 33217225
DOI: 10.1002/jrsm.1469 -
Clinical Microbiology and Infection :... Jun 2020Cerebrospinal fluid (CSF) testing is a key component for the diagnosis of central nervous system (CNS) infections. Current meningitis and encephalitis management... (Review)
Review
BACKGROUND
Cerebrospinal fluid (CSF) testing is a key component for the diagnosis of central nervous system (CNS) infections. Current meningitis and encephalitis management guidelines agree on the need for CSF molecular testing in combination with other direct and indirect biological testing, both in CSF and blood. Multiplex molecular tests have been developed to reduce turnaround times and facilitate the diagnostic approach.
OBJECTIVES
We aim to discuss the role of multiplex molecular panels in the management of CNS infections.
SOURCES
The MEDLINE database and the grey literature have been searched for relevant articles.
CONTENT
New molecular multiplex panels are being developed to simultaneously detect a large array of neuropathogens in CSF. Although one of these assays has been US Food and Drug Administration-approved, extensive analytical and clinical validation is still missing, and suboptimal performance related issues have been raised. Its use has been associated with decreased costs, reduced length of hospital stay and reduced antiviral therapy administration in retrospective, industry-sponsored studies. The pros and cons of this multiplex syndromic approach are discussed in this narrative review.
IMPLICATIONS
Molecular multiplex CNS infection diagnosis panels have been developed and present several attractive features, including ease of use and low turnaround time. However, suboptimal analytical performances render these tests difficult to use without additional confirmatory tests. Such panels are not comprehensive nor adapted to all situations, depending on the epidemiological or clinical context. Overall, available data in the literature currently do not support the use of a multiplex PCR panel in clinical routine as a 'stand-alone' molecular assay. Except in restricted laboratory capacity settings where such easy-to-use multiplex panels offer the diagnostic means that would otherwise not be available, the stepwise testing approach remains a more rational option. Serological testing both in blood and CSF should not be neglected, but it represents essential complementary tools regarding some neuropathogens.
Topics: Central Nervous System Infections; Diagnostic Tests, Routine; Encephalitis; Humans; Meningitis; Molecular Diagnostic Techniques; Retrospective Studies
PubMed: 31899336
DOI: 10.1016/j.cmi.2019.12.013