Performance Of Screening Tests Research Articles

222Rn and 226Ra concentrations in selected shallow circulation groundwaters from the Fore-Sudetic Monocline area

Natural radioactive isotopes occur in various components of the natural environment, including groundwater. The general population, not always aware of possible threats, can use its resources. The activity concentration of some of the radioactive isotopes should be monitored, especially in those intakes from which it is possible to obtain water for human consumption, e.g. in domestic wells. The conducted research was innovative due to the fact that in many countries, including Poland, there are no regulations on waters exploited from home wells using as a drinking water source. As the groundwaters from this area have not been examined for radon (222Rn) and radium (226Ra) occurrence yet, the goal of this research was to perform screening tests in this part of the Fore-Sudetic Monocline. For this purpose, the authors have measured the concentration of 222Rn and 226Ra activity in groundwater collected from this geological unit located in south-western Poland. 222Rn and 226Ra occurrence was researched, and specific electrolytic conductivity, redox potential, pH and temperature were measured in 52 groundwater samples. 222Rn activity concentration ranged from 0.18 to 19.78 Bq/dm3. Only in three cases, 226Ra activity concentration reached a value above the lower detection limit of the applied method, i.e. 0.05 Bq/dm3 (max. 0.77 Bq/dm3). The authors present completely new data on the occurrence of these radioactive isotopes in the waters of the first aquifer in the Fore-Sudetic Monocline, which is not without significance for the health of consumers of these waters.

Potential overestimation of cognitive impairment due to hearing loss: Impact of test modalities on cognitive test scores.

Hearing impairment in older adults may affect cognitive function and increase the risk of dementia. Most cognitive tests are delivered auditorily, and individuals with hearing loss may fail to hear verbal instructions. Greater listening difficulty and fatigue in acoustic conditions may impact test performance. This study aimed to examine the effect of decreased audibility on cognitive screening test performance in older adults. Older adults (n = 63) with different levels of hearing loss completed a standard auditory Mini-Mental State Examination test and a written version of the test. Individuals with moderate to moderately severe hearing loss (41-70 dB) performed significantly better on the written (24.34 ± 4.90) than on the standard test (22.55 ± 6.25), whereas scores were not impacted for mild hearing loss (less than 40 dB). Hearing evaluations should be included in cognitive assessment, and test performance should be carefully interpreted in individuals with hearing loss to avoid overestimating cognitive decline.

ELISA “in house” para o diagnóstico de leishmaniose: desenvolvimento e aplicação em caninos da fronteira Oeste do Brasil

ABSTRACT: Leishmaniosis is a great public health problem affecting both humans and animals. The disease is caused by the protozoan Leishmania spp., which has a complex cycle involving a phlebotomine vector. The ELISA test (Enzyme-Linked Immunosorbent Assay) along with a chromatographic immunoassay was defined by the Brazil Health Ministry as the confirmatory screening protocol in 2011. Uruguaiana city is 630 km away from Porto Alegre, which makes it difficult to send samples and diagnose leishmaniasis, as well as receive quick results. In view of this, the present study evaluated an in-house indirect ELISA method compared to indirect immunofluorescence assay (IFA) and dual-path platform chromatographic immunoassay (DPP-BioManguinhos®) for the detection of an immune response to Leishmania spp. in canine species. The serological evaluation included 48 canines from the western border of Brazil (Uruguaiana and Barra do Quaraí city). Among the 48 canine samples tested, 18 were positive when using the ELISA technique, 19 were positive with IFA, and 17 were positive with rapid test DPP®. The ELISA technique showed a sensitivity/specificity of 83.3%/86.7% when compared to IFA and 100%/96.8% compared to DPP®. The present study showed a prevalence of 37.5%, demonstrating that the infection circulates in the studied population. It can be concluded that the ELISA technique was valuable for use in field conditions when performing screening tests in endemic areas.

Diagnostic Performance of a Tablet Computer-Based Cognitive Screening Test for Identification of Amnestic Mild Cognitive Impairment.

Early and appropriate diagnosis of amnestic mild cognitive impairment (aMCI) is clinically important because aMCI is considered the prodromal stage of dementia caused by Alzheimer's disease (AD). aMCI is assessed using the comprehensive neuropsychological (NP) battery, but it is rater-dependent and does not provide quick results. Thus, we investigated the performance of the computerized cognitive screening test (Inbrain Cognitive Screening Test; Inbrain CST) in the diagnosis of aMCI and compared its performance to that of the Korean version of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) test (CERAD-K), a comprehensive and pencil-and-paper NP test. A total of 166 participants were included in this cross-sectional study. The participants were recruited as part of a prospective, community-based cohort study for MCI (PREcision medicine platform for mild cognitive impairment on multi-omics, imaging, evidence-based R&BD; PREMIER). All participants were assessed using the CERAD-K and the Inbrain CST. The Inbrain CST comprised seven subtests that assessed the following five cognitive domains: attention, language, visuospatial, memory, and executive functions. Seventy-six participants underwent brain magnetic resonance imaging and [18F]-flutemetamol positron emission tomography (PET). We evaluated the diagnostic performance of the Inbrain CST for the identification of aMCI by comparing the findings with those of CERAD-K. We also determined the characteristics of aMCI patients as defined by the CERAD-K and Inbrain CST. Of the 166 participants, 93 were diagnosed with aMCI, while 73 were cognitively unimpaired. The sensitivity of the Inbrain CST for aMCI diagnosis was 81.7%, and its specificity was 84.9%. Positive and negative predictive values were 87.4% and 78.5%, respectively. The diagnostic accuracy was 83.1%, and the error rate was 16.9%. Demographic and clinical characteristics between individuals with aMCI defined by the Inbrain CST and CERAD-K were not significantly different. The frequency of positive amyloid PET scan, the hippocampal/parahippocampal volumes, and AD signature cortical thickness did not differ between the patients with aMCI defined by CERAD-K and those with aMCI defined by the Inbrain CST. The Inbrain CST showed sufficient sensitivity, specificity, and positive and negative predictive values for diagnosing objective memory impairment in aMCI. In addition, aMCI patients identified by CERAD-K and the Inbrain CST showed comparable clinical and neuroimaging characteristics. Therefore, the Inbrain CST can be considered an alternative test to supplement the limitations of existing pencil-and-paper NP tests.

Impact of the COVID-19 pandemic on gestational diabetes screening test performance in WNC

To assess the impact of the COVID-19 pandemic across 3 parallel, 12-month epochs, pre-pandemic through post vaccine availability, on standard of care gestational diabetes screening.

Development and Validation of a Rapid Screening Test for HTLV-I IgG Antibodies.

Initial diagnosis of human T cell lymphotropic virus (HTLV) infections is mainly based by detecting antibodies in plasma or serum using laboratory-based methods. The aim of this study was to develop and evaluate a rapid screening test for HTLV-I antibodies. Our rapid screening test uses HTLV-I p24 antigen conjugated to gold nanoparticles and an anti-human IgG antibody immobilized to a nitrocellulose strip to detect human HTLV-I p24-specific IgG antibodies via immunochromatography. Performance of the rapid screening test for HTLV-I was conducted on a total of 118 serum specimens collected in Salvador, Bahia, the epicenter for HTLV-1 infection in Brazil. Using a Western blot test as the comparator, 55 serum specimens were HTLV-I positive, 5 were HTLV-I and HTLV-II positive, and 58 were negative. The sensitivity of the rapid screening test for HTLV-1 was 96.7% and the specificity was 100%. The rapid screening test did not show cross-reaction with serum specimens from individuals with potentially interfering infections including those caused by HTLV-II, HIV-I, HIV-II, hepatitis A virus, hepatitis B virus, hepatitis C virus, herpes simplex virus, Epstein-Barr virus, SARS-CoV-2, Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum, Toxoplasma gondii, and Plasmodium falciparum. The rapid screening test also did not show cross-reaction with potentially interfering substances. Strategies for HTLV diagnosis in non- and high-endemic areas can be improved with low-cost, rapid screening tests.

Factors Associated with Undertaking Health-Promoting Activities by Older Women at High Risk of Metabolic Syndrome

The complexity of health problems concerning women aged ≥60 years makes it necessary to develop effective, low-cost strategies involving biopsychosocial interventions. The aim of this study is to identify the factors associated with undertaking health-promoting activities by older women at high risk of metabolic syndrome (MetS) with or without depressive symptoms. The study group consisted of 70 older women (62-84 years old) undertaking regular physical activity. A self-developed questionnaire (used to determine the living situation, selected lifestyle components and health problems), the Perceived Stress Questionnaire (PSQ) and the Geriatric Depression Scale (GDS) were used. In the study group undertaking regular physical activity, 40% had increased symptoms of depression (D group), and 60% were classified as non-depressed (ND group). The D group had a higher general stress level (t = -6.18, p = 0.001). Improving and/or maintaining physical fitness was identified as the greatest motivation in both groups. Willingness to spend time with other people significantly differed between the two groups (χ2 = 4.148, p = 0.042). The sole factor significantly differentiating between both groups was lack of time (χ2 = 8.777, p = 0.003). Motivations and barriers to undertaking health-promoting activities and levels of perceived stress were significantly different between the depressed and non-depressed groups. It is important to encourage primary care physicians to perform screening tests for late-life depression and to provide information on where therapeutic interventions are available for patients with symptoms of MetS and coexisting depressive symptoms.

The Influence of Vaginal HPV Self-Sampling on the Efficacy of Populational Screening for Cervical Cancer—An Umbrella Review

Early detection of cervical cancer is a matter of great importance as the prognosis depends on the stage of the disease. The objective of the study consisted in the assessment of the impact of HPV self-sampling on the efficacy of populational screening programs aimed at early CC detection. The analysis was performed taking into account the Cochrane Collaboration guidelines for systematic reviews. The analyzed articles were searched for in the following databases: Medline (PubMed), Embase (Ovid), and Cochrane Library. From a total of 60 citations, 16 studies were included in this review. The HPV test is highly sensitive and specific although the diagnostic accuracy of tests carried out in self-collected samples is slightly lower than that of tests carried out in samples collected by clinicians. The results of meta-analyses for HPV tests performed on self-collected samples indicate that the sensitivity for detecting CIN2+ ranges from 74% to 86% (depending on the publication and the analyzed population), and for CIN3+ from 75% to 86%. One publication showed a clearly lower sensitivity of 42% in detecting CIN3+, but the result is for a high-risk population and comes from only 1 RCT. The specificity of the assay exceeds 80% and 79.5% with regard to the detection of CIN2+ and CIN3+, respectively. As shown by the studies included in the review, both the offering of HPV self-sampling kits to patients and the mailing of such kits significantly increase the uptake of and participation in cervical cancer screening programs. In addition, self-sampling was found to be acceptable by the female subjects. HPV self-sampling is an innovative and cost-effective way to perform screening tests. In addition, self-sampling significantly increases the willingness to participate in screening programs among female subjects.

Traditional, Vegetarian, or Low FODMAP Diets and Their Relation to Symptoms of Eating Disorders: A Cross-Sectional Study among Young Women in Poland.

Background: Eating disorders (EDs) are an ever-growing problem, seen most commonly among young women. People with EDs are particularly predisposed to restrictive eating patterns. Diet therapy for many diseases involves the elimination of certain food groups, and the use of restrictive diets in people with EDs may indirectly influence the recurrence of the disorder. The aim of this study was to assess the prevalence of the possible presence of EDs and orthorexia symptoms among young women following a traditional, alternative (vegetarian), or therapeutic (low FODMAP) diet. Methods: The analysis was based on 420 responses from female respondents aged 19 to 30 years. The research tool consisted of questionnaires to assess the possible presence of EDs (SCOFF), cognitive-behavioral aspects of eating (TFEQ-13), and the presence of orthorexia symptoms (ORTO-15). Results: Uncontrolled and emotional eating was least common in women on a vegetarian diet (5.6 ± 3.7; 3.5 ± 2.7; p < 0.05). Women on a low FODMAP diet were most prevalent with symptoms of orthorexia (n = 37, 47.4%; p < 0.05). Conclusions: It seems important to perform screening tests for eating disorders before recommending diet therapy in order to individually adjust the dietary regimen and refer patients to appropriate specialists.

Panels of circulating microRNAs as potential diagnostic biomarkers for breast cancer: a systematic review and meta-analysis.

Circulating microRNAs (miRNAs) are potential diagnostic biomarkers for breast cancer (BC). The application of miRNA panels could improve the performance of screening tests. Here, we integrated bioinformatic tools and meta-analyses to select circulating miRNAs with high diagnostic accuracy and combined these markers to develop diagnostic panels for BC. Analyses across databases were performed to identify potential BC-related circulating miRNAs. Next, a comprehensive meta-analysis was conducted for each miRNA following the PRISMA guidelines. An electronic and manual search for relevant literature was carried out by two reviewers through PubMed, ScienceDirect, Biomed Central, and Google Scholar. The quality of the included studies was assessed using the QUADAS-2, and the statistical analyses were performed using R software 4.1.1. Finally, the accurate biomarkers confirmed through meta-analyses were combined into diagnostic models for BC. Twenty-seven circulating miRNAs were identified as BC-related by bioinformatic tools. After screening, only 10 miRNAs presented in 45 studies were eligible for meta-analyses. By assessing pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio, 8 miRNAs (miR-21, miR-30b, miR-125b, miR-145, miR221 miR-222, and miR-335) were revealed as promising BC diagnostic biomarkers. Two panels constructed from these miRNAs showed excellent diagnostic accuracy for BC, with areas under the SROC curve of 0.917 and 0.944. We identified 8 potential circulating miRNAs and 2 diagnostic models that are useful for diagnosing BC. However, the established miRNA panels have not been tested in any experimental studies and thus should be validated in large case-control studies for clinical use.

The diagnostic accuracy of spirometry versus peak expiratory flow test for follow-up of adult asthma patients at primary care level.

Background: The asthma burden is growing worldwide, and this is predisposed by environmental and occupational exposures as well as individual risk factors. This study was aimed at a comparison of diagnostic accuracy of spirometry and peak expiratory flow rate (PEFR) in asthma screening of adult patients with lung function abnormalities that present at the level of primary care. Methods: This study was conducted in Shymkent city, South Kazakhstan, the third most populous city of the country with developed industries and high rates of pulmonary diseases. Four hundred and ninety-five adult patients with lung function abnormalities were enrolled in the study and underwent two screening tests (spirometry and PEFR). The diagnosis of asthma was verified by a qualified pulmonologist after performance of screening tests and was based on symptoms, medical history, and laboratory and lung function tests. Results: The sensitivity of spirometry was 0.97 and that of PEFR was 0.95 (p = 0.721), whereas the specificity of spirometry was 0.37 and that of PEFR was 0.28 (p = 0.227). Both tests yielded the same results for the positive predictive value (0.98). The negative predictive value was significantly higher for spirometry versus PEFR (0.23 versus 0.08; p = 0.006). The positive and negative likelihood ratios of the two tests also differed significantly (p = 0.001 and p = 0.006, respectively), whereas the overall accuracy was comparable between the two tests (0.96 for spirometry and 0.94 for PEFR; p = 0.748). Conclusion: Ambulatory PEFR monitoring is non-inferior to the monitoring of the forced expiratory volume in 1 second and could be used for screening purposes on equal grounds with spirometry.

Who to screen and how to screen for celiac disease

Celiac disease (CeD) is a chronic gluten-induced enteropathy with plethoric manifestations. The typical manifestations of CeD such as chronic diarrhea and malabsorption are widely recognized, however, many patients have atypical manifestations like iron deficiency anemia, idiopathic short stature, hypertransaminesemia or infertility, etc. These patients often present to the primary care physicians and/or non-gastrointestinal specialties. However, due to a lack of awareness among the healthcare professionals about the various atypical manifestations, many patients are not screened for CeD. In this review, we have summarized the available literature about the prevalence of CeD in various gastrointestinal (chronic diarrhea) and non-gastrointestinal conditions (iron deficiency anemia, short stature, cryptogenic hypertransaminesemia, cryptogenic cirrhosis or idiopathic ataxia etc.) where the diagnosis of CeD should be con-sidered. In addition, we also discuss special scenarios where screening for CeD should be considered even in absence of symptoms such as patients with type 1 diabetes, Down’s syndrome, and first-degree relatives of patients with CeD. Further, we discuss the diagnostic performance and limitations of various screening tests for CeD such as IgA anti-tissue transglutaminase antibodies, anti-endomysial antibodies and anti-deamidated gliadin antibodies. Based on the current recommendations, we propose a diagnostic algorithm for patients with suspected CeD.

A comparison of detection of chromosomal abnormalities by Amniocentesis in patients screened by dual marker test vs those screened by ultrasonography for nuchal translucency and nasal bone in first trimester

It becomes important to detect chromosomal abnormalities prenatally and early in the pregnancy. The present thesis is aimed to assess the performance of prenatal screening tests for chromosomal abnormalities detection i.e., dual marker test, first trimester ultrasound which measures the nuchal translucency and presence or absence of nasal bone, and their correlation with diagnostic test which is the karyotyping after amniocentesis. It is a prospective &amp; observational clinical study conducted in Obstetrics and gynaecology department of a tertiary care hospital. Two hundred pregnant females above 18 years of age attending ANC OPD (Antenatal Check-up Out-patient department) were considered for this study. In this study we found the presence of chromosomal abnormalities in 10% of participants. Combined sensitivity of NT and Dual marker test was found to be 83.75% in detecting chromosomal abnormalities. It can be concluded at the end of the study that; prenatal diagnosis with ultrasonography for nuchal translucency either alone or in combination with dual marker test offered good detection rate for these chromosomal abnormalities.

Comparison of screening with the use of Biochip Array Technology to the direct analysis of 521 psychoactive compounds and their residues with the use of LC-MS/MS method – does it mean the end of an era for immunochemical research?

The classical strategy for toxicology testing of road users involves preliminary immunochemical screening and in case of obtaining the positive result, the instrumental tests are necessary to confirm the result. Immunochemical tests are a cheap, quick and simple tool to confirm the presence of a particular substance in the biological material such as saliva, urine or blood. Their fundamental disadvantages are the limited specificity and the scope of analyses. The field tests allow to determine the presence of a few groups of compounds in one single test. Laboratory tests ELISA usually allow for detecting a few epitopes in one test. In the era of many NPS (novel psychoactive substances) and psychoactive drugs used for recreational purposes, the limited multiplexity factor related to immunochemical arrays is becoming a more serious problem. Therefore, some solution is the application of matrix screening. Biochip Array Technology matrix test allows to analyse 20 various groups of compounds on one chip. Another approach is to completely abandon screening for the sake of definite identification and quantitative determination. In order to satisfy the current situation, the multiplex method with the use of LC-MS/MS method to detect 521 psychoactive compounds and their metabolites was worked out. The experimental material consisted of 300 blood samples taken from road users in Poland, routinely tested in the laboratory of the Institute of Forensic Genetics from 2019 to 2021. The immunochemical tests were carried out with the use of Randox Evidence MultiSTAT analyser. The research with the use of LC-MS/MS method was carried out to detect the presence of 521 psychoactive compounds and their residues in blood taken from the drivers. Blood extraction was carried out using a one-step solid-liquid method. Validation was carried out for quantitative analysis of 521 analytes following the SWGTOX guidelines. Two MRM pairs were selected for each analyte according to the valid mass spectrometry standards and optimal analysis parameters were determined. The analyses were carried out using LC-MS/MS (Kinetex C18 100 × 3 mm, 2.6 μm chromatographic column, mobile phases (in formate buffer) water/methanol, QTRAP 5500 system operated in ESI mode). Comparison of results determined with the use of immunochemical and LC-MS/MS methods indicates that screening immunochemical tests may generate both false positive and false negative results. In spite of the application of the matrix immunochemical test, which allowed the detection of 20 groups of psychoactive substances and metabolites, the LC-MS/MS method made it possible to detect and determine the concentration in a greater number of cases. Taking into account the enormous number of compounds which detection is required while performing screening tests and the need to carry out the confirmation tests, it is justifiable to consider the change of strategy for the sake of the direct instrumental analysis in order to determine a great number of compounds with the use of multiplex analytical methods.

IMPROVING THE PERFORMANCE OF THE MANAGEMENT OF GENETIC SCREENING AMONG ARAB WOMEN IN ISRAEL

This study examined the management of the performance of genetic screening tests by Arab women in Israel, the rate of responsiveness to genetic screening tests among Arab women in Israel, and the link between socioeconomic status, education, and religion, and the responsiveness to performing genetic screening tests among the research population, and the factors that influence Arab women’s decision to perform genetic screening tests prior to pregnancy. The study addresses existing opinions and perceptions regarding Arab women’s level of adherence to pre-pregnancy genetic screening tests. This is an empirical quantitative research and its findings related to the responses given by Arab women, considered the most important stakeholder, the clients of the genetic screening test system. The main findings are that women have a great deal of support for a binding law mandating the performance of tests as well as the requirement to predicate marriage on tests, and for enforcing its application. Another finding is that there is a strong influence of religion and Muslim clerics on the willingness to perform tests among the population. . A special contribution of the study is a change in religious policy by the Chairman of the Muslim Court in Israel, who issued a fatwa (religious order) that commands and directs the Muslim population to perform the tests. Recommendations are made concerning the development of a national program that promotes genetic health and directly influences responsiveness to pre-pregnancy tests aimed towards the main stakeholder group that is Arab women in Israel.

Phase I of the DiaVACCS screening trial: Study design, methods, population demographics and baseline results

&#x0D; &#x0D; &#x0D; &#x0D; Background. Human papillomavirus (HPV)-based primary screening guidelines are based on screening test performance and prevalence data generated in high-resource areas with low HIV infection rates. There is an urgent need for local data on infection and disease prevalence, as well as screening test performance, among both HIV-positive and HIV-negative South African (SA) women, in order to inform updated screening guidelines.&#x0D; Objectives. This study describes the baseline characteristics of participants in the cross-sectional phase of the multicentric DIAgnosis in Vaccine And Cervical Cancer Screen (DiaVACCS) screening trial. The objective was to determine the prevalence of positive screening and pre-invasive disease using different tests and strategies in the SA HIV-positive and HIV-negative population.Methods. A total of 1 104 women aged 25 - 65 years and eligible for screening were included, 465 HIV positive and 639 HIV negative. Visual inspection and molecular and cytological screening tests were done on self-sampled and healthcare worker-collected specimens. All participants who screened positive and 49.1% of those who screened negative were invited for colposcopy and biopsy, and those qualifying for treatment were recalled for large loop excision of the transformation zone as part of the trial. The worst histology result for each participant was used, and for untested women, multiple imputation was used to estimate verification bias- adjusted histology values.&#x0D; Results. Visual inspection was positive in 50.4% of HIV-positive v. 20.9% of HIV-negative women, cytology (atypical squamous cells of undetermined significance) in 39.9% v. 17.0%, and high-risk HPV DNA in 41.2% v. 19.6%. Overall, high-grade squamous intraepithelial lesion-positive cytology peaked in the age group 30 - 39 years at 16.7%. After adjustment for verification bias, histological diagnosis of cervical intraepithelial neoplasia (CIN)2+ was suspected in 44.7% v. 23.5% and CIN3+ in 23.3% v. 10.2% of HIV-positive and negative women, respectively. Invasive cancer was diagnosed in 15 women (1.95% of histological studies performed), and verification bias adjustment suggested 20 cases (1.8% of the study population).&#x0D; Conclusion. The baseline findings from the DiaVACCS trial confirm a high prevalence of HPV-related cervical pathology in the SA HIV-negative screening population, showing a clear need to reach these women with a screening programme. Among HIV-positive women, prevalence values were almost doubled. The prevalence of existing invasive cervical cancer was 1 - 2% of all women. Further analysis of the performance of single and multiple screening tests between the two subgroups will contribute to the choice of the most effective strategies to identify women at risk of developing invasive cancer.&#x0D; &#x0D; &#x0D; &#x0D;

Validity and Utility of Non-Invasive Prenatal Testing for Copy Number Variations and Microdeletions: A Systematic Review.

Valid data on prenatal cell-free DNA-based screening tests for copy number variations and microdeletions are still insufficient. We aimed to compare different methodological approaches concerning the achieved diagnostic accuracy measurements and positive predictive values. For this systematic review, we searched the Scopus and PubMed databases and backward citations for studies published between 2013 and 4 February 2022 and included articles reporting the analytical and clinical performance of cfDNA screening tests for CNVs and microdeletions. Of the 1810 articles identified, 32 met the criteria. The reported sensitivity of the applied tests ranged from 20% to 100%, the specificity from 81.62% to 100%, and the PPV from 3% to 100% for cases with diagnostic or clinical follow-up information. No confirmatory analysis was available in the majority of cases with negative screening results, and, therefore, the NPVs could not be determined. NIPT for CNVs and microdeletions should be used with caution and any developments regarding new technologies should undergo strict evaluation before their implementation into clinical practice. Indications for testing should be in correlation with the application guidelines issued by international organizations in the field of prenatal diagnostics.

Screening is not always healthy: an ethical analysis of health screening packages in Singapore

BackgroundHealth screening is undertaken to identify individuals who are deemed at higher risk of disease for further diagnostic testing so that they may possibly benefit from interventions to modify the natural course of disease. In Singapore, screening tests are widely available in the form of a package, which bundles multiple tests in one session and commonly includes non-recommended tests. There are various ethical issues associated with such testing as they may not be clinically appropriate and can result in more harm than benefit. This article describes the practice of health screening packages, identifies the ethical issues arising from such packages and discusses the implications of these ethical issues on policy and practice of screening in Singapore.MethodsA content analysis of the websites of providers offering general health screening packages to individuals was conducted. A total of 14 health screening package providers were analysed for how packages were conducted and promoted, how clinically appropriate screening tests were, and the price range and composition of screening packages. A normative ethical analysis based on the four principles approach of beneficence, non-maleficence, autonomy and justice in biomedical ethics was used.ResultsTwelve of the 14 providers included non-recommended tests such as tumour markers, treadmill stress tests and MRI scans in their general health screening packages. Package prices ranged from S$26 to S$10,561, with providers charging higher when more tests were included. Health screening packages were broadly conducted in three stages: (1) the offer and selection of a health screening package; (2) medical assessment and performance of screening tests; (3) a post-screening review. While material provided by all providers was factual, there was no information on the potential risks or harms of screening.ConclusionSeveral ethical issues were identified that should be addressed with regard to health screening packages in Singapore. A key issue was the information gap between providers and patients, which may result in patients undergoing inappropriate testing that may be more harmful than beneficial. Health screening packages can stimulate unnecessary demand for healthcare and contribute to an inequitable distribution of healthcare resources.

Screening for high frequency malignant disease (SHIELD).

TPS1602 Background: Implementation of asymptomatic cancer screening has yielded positive impacts on global cancer mortality rates. However, significant screening adherence gaps exist. A blood-based multi-cancer screening test with clinically significant performance in cancers where early detection and intervention can save lives, can address adherence gaps, especially by reducing access barriers inherent to current screening options. Effective evaluation of such a test in screen relevant populations requires studies designed to enroll individuals across multiple cancer types, taking into account prevalence rates for the cancers being evaluated, allowing for overlapping screen-eligible populations, and ensuring representation of individuals from diverse ethnicities and geographies. Methods: SHIELD (Screening for High Frequency Malignant Disease; NCT# 05117840) is a prospective, observational, multi-center basket study ongoing in the United States and Europe uniquely designed to recruit individuals across multiple cancer types. The study’s primary objective is to evaluate the performance of a blood-based multi-cancer screening test (GuardantLUNAR-2, Guardant Health, USA) to detect cancer in screen-relevant individuals as compared to the reference standard cancer screening modality. The study will recruit eligible individuals into multiple separate cohorts with specified pathways for cancer screening. Within each cohort, eligible individuals consent to whole blood collection within 90-days of the standard of care screening method. Clinical diagnoses, including the diagnosis of cancer, are made per standard of care. Primary outcomes are sensitivity, specificity, negative predictive value, and positive predictive value of the test as compared to the standard of care screening modality. Secondary outcome is the number of screen-detected cancers, early- (stage I/II) and late-stage (stage III/IV), per 1000 screened individuals. Follow-up continues for 24 months with outcomes collected at one and two-years to investigate the possibility of incidental non-screen relevant cancer cases and interval screen-relevant cancer cases that had not reached clinical threshold for detection at initial screening. Additional cancer specific follow-up is designed per cohort. The first cohort to enroll screen-eligible individuals, cohort A, is focused on those who meet guideline criteria for lung cancer screening with low dose CT. Additional cancer-risk cohorts will begin enrolling as the study expands and are designated cohort B, C, etc. Cohort A: Eligibility criteria are aligned with lung cancer screening guidelines – age 50-80 years with &gt; 20 pack-year smoking history who are current smokers or have quit &lt; 15 years prior, without a cancer history, preinvasive lung lesions, or current treatment for pneumonia. Cohort A enrollment, targeting 9,000 subjects over 24 months at up to 120 global sites, began in January 2022. Clinical trial information: NCT05117840.

Diagnostic performance of brief cognitive tests in cognitive impairment screening

Introduction and objectivesThis study aims to assess and compare the diagnostic performance of brief cognitive tests for cognitive impairment (CI) screening recommended by the Spanish guidelines for the integral care of people with Alzheimer’s disease and other dementias. Material and methodsWe performed a phase iii study into the accuracy of diagnostic tests, including patients with suspected CI in a primary care setting. All patients completed the Mini–Mental State Examination (MMSE), the Mini Examen Cognoscitivo (MEC), the Short Portable Mental Status Questionnaire (SPMSQ), the Memory Impairment Screen (MIS), the Clock Drawing Test (CDT), the Eurotest, the Fototest, and the Memory Alteration Test (M@T). CI was diagnosed independently by researchers blinded to scores on these tests. Diagnostic performance was evaluated by calculating the area under the receiver operating characteristic curve (AUC). ResultsThe study included 141 individuals (86 with CI). The Eurotest and M@T (AUC±SE: 0.91±0.02 and 0.90±0.02, respectively) took longer to administer (mean [SD]: 7.1 [1.8] and 6.8 [2.2]min, respectively) and have significantly better diagnostic performance compared to the MMSE, MEC, SPMSQ, and CDT, but not compared to MIS or Fototest (both with an AUC of 0.87±0.03), with the latter taking less than half as long to administer (2.8 [0.8]min). The M@T and MIS only evaluate memory, and the latter cannot be administered to illiterate people. ConclusionThe most advisable tests for CI screening in primary care are the Eurotest, M@T, and Fototest, with the latter being the most efficient as it takes half as long to administer.