Validation Of Screening Methods Research Articles

Development and validation of an LC-MS/MS screening method for macrolide and quinolone residues in baby food

A simple, rapid and sensitive screening method by liquid chromatography-tandem mass spectrometry (LC-MS/MS) was developed for the identification of 7 macrolides (clarithromycin, erythromycin, oleandomycin, spiramycin, tilmicosin, troleandomycin and tylosin) and 8 quinolones (ciprofloxacin, difloxacin, enrofloxacin, flumequine, moxifloxacin, nalidixic acid, norfloxacin and ofloxacin) in meat and egg-based baby foods. Sample preparation was performed using an alkaline modified QuEChERS (Quick, Easy, Cheap, Effective, Rugged, Safe) extraction method without additional clean-up steps. A simplex-lattice mixture experimental design was used in the optimization of the QuEChERS extraction solvent. The developed method was successfully validated according to the Commission Decision 2002/657/EC and the European Community Reference Laboratories Residues Guidelines regarding the validation of screening methods 20/01/2010, adopting a fixed permited tolerance for relative ion ratio. Samples of baby food (n = 44) commercialized in Rio de Janeiro, Brazil, were analyzed using the validated method and none of them presented residues of the searched macrolides and quinolones, with a screening target value of 5 µg kg−1.

Nutrition risk screening methods for adults living with severe mental illness: A scoping review.

Adults living with severe mental illness experience a greater burden of physical comorbidities and earlier mortality than the general population. Malnutrition, overnutrition, dysphagia, constipation and disordered eating have been observed in this population and can lead to poor nutritional status. Early identification of such conditions may reduce their impact on functional status, quality of life and health outcomes. This scoping review aimed to identify all nutrition risk screening methods published in English internationally for use with adults living with severe mental illness and ascertain which, if any, were validated for the target population. A four-step search strategy was used to search six electronic databases and grey literature, from inception to April 2020, for articles reporting nutrition risk screening methods used in this population. Information on the content and validity of screening methods was extracted and analysed by three independent reviewers. Seventeen nutrition risk screening methods were identified, of which three were validated within a population of adults with severe mental illness. One screening method was found for both malnutrition and dysphagia risk, respectively, and three for constipation risk. No single method was found for overnutrition. Eleven screening methods were identified for disordered eating risk, of which two were validated for the target population. Nutrition risk screening methods and their validation in adults living with severe mental illness are inadequately researched. This scoping review highlights the need for future research to develop new or validate existing screening methods specifically for the target population.

Validation of a Multiclass Method for the Screening of 15 Antibiotic Residues in Milk Using Biochip Multi-array Technology and Its application to Monitor Real Samples.

Veterinary drugs are extensively and legally consumed to treat and prevent disease in chattels but some are also used illegally as growth-stimulating agents. Inappropriate or intensive use of antibiotics can cause allergic reactions and, above all, antibiotic resistance. A multiclass approach for the screening of antimicrobial substances in milk was validated in consonance with Commission Decision 2002/657/EC and to the European guideline for the validation of screening methods for veterinary medicines. This biochip-based approach enables the simultaneous determination of a total of 13 sulphonamide, dapsone and trimethoprim. For monitoring of antibiotic residues, 53 UHT milk samples collected from Tehran, IR Iran were screened applying this technology. The result showed that for all antibiotic residues, the positivity threshold T was much more than the cut-off value Fm. A false positive rate of less than 5% was found for all antibiotics which are satisfactory. All detection capabilities (CCβ) were well below the Maximum Residue Level (MRL) set by the European Commission (100 µg/kg for the sum of all sulphonamides and 50 µg/kg for trimethoprim in milk). The screening results of 53 milk samples showed that 71.7% of samples were compliant and all positive samples were below the MRL set by European Commission. This study showed that the biochip-based technique is valid to identify and quantify antibiotic residues in milk at the studied validation levels. The method was rapid, easy, safe, and able to screen 13 sulphonamide, dapsone and trimethoprim from a single milk sample simultaneously with no sample preparation procedure (or just one-step centrifugation).

5.41 Evaluation of Patient Health Questionnaire Screening and Individual Symptom Analysis Among Adolescents With Depression

The American Academy of Pediatrics in 2018 released new guidelines recommending annual depression screening in adolescents ages 12 years and older. However, the validity of screening methods in the adolescent population requires further study. The 2-item Patient Health Questionnaire (PHQ-2) is a widely used depression-screening tool, particularly in primary care settings. We hypothesized that there are distinguishing symptoms differentiating depressed patients with positive PHQ-2 screening from those with negative PHQ-2 screening. The aim of this study was to identify the distinguishing symptoms of patient who are depressed but not identified as depressed based on their initial screening with the PHQ-2.

Валідація методу кількісного визначення нітрофурану (АОЗ) і хлорамфеніколу у зразках меду натурального за допомогою тест-системи RidaScreen®

<p><span lang="EN-US">We presented the validation method of the quantitative determination of Nitrofuran (AOZ) and Chloramphenicol in honey samples by the RidaScreen® test system (according to Commission Decision 2002/657/EC and Guidelines for the validation of screening methods for residues of veterinary medicines (initial validation and transfer) of 20/01/2010). We revealed several validation indicators like ccβ (detection capability), accuracy (precision), recovery and some others during the initial validation (specificity and selectivity). We determined the minimum detection values of Nitrofuran (AOZ) in honey, the highest value (the highest response) for blank samples is 0.066 μg/kg and the lowest value for enriched samples (lowest response) is 0.401 μg/kg. Based on the obtained results none of the responses for enriched samples do not coincide with the range of replies of blank samples. Hence, it follows that the detection capability (CCβ) for this screening method is less than or equal to 0.4 μg/kg. For the determination of Chloramphenicol, the highest response is noted for blank samples – 0.021 μg/kg (21 ng/kg) and the lowest response noted for enriched samples is 0.048 μg/kg (48 ng/kg). None of the responses for enriched samples do not coincide with the range of replies of blank matrix (samples), therefore we could conclude that the CCβ of this screening method is less than or equal to 0.05 μg/kg (β-error < 5 %) and the cut-off value of this test is 0.048. According to the validation the lowest value of substances that could detected by ELISA using the following test systems for competitive ELISA (enzyme-linked immunoassay) for Nitrofuran (AOZ) – 0.4 μg/kg, for Chloramphenicol </span><span lang="UK">–</span><span lang="EN-US"> 0.05 μg/kg. Described in State Standard 4497:2005 “Natural Honey. Technical conditions” the maximum allowable level for Chloramphenicol </span><span lang="UK">–</span><span lang="EN-US"> 0.3 μg/kg and Nitrofuran (AOZ) </span><span lang="UK">–</span><span lang="EN-US"> 0.6 μg/kg require</span><span lang="EN-US">correction according to the established validation parameters. </span></p>

Evaluation and validation of a biochip multi-array technology for the screening of 14 sulphonamide and trimethoprim residues in honey according to the European guideline for the validation of screening methods for veterinary medicines

Honey could be contaminated by antibiotic residues. There is still a great need for a cheap and single multi-residue method. The Evidence Investigator™ system is a biochip and semi-automated system. The microarray kit I (AM I) for the detection of sulphonamide and trimethoprim (TMP) residues in honey was evaluated, and then validated according to the European decision EC/2002/657 and to the European guideline for the validation of screening methods for veterinary medicines (2010). The method was found to be rapid and able to screen simultaneously 14 sulphonamides and TMP in honey with a very easy sample preparation procedure. The false–positive rate of 4% maximum is very satisfactory. All detection capabilities (CCβ) were well below the recommended concentration (RC) of 50 µg kg−1. The applicability of AM I kit with different types of honey (monofloral or multifloral, liquid or solid, different floral origins, etc.) has been proved.

Evaluation and validation of biochip multi-array technology for the screening of six families of antibiotics in honey according to the European guideline for the validation of screening methods for residues of veterinary medicines

The main chemicals used against varoa are acaricides, and the antibiotics used for the control of bee bacterial diseases are mainly tetracyclines, streptomycins, sulfonamides and chloramphenicol. No maximum residue limits (MRLs) have been set for any antibiotics in honey. Therefore, in the European Union, minimum recommended concentrations (RC) for the analytical performance of methods to control a certain set of these non-authorised chemicals in honey were published by the European Union Reference Laboratory (EU-RL) in 2007. Concerning the strategy for the control for antibiotic residues in honey, there is still a great need for a cheap and single multi-residue method. Biochip array technology is an innovative assay technology for the multi-analyte screening of biological samples in a rapid and easy-to-use format. A multi-array system, called Evidence Investigator™ (Randox, Crumlin, Co., Antrim, UK), was evaluated in our laboratory. It is a semi-automated biochip system designed for research, clinical applications and veterinary use. A competitive chemiluminescent immunoassay is employed for the detection of antimicrobials. The MicroArray II kit (AM II) dedicated to the screening of six different families of antibiotic residues was validated according to the European guideline for the validation of screening methods for residues of veterinary medicines. The specificity was proven to be very satisfactory, and applicability to different kinds of honey was demonstrated. The detection capabilities (CCβ) of six antibiotic residues were determined and were below the RCs when exist. The AM II kit could detect at least six quinolones, four tetracyclines and three epimers, three aminoglycosides, three macrolides, thiamphenicol, florfenicol and ceftiofur along with one of its stabilised metabolites, the desfuroylceftiofurcysteine disulfide (DCCD).

Development and validation of a methodology to qualitatively screening veterinary drugs in porcine muscle via an innovative extraction/clean-up procedure and LC-MS/MS analysis

A qualitative multiresidue method that facilitates rapid monitoring of veterinary drugs in porcine muscle is described. The method comprises the application of an innovative extraction/clean-up procedure, namely liquid–liquid extraction with partition at very low temperature (LLE-FPVLT), and analysis by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). Besides the high selectivity, sensitivity and specificity, this high-throughput method proved to be quite general as 34 veterinary drugs (from six distinct classes: tetracyclines, sulfonamides, penicillins, quinolones, macrolides and benzimidazoles) could be successfully detected. The whole screening procedure was validated according to the directives from European Commission Decision 2002/657/EC and guidelines for the validation of screening methods. Acceptable values for the evaluation parameters were achieved for all analytes (except for ampicillin, clindamycin and erythromycin). Finally, these very promising results have strengthened the possibility of inclusion of such a methodology as an integral part of the National Residue Control Plan scope of the Ministry of Agriculture, Livestock and Food Supply of Brazil.

Development, validation and data quality assurance of screening methods: A case study

Despite the growing importance of qualitative screening tests in routine laboratories involved in the EU official control, their validation is not as deeply explained in Commission Decision 2002/657/EC as the validation of quantitative confirmatory methods. At the same time, the issue of quality assurance of screening assays defining internal quality control (IQC) procedures as required by accreditation bodies is undoubtedly less developed in this analytical field. As an example the present study describes the development, the validation and the IQC implemented for a commercial enzyme linked immunosorbent assay (ELISA) able to detect 17-α-19-nortestosterone (α-NT) and 17-β-19-nortestosterone (β-NT) isomers in bullock urine. In order to select a suitable sample treatment, two SPE purification protocols were preliminary compared. The chosen method was therefore fully validated determining the mandatory parameters required by Commission Decision 2002/657/EC: specificity, detection capability and robustness. An in-depth discussion was carried out illustrating the possible validation approaches and their implications especially in the assessment of the key performance characteristic: detection capability. Finally, the control charts implemented for continuous method verification during analyses of real samples were reported.

Space conditions and prevalence of anterior spacing and crowding among nine-year-old schoolchildren

To give detailed insight into the space conditions and prevalence of spacing and crowding in schoolchildren at nine years of age. The reliability and validity of screening methods was also assessed. Epidemiological survey. South-western part of Germany (Rhein-Neckar-Kreis); elementary schools in a region with a low orthodontic care rate. 494 nine-year-old German schoolchildren (237 males, 257 females, median age 9 years) were examined orthodontically in cooperation with the local community dentistry service. A special measurement ruler was developed to enhance validity and reliability of space measurements on location in the schools. Concerning space conditions in the incisor segments: in the maxilla the variety encountered comprised both space excess and moderate to severe crowding. This was considerably larger in the maxilla than in the mandible. Severe crowding (> 5 mm) was found more often in the maxilla than in the mandible and affected around 2-3% of the maxillary dentitions. Also severe contact point displacements (IOTN Grade 4) were mainly restricted to the maxilla (prevalence approximately 3%). In the canine-premolar segments, the arch segments in males were in general around 0.5 mm larger than among the females, also within each dental stage. In general, the maxilla was more often affected by posterior crowding than the mandible. Anterior crowding seemed to be more prevalent than posterior crowding. With respect to the screening methods used in the present study, reliable and valid measurements were also found to be possible in schools. This may open up further opportunities for orthodontic screening by community dentistry services or similar organizations.

Screening for dysphagia and aspiration in acute stroke: a systematic review.

Stroke is a common problem, producing a variety of neurological problems that affect eating. Dysphagia is a particular concern because of its potential for airway obstruction, malnutrition, and aspiration pneumonia. With chest infection reported in up to 32% of stroke patients, this is a major clinical issue. The following research questions are raised: (1) What are the incidence and outcomes of dysphagia and aspiration in acute stroke? (2) What screening interventions are available to detect dysphagia in patients with acute stroke and what effect have they on patient outcomes? A systematic review was carried out using methods and quality criteria of the NHS Centre for Reviews and Dissemination (1996), focusing on studies of adults with acute stroke. Data were extracted, collated, and presented descriptively. Two hundred forty-eight articles were retrieved with 26 meeting inclusion and quality criteria. Clinical dysphagia is common, associated with a range of deleterious outcomes and clearly linked to development of chest infection. Interpretation of aspiration on videofluoroscopy is not as straightforward but probably also confers additional risk. Further work is required on the relationship between aspiration and pneumonia, and pneumonia prevention. This will include exploration of the effects of screening, and the further development and validation of screening methods. While studies indicate current "best practice," in this important area of patient care further work is urgently required.

Prevalence of dementia in an urban slum population in thailand: Validity of screening methods

AbstractA randomly selected sample of 500 subjects over 60 years old and their relatives were studied using standardized methods for assessment of cognitive impairment. The prevalence of DSM‐III‐R dementia was 1.8% (95% confidence intervals 0.6‐3%), and the majority of cases had a probable diagnosis of Alzheimer's disease. The sensitivity and specificity of the field survey version of the Mini‐Mental State Examination (MMSE) for a diagnosis of dementia using a threshold of 21 were 100% and 53% respectively. This was associated with a positive predictive value of dementia, given a low score, of only 3%. A high prevalence of low MMSE scores was found: 23% of men and 50% of women had scores below 21, and there were strong relationship between low scores and age. Strong associations between low MMSE scores and no education were found, and weaker associations with female sex, deafness and poor sight. The MMSE is markedly affected by educational level, which together with its low positive predictive value for dementia in this population makes it a poor screening of research tool. A Behaviour Rating Scale score had a higher specificity leading to fewer false positives, but only achieved a sensitivity of 67%. In populations with low levels of education it is recommended that behavioural disabilities scales should be developed as a means of screening for dementia syndromes.