Practical application of the patient data-based quality control method: the potassium example.

Introduction: Internal quality control (IQC) is a core pillar of laboratory quality control strategies. Internal quality control commercial materials lack the same characteristics as patient samples and IQC contributes to the costs of laboratory testing. Patient data-based quality control (PDB-QC) may be a valuable supplement to IQC; the smaller the biological variation, the stronger the ability to detect errors. Using the potassium concentration in serum as an example study compared error detection effectiveness between PDB-QC and IQC. Materials and methods: Serum potassium concentrations were measured by using an indirect ion-selective electrode method. For the training database, 23,772 patient-generated data and 366 IQC data from April 2022 to September 2022 were used; 15,351 patient-generated data and 246 IQC data from October 2022 to January 2023 were used as the testing database. For both PDB-QC and IQC, average values and standard deviations were calculated, and z-score charts were plotted for comparison purposes. Results: Five systematic and three random errors were detected using IQC. Nine systematic errors but no random errors were detected in PDB-QC. The PDB-QC showed systematic error warnings earlier than the IQC. Conclusions: The daily average value of patient-generated data was superior to IQC in terms of the efficiency and timeliness of detecting systematic errors but inferior to IQC in detecting random errors.

Universal pictures: A lithophane codex helps teenagers with blindness visualize nanoscopic systems.

People with blindness have limited access to the high-resolution graphical data and imagery of science. Here, a lithophane codex is reported. Its pages display tactile and optical readouts for universal visualization of data by persons with or without eyesight. Prototype codices illustrated microscopy of butterfly chitin-from N-acetylglucosamine monomer to fibril, scale, and whole insect-and were given to high schoolers from the Texas School for the Blind and Visually Impaired. Lithophane graphics of Fischer-Spier esterification reactions and electron micrographs of biological cells were also 3D-printed, along with x-ray structures of proteins (as millimeter-scale 3D models). Students with blindness could visualize (describe, recall, distinguish) these systems-for the first time-at the same resolution as sighted peers (average accuracy = 88%). Tactile visualization occurred alongside laboratory training, synthesis, and mentoring by chemists with blindness, resulting in increased student interest and sense of belonging in science.

Quality assurance programs for vitamin A and E in serum: are we doing enough to assess laboratory performance?

OBJECTIVES: Monitoring serum vitamin A (retinol) and vitamin E (α-tocopherol) concentrations is common practice for assessing nutritional status. Measurement of these vitamins can be challenging due to several factors. Whilst the RCPAQAP Vitamins: Serum Program assists participating laboratories in harmonisation, the materials provided do not contain the analogues of retinol and α-tocopherol that may be present in real patient samples. We aimed to assess participants' capacity to accurately report retinol and α-tocopherol in the presence of the vitamin E analogues tocopherol acetate and γ-tocopherol. METHODS: A supplementary series of a control sample and three matched spiked samples were distributed to each laboratory participating in the Program. Retinol and α-tocopherol results for each spiked sample were compared to the results of the control sample submitted by each participant. Acceptability of retinol and α-tocopherol results was determined based on the RCPAQAP allowable performance specifications (APS). RESULTS: Thirteen participants returned results for the supplementary sample series. Interference from α-tocopherol acetate was observed with results below the APS in 30 % (n=4) of laboratories for retinol quantification and in 23 % (n=3) for α-tocopherol quantification. One laboratory returned results above the APS for α-tocopherol when γ-tocopherol was present. CONCLUSIONS: This supplementary sample series has shown that the presence of vitamin E analogues can lead to the over or under estimation of nutritional status by some participants. Affected laboratories are encouraged to review their analytical procedures. To further assess laboratory competence, EQA providers should consider using patient samples or spiked challenge samples.

Field Collection and Laboratory Routine Identification of Rhodiola crenulata.

The identification of medicinal materials is the premise and guarantee of drug safety. The majority of scientific researchers are bound to favor the simple, fast, effective, and inexpensive identification process of herbals. Rhodiola crenulata is a traditional Tibetan medicine grown at high altitudes, mainly distributed in Tibet, Yunnan, and Sichuan regions of China. Rhodiola crenulate possesses multiple bioactivities, such as anti-inflammatory, anti-hypoxia, and antioxidant properties, and has great potential for development. With the increasing market demand and a rapid decrease in resource content, a large number of confused products of Rhodiola crenulata have been troubling people. Therefore, this protocol introduces a standard process for the identification of Rhodiola crenulata in the field combined with routine laboratory testing. The combination of habitat, microscopic features, and thin-layer chromatography will undoubtedly identify Rhodiola crenulata quickly, efficiently, and economically, contributing to the continuous development of Tibetan medicine and the quality control of medicinal materials.

From routine sample measurements in CEA to the Oklo phenomenon.

In 1972, before shipping natural uranium to the USSR for enrichment operations in 235 U, the analysts at Pierrelatte plant noted a slight deficit in 235U: 0.7171 instead of 0.7202. The Direction des Productions of the CEA launched a vast campaign of analyses for the different mines exploited, at all stages of the elaboration of uranium; for this analysis campaign, the Direction des Productions relied on the analytical laboratory of the Pierrelatte plant and on the Central Analytical Laboratory of the CEA where I was in charge of analyses by mass spectrometry.

Acute effects of mindful interval exercise on cognitive performance in a higher education setting.

Interval exercise (IE) has been shown to have acute facilitating effects on cognition; however, the existing literature has been limited to laboratory settings and has focused on manipulating the parameters of exercise bouts during IE. This study included two classroom-based experiments to (1) investigate the effect of an acute bout of IE delivering mindfulness activity during its recovery intervals (mindful IE) on cognitive performance, and (2) compare cognitive performance following acute bouts of mindful IE with non-mindful IE. Experiment 1: Using a class-based within-subject crossover design, 59 participants completed the Stroop, d2, and trail-making tests to measure inhibitory control, attention, and cognitive flexibility, after a 30-min non-exercise or mindful IE session on separate counterbalanced days. Experiment 2: Using a similar design, 70 participants were assigned to two groups to receive a non-exercise and an IE session with (mindful) or without (non-mindful) mindfulness-based recovery intervals on separate counterbalanced days. Results from Experiment 1 showed superior d2 performance following the mindful IE than the non-exercise session. Although Experiment 2 found exercise-related decreases in commission error rate during the d2 test in both groups, the non-mindful group showed additional decreases in omission and total error rates. Further, higher scores on the nonreactivity facet of dispositional mindfulness were correlated with larger decreases in omission and total error rates during the d2 test for the mindful IE group. No exercise-related effect was found for outcomes of the Stroop and trail-making tests in both experiments. These findings in the selective improvements in d2 test performance are the first to suggest the feasibility of integrating mindfulness activity into the recovery intervals of IE for enhanced cognitive performance that may depend on individual differences in dispositional mindfulness.

Analytical Unreliability of 25 Hydroxy Vitamin D Measurements in Pre-Term Neonates.

BACKGROUND: Vitamin D supplementation is common practice for neonates and infants due to limited stores of vitamin D at birth. Although not commonly encountered, vitamin D toxicity can occur due to over-supplementation. However, toxic concentrations are often not included in method validation experiments, and assays often are not validated in the neonatal population. METHODS: We compared serial 25 hydroxy vitamin D [25(OH)D] measurements in pre-term neonates receiving 25(OH)D supplementation and identified 12 patients wherein concentrations of 25(OH)D were above 50 ng/mL (125 nM) that required additional investigations as the 25(OH)D results did not match the clinical picture. Available samples were compared across 4 immunoassay platforms (LIAISON XL, Roche Cobas e602, Abbott Alinity i, and Siemens Centaur XP) and LC-MS/MS. RESULTS: Concentrations of 25(OH)D observed on one individual immunoassay platform (LIAISON XL) fluctuated substantially between subsequent blood draws in select neonates with elevated concentrations. Serum samples from these patients showed variable agreement between LC-MS/MS and other immunoassay platforms. These fluctuations were not explained by the presence of 3-epimer-25(OH)D or 24,25(OH)2D. CONCLUSIONS: Although we were unable to identify a cause for the variable elevated results, our findings suggest that neonatal 25(OH)D measurements alone should not be used for assessment of nutritional monitoring, and that clinical correlation and other laboratory parameters including ionized calcium should be considered.

Laboratory Selection in Germline Genetic Testing: Laboratory Science Matters.

There are multiple laboratories that offer germline genetic testing, and it can be difficult to discern which one to use for testing. Some laboratories have more comprehensive analysis techniques and capability, which increases the accuracy of testing. The ordering provider has a responsibility to select the appropriate laboratory with technologic capability for the needed testing, inform the laboratory of prior testing results in the patient and family so known familial variants have targeted testing, and use appropriate terminology and nomenclature when communicating information to other healthcare professionals, patients, and families. This report presents a case illustrating the potential errors that can occur when a provider selects a laboratory that lacks the capacity to detect certain pathogenic variants, such as large deletions and duplications. False-negative germline testing results lead to missed opportunities in prevention and early detection for not only the patient but often multiple family members, which may lead to psychosocial distress and late-detected cancers. This case highlights the complexities of genetic care and why management by a genetics professional can facilitate more fiscally responsible care, appropriate genetic testing, and comprehensive care for all family members at risk.

The accessibility, necessity, and significance of certified reference materials for total selenium content and its species to improve food laboratories' performance.

Micronutrients are one of the most important groups of nutrients that our body needs daily in trace amounts to tackle deficiencies. Selenium (Se) is a mineral that occurs naturally in foods and is an essential component of selenoproteins that support the healthy functioning of the human body. Therefore, monitoring dietary Se concentrations must be a higher priority to meet daily intakes. Fulfillment can be addressed through applying various analytical techniques, and the certified reference materials (CRMs) tool plays a crucial role in quality assurance/quality control (QA/QC). The availability of certified CRMs for total Se content with addition to their species is presented. The review emphasizes the necessity of incorporating more food matrix CRMs certifying Se species, apart from total Se content, to meet method validation requirements for food analysis laboratories. This would help CRM producers bridge the gap between available food matrix materials that are not certified for Se species.

Verification of the sampling procedure for radioactivity analysis of waste and industrial material.

In accordance with ISO/IEC 17025:2017, the testing laboratory needs to verify its ability to properly perform methods. For radiological testing, the sampling does not affect the results directly, but it has to ensure that sample adequately represents the tested material. To verify the procedure, a sampling of red mud and bauxite ore was conducted. All samples were measured in identical geometry by HPGe spectrometer. The counting rates per unit mass in the recorded spectra were compared. For each measurement series, the mean and standard deviations of respected peaks were calculated, as well as average and standard deviation of all series. The obtained results of each individual series were considered satisfactory, i.e. sampling procedure ensures the representativeness of the bulk material, if it is within ± two standard deviations of the average of the mean values.

An Antimicrobial Fabric Using Nano-Herbal Encapsulation of Essential Oils.

Lab coats are widely used in biohazard laboratories and healthcare facilities as protective garments to prevent direct exposure to pathogens, spills, and burns. These cotton-based protective coats provide ideal conditions for microbial growth and attachment sites due to their porous nature, moisture-holding capacity, and retention of warmth from the user's body. Several studies have demonstrated the survival of pathogenic bacteria on hospital garments and lab coats, acting as vectors of microbial transmission. A common approach to fix these problems is the application of antimicrobial agents in textile finishing, but concerns have been raised due to the toxicity and environmental effects of many synthetic chemicals. The ongoing pandemic has also opened a window for the investigation of effective antimicrobials and eco-friendly and toxic-free formulations. This study uses two natural bioactive compounds, carvacrol and thymol, encapsulated in chitosan nanoparticles, which guarantee effective protection against four human pathogens with up to a 4-log reduction (99.99%). These pathogens are frequently detected in lab coats used in biohazard laboratories. The treated fabrics also resisted up to 10 wash cycles with 90% microbial reduction, which is sufficient for the intended use. We made modifications to the existing standard fabric tests to better represent the typical scenarios of lab coat usage. These refinements allow for a more accurate evaluation of the effectiveness of antimicrobial lab coats and for the simulation of the fate of any accidental microbial spills that must be neutralized within a short time. Further studies are recommended to investigate the accumulation of pathogens over time on antimicrobial lab coats compared to regular protective coats.

Development and Implementation of a Standard Format for Clinical Laboratory Test Results.

OBJECTIVES: Surprisingly, laboratory results, the principal output of clinical laboratories, are not standardized. Thus, laboratories frequently report results with identical meaning in different formats. For example, laboratories report a positive pregnancy test as "+," "P," or "Positive." To assess the feasibility of a widespread implementation of a result standard, we (1) developed a standard result format for common laboratory tests and (2) implemented a feedback system for clinical laboratories to view their unstandardized results. METHODS: In the largest integrated health care system in America, 130 facilities had the opportunity to collaboratively develop the standard. For 15 weeks, clinical laboratories received a weekly report of their unstandardized results. At the study's conclusion, laboratories were compared with themselves and their peers by metrics that reflected their unstandardized results. RESULTS: We rereviewed 156 million test results and observed a 51% decline in the rate of unstandardized results. The number of facilities with fewer than 23 unstandardized results per 100,000 (Six Sigma σ > 5) increased by 58% (52 to 82 facilities; ß = 1.79; P < .001). CONCLUSIONS: This study demonstrated significant improvement in the standardization of clinical laboratory results in a relatively short time. The laboratory community should create and promulgate a standardized result format.

Insights into National Laboratory Newborn Screening and Future Prospects.

Newborn screening (NBS) is a group of tests that check all newborns for certain rare conditions, covering several genetic or metabolic disorders. The laboratory NBS is performed through blood testing. However, the conditions that newborn babies are screened for vary from one country to another. Since NBS began in the 1960s, technological advances have enabled its expansion to include an increasing number of disorders, and there is a national trend to further expand the NBS program. The use of mass spectrometry (MS) for the diagnosis of inborn errors of metabolism (IEM) obviously helps in the expansion of the screening panels. This technology allows the detection of different metabolic disorders at one run, replacing the use of traditional techniques. Analysis of the targeted pathogenic gene variant is a routine application in the molecular techniques for the NBS program as a confirmatory testing to the positive laboratory screening results. Recently, a lot of molecular investigations, such as next generation sequencing (NGS), have been introduced in the routine NBS program. Nowadays, NGS techniques are widely used in the diagnosis of IMD where its results are rapid, confirmed and reliable, but, due to its uncertainties and the nature of IEM, it necessitates a holistic approach for diagnosis. However, various characteristics found in NGS make it a potentially powerful tool for NBS. A range of disorders can be analyzed with a single assay directly, and samples can reduce costs and can largely be automated. For the implementation of a robust technology such as NGS in a mass NBS program, the main focus should not be just technologically biased; it should also be tested for its long- and short-term impact on the family and the child. The crucial question here is whether large-scale genomic sequencing can provide useful medical information beyond what current NBS is already providing and at what economical and emotional cost? Currently, the topic of newborn genome sequencing as a public health initiative remains argumentative. Thus, this article seeks the answer to the question: NGS for newborn screening- are we there yet?

The effects of add-on therapy of Phyllanthus Emblica (Amla) on laboratory confirmed COVID-19 Cases: A randomized, double-blind, controlled trial.

OBJECTIVE: This randomized, double-blind, controlled trial (RCT) aimed to evaluate the effect of Phyllanthus Emblica (Amla) as an add-on therapy on COVID-19_ related biomarkers and clinical outcomes in COVID-19 patients. METHODS: In this RCT, sixty-one patients were randomly assigned into two arms [the intervention (n=31) and control arms (n=30)]. The effect of Amla on diagnostic Reverse-transcription Polymerase Chain Reaction (RT-PCR) test results between the first and the last days of the study, the length of stay (LOS) in hospital, the percentage of lung involvement on CT scans, changes in the clinical symptoms, and the laboratory markers were assessed. RESULTS: The two study groups had similar baseline demographics and characteristics in terms of medical history. The mean of LOS in the intervention arm (4.44 days) was significantly shorter than in the control arm (7.18 days, P < 0.001); RT-PCR results were not significantly different between the two arms (P = 0.07). All clinical variables decreased over time in the two groups (P < 0.001). However, the difference between the two groups in terms of fever (P = 0.004), severity of cough (P = 0.001), shortness of breath (P = 0.004), and myalgia (P = 0.005) were significant, but this intergroup comparison was not significant with regard to respiratory rate (P = 0.29), severity of chills (P = 0.06), sore throat (P = 0.22), and weakness (P = 0.12). Out of the eight evaluated para-clinical variables, three variables showed significant improvement in the intervention arm, including the mean increase in oxygen saturation (SpO2) level (P < 0.001), the reduction in the mean percentage of lung involvement on CT (P < 0.001), and the improvement in C-reactive protein test results (P < 0.001). CONCLUSION: Organic herbal Amla tea cannot significantly affect the RT-PCR results and or degree of lung involvement. Nevertheless, it showed an ameliorative effect on the severity of clinical signs and CRP levels. Also, Amla tea may shorten the recovery times of symptoms and LOS in COVID-19 patients.

Influence of point-of-use filters and stagnation on water quality at a preschool and under laboratory conditions.

A local preschool installed NSF/ANSI 42 and 53 certified point-of-use (POU) filters in its classroom sinks and drinking fountains to protect children from the possibility of elevated lead (Pb) levels in drinking water. We examined the effects of these filters during flowing water and immediately following stagnation periods on Pb, chlorine, and bacterial concentrations in the field and the laboratory. Before and after typical school stagnation periods, we collected samples from filtered classroom sinks, a filtered drinking fountain and nearby unfiltered sinks for a year. No unfiltered samples exceeded Illinois State limits of 5 µg/L for Pb in pre-K through 5th grade schools. However, following stagnation periods as short as overnight (14.5 h), over half of post-stagnation filtered samples from classroom sinks exceeded 5 µg/L while post-stagnation unfiltered samples remained below 5 µg/L. Laboratory testing showed no significant increases in Pb with stagnation, suggesting that the preschool classrooms may have had Pb-bearing plumbing downstream of the filters which released Pb into the filtered drinking water. The filters effectively removed free chlorine (99% decrease) in both the preschool and laboratory. Installing the filters had the unintended consequence of significantly increasing the bacterial concentrations (as measured by qPCR) in the preschool's drinking water and in laboratory filter effluent. Legionella pneumophila, Pseudomonas aeruginosa, and Mycobacterium spp. were not detected in pre-stagnation unfiltered and post-stagnation filtered samples. These results suggest that the installation of POU filters be considered as one component of an overall strategy to decrease Pb concentrations in school drinking water that holistically considers the premise plumbing system. A 5-minute flush significantly decreased concentrations of Pb and bacteria in filtered sinks. Replacing Pb-bearing plumbing components downstream of a POU filter may also be needed to combat Pb levels in drinking water.

Genomics and simulated laboratory studies reveal Thermococcus sp. 101C5 as a novel hyperthermophilic archaeon possessing a specialized metabolic arsenal for enhanced oil recovery.

Laboratory evaluation of hyperthermophiles with the potential for Enhanced Oil Recovery (EOR) is often hampered by the difficulties in replicating the in situ growth conditions in the laboratory. In the present investigation, genome analysis was used to gain insights into the metabolic potential of a hyperthermophile to mobilize the residual oil from depleting high-temperature oil reservoirs. Here, we report the 1.9 Mb draft genome sequence of a hyperthermophilic anaerobic archaeon, Thermococcus sp. 101C5, with a GC content of 44%, isolated from a high-temperature oil reservoir of Gujarat, India. 101C5 possessed the genetic arsenal required for adaptation to harsh oil reservoir conditions, such as various heat shock proteins for thermo-adaptation, Trk potassium uptake system proteins for osmo-adaptation, and superoxide reductases against oxidative stress. Microbial Enhanced Oil Recovery (MEOR) potential of the strain was established by ascertaining the presence of genes encoding enzymes involved in the production of the metabolites such as hydrogen, bio-emulsifier, acetate, exopolysaccharide, etc. Production of these metabolites which pressurize the reservoir, emulsify the crude oil, lower the viscosity and reduce the drag, thus facilitating mobilization of the residual oil was experimentally confirmed. Also, the presence of crude oil degradative genes highlighted the ability of the strain to mobilize heavy residual oil, which was confirmed under simulated conditions in sand-pack studies. The obtained results demonstrated additional oil recoveries of 42.1% and 56.5% at 96 °C and 101 °C, respectively, by the strain 101C5, illustrating its potential for application in high-temperature oil reservoirs. To our best knowledge, this is the first report of genome analysis of any microbe assessed for its suitability for MEOR from the high-temperature oil reservoir.

Protein extraction from cold-pressed hempseed press cake: From laboratory to pilot scale.

During the production of industrial hempseed oil, a press cake is formed as a byproduct, which is often used as animal feed although it contains a high amount of protein that could be used for human consumption. Extracting this valuable protein would reduce food waste and increase the availability of plant-based protein. A protein extraction process based on the pH-shift method was adapted to improve the protein extraction yield from industrial hempseed press cake (HPC). Parameters such as alkali extraction pH, time, and temperature, as well as isoelectric precipitation pH, were investigated in laboratory scale and were thereafter carried out in a pilot trial to explore the suitability for future scale up. The phytic acid content of the extracted protein isolate was also analyzed to investigate any potential inhibitory effect on mineral absorption. A final protein yield of 60.6%, with a precipitated protein content of 90.3% (dw), was obtained using a constant alkali extraction pH of 10.5 for 1 h at room temperature, followed by precipitation at pH 5.5. The pilot trial showed promising results for the future production of industrial hemp protein precipitate on a larger scale, showing a protein yield of 57.0% and protein content of 90.8% (dw). The amount of phytic acid in the protein isolate produced in the optimal laboratory experiment and in the pilot trial was 0.595 and 0.557 g phytic acid/100 g dw, respectively, which is 83%-88% less than in the HPC. This is in the range of other plant-based protein sources (tofu, kidney beans, peas, etc.). PRACTICAL APPLICATION: Industrial hempseed press cake is a byproduct in the production of industrial hempseed oil, which is mostly used as animal feed, but has the potential to become an additional source of plant-based protein for human consumption with a suitable protein extraction method. The extracted hemp protein could be used to develop new plant-based dairy or meat analog products.

Chronic toxicity of uranium to three benthic organisms in laboratory spiked sediment.

Due to mining activities, concentration of uranium (U) in the environment nearby former and operating sites can be higher than in other areas. The derivation of quality criteria for U in freshwater ecosystems, rivers and lakes includes the consideration of contaminated sediments and the associated risk to the benthic life. Therefore, the derivation of a quality criteria for sediment has been viewed as a logical and necessary extension of the work already done to establish water quality criteria. In order to contribute to the determination of a Quality Standard for sediment (QSsediment) according to the European recommendations, this study focuses on the acquisition of a new toxicity dataset, to enrich the few rare existing data, most often unsuitable. A basic set of organisms, including three complementary benthic organisms (Chironomus riparius, Hyalella azteca, Myriophyllum aquaticum), was chronically exposed to U spiked to a standard laboratory-formulated sediment, according to the related bioassay guidelines (ISO/FDIS16303, OECD 218/9, ISO/DIS 16191). We looked to determine when possible both NOEC and EC10 values for each organism. For C. riparius, a NOEC (emergence rate) value was estimated at 62 mgU, kg-1, dm and the EC10 value reached 188 mgU, kg-1, dm (CI95% 40-885 mgU kg-1, dm). For H. azteca, a NOEC (survival rate) value of 40 mgU kg-1, dm was observed while the EC10 value at 296 mgU kg-1, dm (CI95% = 155-436 mgU kg-1, dm) was slightly higher than for growth at 199 mgU kg-1, dm (CI95% = 107-291 mgU kg-1 dm). Finally, the less sensitive organism seemed to be the plant, M. aquaticum, for which we determined a NOEC value of 100 mgU kg-1, dm. Results obtained regarding the toxicity of U made it possible to suggest a preliminary QSsediment value of 4 mgU kg-1, dry mass. This value was shown conservative compared to U sediment quality criteria derived by other jurisdictions.