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This article discusses a new method for diagnosing brain lymphoma using nanopore sequencing of cerebrospinal fluid (CSF). The study demonstrates the clinical application of this method in two cases of CNS lymphoma. The researchers adapted their fast-track unsupervised machine learning approach for cases with a differential diagnosis of lymphoma and other malignant brain tumors. The results showed that nanopore sequencing-derived methylation patterns can be used for next-day diagnosis and treatment initiation. This point-of-care protocol has the potential to significantly reduce neurological impairment through timely and non-invasive testing. [Extracted from the article]

Background and Objectives: This study evaluated the efficacy of the TrueLab™ Real Time mini-PCR system in providing rapid and accurate diagnostic results for tuberculosis (TB) detection in India. The goal is to improve case detection and accelerate treatment in settings with limited resources. Materials and Methods: This prospective study was conducted by the Department of Microbiology on 120 patients, age ranging from >=15 years with at least two clinical symptoms of pulmonary TB. Molbio and Universal Cartridge Based Sample Prep were the 2 methods used for processing sputum samples. The diagnosis was based on the MTB Real Time PCR test, which has a detection limit of 100 CFU/mL. Patients under 15 years, samples lacking clinical background, saliva specimens or extra-pulmonary TB cases were excluded from the study. Results: A total of 44.17% samples were positive for TB with maximum positivity in the age group 31-45 years. Positivity rate was found to be higher in females. In 4.17% of cases there was rifampicin resistance, which was significantly high in previously treated cases. Comparison of Truenat with Ziehl-Neelsen and fluorescent method revealed that it was more sensitive and less time consuming. Conclusion: Truenat MTB/RIF is a sensitive detection system for TB with rapid results, which serves as an important tool in the early management of tuberculosis patients and drug-resistant-TB cases. [ABSTRACT FROM AUTHOR]

In the face of the SARS-CoV-2 pandemic, characterized by the virus's rapid mutation rates, developing timely and targeted therapeutic and diagnostic interventions presents a significant challenge. This study utilizes bioinformatic analyses to pinpoint conserved genomic regions within SARS-CoV-2, offering a strategic advantage in the fight against this and future pathogens. Our approach has enabled the creation of a diagnostic assay that is not only rapid, reliable, and cost-effective but also possesses a remarkable capacity to detect a wide array of current and prospective variants with unmatched precision. The significance of our findings lies in the demonstration that focusing on these conserved genomic sequences can significantly enhance our preparedness for and response to emerging infectious diseases. By providing a blueprint for the development of versatile diagnostic tools and therapeutics, this research paves the way for a more effective global pandemic response strategy. [ABSTRACT FROM AUTHOR]

Background: Most respiratory viruses can cause serious lower respiratory diseases at any age. Therefore, timely and accurate identification of respiratory viruses has become even more important. This study focused on the development of rapid nucleic acid testing techniques for common respiratory infectious diseases in the Chinese population. Methods: Multiplex fluorescent quantitative polymerase chain reaction (PCR) assays were developed and validated for the detection of respiratory pathogens including the novel coronavirus (SARS-CoV-2), influenza A virus (FluA), parainfluenza virus (PIV), and respiratory syncytial virus (RSV). Results: The assays demonstrated high specificity and sensitivity, allowing for the simultaneous detection of multiple pathogens in a single reaction. These techniques offer a rapid and reliable method for screening, diagnosis, and monitoring of respiratory pathogens. Conclusion: The implementation of these techniques might contribute to effective control and prevention measures, leading to improved patient care and public health outcomes in China. Further research and validation are needed to optimize and expand the application of these techniques to a wider range of respiratory pathogens and to enhance their utility in clinical and public health settings. [ABSTRACT FROM AUTHOR]

Iron (Fe) is a micronutrient that can be toxic at elevated concentrations, prompting its significance in frequent environmental monitoring. Typically analyzed using methods such as FAAS, ICP-OES and ICP-MS, the challenge of expensive instrumentation operated only in the laboratory presents a barrier for rapid and frequent testing. This study aimed to develop a silica-based smartphone-assisted on-site method for rapid detection of Fe in water using ImageJ software. Suitable conditions, including reagents and a color intensity measurement tool, were optimized for this method. Figures of merit such as detection limit, accuracy and precision were determined. The results showed that adding polyacrylic acid to detection points for silica worsened the results, in contrast to results for paper devices. It was also found that, on ImageJ, it is best to use an integrated density tool to measure color intensity, contrary to the previously reported mean gray tool. Results showed a limit of detection of 0.2 ng, a limit of quantification of 0.6 ng, a linear range of 0.6 ng to 4.5 ng and RSD of <20%. This method is therefore an alternative in field pre-testing and screening. Future studies include application of this method in the field with real samples and in the analysis of other metals. [ABSTRACT FROM AUTHOR]

This review aims to explore the role of professional diagnostic rapid testing of acute respiratory infections (ARIs), especially COVID-19 and influenza, ensuring proper disease management and treatment in Europe, and particularly in Czech Republic, Poland, and Romania. The paper was constructed based on a review of scientific evidence and national and international policies and recommendations, as well as a process of validation by four experts. The development of new testing technologies, treatment options, and increased awareness of the negative multidimensional impact of ARI profiles transformed differential diagnosis into a tangible and desirable reality. This review covers the following topics: (1) the multidimensional impact of ARIs, (2) ARI rapid diagnostic testing platforms and their value, (3) the policy landscape, (4) challenges and barriers to implementation, and (5) a set of recommendations illustrating a path forward. The findings indicate that rapid diagnostic testing, including at the point of care (POC), can have a positive impact on case management, antimicrobial and antibiotic stewardship, epidemiological surveillance, and decision making. Integrating this strategy will require the commitment of governments and the international and academic communities, especially as we identified room for improvement in the access and expansion of POC rapid testing in the focus countries and the inclusion of rapid testing in relevant policies. [ABSTRACT FROM AUTHOR]

Background and Objectives: This study evaluated the efficacy of the TrueLab™ Real Time mini-PCR system in providing rapid and accurate diagnostic results for tuberculosis (TB) detection in India. The goal is to improve case detection and accelerate treatment in settings with limited resources. Materials and Methods: This prospective study was conducted by the Department of Microbiology on 120 patients, age ranging from >=15 years with at least two clinical symptoms of pulmonary TB. Molbio and Universal Cartridge Based Sample Prep were the 2 methods used for processing sputum samples. The diagnosis was based on the MTB Real Time PCR test, which has a detection limit of 100 CFU/mL. Patients under 15 years, samples lacking clinical background, saliva specimens or extra-pulmonary TB cases were excluded from the study. Results: A total of 44.17% samples were positive for TB with maximum positivity in the age group 31-45 years. Positivity rate was found to be higher in females. In 4.17% of cases there was rifampicin resistance, which was significantly high in previously treated cases. Comparison of Truenat with Ziehl-Neelsen and fluorescent method revealed that it was more sensitive and less time consuming. Conclusion: Truenat MTB/RIF is a sensitive detection system for TB with rapid results, which serves as an important tool in the early management of tuberculosis patients and drug-resistant-TB cases.

Abstract Background In Ontario, Canada we developed and implemented an online screening algorithm for the distribution of HIV self-tests, known as GetaKit. During the COVID pandemic, we adapted the GetaKit algorithm to screen for COVID based on population and infection data and distributed COVID rt-LAMP self-tests (using the Lucira Check-It®) to eligible participants. Methods GetaKit/COVID was a prospective observational study that occurred over a 7-month period from September 2021 to April 2022. All potential participants completed an online registration and risk assessment, including demographic information, COVID symptoms and risk factors, and vaccination status. Bivariate comparisons were performed for three outcomes: results reporting status, vaccination status, and COVID diagnosis status. Data were analysed using Chi-Square for categorial covariates and Independent Samples T-Test and Mann-Whitney U test for continuous covariates. Bivariate logistic regression models were applied to examine associations between the covariates and outcomes. Results During the study period, we distributed 6469 COVID self-tests to 4160 eligible participants; 46% identified as Black, Indigenous or a Person of Colour (BIPOC). Nearly 70% of participants reported their COVID self-test results; 304 of which were positive. Overall, 91% also reported being vaccinated against COVID. Statistical analysis found living with five or fewer people, having tested for COVID previously, and being fully vaccinated were positive factors in results reporting. For COVID vaccination, people from large urban centers, who identified their ethnicity as white, and who reported previous COVID testing were more likely to be fully vaccinated. Finally, being identified as a contact of someone who had tested positive for COVID and the presence of COVID-related symptoms were found to be positive factors in diagnosis. Conclusions While most participants who accessed this service were vaccinated against COVID and the majority of diagnoses were identified in participants who had symptoms of, or an exposure to, COVID, our program was able to appropriately link participants to recommended follow-up based on reported risks and results. These findings highlight the utility of online screening algorithms to provide health services, particularly for persons with historical barriers to healthcare access, such as BIPOC or lower-income groups.

This review provides a comprehensive summary of evidence to explore the role and value of differential diagnosis in the management of Acute Respiratory Infections (ARIs) through point-of-care (POC) rapid testing in a post-pandemic scenario, paying particular attention to coronavirus disease 2019 (COVID-19), influenza, and respiratory syncytial virus (RSV). The document builds on a review of literature and policies and a process of validation and feedback by a group of seven experts from Latin America (LATAM). Evidence was collected to understand scientific and policy perspectives on the differential diagnosis of ARIs and POC rapid testing, with a focus on seven countries: Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru. The evidence indicates that POC rapid testing can serve to improve ARI case management, epidemiological surveillance, research and innovation, and evidence-based decision-making. With multiple types of rapid tests available for POC, decisions regarding which tests to use require the consideration of the testing purpose, available resources, and test characteristics regarding accuracy, accessibility, affordability, and results turnaround time. Based on the understanding of the current situation, this document provides a set of recommendations for the implementation of POC rapid testing in LATAM, supporting decision-making and guiding efforts by a broad range of stakeholders.

Background: In Ontario, Canada we developed and implemented an online screening algorithm for the distribution of HIV self-tests, known as GetaKit. During the COVID pandemic, we adapted the GetaKit algorithm to screen for COVID based on population and infection data and distributed COVID rt-LAMP self-tests (using the Lucira Check-It®) to eligible participants. Methods: GetaKit/COVID was a prospective observational study that occurred over a 7-month period from September 2021 to April 2022. All potential participants completed an online registration and risk assessment, including demographic information, COVID symptoms and risk factors, and vaccination status. Bivariate comparisons were performed for three outcomes: results reporting status, vaccination status, and COVID diagnosis status. Data were analysed using Chi-Square for categorial covariates and Independent Samples T-Test and Mann-Whitney U test for continuous covariates. Bivariate logistic regression models were applied to examine associations between the covariates and outcomes. Results: During the study period, we distributed 6469 COVID self-tests to 4160 eligible participants; 46% identified as Black, Indigenous or a Person of Colour (BIPOC). Nearly 70% of participants reported their COVID self-test results; 304 of which were positive. Overall, 91% also reported being vaccinated against COVID. Statistical analysis found living with five or fewer people, having tested for COVID previously, and being fully vaccinated were positive factors in results reporting. For COVID vaccination, people from large urban centers, who identified their ethnicity as white, and who reported previous COVID testing were more likely to be fully vaccinated. Finally, being identified as a contact of someone who had tested positive for COVID and the presence of COVID-related symptoms were found to be positive factors in diagnosis. Conclusions: While most participants who accessed this service were vaccinated against COVID and the majority of diagnoses were identified in participants who had symptoms of, or an exposure to, COVID, our program was able to appropriately link participants to recommended follow-up based on reported risks and results. These findings highlight the utility of online screening algorithms to provide health services, particularly for persons with historical barriers to healthcare access, such as BIPOC or lower-income groups. [ABSTRACT FROM AUTHOR]

This review provides a comprehensive summary of evidence to explore the role and value of differential diagnosis in the management of Acute Respiratory Infections (ARIs) through point-of-care (POC) rapid testing in a post-pandemic scenario, paying particular attention to coronavirus disease 2019 (COVID-19), influenza, and respiratory syncytial virus (RSV). The document builds on a review of literature and policies and a process of validation and feedback by a group of seven experts from Latin America (LATAM). Evidence was collected to understand scientific and policy perspectives on the differential diagnosis of ARIs and POC rapid testing, with a focus on seven countries: Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru. The evidence indicates that POC rapid testing can serve to improve ARI case management, epidemiological surveillance, research and innovation, and evidence-based decision-making. With multiple types of rapid tests available for POC, decisions regarding which tests to use require the consideration of the testing purpose, available resources, and test characteristics regarding accuracy, accessibility, affordability, and results turnaround time. Based on the understanding of the current situation, this document provides a set of recommendations for the implementation of POC rapid testing in LATAM, supporting decision-making and guiding efforts by a broad range of stakeholders. [ABSTRACT FROM AUTHOR]

Abstract Despite of the global unity against COVID-19 pandemic, the threat of SARS-CoV-2 variants on the lives of human being is still not over. SARS-CoV-2 pandemic has urged the need of rapid viral detection at earliest. To cope with gradually expanding scenario of SARS-CoV-2, accurate diagnosis is extremely crucial factor which should be noticed by international health organizations. Limited research followed by sporadic marketing of SARS-CoV-2 rapid pharmaceutical detection kits raises critical questions against quality assurance and quality control measures. Herein we aimed to interrogate effectivity and specificity analysis of SARS-CoV-2 pharmaceutical rapid detection kits (nasopharyngeal swab based) using conventional gold standard triple target real-time polymerase chain reaction (USFDA approved). A cross-sectional study was conducted over 1500 suspected SARS-CoV-2 patients. 100 real time-PCR confirmed patients were evaluated for pharmaceutical RDT kits based upon nasopharyngeal swab based kits. The SARS-CoV-2 nasopharyngeal swab based rapid diagnostic kit (NSP RDTs) analysis showed 78% reactivity. Among real time PCR confirmed negative subjects, 49.3% represented false positivity. The positive predictive analysis revealed 67.82%, while negative predictive values were 64.40%. The NSP RDTs showed limited sensitivities and specificities as compared to gold standard real time PCR. Valid and authentic detection of SARS-CoV-2 is deemed necessary for accurate COVID-19 surveillance across the globe. Current study highlights the potential consequences of inadequate detection of SARS-CoV-2 and emerging novel mutants, compromising vaccine preventable diseases. Current study emphasizes need to wake higher authorities including strategic organizations for designing adequate measures to prevent future SARS-CoV-2 epidemics.

ABSTRACT: The objective of this cross-sectional study was to standardize a reliable and repeatable swabbing technique using ATP luminometry (light emission proportional to the amount of ATP with result provided in relative light units [RLU]) to describe the cleanliness of various feeding equipment used for preweaning calves in dairy farms. A total of 7 Québec commercial dairy herds were selected conveniently. Following visual hygiene scoring, the cleanliness of every available piece of feeding equipment was assessed using direct surface swabbing for buckets and nipples with Hygiena UltraSnap swabs. A liquid rinsing technique was used for esophageal feeders, bottles, and automatic milk feeders (AMF) with UltraSnap, AquaSnap, and MicroSnap swabs. To validate direct swabbing technique of buckets, a stage within and between operators was realized, as well as a conventional bacterial culture. A total of 519 swab samples were obtained from 201 pieces of equipment. The median (interquartile range) contamination in RLU for a bottle, esophageal feeder, AMF, bucket and nipple was 2 (1;6), 2 (0;12), 52 (19;269), 886 (128;7,230) and 899 (142;6,928), respectively. The direct swabbing technique, which consists in swabbing directly the surface of an equipment, showed excellent correlation for intrarater reliability (intraclass correlation (ICC) = 0.93; 95% CI: 0.88–0.96). The interoperator (2 sessions with 3 different operators) reliability also showed high correlation (ICC = 0.88; 95% CI: 0.78–0.94 for the first session, and ICC = 0.89; 95% CI: 0.79–0.95 for the second session). Luminometer values were positively associated with the visual score of esophageal feeders, AMF and buckets. A positive correlation between bacterial culture and direct swabbing of buckets was also found for the UltraSnap (rs = 0.653; 95% CI: 0.283–0.873; P = 0.0003) and MicroSnap (rs = 0.569, 95% CI: 0.309–0.765; P = 0.002). This study describes a standardized and practical on-farm swabbing technique for assessing the hygienic status of feeding equipment by luminometry, which can be integrated in the investigation of preweaning dairy calves problems.

The objective of this cross-sectional study was to standardize a reliable and repeatable swabbing technique using ATP luminometry (light emission proportional to the amount of ATP with result provided in relative light units [RLU]) to describe the cleanliness of various feeding equipment used for preweaning calves in dairy farms. A total of 7 Québec commercial dairy herds were selected conveniently. Following visual hygiene scoring, the cleanliness of every available piece of feeding equipment was assessed using direct surface swabbing for buckets and nipples with Hygiena UltraSnap swabs. A liquid rinsing technique was used for esophageal feeders, bottles, and automatic milk feeders (AMF) with UltraSnap, AquaSnap, and MicroSnap swabs. To validate direct swabbing technique of buckets, a stage within and between operators was realized, as well as a conventional bacterial culture. A total of 519 swab samples were obtained from 201 pieces of equipment. The median (interquartile range) contamination in RLU for a bottle, esophageal feeder, AMF, bucket and nipple was 2 (1;6), 2 (0;12), 52 (19;269), 886 (128;7,230) and 899 (142;6,928), respectively. The direct swabbing technique, which consists in swabbing directly the surface of an equipment, showed excellent correlation for intrarater reliability (intraclass correlation (ICC) = 0.93; 95% CI: 0.88–0.96). The interoperator (2 sessions with 3 different operators) reliability also showed high correlation (ICC = 0.88; 95% CI: 0.78–0.94 for the first session, and ICC = 0.89; 95% CI: 0.79–0.95 for the second session). Luminometer values were positively associated with the visual score of esophageal feeders, AMF and buckets. A positive correlation between bacterial culture and direct swabbing of buckets was also found for the UltraSnap (r s = 0.653; 95% CI: 0.283–0.873; P = 0.0003) and MicroSnap (r s = 0.569, 95% CI: 0.309–0.765; P = 0.002). This study describes a standardized and practical on-farm swabbing technique for assessing the hygienic status of feeding equipment by luminometry, which can be integrated in the investigation of preweaning dairy calves problems. [ABSTRACT FROM AUTHOR]

As lithium-ion battery (LIB) cells degrade over time and usage, it is crucial to understand their remaining capacity, also known as State of Health (SoH), and inconsistencies between cells in a pack, also known as cell-to-cell variation (CtCV), to appropriately operate and maintain LIB packs. This study outlines efforts to model pack SoH and SoH CtCV of nickel-cobalt-aluminum (NCA) and lithium-iron-phosphate (LFP) battery packs consisting of four cells in series using pack-level voltage data. Using small training data sets and rapid testing procedures, partial least squares regression (PLS) models were built and achieved a mean absolute error of 0.38% and 1.43% pack SoH for the NCA and LFP packs, respectively. PLS models were also built that correctly categorized the packs as having low, medium, and high-ranked SoH CtCV 72.5% and 65% of the time for the NCA and LFP packs, respectively. This study further investigates the relationships between pack SoH, SoH CtCV, and the voltage response of the NCA and LFP packs. The slope of the discharge voltage response of the NCA packs was shown to have a strong correlation with pack dynamics and pack SoH, and the lowest SoH cell within the NCA packs was shown to dominate the dynamic response of the entire pack. [ABSTRACT FROM AUTHOR]

Some experts have promoted the use of rapid testing for COVID-19. However, with the current technologies available, continuing to replace laboratory-based, real-time reverse transcription polymerase chain reaction tests with rapid (point-of-care) tests may lead to an increased number of false negative tests. Moreover, the more rapid dissemination of false negative results that can occur with the use of rapid tests for COVID-19 may lead to increased spread of the novel coronavirus if patients do not understand the concept of false negative tests. One means of combatting this would be to tell patients who have a “negative” rapid COVID-19 test that their test result was “indeterminate.”

In the face of the SARS-CoV-2 pandemic, characterized by the virus’s rapid mutation rates, developing timely and targeted therapeutic and diagnostic interventions presents a significant challenge. This study utilizes bioinformatic analyses to pinpoint conserved genomic regions within SARS-CoV-2, offering a strategic advantage in the fight against this and future pathogens. Our approach has enabled the creation of a diagnostic assay that is not only rapid, reliable, and cost-effective but also possesses a remarkable capacity to detect a wide array of current and prospective variants with unmatched precision. The significance of our findings lies in the demonstration that focusing on these conserved genomic sequences can significantly enhance our preparedness for and response to emerging infectious diseases. By providing a blueprint for the development of versatile diagnostic tools and therapeutics, this research paves the way for a more effective global pandemic response strategy.

Iron (Fe) is a micronutrient that can be toxic at elevated concentrations, prompting its significance in frequent environmental monitoring. Typically analyzed using methods such as FAAS, ICP-OES and ICP-MS, the challenge of expensive instrumentation operated only in the laboratory presents a barrier for rapid and frequent testing. This study aimed to develop a silica-based smartphone-assisted on-site method for rapid detection of Fe in water using ImageJ software. Suitable conditions, including reagents and a color intensity measurement tool, were optimized for this method. Figures of merit such as detection limit, accuracy and precision were determined. The results showed that adding polyacrylic acid to detection points for silica worsened the results, in contrast to results for paper devices. It was also found that, on ImageJ, it is best to use an integrated density tool to measure color intensity, contrary to the previously reported mean gray tool. Results showed a limit of detection of 0.2 ng, a limit of quantification of 0.6 ng, a linear range of 0.6 ng to 4.5 ng and RSD of

This review aims to explore the role of professional diagnostic rapid testing of acute respiratory infections (ARIs), especially COVID-19 and influenza, ensuring proper disease management and treatment in Europe, and particularly in Czech Republic, Poland, and Romania. The paper was constructed based on a review of scientific evidence and national and international policies and recommendations, as well as a process of validation by four experts. The development of new testing technologies, treatment options, and increased awareness of the negative multidimensional impact of ARI profiles transformed differential diagnosis into a tangible and desirable reality. This review covers the following topics: (1) the multidimensional impact of ARIs, (2) ARI rapid diagnostic testing platforms and their value, (3) the policy landscape, (4) challenges and barriers to implementation, and (5) a set of recommendations illustrating a path forward. The findings indicate that rapid diagnostic testing, including at the point of care (POC), can have a positive impact on case management, antimicrobial and antibiotic stewardship, epidemiological surveillance, and decision making. Integrating this strategy will require the commitment of governments and the international and academic communities, especially as we identified room for improvement in the access and expansion of POC rapid testing in the focus countries and the inclusion of rapid testing in relevant policies.

While Mpox virus (MPXV) diagnostics were performed in specialized laboratories only, the global emergence of Mpox cases in 2022 revealed the need for a more readily available diagnostic. Automated random‐access platforms with fast nucleic acid extraction and PCR have become established in many laboratories, providing faster and more accessible testing. In this study, we adapted a previously published generic MPXV‐PCR as a lab‐developed test (LDT) on a NeuMoDx Molecular System and isolated MPXV clones from patient materials. To reduce the handling of infectious material, we evaluated a viral lysis buffer (VLB) for sample pretreatment. We further compared the MPXV‐LDT‐PCR to conventional real‐time PCR, determined its sensitivity and specificity using positive swabs, and assessed its performance using external quality assessment samples. Pretreatment of samples with 50% VLB reduced MPXV infectivity by approximately 200‐fold while maintaining PCR sensitivity. The assay demonstrated a sensitivity and specificity of 100% with no cross‐reactivity in the samples tested and performed with a limit of detection of 262 GE/mL. In summary, the assay had a turnaround time of fewer than 2 h and can easily be transferred to other automated PCR platforms, providing a basis for developing rapid assays for upcoming pandemics. [ABSTRACT FROM AUTHOR]

Background: Isoniazid is a leading tuberculosis treating medication. Global supply chains provide essential medicines such as isoniazid to resource-limited areas. Ensuring the safety and efficaciousness of these medicines is essential to public health programs. Handheld spectrometers are becoming increasingly approachable in cost and usability. As supply chains expand, quality compliance screening of essential medications is necessary in site-specific locations. Here, a brand-specific qualitative discrimination analysis of isoniazid is approached by collecting data from two handheld spectrometers in two countries with the intent to build a multi-location quality compliance screening method for a brand of isoniazid. Methods: Two handheld spectrometers (900–1700 nm) were used to collect spectra from five manufacturing sources (N = 482) in Durham, North Carolina, USA, and Centurion, South Africa. A qualitative brand differentiation method was established from both locations by applying a Mahalanobis distance thresholding method as a measure of assessing similarity. Results: Combining data from both locations resulted in a 100% classification accuracy, at both locations, for brand 'A' and resulted in the four other brands classifying as dissimilar. Bias was found between sensors in terms of resulting Mahalanobis distances, but the classification method proved to be robust enough to accommodate. Several spectral peaks found in isoniazid references appear within the 900–1700 nm range, as well as variation in the excipients per manufacturer. Conclusions: Results show promise for compliance screening isoniazid as well as other tablets in multiple geographic locations using handheld spectrometers. [ABSTRACT FROM AUTHOR]

Seasonal influenza virus is associated with high morbidity and mortality especially in vulnerable patient populations. Here, we demonstrate the novel use of Sofia influenza A+B fluorescent immunoassay (FIA), a rapid antigen-based influenza point-of-care test (POCT), combined with Virena software for automatic deidentified tracking of influenza activity across the Los Angeles area and for predicting surges of influenza cases in the emergency department (ED). We divided outpatient clinics into 6 geographic zones and compared weekly influenza activity. In the outpatient setting, there were 1,666 and 274 influenza A and influenza B positives, respectively, across the 2018 to 2019 influenza season and 1,857 and 1,449 influenza A and influenza B positives, respectively, during the 2019 to 2020 influenza season, with zone-specific differences observed. Moreover, we found that a rapid increase in outpatient influenza was followed by an influx in influenza-positive cases in the ED, offering a 1- to 3-week warning sign for ED influx of triple or quadruple the number of influenza cases compared to the prior week. Sofia influenza A+B FIA allows for surveillance of real-time deidentified influenza activity. Tracking of such data may serve as a valuable region-specific influenza indicator and predictor to guide infection prevention measures in both the outpatient and hospital settings. High-impact interventions include designating areas for waiting rooms for influenza-like illnesses, altering staff scheduling in anticipation of surges, and securing sufficient personal protective equipment and antivirals during the height of influenza season.

Background: The rapid provision of blood products is life‐saving for patients with massive hemorrhage. Ideally, RhD‐negative blood products would be supplied to a woman of childbearing potential whose Rh type is unknown due to the risk of D‐alloimmunization and the potential for hemolytic disease of the fetus and newborn to occur if RhD‐positive blood products are transfused. Therefore, there is a need for a test that rapidly determines her RhD type. This study compared the RhD type determined using a rapid ABO and RhD test to the RhD type determined by an immunohematology reference laboratory. Methods: After receiving ethics review board approval, 200 random, unique, deidentified patient samples that had undergone routine pretransfusion testing in an immunohematology reference laboratory using column agglutination technology were collected and tested using a rapid ABO and RhD test (Eldoncard Home kit 2511). The RhD typing results from these two methods were compared to determine the accuracy of the rapid ABO and RhD test. Results: The rapid ABO and RhD test produced results that were concordant with the transfusion service's results in 199/200 (99.5%) of cases, with a negative predictive value of 98.2% and 99.3% sensitivity. The single outlier was likely an RhD variant due to its serological characteristics. Discussion: These data indicate that this rapid ABO and RhD test could be used for the rapid determination of a patient's RhD type, perhaps even in the emergency department, which could guide the selection of blood products provided during their resuscitation. [ABSTRACT FROM AUTHOR]

Given the global rise in antimicrobial resistance levels, there is an urgent need to obtain the minimal inhibitory concentration (MIC) of an antibiotic as early as possible. In this paper, we present the first test results of a light-based concept where the interaction of a laser beam with the drug–bacterium sample is used to calculate MIC values within 6 h after cultivation. For this preliminary study, a total of 163 drug–bacterium pairs were tested and benchmarked with broth microdilution (BMD). The pathogen set included Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter baumannii, Staphylococcus aureus, Staphylococcus capitis, Staphylococcus cohnii, Staphylococcus epidermis, Staphylococcus haemolyticus, Enterococcus and Streptococcus pneumoniae . The selected drugs belonged to 10 different classes. The method under investigation showed a categorical concordance of 86.1% and an essential agreement of 80.3% with BMD. Due to its simplicity, the concept can be easily implemented on existing commercial platforms. This research shows promise for further studies potentially leading to a novel concept that can be employed to rapidly determine MIC values.

Background: Since the outbreak of coronavirus disease (COVID-19), the high infection rate and mutation frequency of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent, have contributed to the ongoing global pandemic. Vaccination has become the most effective means of controlling COVID-19. Traditional neutralizing tests of sera are complex and labor-intensive, therefore, a rapid test for detecting neutralizing antibodies and antibody status post-immunization is needed. Methods: Based on the fact that antibodies exhibit neutralizing activity by blocking the binding of the S protein receptor-binding domain (S-RBD) to ACE2, we developed a rapid neutralizing antibody test, ACE2-Block-ELISA. To evaluate the sensitivity and specificity, we used 54 positive and 84 negative serum samples. We also tested the neutralizing activities of monoclonal antibodies (mAbs) and 214 sera samples from healthy individuals immunized with the inactivated SARS-CoV-2 vaccine. Results: The sensitivity and specificity of the ACE2-Block ELISA were 96.3% and 100%, respectively. For neutralizing mAb screening, ch-2C5 was selected for its ability to block the ACE2–S-RBD interaction. A plaque assay confirmed that ch-2C5 neutralized SARS-CoV-2, with NT50 values of 4.19, 10.63, and 1.074 µg/mL against the SARS-CoV-2 original strain, and the Beta and Delta variants, respectively. For the immunized sera samples, the neutralizing positive rate dropped from 82.14% to 32.16% within 4 months post-vaccination. Conclusions: This study developed and validated an ACE2-Block-ELISA to test the neutralizing activities of antibodies. As a rapid, inexpensive and easy-to-perform method, this ACE2-Block-ELISA has potential applications in rapid neutralizing mAb screening and SARS-CoV-2 vaccine evaluation.

Deoxynivalenol (DON) contamination of food crops and feeds is almost impossible to avoid completely; however, through best management practices, this risk can be effectively managed and maximumly mitigated. Accurate and rapid detection of DON contamination as early in the entire value chain as possible is critical. To achieve this goal, we developed a DON test strip based on time-resolved fluorescence immunoassay (TRFIA) and a specific DON monoclonal antibody for the rapid quantification of DON in food crops and feeds. The strip displayed a good linearity (R2 = 0.9926), with a limit of quantification of 28.16 μg/kg, a wide linear range of 50 ~ 10,000 μg/kg. The intra-batch coefficient of variation (CV) and the inter-batch CV was

The rapid identification of pathogens of bloodstream infections (BSIs) and the detection of antibiotic resistance markers are critically important for optimizing antibiotic therapy and infection control. The purpose of this study was to evaluate two approaches based on MALDI-TOF MS technology for direct identification of Gram-negative bacteria and automatic detection of Klebsiella pneumoniae carbapenemase (KPC) producers using the Bruker MBT Subtyping IVD Module in a large routine laboratory over a three-year period. MALDI-TOF MS analysis was performed directly from blood culture (BC) bottles following bacterial pellet recovery by Rapid MBT Sepsityper® Kit and on blood agar 4-h subcultures. Automated detection of blaKPC-carrying pKpQIL-plasmid by Bruker MBT Subtyping Module was evaluated in BCs tested positive to K. pneumoniae or E. coli. The results were compared with those obtained with conventional reference methods. Among the 2858 (93.4%) monomicrobial BCs, the overall species identification rates of the Rapid Sepsityper and the short-term subculture protocols were 84.5% (n = 2416) and 90.8% (n = 2595), respectively (p < 0.01). Excellent specificity for KPC-producers identification were observed for both MALDI-TOF MS protocols. The pKpQIL plasmid-related peak was detected in overall 91 of the 120 (75.8%) KPC-producing isolates. Notably, 14 out of the 17 (82.3%) K. pneumoniae isolates carrying blaKPC variants associated with ceftazidime/avibactam resistance and tested negative by the immunocromatography assay, were correctly identified as KPC-producers by MALDI-TOF MS. In conclusion, combination of both Rapid Sepsityper and short-term subculture protocols may represent an optimal solution to promptly identify more than 95% of Gram-negative bacteria causing BSIs. MALDI Biotyper® platform enabled a reliable and robust automated detection of KPC producers in parallel with species identification. However, integration of molecular or immunocromatographic assays are recommended according to local epidemiology. [ABSTRACT FROM AUTHOR]

Porcine reproductive and respiratory syndrome (PRRS) caused by PRRS virus (PRRSV) is one of the most complicated and dangerous diseases in pigs with high mortality since it modulates the immune system of the lungs and has been closely associated with secondary infection of other lethal bacteria and viruses. The gold standard of molecular diagnosis for PRRSV, reverse transcription (RT)-PCR, is time-consuming, expensive and requires transportation of samples to a specialized laboratory. In this study, a direct colorimetric RT-loop-mediated isothermal amplification (RT-LAMP) method was developed to specifically and rapidly detect PRRSV. The RT-LAMP outcomes can be visualized by the naked eye after 45 min of incubation at 65°C without any cross-reactivity recorded with the bacteria and other viruses tested. In particular, the mobile, non-instrumented, commercial pocket hand warmers were demonstrated to successfully provide constant temperature for consistent nucleic acid amplification throughout the RT-LAMP reactions. The limit of detection of the assay was defined as the genomic RNA concentration extracted from a known viral titer of 10-2.5 TCID50/ml. The direct use of clinical serum samples required a simple dilution to maintain the performance of the colorimetric RT-LAMP assay. Therefore, the direct colorimetric RT-LAMP assay developed is well-qualified for producing a ready-to-use kit for PRRSV diagnosis in the field. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to confirm NeuMoDx™ SARS-CoV-2 assay (NeuMoDx assay) functionality using off-label collection media, determine assay performance versus other SARS-CoV-2 RNA assays, and assess any cross-reactivity with other respiratory viruses (human coronavirus NL63, influenza, and respiratory syncytial virus). Methods: Nasopharyngeal swab samples in off-label collection media and external quality assessment (EQA) samples were dual-tested, first using either the RealStar® SARS-CoV-2 reverse transcriptase polymerase chain reaction assay or the QIAstat-Dx® Respiratory SARS-CoV-2 Panel and then using the NeuMoDx assay. Samples found to be positive for respiratory viruses and negative for SARS-CoV-2 were then tested using the NeuMoDx assay to assess cross-reactivity. Results: Overall, 274 samples (244 patient and 30 EQA samples) were dual-tested; 154 were SARS-CoV-2 positive and 120 were negative. No false-positive or false-negative results were identified, regardless of collection medium used. The NeuMoDx assay sensitivity was 100% (95% confidence interval [CI] 97.63-100.00) and the specificity was 100% (95% CI 96.97-100.00). The assay did not exhibit any cross-reactivity with other respiratory viruses. Conclusion: The NeuMoDx assay demonstrated high sensitivity and specificity on a platform well-suited for fully automated SARS-CoV-2 testing.

ABSTRACT: The objective of this observational cross-sectional study was to describe the cleanliness of various equipment used for colostrum harvest and calf feeding procedures on dairy farms in Québec, Canada. The study was performed on 42 commercial dairy herds also enrolled in another study aiming to determine the transfer of passive immunity over a 14-mo period. Information on colostrum quality (using Brix value) and cleanliness (total aerobic and total coliform count) were recorded as well as various practices focused on colostrum-feeding equipment and preweaning period using a standard questionnaire. During the study period, colostrum and milk-feeding equipment cleanliness was assessed using direct surface swabbing with Hygiena Ultrasnap swabs. A total of 155 swab samples were obtained from 6 pieces of equipment. Adenosine triphosphate collected from the swabbed surface reacts with the luciferase solution present in the swab by bioluminescence, which is proportional to the quantity of ATP present and quantified as relative light units (RLU). The description of feed equipment cleanliness (defined as the maximal RLU found for a specific herd, dichotomized as

The aim of the current study is to perform model calculations on the possible use of SARS-CoV-2-rapid point-of-care tests as mass tests, using the quality criteria extracted from evidence-based research as an example for the Federal Republic of Germany. In addition to illustrating the problem of false positive test results, these calculations are used to examine their possible influence on the 7-day incidence. For a substantial period of time, this parameter formed the decisive basis for decisions on measures to protect the population in the wake of the COVID pandemic, which were taken by the government. Primarily, model calculations were performed for a base model of 1,000,000 SARS-CoV-2-rapid point-of-care tests per week using various sensitivities and specificities reported in the literature, followed by sequential testing of the test positives obtained by a SARS-CoV-2 PCR test. Furthermore, a calculation was performed for an actual maximum model based on self-test contingents by the German Federal Ministry of Health. Assuming a number of 1,000,000 tests per week at a prevalence of 0.5%, a high number of false positive test results, a low positive predictive value, a high negative predictive value, and an increase in the 7-day incidence due to the additional antigen rapid tests of approx. 5/100,000 were obtained. A previous maximum calculation based on contingent numbers for self-tests given by the German Federal Ministry of Health even showed an additional possible influence on the 7-day incidence of 84.6/100,000. The model calculations refer in each case to representative population samples that would have to be drawn if the successive results were comparable which should be given, as far-reaching actions were based on this parameter. The additionally performed SARS-CoV-2-rapid point-of-care tests increase the 7-day incidence in a clear way depending on the number of tests and clearly show their dependence on the respective number of tests. SARS-CoV-2-rapid point-of-care tests as well as the SARS-CoV-2-PCR test method should both be used exclusively in the presence of corresponding respiratory symptoms and not in symptom-free persons.

Introduction: Gene rearrangements are frequent oncologic drivers in NSCLC, and many are suitable for treatment with Food and Drug Administration–approved or experimental targeted therapies. We evaluated the accuracy, specimen acceptance profile, and limits of detection of a rapid fusion assay (Idylla GeneFusion Assay), a commercially available ultrarapid molecular assay, for its clinical utility. Methods: A collection of 97 specimens which had previously undergone next-generation sequencing testing were analyzed using the rapid fusion assay. Accuracy was evaluated by sensitivity and specificity compared with the next-generation sequencing results. The performance characteristics were tested by using a variety of different clinically relevant specimen types. Limits of detection were assessed by evaluating different input of tumor percentage and material amount. Results: The rapid fusion assay was found to have 100% sensitivity in detecting fusions of ALK, ROS1, RET, NTRK1, and MET exon 14 skipping and 83% sensitivity for NTRK2/3 fusions. There were 100% specificity in detecting fusions of ROS1, RET, NTRK2/3, and MET exon 14 skipping and 98% specificity for ALK. Testing was successful with formalin-fixed paraffin-embedded biopsy and surgical tissues, cell blocks from fine-needle aspiration and pleural fluid (down to 5% tumor content, 18 mm2 tissue scraped), cytology smears (≥300 cells), and previously extracted RNA (minimal 20 ng). Conclusions: The rapid fusion assay is quick, accurate, and versatile, allowing reliable detection of ALK, ROS1, RET fusions, and MET exon 14 skipping in NSCLC, and NTRK fusions. Rapid molecular testing may expedite treatment with appropriate targeted therapies.

The STANDARD M10 is a novel cartridge-based real time RT-PCR point of care platform that provides significant advantages regarding SARS-CoV-2 detection including fast turnaround times and no need for specialized personnel and facilities. This assay was recently evaluated in our hospital as a rapid alternative to the already present NeuMoDx assay that is used in everyday practice. For this purpose, 30 nasopharyngeal samples by patients admitted to our hospital were used, regardless of clinical suspicion of COVID-19. In our evaluation, the sensitivity of STANDARD M10 was 95%, the specificity was 100%, the positive predictive value was 100%, the negative predictive value was 90% and the kappa coefficient of agreement was 0.927 (p < 0.001).

Point-of-care tests are highly valuable in providing fast results for medical decisions for greater flexibility in patient care. Many diagnostic tests, such as ELISAs, that are commonly used within clinical laboratory settings require trained technicians, laborious workflows, and complex instrumentation hindering their translation into point-of-care applications. Herein, we demonstrate the use of a homogeneous, bioluminescent-based, split reporter platform that enables a simple, sensitive, and rapid method for analyte detection in clinical samples. We developed this point-of-care application using an optimized ternary, split-NanoLuc luciferase reporter system that consists of two small reporter peptides added as appendages to analyte-specific affinity reagents. A bright, stable bioluminescent signal is generated as the affinity reagents bind to the analyte, allowing for proximity-induced complementation between the two reporter peptides and the polypeptide protein, in addition to the furimazine substrate. Through lyophilization of the stabilized reporter system with the formulated substrate, we demonstrate a shelf-stable, all-in-one, add-and-read analytedetection system for use in complex sample matrices at the point-of-care. We highlight the modularity of this platform using two distinct SARS-CoV-2 model systems: SARS-CoV-2 N-antigen detection for active infections and anti-SARS-CoV-2 antibodies for immunity status detection using chemically conjugated or genetically fused affinity reagents, respectively. This technology provides a simple and standardized method to develop rapid, robust, and sensitive analyte-detection assays with flexible assay formatting making this an ideal platform for research, clinical laboratory, as well as point-of-care applications utilizing a simple handheld luminometer. [ABSTRACT FROM AUTHOR]

Acrylamide is a probable human carcinogen with a wide occurrence in commonly consumed food. Because of the lack of specific antibodies against acrylamide, immunoassays usually measure acrylamide derivates, which require long derivatization times at elevated temperatures. One exception is xanthylacrylamide (XAA), which can be derived from acrylamide at room temperature within 30 min. Here, we present the development of a monoclonal antibody against XAA and a competitive enzyme-linked immunosorbent assay (ELISA) based on the multicolor detection of gold nanorods (AuNRs). The biotinylated monoclonal antibodies bound streptavidin alkaline phosphatase, which induced XAA concentration-dependent silver deposition on the AuNRs. The resulting blue shift of the AuNR surface plasmon resonance peak translated into a strong gray-to-orange color change that could be conveniently distinguished by the naked eye or smartphone color detection. The assay showed a broad linear range (0.3–17.2 ng/mL), a low limit of detection (0.06 ng/mL), and a 3.6-fold sensitivity improvement compared to those of conventional tetramethylbenzidine-based ELISA. The analysis of several different food products showed excellent acrylamide concentration recoveries (84–102%) and confirmed its applicability as an effective tool for routine monitoring of acrylamide in food. Rapid and simple color analysis demonstrated a strong potential for implementation into direct consumer product testing. [ABSTRACT FROM AUTHOR]

The assessment of food quality is of significant importance as it allows control over important features, such as ensuring adherence to food standards, longer shelf life, and consistency and quality of taste. Rice is the predominant dietary source of half the world's population, and Pakistan contributes around 80% of the rice trade worldwide and is among the top three of the largest exporters. Hitherto, the rice industry has depended on antiquated methods of rice quality assessment through manual inspection, which is time consuming and prone to errors. In this study, an efficient desktop-application-based rice quality evaluation system, 'National Grain Tech', based on computer vision and machine learning, is presented. The analysis is based on seven main features, including grain length, width, weight, yellowness, broken, chalky, and/or damaged kernels for six different types of rice: IRRI-6, PK386, 1121 white and Selah, Super kernel basmati brown, and white rice. The system was tested in rice factories for 3 months and demonstrated 99% accuracy in determining the size, weight, color, and chalkiness of rice kernels. An accuracy of 98.8% was achieved for the classification of damaged and undamaged kernels, 98% for determining broken kernels, and 100% for paddy kernels. The results are significant because the developed system improves the local rice quality testing capacity through a faster, more accurate, and less expensive mechanism in comparison to previous research studies, which only evaluated four features of the singular rice type, rather than the seven features achieved in this study for six rice types. [ABSTRACT FROM AUTHOR]

Aims: Glucose‐6‐phosphate dehydrogenase (G6PD) deficiency, the most common enzymopathy in humans, can cause acute haemolysis resulting from exposure to certain medications, chemicals, infections and fava beans. Rasburicase, used to manage elevated uric acid levels in the oncologic emergency of tumour lysis syndrome, is one such drug. The US Food and Drug Administration (FDA) recommends testing of G6PD status prior to rasburicase administration for patients at higher risk for G6PD deficiency. Methods: We performed a retrospective chart review of all oncology patients for whom a semi‐quantitative biochemical test for detecting G6PD deficiency was performed prior to rasburicase administration over a 2.5‐year period, in a large academic metropolitan hospital. Results: We identified 16 out of 260 tested individuals as G6PD‐deficient (6.1%), including six females. On average, test results were electronically available to health care providers within 4 hours of sample collection, with most results available within 2–3 hours. Four G6PD‐deficient patients developed elevated uric acid levels. Two of the G6PD‐deficient patients were treated with rasburicase, and subsequently developed haemolysis, which was appropriately managed. Conclusion: In summary, by providing information about G6PD status with a rapid turnaround time, we have taken a significant step towards personalized medicine in our institution. In spite of the test implementation, two out of four G6PD‐deficient patients, who were no longer candidates for rasburicase use, still received the drug, highlighting the need for improved provider education. [ABSTRACT FROM AUTHOR]

Rapid antigen detection tests (RADTs) offer advantages over gold‐standard reverse transcription polymerase chain reaction (RT‐PCR) tests in that they are cheaper and provide faster results, thus enabling prompt isolation of positive SARS‐CoV‐2 cases and quarantine of close contacts. The aim of this study was to collate and synthesise empirical evidence on the effectiveness of rapid antigen testing for the screening (including serial testing) and surveillance of asymptomatic individuals to limit the transmission of SARS‐CoV‐2. A rapid review was undertaken in MEDLINE (EBSCO), EMBASE (OVID), Cochrane Library, Europe PMC and Google Scholar up until 19 July 2021, supplemented by a grey literature search. Of the identified 1222 records, 19 reports referring to 16 studies were included. Eight included studies examined the effectiveness of RADTs for population‐level screening, four for pre‐event screening and four for serial testing (schools, a prison, a university sports programme and in care homes). Overall, there is uncertainty regarding the effectiveness of rapid antigen testing for the screening of asymptomatic individuals to limit the transmission of SARS‐CoV‐2. This uncertainty is due to the inconsistent results, the relatively low number of studies identified, the predominantly observational and/or uncontrolled nature of the study designs used, and concerns regarding methodological quality. Given this uncertainty, more real‐world research evidence in relevant settings, which is of good quality and timely, as well as economic evaluation, is required to inform public policy on the widespread use of RADTs in asymptomatic individuals. [ABSTRACT FROM AUTHOR]

Purpose: To develop and evaluate a scalable national program to build confidence, competence and capability in the use of rapid genomic testing (rGT) in the acute pediatric setting., Methods: We used theory-informed approaches to design a modular, adaptive program of blended learning aimed at diverse professional groups involved in acute pediatric care. The program comprised 4 online learning modules and an online workshop and was centered on case-based learning. We evaluated the program using the Kirkpatrick 4-level model of training evaluation and report our findings using the Reporting Item Standards for Education and its Evaluation (RISE2) guidelines for genomics education and evaluation., Results: Two hundred and two participants engaged with at least 1 component of the program. Participants self-reported increased confidence in using rGT, (P < .001), and quiz responses objectively demonstrated increased competence (eg, correct responses to a question on pretest counseling increased from 30% to 64%; P < .001). Additionally, their capability in applying genomic principles to simulated clinical cases increased (P < .001), as did their desire to take on more responsibility for performing rGT. The clinical interpretation of more complex test results (such as negative results or variants of uncertain significance) appeared to be more challenging, indicating a need for targeted education in this area., Conclusion: The program format was effective in delivering multidisciplinary and wide-scale genomics education in the acute care context. The modular approach we have developed now lends itself to application in other medical specialties or areas of health care., Competing Interests: Conflict of Interest The authors declare no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Many emergency departments (ED) use rapid human immunodeficiency virus (HIV) antibody tests as screening tools, despite limited sensitivity for detecting acute HIV infections. In a 4-year retrospective analysis of 1,192 patients, we evaluated the performance of a third-generation rapid HIV antibody assay tested at point-of-care (POC, Chembio Sure Check HIV 1/2) against in-lab fourth-generation screening (Abbott Architect Ag/Ab Combo). Compared to complete algorithmic testing, the POC test demonstrated a 92.5% sensitivity (95% CI = 84.6-96.5), 98.1% specificity (95% CI = 97.1-98.8), 99.5% negative predictive value (NPV; 95% CI = 98.8-99.8), and a 77.9% positive predictive value (PPV; 95% CI = 68.6-85.1). Notably, the POC test failed to detect 100% (3/3) of acute HIV infections (defined as Fiebig stage 2) and 3.8% (2/52) established HIV infections, where viral loads were 5.9, 6.7, and >7 log 10 copies/mL. Symptoms such as fever, nausea/vomiting, malaise, headache, and photophobia were significantly associated with acute HIV infections diagnosed in the ED. The rapid HIV antibody test demonstrated high sensitivity, specificity, and NPV in our study population, reaffirming its effectiveness as a valuable screening tool. However, the low PPV and 100% failure to detect acute HIV infections underscore the importance of prioritizing in-lab fourth-generation HIV antigen/antibody combination immunoassays in cases of suspected acute HIV infection to ensure a timely and accurate diagnosis., Competing Interests: T.I.B. has no conflict of interest. N.W.A. has served on scientific advisory boards for Roche Diagnostics and Diasorin Molecular. C.W.F. has served on scientific advisory boards for Werfen, Abbott Laboratories, Roche Diagnostics, and Cytovale and received research funding from Beckman Coulter, Abbott Laboratories, Roche Diagnostics, Cepheid, Siemens Healthineers, and Biomerieux.

Point-of-care tests are highly valuable in providing fast results for medical decisions for greater flexibility in patient care. Many diagnostic tests, such as ELISAs, that are commonly used within clinical laboratory settings require trained technicians, laborious workflows, and complex instrumentation hindering their translation into point-of-care applications. Herein, we demonstrate the use of a homogeneous, bioluminescent-based, split reporter platform that enables a simple, sensitive, and rapid method for analyte detection in clinical samples. We developed this point-of-care application using an optimized ternary, split-NanoLuc luciferase reporter system that consists of two small reporter peptides added as appendages to analyte-specific affinity reagents. A bright, stable bioluminescent signal is generated as the affinity reagents bind to the analyte, allowing for proximity-induced complementation between the two reporter peptides and the polypeptide protein, in addition to the furimazine substrate. Through lyophilization of the stabilized reporter system with the formulated substrate, we demonstrate a shelf-stable, all-in-one, add-and-read analyte-detection system for use in complex sample matrices at the point-of-care. We highlight the modularity of this platform using two distinct SARS-CoV-2 model systems: SARS-CoV-2 N-antigen detection for active infections and anti-SARS-CoV-2 antibodies for immunity status detection using chemically conjugated or genetically fused affinity reagents, respectively. This technology provides a simple and standardized method to develop rapid, robust, and sensitive analyte-detection assays with flexible assay formatting making this an ideal platform for research, clinical laboratory, as well as point-of-care applications utilizing a simple handheld luminometer.

Objectives: This study aimed to compare the performance of the NeuMoDx™ SARS-CoV-2 Assay, implemented on the NeuMoDx 96 Molecular System, with that of the ThermoFisher TaqPath™ COVID-19 CE-IVD RT-PCR Kit (reference method). Methods: Overall, 450 nasopharyngeal swab samples, previously tested using the reference method, were tested by the NeuMoDx Assay, and the clinical sensitivity and specificity of the assay were analyzed. Results: By retrospective statistical analysis of all valid results, the NeuMoDx Assay had a clinical specificity of 100% (95% confidence interval [CI]: 98.65–100.00) and a clinical sensitivity of 98.73% (95% CI: 95.47–99.85). Conclusions: The NeuMoDx SARS-CoV-2 Assay demonstrated comparable analytical and clinical performance to the ThermoFisher TaqPath COVID-19 CE-IVD RT-PCR Kit. The NeuMoDx 96 Molecular System is well suited for automating medium-throughput routine SARS-CoV-2 testing or as an addition to high-throughput systems to allow fast-tracking for highly urgent clinical samples.

As lithium-ion battery (LIB) cells degrade over time and usage, it is crucial to understand their remaining capacity, also known as State of Health (SoH), and inconsistencies between cells in a pack, also known as cell-to-cell variation (CtCV), to appropriately operate and maintain LIB packs. This study outlines efforts to model pack SoH and SoH CtCV of nickel-cobalt-aluminum (NCA) and lithium-iron-phosphate (LFP) battery packs consisting of four cells in series using pack-level voltage data. Using small training data sets and rapid testing procedures, partial least squares regression (PLS) models were built and achieved a mean absolute error of 0.38% and 1.43% pack SoH for the NCA and LFP packs, respectively. PLS models were also built that correctly categorized the packs as having low, medium, and high-ranked SoH CtCV 72.5% and 65% of the time for the NCA and LFP packs, respectively. This study further investigates the relationships between pack SoH, SoH CtCV, and the voltage response of the NCA and LFP packs. The slope of the discharge voltage response of the NCA packs was shown to have a strong correlation with pack dynamics and pack SoH, and the lowest SoH cell within the NCA packs was shown to dominate the dynamic response of the entire pack.

Our study aim was to evaluate the performance of the automated Sysmex HISCL® severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) antigen assay against reverse‐transcription polymerase chain reaction (RT‐PCR). We tested 277 remnant frozen nasopharyngeal swab samples, stored in universal transport medium (UTM), yielding a sensitivity of 94.9% against historical RT‐PCR results with cycle threshold (Ct) < 30, and a sensitivity of 76.7% for Ct < 35, and specificity of 100% (all Ct values) confirming compatibility of UTM‐diluted samples with the assay system. Thereafter, we prospectively collected 141 nasopharyngeal swab samples in UTM from healthcare workers and 1369 paired swabs (400 UTM; 969 dry) from individuals at a public health testing center, with the first swab (UTM) reserved for RT‐PCR, yielding a positivity rate of 4.6%. HISCL assay performance using UTM swabs was superior to dry swabs, with a sensitivity of 100% (95% confidence interval [CI] 71.5%–100%) at Ct < 30 versus 92.3% (95%CI 81.5%–97.9%), and a specificity of 99.3% (95% CI 98.1–99.89) against 83.3% (95%CI 80.7%–85.6%). We conclude that this antigen assay is suitable for high throughput facilities where the primary indication for testing is to rule out infection with low RT‐PCR Ct values (proxy for high viral loads) to curb viral spread. [ABSTRACT FROM AUTHOR]

Kynurenine is a tryptophan metabolite linked to several inflammatory processes including transplant failure, a significant challenge in transplant medicine. The detection of small molecules such as kynurenine, however, is often complex and time consuming. Herein, we report the successful synthesis of a fluorescently labelled kynurenine derivative, showing proper fluorescence and anti-kynurenine antibody binding behavior in a magnetic bead immunoassay (MIA). The fluorescent kynurenine–rhodamine B conjugate shows a KD-value of 5.9 µM as well as IC50 values of 4.0 µM in PBS and 10.2 µM in saliva. We thus introduce a rapid test for kynurenine as a potential biomarker for kidney transplant failure. [ABSTRACT FROM AUTHOR]

ABSTRACT The Omicron (B.1.1.529) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the last variant of concern (VOC) identified to date. Compared to whole-genome or gene-specific sequencing methods, reverse-transcription PCR assays may be a simpler approach to study VOCs. We used a point-of-care COVID-19 diagnostic PCR assay to detect the Omicron SARS-CoV-2 variant in the respiratory tract samples of COVID-19 patients who had tested positive for SARS-CoV-2 RNA between April 2021 and January 2022. Sequencing analyses had shown that 87 samples were positive for the Omicron variant and 43 samples were positive for a non-Omicron variant (Delta, 18 samples; Alpha, 13 samples; Gamma, 10 samples; Beta, 1 sample; or Epsilon, 1 sample). According to results by the PCR assay, whose primers anneal a nucleocapsid (N) gene region that comprises the E31/R32/S33 deletion (also termed the del31/33 mutation), we found that N gene target failure/dropout (i.e., a negative/low result) occurred in 86 (98.8%) of 87 Omicron variant-positive samples tested. These results were assessed in relation to those of the spike (S) gene, which expectedly, was detected in all (100%) 130 samples. A total of 43 (100%) of 43 Delta, Alpha, Gamma, Beta, or Epsilon variant-positive samples had a positive result with the N gene. Importantly, in 86 of 87 Omicron variant-positive samples, the del31/33 mutation was detected together with a P13L mutation, which was, instead, detected alone in the Omicron variant-positive sample that had a positive N-gene result. IMPORTANCE Rapid detection of the Omicron SARS-CoV-2 variant in patients’ respiratory tract samples may influence therapeutic choices, because this variant is known to escape from certain monoclonal antibodies. Our findings strengthen the importance of manufacturers’ efforts to improve the existing COVID-19 diagnostic PCR assays and/or to develop novel variant-specific PCR assays. Furthermore, our findings show that only a small fraction of SARS-CoV-2-positive samples may require whole-genome sequencing analysis, which is still crucial to validate PCR assay results. We acknowledge that the emergence of novel variants containing mutations outside the PCR assay target region could, however, allow an assay to work as per specifications without being able to identify a SARS-CoV-2-positive sample as a variant. Future work and more experience in this topic will help to reduce the risk of misidentification of SARS-CoV-2 variants that is unavoidable when using the current PCR assays.

Background: Different diagnostic tools could improve early detection of coronavirus disease 2019 (COVID-19). A number of antibody-based serological point-of-care tests have been developed to supplement real-time reverse transcriptase polymerase chain reaction (RT-PCR)-based diagnosis. This study describes the validity of an antibody test, namely the immunoglobulin G (IgG)/immunoglobulin M (IgM) Rapid Test Cassette® (BNCP – 402 and BNCP402), manufactured by Spring Healthcare Services. Methods: A prospective cohort validation study was undertaken at Chris Hani Baragwanath Academic Hospital between 16 July 2020 and 12 August 2020. A total of 101 patients admitted as COVID-19 cases under investigation were included in the study. They were divided into two categories depending on time since symptom onset: testing performed within seven days (early cohort) and after seven days (late cohort). The rapid antibody test was compared to the RT-PCR. Results: Overall, the test has a sensitivity and specificity of 85.2% and 80.0%, respectively, for a combination of IgG and IgM. Sensitivity and specificity of IgG testing alone were 81.5% and 85%. Sensitivity improved for testing with increasing time from symptom onset; however, specifity was not significantly different. Conclusion: The study data adds to the body of evidence that because of relatively low sensitivity and specificity, there is a limited role for antibody-based point-of-care testing in the acute phase of COVID-19 infection, as was the case with this IgG/IgM Rapid Test Cassette (BNCP – 402 and BNCP402). There may exist a role for such testing in patients recovered from prior COVID-19 infection or in seroprevalence studies; however, additional evaluations at later timepoints from symptom onset are required.