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In the modern food production technologies, the tools and means of simple and rapid testing raw materials, intermediate products and the final ready-to-consume food products are in high demand. This monitoring allows determining the content of toxic and pathogenic contaminants and confirms the compliance of the objects being tested with the established regulatory requirements. Mobile tests tools and means (so called test systems) provide the opportunity of wide range monitoring without involving the specialized laboratories and highly qualified specialists. Thus, test systems for detection of toxic and pathogenic contaminants serve as the useful addition to confirming instrumental analytical methods. An actively developing approach for this field testing is the using of immunochromatographic test strips, in which strips all the necessary reagents are applied to the membrane components of the analytical system. Contact of the test strip with the sample being tested, initiates all further interactions and generates the recordable or visually assessable optical signal. The market of test systems based on immunochromatographic analysis is constantly growing, thus offering the permanently widening choice of solutions. However, in recent years there has been a real boom of new developments in immunochromatography field, thus offering various options for highly sensitive and information capacitive analytical systems. This study systematizes these developments and provides their comparative assessment in terms of prospects for their technological implementation and practical application in the coming years. The opportunities of designing the antibodies and alternative receptor molecules for controlling the affinity and the selectivity of recognition of the compounds being monitored are considered. The advantages and limitations of the new nanodispersed markers and non-optical methods for their registration in immunochromatography are discussed. The methods for quantitative assessment of the contaminants content via immunochromatography are characterized. The developed design options of the test systems for multiplex control — simultaneous detection of several compounds — are presented. Examples of integration of immunochromatographic tests with the systems of automatic registration, processing, transfer, storage and analysis of results of numerous tests are represented.

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Honey adulteration has been on the rise with the increasing demand for high-quality honey. The ladders-shape melting temperature isothermal amplification (LMTIA) was a newly developed nucleic acid amplification technique, and the aim of this study was to establish a method combining the LMTIA with the proofreading enzyme-mediated probe cleavage (Proof-man probe) for detecting the thaumatin-like protein (TLP) genes of Brassica rapa var. oleifera in honey. The LMTIA primers was selected as a target to be designed, the temperature of the Proof-man LMTIA reaction was optimized, and the specificity, sensitivity, and applicability to the honey samples were determined. The results showed that the Proof-man LMTIA method was highly specific with a detection sensitivity of 30-40 copies genomic DNA/reaction at the optimal temperature of 60°C, and the amplification could be completed within 20 min. This method can detect the adulteration of low-price B. rapa honey into high-price honey. [ABSTRACT FROM AUTHOR]

Background: Standard test methods for evaluating the antibacterial performance of plastic (non-porous) and textile (porous) materials are accurate and reliable, but completing a standard assessment generally requires at least several days to a week. Well-trained and experienced technicians are also required to conduct the standard tests consistently and analyse the samples and test results systemically. These costs are often not favourable for the performance assurance of antimicrobial products in industrial production, nor for meeting the fast-return demands in research and development of antimicrobial materials nowadays. Methods: In this study, "Rapid Tests" are developed to evaluate the antibacterial activities of plastic and textile materials. Results: The assessment results from Rapid Tests for plastics and textiles are highly correlated to those from the ISO 22196 and the AATCC Test Method 100, respectively, whereas the evaluation operation can be completed within one day. Based on bioluminescence technology, colony-forming units of E. coli from the inoculated specimens are determined via luminometry. Antibacterial efficacy of the treated plastic and textile samples can be examined effectively. Conclusions: By analysing antimicrobial artificial leather samples composed of hydrophilic polyurethane polymer using Rapid Tests for plastics and textiles, the applicability and scope of these tests were remarkedly recognised and verified. [ABSTRACT FROM AUTHOR]

This European Society of Clinical Microbiology and Infectious Diseases guideline provides evidence-based recommendations to support a selection of appropriate antibiotic use practices for patients seen in the emergency department (ED) and guidance for their implementation. The topics addressed in this guideline are (a) Do biomarkers or rapid pathogen tests improve antibiotic prescribing and/or clinical outcomes? (b) Does taking blood cultures in common infectious syndromes improve antibiotic prescribing and/or clinical outcomes? (c) Does watchful waiting without antibacterial therapy or with delayed antibiotic prescribing reduce antibiotic prescribing without worsening clinical outcomes in patients with specific infectious syndromes? (d) Do structured culture follow-up programs in patients discharged from the ED with cultures pending improve antibiotic prescribing? An expert panel was convened by European Society of Clinical Microbiology and Infectious Diseases and the guideline chair. The panel selected in consensus the four most relevant antimicrobial stewardship topics according to pre-defined relevance criteria. For each main question for the four topics, a systematic review was performed, including randomized controlled trials and observational studies. Both clinical outcomes and stewardship process outcomes related to antibiotic use were deemed relevant. The literature searches were conducted between May 2021 and March 2022. In April 2022, the panel members were formally asked to suggest additional studies that were not identified in the initial searches. Data were summarized in a meta-analysis if possible or otherwise summarized narratively. The certainty of the evidence was classified according to the Grading of Recommendations Assessment, Development and Evaluation criteria. The guideline panel reviewed the evidence per topic critically appraising the evidence and formulated recommendations through a consensus-based process. The strength of the recommendations was classified as strong or weak. To substantiate the implementation process, implementation trials or observational studies describing facilitators/barriers for implementation were identified from the same searches and were summarized narratively. The recommendations on the use of biomarkers and rapid pathogen diagnostic tests focus on the initiation of antibiotics in patients admitted through the ED. Their effect on the discontinuation or de-escalation of antibiotics during hospital stay was not reported, neither was their effect on hospital infection prevention and control practices. The recommendations on watchful waiting (i.e. withholding antibiotics with some form of follow-up) focus on specific infectious syndromes for which the primary care literature was also included. The recommendations on blood cultures focus on the indication in three common infectious syndromes in the ED explicitly excluding patients with sepsis or septic shock. Most recommendations are based on very low and low certainty of evidence, leading to weak recommendations or, when no evidence was available, to best practice statements. Implementation of these recommendations needs to be adapted to the specific settings and circumstances of the ED. The scarcity of high-quality studies in the area of antimicrobial stewardship in the ED highlights the need for future research in this field. [ABSTRACT FROM AUTHOR]

Introduction: Leptospirosis is an acute treponemal infection with high mortality and morbidity. Due to varied presentations in different geographical areas and unexpected seasonal patterns, clinical diagnosis is difficult. The present study aims to analyze the varied clinical presentations and epidemiological factors in correlation with laboratory diagnosis. Materials and Methods: A retrospective study was conducted among the clinically suspected cases of leptospirosis at R. L. Jalappa Hospital, Kolar, from January 2023 to December 2023. A total of 750 blood samples were tested for IgM ELISA leptospira test. All patient samples that tested positive for IgM antibodies were considered seropositive for Leptospira. The clinical history, laboratory parameters, management, course, and outcome of these patients were recorded. Results: The majority of the affected population were in the 41-60 year age group. Males were more affected than females. Due to unexpected rains, cases peaked in March. Thrombocytopenia was observed in 32 patients (34%), hyperbilirubinemia in 28 patients (30%), raised transaminases in 27 patients (29%), followed by low hemoglobin levels in 27 patients (28%). Severe acute respiratory illness (SARI) was the most common complication, seen in 24 patients (26%), followed by renal failure in 11 patients (12%). Conclusion: The morbidity and mortality due to leptospirosis can be reduced by better understanding environmental factors, by early detection through rapid tests, and predicting the severity of illness using laboratory parameters.

Rapid nucleic acid assays have been approved by FDA for managing the COVID-19 pandemic, however its analytical efficiency has not been thoroughly validated. This study evaluates the detection and identification of COVID-19 virus using Abbott ID-Now to rapidly identify cases and intervention practices in comparison to nucleic acid detection. Nasopharyngeal Swabs collected from 611 participants were tested for Abbott ID-NOW and LabGun COVID-19 ExoFast RT-PCR Kit as per manufacturer’s protocol. The results from the ID NOW™ COVID-19 assay were evaluated by comparing results with the standard RT-PCR, which served as a standard reference. The infection burden of SARS-CoV-2 in the population of UAE was 11.62%. Compared to detection using real time-based platforms, the sensitivity, specificity, positive and negative predictive values of the ID-Now were 84.51%, 99.81%, 98.36% and 98.00% respectively for COVID-19. A stratified analysis was also carried out using cycle threshold (Ct) values categorizing as Ct>33 as with low viral loads while those with Ct

Deficiencies in knowledge about water quality prevent or obscure progress on a panoply of public health problems globally. Specifically, such lack of information frustrates effective and efficient government regulation to protect the public from contaminated drinking water. In this Practical Paper, we lay out how recent scientific innovations in synthetic biology mean that rapid, at-home tests based on biosensor technology could be used to improve water quality monitoring and regulation, using the example of the U.S. Environmental Protection Agency's Lead and Copper Rule currently under revision. Biosensor tests can be used by non-scientists and the information that biosensor tests generate is relatively cheaper and faster than standard laboratory techniques. As such, they have the potential to make it possible to increase the number and frequency of samples tested. This, in turn, could facilitate more accurate compliance monitoring, justify more protective substantive standards, and more efficiently identify infrastructure priorities. Biosensors can also empower historically underrepresented communities by facilitating the visibility of inequities in lead exposure, help utilities to ensure safe water delivery, and guide policy for identifying and replacing lead-bearing water infrastructure, thereby improving public health. As the technology matures, biosensors have great potential to reveal water quality issues, thereby reducing public health burdens. HIGHLIGHTS At-home biosensor tests have recently been developed for use by the general public to rapidly detect drinking water contaminants.; They are relatively simpler, cheaper, and faster than conventional lab techniques, permitting widespread use and thereby democratizing water safety knowledge.; At-home lead biosensor data could improve the U.S. Environmental Protection Agency's Lead and Copper Rule, which is currently under revision.;

Rapid nucleic acid assays have been approved by FDA for managing the COVID-19 pandemic, however its analytical efficiency has not been thoroughly validated. This study evaluates the detection and identification of COVID-19 virus using Abbott ID-Now to rapidly identify cases and intervention practices in comparison to nucleic acid detection. Nasopharyngeal Swabs collected from 611 participants were tested for Abbott ID-NOW and LabGun COVID-19 ExoFast RT-PCR Kit as per manufacturer’s protocol. The results from the ID NOW™ COVID-19 assay were evaluated by comparing results with the standard RT-PCR, which served as a standard reference. The infection burden of SARS-CoV-2 in the population of UAE was 11.62%. Compared to detection using real time-based platforms, the sensitivity, specificity, positive and negative predictive values of the ID-Now were 84.51%, 99.81%, 98.36% and 98.00% respectively for COVID-19. A stratified analysis was also carried out using cycle threshold (Ct) values categorizing as Ct>33 as with low viral loads while those with Ct<33 as high. This demonstrated statistically significant (P<0.0001) decrease in sensitivity in samples (97.87% in low Ct value samples versus 58.33% in high Ct value samples). Even though the sensitivity for Abbott ID NOW™ in this study was lower, the specificity, positive predictive values and negative predictive values were significant in low viral load samples. It is easy to use and interpret, giving early information to support clinical decision-making ID-NOW could be possibly used as a point-of-care test after evaluation in epidemic and endemic settings. [ABSTRACT FROM AUTHOR]

Given the growing hepatitis C virus (HCV) epidemic in the United States, it is imperative to implement a coordinated, equitable public health approach to HCV testing that will facilitate immediate access to treatment, especially for individuals with limited healthcare access and those who inject drugs. Point-of-care RNA diagnostic tests have the greatest potential to address this need. Future regulatory approval has been facilitated by a recent change in the US Food and Drug Administration's approach to evaluating point-of-care diagnostic tests that have been developed and validated. [ABSTRACT FROM AUTHOR]

ABSTRACT The use of rapid disk diffusion or modified automated antimicrobial susceptibility testing (AST) system approaches demonstrates excellent performance for gram-negative organisms directly from blood cultures. In a recent study, S. Khan, A. Das, A. Mishra, A. Vidyarthi, et al. (Microbiol Spectr 12:e03081-23, 2024, https://doi.org/10.1128/spectrum.03081-23) compared the performance of three direct-from-blood AST methods against standard of care disk diffusion and automated AST. The results demonstrated high categorical agreements and low error rates across three protocols. The study suggests that locally validated direct-from-blood AST protocols offer reliable and fast results, particularly for resource-limited settings. However, local context and workflows should be considered prior to implementing rapid AST protocols, and more research is needed on the performance of rapid AST protocols for gram-positive organisms.

Background: Standard test methods for evaluating the antibacterial performance of plastic (non-porous) and textile (porous) materials are accurate and reliable, but completing a standard assessment generally requires at least several days to a week. Well-trained and experienced technicians are also required to conduct the standard tests consistently and analyse the samples and test results systemically. These costs are often not favourable for the performance assurance of antimicrobial products in industrial production, nor for meeting the fast-return demands in research and development of antimicrobial materials nowadays. Methods: In this study, “Rapid Tests” are developed to evaluate the antibacterial activities of plastic and textile materials. Results: The assessment results from Rapid Tests for plastics and textiles are highly correlated to those from the ISO 22196 and the AATCC Test Method 100, respectively, whereas the evaluation operation can be completed within one day. Based on bioluminescence technology, colony-forming units of E. coli from the inoculated specimens are determined via luminometry. Antibacterial efficacy of the treated plastic and textile samples can be examined effectively. Conclusions: By analysing antimicrobial artificial leather samples composed of hydrophilic polyurethane polymer using Rapid Tests for plastics and textiles, the applicability and scope of these tests were remarkedly recognised and verified.

Synopsis: ASSURED criteria for POC test evaluation and rapid test analysis for STIs are discussed for cost‐effective screening, especially in low‐resource settings. Universal antepartum screening is advocated, with rapid tests as a viable option in low‐resource settings. [ABSTRACT FROM AUTHOR]

Pneumonia is a common and severe illness that requires prompt and effective management. Advanced, rapid, and accurate tools are needed to diagnose patients with severe bacterial pneumonia, and to rapidly select appropriate antimicrobial therapy, which must be initiated within the first few hours of care. Two multiplex molecular tests, Unyvero HPN and FilmArray Pneumonia+ Panel, have been developed using the multiplex polymerase chain reaction (mPCR) technique to rapidly identify pathogens and their main antibiotic resistance mechanisms from patient respiratory specimens. Performance evaluation of these tests showed strong correlations with reference techniques. However, good knowledge of their indications, targets, and limitations is essential. Collaboration with microbiologists is, therefore, crucial for their appropriate use. Under these conditions, and with standardized management, these rapid tests can improve the therapeutic management of severe pneumonia faster, more precisely, and with narrow-spectrum antibiotic therapy. Further randomized controlled trials are needed to address the many unanswered questions about multiplex rapid molecular testing during the diagnosis and the management of severe pneumonia. This narrative review will address the current knowledge, advantages, and disadvantages of these tests, and propose solutions for their routine use. [ABSTRACT FROM AUTHOR]

Background and Aim: Although most cases of coronavirus disease-2019 (COVID-19) are in humans, there is scientific evidence to suggest that the virus can also infect dogs and cats. This study investigated the circulation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), canine coronavirus (CCV), and canine influenza virus (CIV) in domiciled and/or stray dogs from different locations in the State of Minas Gerais, Brazil, during the COVID-19 pandemic. Materials and Methods: In total, 86 dogs living in homes, on the streets, or in shelters in the cities of Taiobeiras, Salinas, Araçuaí, and Almenara were randomly selected for this study. The COVID Ag Detect® Self-Test was used to detect SARS-CoV-2. The ACCUVET CCV AG TEST – CANINE CORONAVIROSIS® was used to detect CCV, whereas canine influenza was detected using the ACCUVET CIV AG TEST – INFLUENZA CANINA®. All collected data were mapped using QGIS 3.28.1 for spatial data analysis and the identification of disease distribution patterns. Descriptive analysis of the collected data, prevalence calculations, odds ratios (ORs), and 95% confidence intervals, when possible, was performed. Results: Of the 86 animals tested, only one dog tested positive for SARS-CoV-2 using the rapid test for viral antigen detection. No animals tested positive for CIV. Canine coronavirus was detected in almost half of the animals tested in Almenara. Severe acute respiratory syndrome-CoV-2 had a low prevalence (1.16%), versus 15.62% for CCV. Although the results were not significant, the age and breed of animals appeared to be associated with the occurrence of CCV. The results indicated that younger animals were 2.375-fold more likely to be infected. Likewise, purebred animals were more likely to contract the disease (OR = 1.944). Conclusion: The results indicate the need to maintain preventive measures against CCV, canine influenza, and SARS-CoV-2 in dogs. More studies are needed to better elucidate the panorama of these diseases in dogs, mainly in underdeveloped and developing countries.

Background: A rapid and accurate test to detect SARS-CoV-2 is essential for controlling the transmission of the COVID-19. Rapid diagnostic tests are currently marketed, although it is uncertain how well they perform in actual clinical settings and with relevant subpopulations. We evaluated the clinical performance of the Direct Detect® SARS-CoV-2 Detection Kit (Coyote Bioscience Co., Ltd., Beijing, China) rapid, molecular-based assay. Methods and Results: The clinical laboratory received 707 clinical samples for rapid PCR between December 2021 and March 2022, including confirmed or suspected COVID-19 cases. These samples were tested by the Direct Detect® SARS-CoV-2 Detection Kit and by the LabGun® COVID-19 ExoFast RT-PCR Kit. Of 707 specimens tested, 649(91.79%) were negative and 58(8.20%) were positive. The sensitivity and specificity of the rapid RT-PCR test were 79.31% (95% CI: 66.65% to 88.83%) and 99.54% (95% CI: 98.66% to 99.90%), respectively. Conclusion: The Direct Detect® SARS-CoV-2 Detection Kit evaluated in this study was able to detect SARS-CoV-2 infection with high viral loads but not so for higher loads. To determine strategies for appropriate use, more investigation of the assay's field performance in various conditions is required.

Antimicrobial resistance is a global health threat. Among Gram-negative bacteria, resistance to carbapenems, a class of β-lactam antibiotics, is usually a proxy for difficult-to-treat resistance, since carbapenem-resistant organisms are often resistant to many classes of antibiotics. Carbapenem resistance in the Gram-negative pathogen Klebsiella pneumoniae is mostly due to the production of carbapenemases, enzymes able to hydrolyze carbapenems, and K. pneumoniae carbapenemase (KPC)-type enzymes are overall the most prevalent carbapenemases in K. pneumoniae. In the last decade, the management of severe infections due to KPC-producing K. pneumoniae (KPC-Kp) in humans has presented many peculiar challenges to clinicians worldwide. In this perspective, we discuss how the treatment of severe KPC-Kp infections has evolved over the last decades, guided by the accumulating evidence from clinical studies, and how recent advances in diagnostics have allowed to anticipate identification of KPC-Kp in infected patients. In the last decade, the management of severe infections due to KPC-Kp has presented many peculiar challenges to clinicians worldwide Following the introduction in clinical practice of novel β-lactam/β-lactamase inhibitor combinations and novel β-lactams active against KPC-producing bacteria, the management of severe KPC-Kp infections has witnessed a remarkable evolution Treatment of severe KPC-Kp infections is a highly dynamic process, in which the wise use of novel antimicrobials should be accompanied by a continuous refinement based on evolving clinical evidence and laboratory diagnostics [ABSTRACT FROM AUTHOR]

Abstract Background The global spread of COVID-19 created an explosion in rapid tests with results in

Abstract Background Rapid diagnostic tests have revolutionized the HIV response in low resource and high HIV prevalence settings. However, disconcerting levels of misdiagnosis at the point-of-care call for research into their root causes. As rapid HIV tests are technologies that cross borders and have inscribed within them assumptions about the context of implementation, we set out to explore the (mis)match between intended and actual HIV testing practices in Zimbabwe. Methods We examined actual HIV testing practices through participant observations in four health facilities and interviews with 28 rapid HIV testers. As time was identified as a key sphere of influence in thematic analyses of the qualitative data, a further layer of analysis juxtaposed intended (as scripted in operating procedures) and actual HIV testing practices from a temporal perspective. Results We uncover substantial discrepancies between the temporal flows assumed and inscribed into rapid HIV test kits (their intended use) and those presented by the high frequency testing and low resource and staffing realities of healthcare settings in Zimbabwe. Aside from pointing to temporal root causes of misdiagnosis, such as the premature reading of test results, our findings indicate that the rapidity of rapid diagnostic technologies is contingent on a slow, steady, and controlled environment. This not only adds a different dimension to the meaning of “rapid” HIV testing, but suggests that errors are embedded in the design of the diagnostic tests and testing strategies from the outset, by inscribing unrealistic assumptions about the context within which they used. Conclusion Temporal analyses can usefully uncover difficulties in attuning rapid diagnostic test technologies to local contexts. Such insight can help explain potential misdiagnosis ‘crisis points’ in point-of-care testing, and the need for public health initiatives to identify and challenge the underlying temporal root causes of misdiagnosis.

ABSTRACT The continuous genetic evolution of SARS-CoV-2 resulting in the immune escape variant of concern (VoC) Omicron poses a challenge to rapid and accurate diagnosis of infection, especially in high-risk groups such as healthcare workers. We performed a clinical study to determine the diagnostic accuracy and robustness of a second-generation rapid antigen test compared to a first-generation rapid antigen test with an RT-qPCR-based assay as gold standard, for early detection of infections with SARS-CoV-2 Omicron VoC. A total of 428 healthcare workers with COVID-19-associated symptoms or during routine testing participated in the study and completed a questionnaire on infection-associated symptoms, previous SARS-CoV-2 infections, and vaccination status. All participants performed a second- and first-generation rapid antigen test on the day of presentation and repeated the test 2 days later, and a diagnostic SARS-CoV-2 RT-qPCR assay was performed. qPCR-confirmed SARS-CoV-2 infections (n = 104) with Omicron VoC (BA.2, BA.4, BA.5) were detected by the first-generation rapid antigen test with a sensitivity of 83.7% (95% CI 75.12%–90.18%), whereas the second-generation rapid antigen test performed with a sensitivity of 89.4% (95% CI 81.9%–94.6%). Increased sensitivity of the second-generation rapid antigen test led to earlier detection of SARS-CoV-2 infection, while lower test sensitivity of the first-generation rapid antigen test was compensated by repeated testing 2 days later. Moreover, direct in vitro comparison revealed a lower limit of detection for the second-generation rapid antigen test for isolates of currently circulating Omicron sub-lineages BA.5.2, BQ.1, and XBB.1. IMPORTANCE The results from this study demonstrate the usefulness of a second-generation rapid antigen test for early detection of infection with the SARS-CoV-2 Omicron variant of concern (VoC) and reveal a higher sensitivity to detect immune escape Omicron VoCs compared to a first-generation rapid antigen test (89.4% vs 83.7%) in the high-risk group of healthcare workers.

The use of oils and fats for frying meals repeatedly causes significant changes in their physical and chemical characteristics. Because of growing health concerns, the assessment of the quality of reused oils has gained a lot of attention, since it is important in identifying the discarding point of the oils. Official analytical procedures employed in laboratories for this purpose need skill, time, and a significant amount of solvent usage. Several rapid test kits based on physical and chemical parameters of oil viz. Fri-Check, Viscofrit, Food oil sensor, Capsens 5000, Food oil monitor, TPM Verifry, Oxifrit, Safetest Peroxide, FFA kit, 3 M oil quality test strips have been developed to simplify oil testing in commercial frying lines, restaurants and food establishment. These test kits typically include a portable apparatus or colorimetric reaction capable of assessing a single parameter directly or indirectly. Besides, the practice of using repeatedly heated oil is very common in food establishments, thence, its essential for rapid assessment of the frying oil quality. This review paper includes the frying concept, health impacts of reusing the frying oil and principle, utility and efficiency of various quality indicators based rapid test kits.

ABSTRACT This prospective study assessed the value of initial microscopy evaluation of sputum samples submitted for rapid syndromic PCR-based testing. Bacterial detections by the BioFire FilmArray Pneumonia Panel plus in 126 high- and 108 low-quality sputum samples, based on initial microscopy evaluation in samples from patients with lower respiratory tract infections were compared. We found that high-quality samples had a higher proportion of bacterial detections compared to low-quality samples (P = 0.013). This included a higher proportion of detections of bacteria deemed clinically relevant by predefined criteria (70% and 55%, P = 0.016), as well as a higher proportion of detections of Haemophilus influenzae (36% and 20%, P = 0.010). High-quality samples also had more detections of bacteria with high semi-quantitative values. The study found no significant difference between high- and low-quality samples in the proportions of samples with a single species of bacteria detected, samples with a bacteria treated by the clinician, samples with detection of a proven etiology of community-acquired pneumonia by predefined criteria, the number of bacterial species detected, or the detection of Streptococcus pneumoniae, Moraxella catarrhalis, or Staphylococcus aureus. The results showed that 40% (95% CI 35%–47%) of the bacterial detections would have been missed if only high-quality samples were analyzed. This included 41% (27%–56%) of detections of S. pneumoniae, 33% (23%–45%) of detections of H. influenzae, 42% (28%–58%) of detections of S. aureus, and 37% (23%–54%) of detections of M. catarrhalis. These findings suggest that all sputum samples submitted for rapid syndromic PCR testing should be analyzed, regardless of initial microscopy quality assessment. (This study has been registered at ClinicalTrials.gov under registration no. NCT04660084.) IMPORTANCE Microscopic quality assessment of sputum samples was originally designed for sputum culture, and its applicability in today’s workflow, which includes syndromic PCR testing, may differ. Addressing this crucial gap, our study emphasizes the need to optimize the use and workflow of syndromic PCR panels, like the BioFire FilmArray Pneumonia plus (FAP plus), in microbiology laboratories. These advanced PCR-based tests offer rapid and comprehensive pathogen detection for respiratory infections, yet their full potential remains uncertain. By comparing bacterial detections in high- and low-quality sputum samples, we underscore the importance of including low-quality samples in testing. Our findings reveal a significant proportion of potentially clinically relevant bacterial detections that would have been missed if only high-quality samples were analyzed. These insights support the efficient implementation of syndromic PCR panels, ultimately enhancing patient care and outcomes.

Romania is one of the European countries with a high prevalence of hepatitis viruses B, C and D infections. The World Health Organization objective is to eradicate the chronic infections with hepatitis viruses B, C and D until 2030. The eradication of these infections is possible only if all people infected with B, C or D hepatitis viruses are identified, all of them are correctly treated and monitored, and their contacts are tested, treated or vaccinated. This is a very strong issue, theoretically possible, but in the current practice, it is need for realistic objectives. LIVERO 2 is an important pilot project for the screening of viral hepatitis B, C and D, addressed to vulnerable people (more than 50% of tested people are mandatory from vulnerable categories). Family doctors had an important contribution in this project, the majority of the subjects being tested in their medical offices. [ABSTRACT FROM AUTHOR]

Background Bloodstream infections (BSIs) in neutropenic patients significantly contribute to morbidity and mortality. The rapid identification and determination of antimicrobial susceptibility of pathogens causing BSIs can help in early initiation of targeted antimicrobial therapy and allow deescalation of unnecessary empirical antimicrobials. Aim This study evaluated the rapidity and accuracy of gramstained smear from blood culture bottles and direct VITEK 2 to identify and determine antimicrobial susceptibility of pathogens causing BSIs and assessed the effect of these tests on modification of empiric therapy. Patients and methods Blood cultures were collected from 100 febrile neutropenic patients from the Hematology Unit in Alexandria Main University Hospital. Gram-stained smears were prepared from blood culture bottles; blood from bottles with suggestive smears was directly inoculated into the VITEK 2 system, and results were compared with conventional methods. Results were instantly reported to clinicians. Empirical antimicrobials and their modification were recorded. Results BSI was detected in 30% of patients. Gramnegative bacteremia was predominant (24/30). Gramstained smears showed complete accordance with conventional methods in 99 samples. VITEK 2 correctly identified all tested microorganisms, and the overall agreement in susceptibility testing was 100 and 95.2% for gram-positive and gram-negative bacteria, respectively. The effect of these rapid tests on empiric antimicrobial therapy was evident in 12 of 30 patients with documented BSIs (40%). Conclusion Gram-stained smear and direct VITEK 2 testing when integrated with instant reporting is a valid approach to guide targeted therapy in neutropenic patients in the context of extremely resistant pathogens. [ABSTRACT FROM AUTHOR]

Timely detection of persistent and emerging pathogens is critical to controlling disease spread, particularly in high-density populations with increased contact between individuals and limited-to-no ability to quarantine. Standard molecular diagnostic tests for surveying pathogenic microbes have provided the sensitivity needed for early detection, but lag in time-to-result leading to delayed action. On-site diagnostics alleviate this lag, but current technologies are less sensitive and adaptable than lab-based molecular methods. Towards the development of improved on-site diagnostics, we demonstrated the adaptability of a loop-mediated isothermal amplification-CRISPR coupled technology for detecting DNA and RNA viruses that have greatly impacted shrimp populations worldwide; White Spot Syndrome Virus and Taura Syndrome Virus. Both CRISPR-based fluorescent assays we developed showed similar sensitivity and accuracy for viral detection and load quantification to real-time PCR. Additionally, both assays specifically targeted their respective virus with no false positives detected in animals infected with other common pathogens or in certified specific pathogen-free animals. IMPORTANCE The Pacific white shrimp (Penaeus vannamei) is one of the most valuable aquaculture species in the world but has suffered major economic losses from outbreaks of White Spot Syndrome Virus and Taura Syndrome Virus. Rapid detection of these viruses can improve aquaculture practices by enabling more timely action to be taken to combat disease outbreaks. Highly sensitive, specific, and robust CRISPR-based diagnostic assays such as those developed here have the potential to revolutionize disease management in agriculture and aquaculture helping to promote global food security. [ABSTRACT FROM AUTHOR]

Under certain conditions, molecular methods of diagnosis have a significant advantage over long-term classical microbiological methods. Because of the highly pathogenic properties of Bacillus anthracis, it is necessary to put into practice express methods of the pathogen identification in сase of a biological threat of the infection expand among vulnerable animals, people, and contamination of the territory. The identification of B. anthracis is difficult because of the spore and vegetative forms and the similarity to closely related species. Ukraine is a disadvantaged country for anthrax. The introduction of reliable, sensitive and specific molecular diagnostic methods is a priority in the issue of biosafety. [ABSTRACT FROM AUTHOR]

In Senegal, the burden of dengue is increasing and expanding. As case management and traditional diagnostic techniques can be difficult to implement, rapid diagnostic tests (RDTs) deployed at point of care are ideal for investigating active outbreaks. The aim of this study was to evaluate the diagnostic performance of the Dengue NS1 and Dengue IgM/IgG RDTs on the serum/plasma samples in a laboratory setting and in the field. During laboratory evaluation, performance of the NS1 RDT was assessed using NS1 ELISA as the gold standard. Sensitivity and specificity were 88% [75–95%] and 100% [97–100%], respectively. Performance of the IgM/IG RDT was assessed using the IgM Antibody Capture (MAC) ELISA, indirect IgG, and PRNT as gold standards. The IgM and IgG test lines respectively displayed sensitivities of 94% [83–99%] and 70% [59–79%] and specificities of 91% [84–95%] and 91% [79–98%]. In the field, the Dengue NS1 RDT sensitivity and specificity was 82% [60–95%] and 75% [53–90%], respectively. The IgM and IgG test lines displayed sensitivities of 86% [42–100%] and 78% [64–88%], specificities of 85% [76–92%] and 55% [36–73%], respectively. These results demonstrate that RDTs are ideal for use in a context of high prevalence or outbreak setting and can be implemented in the absence of a confirmatory test for acute and convalescent patients. [ABSTRACT FROM AUTHOR]

Pneumonia is a common and severe illness that requires prompt and effective management. Advanced, rapid, and accurate tools are needed to diagnose patients with severe bacterial pneumonia, and to rapidly select appropriate antimicrobial therapy, which must be initiated within the first few hours of care. Two multiplex molecular tests, Unyvero HPN and FilmArray Pneumonia+ Panel, have been developed using the multiplex polymerase chain reaction (mPCR) technique to rapidly identify pathogens and their main antibiotic resistance mechanisms from patient respiratory specimens. Performance evaluation of these tests showed strong correlations with reference techniques. However, good knowledge of their indications, targets, and limitations is essential. Collaboration with microbiologists is, therefore, crucial for their appropriate use. Under these conditions, and with standardized management, these rapid tests can improve the therapeutic management of severe pneumonia faster, more precisely, and with narrow-spectrum antibiotic therapy. Further randomized controlled trials are needed to address the many unanswered questions about multiplex rapid molecular testing during the diagnosis and the management of severe pneumonia. This narrative review will address the current knowledge, advantages, and disadvantages of these tests, and propose solutions for their routine use.

Background: The global spread of COVID-19 created an explosion in rapid tests with results in < 1 hour, but their relative performance characteristics are not fully understood yet. Our aim was to determine the most sensitive and specific rapid test for the diagnosis of SARS-CoV-2. Methods: Design: Rapid review and diagnostic test accuracy network meta-analysis (DTA-NMA). Eligibility criteria: Randomized controlled trials (RCTs) and observational studies assessing rapid antigen and/or rapid molecular test(s) to detect SARS-CoV-2 in participants of any age, suspected or not with SARS-CoV-2 infection. Information sources: Embase, MEDLINE, and Cochrane Central Register of Controlled Trials, up to September 12, 2021. Outcome measures: Sensitivity and specificity of rapid antigen and molecular tests suitable for detecting SARS-CoV-2. Data extraction and risk of bias assessment: Screening of literature search results was conducted by one reviewer; data abstraction was completed by one reviewer and independently verified by a second reviewer. Risk of bias was not assessed in the included studies. Data synthesis: Random-effects meta-analysis and DTA-NMA. Results: We included 93 studies (reported in 88 articles) relating to 36 rapid antigen tests in 104,961 participants and 23 rapid molecular tests in 10,449 participants. Overall, rapid antigen tests had a sensitivity of 0.75 (95% confidence interval 0.70–0.79) and specificity of 0.99 (0.98–0.99). Rapid antigen test sensitivity was higher when nasal or combined samples (e.g., combinations of nose, throat, mouth, or saliva samples) were used, but lower when nasopharyngeal samples were used, and in those classified as asymptomatic at the time of testing. Rapid molecular tests may result in fewer false negatives than rapid antigen tests (sensitivity: 0.93, 0.88–0.96; specificity: 0.98, 0.97–0.99). The tests with the highest sensitivity and specificity estimates were the Xpert Xpress rapid molecular test by Cepheid (sensitivity: 0.99, 0.83–1.00; specificity: 0.97, 0.69–1.00) among the 23 commercial rapid molecular tests and the COVID-VIRO test by AAZ-LMB (sensitivity: 0.93, 0.48–0.99; specificity: 0.98, 0.44–1.00) among the 36 rapid antigen tests we examined. Conclusions: Rapid molecular tests were associated with both high sensitivity and specificity, while rapid antigen tests were mainly associated with high specificity, according to the minimum performance requirements by WHO and Health Canada. Our rapid review was limited to English, peer-reviewed published results of commercial tests, and study risk of bias was not assessed. A full systematic review is required. Review registration: PROSPERO CRD42021289712 [ABSTRACT FROM AUTHOR]

Changes in the limits of detection (LODs) for a multiplex lateral flow immunoassay (LFIA) caused by different locations of the binding zone on the test strips were studied. Due to the non-equilibrium conditions of the immune reactions in LFIAs, their analytical parameters are susceptible to the binding constants of antigen–antibody reactions and assay duration. Consequently, the integration of several tests into one multiplex assay can cause a significant worsening of the sensitivity. In this study, we propose a simple methodology for the determination of the best arrangement of binding zones, which takes into account the binding constants for immunoreagents. LFIAs of four mycotoxins, namely, aflatoxin B1, deoxynivalenol, T-2 toxin, and ochratoxin A, were integrated into a multiplex test strip. An enzyme-linked immunosorbent assay was applied to determine the equilibrium and kinetic constants of the immunoreactants for each analyte. It was found that the arrangement of binding zones with a descending order of the equilibrium association constants was optimal and provided both lower detection limits and a more uniform coloration. The selected position of the binding zones allowed decreasing the LODs down to 2 and 27 times for ochratoxin A and deoxynivalenol, respectively. The proposed approach can be applied to multiplex LFIAs for different analytes. [ABSTRACT FROM AUTHOR]

The emergency department (ED) is the initial point of contact between hospital staff and patients potentially infected with SARS-CoV-2, thus, prevention of inadvertent exposure to other patients is a top priority. We aimed to assess whether the introduction of antigen-detecting rapid diagnostic tests (Ag-RDTs) to the ED affected the likelihood of unwanted SARS-CoV-2 exposures. In this retrospective single-center study, we compared the rate of unwarranted exposure of uninfected adult ED patients to SARS-CoV-2 during two separate research periods; one before Ag-RDTs were introduced, and one with Ag-RDT used as a decision-support tool. The introduction of Ag-RDTs to the ED significantly decreased the relative risk of SARS-CoV-2-negative patients being incorrectly assigned to the COVID-19 designated site ("red ED"), by 97%. There was no increase in the risk of SARS-CoV-2-positive patients incorrectly assigned to the COVID-19-free site ("green ED"). In addition, duration of ED admission was reduced in both the red and the green ED. Therefore, implementing the Ag-RDT-based triage protocol proved beneficial in preventing potential COVID-19 nosocomial transmission. [ABSTRACT FROM AUTHOR]

Background: Rapid diagnostic tests have revolutionized the HIV response in low resource and high HIV prevalence settings. However, disconcerting levels of misdiagnosis at the point-of-care call for research into their root causes. As rapid HIV tests are technologies that cross borders and have inscribed within them assumptions about the context of implementation, we set out to explore the (mis)match between intended and actual HIV testing practices in Zimbabwe. Methods: We examined actual HIV testing practices through participant observations in four health facilities and interviews with 28 rapid HIV testers. As time was identified as a key sphere of influence in thematic analyses of the qualitative data, a further layer of analysis juxtaposed intended (as scripted in operating procedures) and actual HIV testing practices from a temporal perspective. Results: We uncover substantial discrepancies between the temporal flows assumed and inscribed into rapid HIV test kits (their intended use) and those presented by the high frequency testing and low resource and staffing realities of healthcare settings in Zimbabwe. Aside from pointing to temporal root causes of misdiagnosis, such as the premature reading of test results, our findings indicate that the rapidity of rapid diagnostic technologies is contingent on a slow, steady, and controlled environment. This not only adds a different dimension to the meaning of "rapid" HIV testing, but suggests that errors are embedded in the design of the diagnostic tests and testing strategies from the outset, by inscribing unrealistic assumptions about the context within which they used. Conclusion: Temporal analyses can usefully uncover difficulties in attuning rapid diagnostic test technologies to local contexts. Such insight can help explain potential misdiagnosis 'crisis points' in point-of-care testing, and the need for public health initiatives to identify and challenge the underlying temporal root causes of misdiagnosis. [ABSTRACT FROM AUTHOR]

Introduction. During the COVID pandemic, there was a need for rapid and accessible detection of SARS-CoV-2 viral infections to assess the exact number of infected people worldwide to take appropriate medical measures. Objective/Aims: The paper proposes an analysis of expert information regarding the particularities of the SARS-CoV-2 virus and the possibilities of detecting anti-SARS-CoV-2 antibodies and viral antigens. Materials and Methods: Studies from the specialized literature that presented information about the working procedures and configurations of anti-SARS-CoV-2 antibody and viral antigen detection systems from the pandemic period and later were considered. Results: RT-PCR testing, the current gold standard for the diagnosis of COVID-19, permits the detection of viral genetic material, a sensitive technique that allows rapid detection in the early phase of the virus. It has been identified that serological tests are recommended for the diagnosis of COVID-19 patients during the acute and early subacute phases. Rapid tests have been developed for the detection of viral antigens or human anti-SARS-CoV-2 antibodies in various biological samples, with a view to frequent monitoring of people working in environments with a high risk of infection. Conclusion: In recent years, significant progress has been made in the field of cell biology, combining high-performance studies carried out in research laboratories with testing and validation of methods quickly implemented in the specialized laboratories of infectious diseases hospitals and not only but also with the development of rapid tests with the possibility of direct purchase by the population. [ABSTRACT FROM AUTHOR]

Emerging infectious diseases and increasing resistance to available antimicrobials are mapping the evolution of clinical microbiology and escalating the nature of undertakings required. Rapid diagnosis has become the need of the hour, which can affect diagnostic algorithms and therapeutic decisions simultaneously. Subsequently, the concept of 'diagnostic stewardship' was introduced into clinical practice for coherent implementation of available diagnostic modalities to ensure that these new rapid diagnostic technologies are conserved, rather than consumed as part of health care resources, with a view to improve the patient care and reduce Turnaround Time (TAT) and treatment expense. The present study highlights the requisite of diagnostic stewardship and outlines the infectious disease diagnostic modalities that can assist in its successful implementation. Diagnostic stewardship promotes precise, timely diagnostics, from the initial specimen collection and identification to reporting with appropriate TAT, so as to enable timely management of the patient. The main aim of diagnostic stewardship is to optimize the right choice of diagnostic test for the right patient to attain clinically significant reports with the least possible TAT for timely management and the least expected adverse effects for the patient, community, and the healthcare system. This underlines the requisite of a multifaceted approach to make technological advancements effective and successful for implementation as a part of diagnostic stewardship for the best patient care., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

ABSTRACT Rapid coronavirus disease 2019 (COVID-19) antigen tests can be used to aid in quickly identifying positive cases, which can help mitigate the spread of COVID-19 infection. Using previously characterized Omicron-positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), non-Omicron-positive SARS-CoV-2, and negative samples, we evaluated five brands of at-home rapid COVID-19 antigen tests (On/Go at-home COVID-19 rapid antigen self-test, iHealth COVID-19 antigen rapid test, QuickVue SARS antigen test, Abbott BinaxNOW COVID-19 card home test, and InBios SCoV-2 Ag detect rapid self-test). Our results showed that these rapid tests had similar levels of sensitivity to Omicron and non-Omicron variants (On/Go, 76.4% and 71.0%; iHealth, 73.0% and 71.0%; QuickVue, 84.3% and 74.3%; BinaxNOW, 69.7% and 71.0%; and InBios, 66.3% and 64.5%, respectively). In conclusion, rapid COVID-19 antigen tests can continue to be used as part of public health measures to combat the spread of the Omicron variant, as their sensitivity was not significantly affected. IMPORTANCE The emergence of the Omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is due to mutations as part of the virus evolution process. These mutations might affect the sensitivity of diagnostic tests that are currently being used to detect the virus. Because rapid coronavirus disease 2019 (COVID-19) antigen tests are commonly used in the general population, it is important to assess their performance in detecting the Omicron variant. Here, we compared the performance of five brands of rapid tests against Omicron and non-Omicron variants using nasopharyngeal swab samples in viral transport media. Our result found no difference in their performance, suggesting no reduction in sensitivity when used to detect the Omicron variant.

Acute febrile syndrome is a frequent reason for medical consultations in tropical and subtropical countries where the cause could have an infectious origin. Malaria and dengue are the primary etiologies in Colombia. As such, constant epidemiological surveillance and new diagnostic tools are required to identify the causative agents. A descriptive cross-sectional study was conducted to evaluate the circulation and differential diagnosis of six pathogens in two regions of Colombia. The results obtained via multiplex reverse transcription polymerase chain reaction combined with a microwell hybridization assay (m-RT-PCR-ELISA) were comparable to those obtained using rapid tests conducted at the time of patient enrollment. Of 155 patients evaluated, 25 (16.1%) and 16 (10.3%) were positive for malaria and dengue, respectively; no samples were positive for any of the other infectious agents tested. In most cases, m-RT-PCR-ELISA confirmed the results previously obtained through rapid testing.

The use of rapid molecular tests may anticipate the identification of causative agents and resistance determinants in the blood of critically ill patients with sepsis. From April to December 2021, all intensive care unit patients with sepsis or septic shock who were tested with the T2Bacteria and T2Resistance assays were included in a retrospective, single center study. The primary descriptive endpoints were results of rapid molecular tests and concomitant blood cultures. Overall, 38 combinations of T2Bacteria and T2Resistance tests were performed. One or more causative agent(s) were identified by the T2Bacteria assay in 26% of episodes (10/38), whereas negative and invalid results were obtained in 66% (25/38) and 8% (3/38) of episodes, respectively. The same pathogen detected by the T2Bacteria test grew from blood cultures in 30% of cases (3/10). One or more determinant(s) of resistance were identified by the T2Resistance assay in 11% of episodes (4/38). Changes in therapy based on T2Bacteria and/or T2Resistance results occurred in 21% of episodes (8/38). In conclusion, T2Bacteria/T2Resistance results can influence early treatment decisions in critically ill patients with sepsis or septic shock in real-life practice. Large, controlled studies remain necessary to confirm a favorable impact on patients' outcomes and antimicrobial stewardship interventions. [ABSTRACT FROM AUTHOR]

Background: The ongoing SARS-CoV-2 pandemic necessitates the development of accurate, rapid, and affordable diagnostics to help curb disease transmission, morbidity, and mortality. Rapid antigen tests are important tools for scaling up testing for SARS-CoV-2; however, little is known about individuals' use of rapid antigen tests at home and how to facilitate the user experience. Objective: This study aimed to describe the feasibility and acceptability of serial self-testing with rapid antigen tests for SARS-CoV-2, including need for assistance and the reliability of self-interpretation. Methods: A total of 206 adults in the United States with smartphones were enrolled in this single-arm feasibility study in February and March 2021. All participants were asked to self-test for COVID-19 at home using rapid antigen tests daily for 14 days and use a smartphone app for testing assistance and to report their results. The main outcomes were adherence to the testing schedule, the acceptability of testing and smartphone app experiences, and the reliability of participants versus study team's interpretation of test results. Descriptive statistics were used to report the acceptability, adherence, overall rating, and experience of using the at-home test and MyDataHelps app. The usability, acceptability, adherence, and quality of at-home testing were analyzed across different sociodemographic, age, and educational attainment groups. Results: Of the 206 enrolled participants, 189 (91.7%) and 159 (77.2%) completed testing and follow-up surveys, respectively. In total, 51.3% (97/189) of study participants were women, the average age was 40.7 years, 34.4% (65/189) were non-White, and 82% (155/189) had a bachelor's degree or higher. Most (n=133/206, 64.6%) participants showed high testing adherence, meaning they completed over 75% of the assigned tests. Participants' interpretations of test results demonstrated high agreement (2106/2130, 98.9%) with the study verified results, with a κ score of 0.29 (P<.001). Participants reported high satisfaction with self-testing and the smartphone app, with 98.7% (157/159) reporting that they would recommend the self-test and smartphone app to others. These results were consistent across age, race/ethnicity, and gender. Conclusions: Participants' high adherence to the recommended testing schedule, significant reliability between participants and study staff's test interpretation, and the acceptability of the smartphone app and self-test indicate that self-tests for SARS-CoV-2 with a smartphone app for assistance and reporting is a highly feasible testing modality among a diverse population of adults in the United States. [ABSTRACT FROM AUTHOR]

Abstract Background Conventional turnaround time (TAT) for positive blood culture (PBC) identification (ID) and antimicrobial susceptibility testing (AST) is 2–3 days. We evaluated the TAT and ID/AST performance using clinical and seeded samples directly from PBC bottles with different commercial approaches: (1) Accelerate Pheno® system (Pheno) for ID/AST; (2) BioFire® FilmArray® Blood Culture Identification (BCID) Panel and/ or BCID2 for ID; (3) direct AST by VITEK® 2 (direct AST); and (4) overnight culture using VITEK® 2 colony AST. Results A total of 141 PBC samples were included in this evaluation. Using MALDI-TOF (Bruker MALDI Biotyper) as the reference method for ID, the overall monomicrobial ID sensitivity/specificity are as follows: Pheno 97.9/99.9%; BCID 100/100%; and BCID2 100/100%, respectively. For AST performance, broth microdilution (BMD) was used as the reference method. For gram-negatives, overall categorical and essential agreements (CA/EA) for each method were: Pheno 90.3/93.2%; direct AST 92.6/88.5%; colony AST 94.4/89.5%, respectively. For gram-positives, the overall CA/EAs were as follows: Pheno 97.2/98.89%; direct AST 97.2/100%; colony AST 97.2/100%, respectively. The BCID/BCID2 and direct AST TATs were around 9–20 h (1/9-19 h for ID with resistance markers/AST), with 15 min/sample hands-on time. In comparison, Pheno TATs were around 8–10 h (1.5/7 h for ID/AST) with 2 min/sample hands-on time, maintains a clinically relevant fast report of antibiotic minimal inhibitory concentration (MIC) and allows for less TAT and hands-on time. Conclusion In conclusion, to the best of our knowledge, this is the first study conducted as such in Asia; all studied approaches achieved satisfactory performance, factors such as TAT, panel of antibiotics choices and hands-on time should be considered for the selection of appropriate rapid ID and AST of PBC methods in different laboratory settings.

Background: This PRONTO study investigated the clinical performance of the Abbott ID NOWTM (IDN) COVID-19 diagnostic assay used at point of care and its impact on turnaround time for divulgation of test results. Methods: Prospective study conducted from December 2020 to February 2021 in acute symptomatic participants presenting in three walk-in centres in the province of Québec. Results: Valid paired samples were obtained from 2,372 participants. A positive result on either the IDN or the standard-of-care nucleic acid amplification test (SOC-NAAT) was obtained in 423 participants (prevalence of 17.8%). Overall sensitivity of IDN and SOC-NAAT were 96.4% (95% CI: 94.2–98.0%) and 99.1% (95% CI: 97.6–99.8), respectively; negative predictive values were 99.2% (95% CI: 98.7–99.6%) and 99.8% (95% CI: 99.5–100%), respectively. Turnaround time for positive results was significantly faster on IDN. Conclusion: In our experience, IDN use in symptomatic individuals in walk-in centres is a reliable sensitive alternative to SOC-NAAT without the need for subsequent confirmation of negative results. Such deployment can accelerate contact tracing, reduce the burden on laboratories and increase access to testing.

Background. Celiac disease (gluten enteropathy) is relatively rare disease. However, such patients have higher risk of skin pathology than general the population, and their therapy efficacy is limited by the use of gluten-free diet. Therefore, screening of dermatologic patients on celiac disease may be relevant. Objective. Our aim was to study the prevalence of celiac disease among children with skin pathology. Methods. The study included children hospitalized in dermatology department. Screening for celiac disease included detection in blood serum of antibodies (IgA, IgG, IgM) to tissue transglutaminase via rapid tests. In case of positive result of rapid test, we have repeated the estimation of antibodies (IgA, IgG) to tissue transglutaminase via immunochemiluminescent method with ImmunoCAP technology or via enzyme immunoassay. In case of positive serological test, we have performed HLA typing to determine haplotypes of DQ2 and DQ8, as well as esophagogastroduodenojejunoscopy (EGDJS) with biopsy of the duodenal and jejunal mucosa for further histological verification of the diagnosis. Results. We examined 1,000 children with various dermatologic pathologies. Rapid tests showed positive result in 21 patients (2.1%; 95% C11.3-3.2%). The presence of antibodies to tissue transglutaminase was confirmed via additional serological examination in all cases. HLA-haplotypes DQ2/8 were revealed in all patients with positive rapid test results. Typical form of gluten enteropathy was confirmed in 18/21 patients (86%) according to a histological study, thus, estimated prevalence of celiac disease is 1.8% (95% C11.1-2.8%). Conclusion. The prevalence of celiac disease remains underestimated among children with skin diseases. More studies are needed on the diagnostic features of rapid tests on tissue transglutaminase, as well as the benefits of screening for celiac disease to achieve patient-relevant clinical outcomes of skin pathology with wider gluten-free diet.

ABSTRACT This study evaluated the BD Veritor system for rapid detection of SARS-CoV-2, an immunochromatographic point-of-care test, by comparing it with a standard reverse transcription-PCR (RT-PCR) methodology using samples from symptomatic patients. Samples from 146 symptomatic and 2 asymptomatic patients between the 1st and the 40th day of infection were evaluated. The nasopharyngeal and/or oropharyngeal swabs were inserted in a tube containing 0.9% saline solution and stored at refrigerator temperature until the moment of use. The samples were first tested with the Xpert Xpress SARS-CoV-2 (GeneXpert) kit (RT-PCR method), and the cycle thresholds (CTs) for the E and N2 genes encoding the SARS-CoV-2 envelope and nucleoprotein, respectively, were established. Subsequently, the same samples were tested using the Veritor rapid test. We analyzed the CTs of the N2 gene, which is detected in both methodologies, and observed sensitivities of 100%, 98.8%, 89.6%, and 82.7% for the CTs of

• Preliminary evaluation of three LFIA prototypes for hantavirus antibody detection. • IgM/IgG prototype showed 100 % sensitivity and 99.3 % specificity. • Expanded control group tested for cross-reactivity with similar symptomatic diseases. • LFIA prototypes offer rapid, accessible diagnostics for low-resource settings. • Future optimizations include separate IgM/IgG lines to enhance specificity. Three lateral flow immunoassay prototypes developed to detect IgM, IgG and IgM/IgG antibodies against Hantavirus were evaluated. A total of 163 samples were tested: 10 from Hantavirus patients, 103 from related diseases, and 50 from healthy controls. The prototypes exhibited 100 % sensitivity, 97.5 % to 99.3 % specificity, indicating promising improved diagnosis. [ABSTRACT FROM AUTHOR]

New tuberculosis (TB) diagnostics are at a crossroads: their development, evaluation, and implementation is severely damaged by resource diversion due to COVID-19. Yet several technologies, especially those with potential for non-invasive non-sputum-based testing, hold promise for efficiently triaging and rapidly confirming TB near point-of-care. Such tests are, however, progressing through the pipeline slowly and will take years to reach patients and health workers. Compellingly, such tests will create new opportunities for difficult-to-diagnose populations, including primary care attendees (all-comers in high burden settings irrespective of reason for presentation) and community members (with early stage disease or risk factors like HIV), many of whom cannot easily produce sputum. Critically, all upcoming technologies have limitations that implementers and health workers need to be cognizant of to ensure optimal deployment without undermining confidence in a technology that still offers improvements over the status quo. In this state-of-the-art review, we critically appraise such technologies for active pulmonary TB diagnosis. We highlight strengths, limitations, outstanding research questions, and how current and future tests could be used in the presence of these limitations and uncertainties. Among triage tests, CRP (for which commercial near point-of-care devices exist) and computer-aided detection software with digital chest X-ray hold promise, together with late-stage blood-based assays that detect host and/or microbial biomarkers; however, aside from a handful of prototypes, the latter category has a shortage of promising late-stage alternatives. Furthermore, positive results from new triage tests may have utility in people without TB; however, their utility for informing diagnostic pathways for other diseases is under-researched (most sick people tested for TB do not have TB). For confirmatory tests, few true point-of-care options will be available soon; however, combining novel approaches like tongue swabs with established tests like Ultra have short-term promise but first require optimizations to specimen collection and processing procedures. Concerningly, no technologies yet have compelling evidence of meeting the World Health Organization optimal target product profile performance criteria, especially for important operational criteria crucial for field deployment. This is alarming as the target product profile criteria are themselves almost a decade old and require urgent revision, especially to cater for technologies made prominent by the COVID-19 diagnostic response (e.g., at-home testing and connectivity solutions). Throughout the review, we underscore the importance of how target populations and settings affect test performance and how the criteria by which these tests should be judged vary by use case, including in active case finding. Lastly, we advocate for health workers and researchers to themselves be vocal proponents of the uptake of both new tests and those – already available tests that remain suboptimally utilized. [ABSTRACT FROM AUTHOR]

Background: We investigated the impact of the indoor mass gathering of young people during the Patras Carnival in Greece on the course of the COVID-19 pandemic and the influenza A epidemic. Materials and Methods: For influenza A, we tested 331 subjects with high fever (>38 °C), who arrived at five separate private laboratories over a two-week period after the carnival, via rapid test. One hundred and eighty-eight of them were young adults (17–35 years old), all unvaccinated against influenza A but all immunized against SARS-CoV-2, either through vaccination or previous infection. For the SARS-CoV-2 pandemic, we tested 2062 subjects at two time periods, two weeks before and two weeks after the carnival, also via rapid test. Additionally, we examined 42 samples positive for influenza A and 51 samples positive for SARS-CoV-2 for the possibility of co-infection via molecular testing (i.e., RT-PCR). Results: 177/331 (53.5%) subjects tested positive for influenza A, and 109/177 (61.6%) of the positive subjects were young adults, and 93/109 (85.3%) of these subjects were tested in the first week after the carnival. Additionally, 42 samples of those subjects were molecularly tested, and 5 were found negative for influenza A but positive for SARS-CoV-2. Regarding the SARS-CoV-2 pandemic, the increase in the positivity index for young adults between the pre-carnival and post-carnival periods was moderate. Conclusions: Our study indicates that the indoor mass gathering of young people during the carnival contributed to the outbreak of an influenza A epidemic and had a moderate but not statistically significant impact on the course of the SARS-CoV-2 pandemic, corroborating the crucial role of vaccination against the epidemic's waves. It also showed the need for the use of high-quality rapid tests for their management. [ABSTRACT FROM AUTHOR]

Objectives: We conducted this study with an objective to compare the diagnostic accuracy of rapid antigen and antibody kits for early detection (<5 days of fever) and late detection (>5 days of fever) of S.Typhi and S.Paratyphi in relation to the Widal test. Methods: A cross-sectional observational study was conducted over 15 months, during which 180 cases of documented fever were enrolled. Paired samples (at <5 and >5 days of fever) were processed for rapid antigen test (RAg), rapid antibody test (RAb) and Widal test. Blood culture (BacT/Alert system) was considered as the gold standard for confirmation. Results: The mean (SD) age of patients with enteric fever was 16.42 (12.53) years, with a slight male preponderance (58.33% males vs. 41.67% females). Positive blood culture was reported in 58 (32.22%) cases. For RAg, RAb and Widal tests, the diagnostic accuracy was 45.56%, 42.22% and 41.11%, respectively, which was comparable for diagnosing enteric fever in cases with <5 days of fever (P = 0.675). For fever >5 days, RAg showed a significantly lower diagnostic accuracy (15%) as compared to RAb (61.11%) and Widal test (66.11%) (P < 0.0001). Conclusion: The study concludes that RAg marks a high sensitivity of accurate diagnosis in the initial five days of typhoid fever while RAb (with or without Widal tests), hold a superior sensitivity for diagnosis after five days of onset of enteric fever. [ABSTRACT FROM AUTHOR]