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Introduction: Milan System for Reporting Salivary Gland Cytopathology (MSRGC) was introduced in the year 2015 to facilitate a standardised reporting format and to improve the overall effectiveness of fine-needle aspiration cytology (FNAC) in the preoperative evaluation of salivary gland lesions. Risk of malignancy (ROM) provided in each category guides the physician for appropriate clinical management. This study was performed prospectively for one year to evaluate the diagnostic utility and validate MSRSGC. Materials and Methods: The study included lesions in the salivary gland area, including intraparotid lymph node. Cytology material from both direct FNAC, which had rapid onsite evaluation (ROSE) for adequacy and ultrasonography-guided procedures, was included for analysis. Relevant clinical information and imaging findings were obtained. Slides were reviewed, and one of the six categories was applied using the Milan system. ROM and risk of neoplasm (RON) were calculated for each category. Results: The study included 62 cases of salivary gland FNAC of which 35.5% of the cases had surgical resection specimens. Category IVA formed the major group, and only 1.6% was given category III. The ROM and RON were calculated for each category and were statistically significant and compared with other studies. Conclusion: MSRSGC is the recent classification system, and it suggests less than 10% of cases under category III to avoid it's over utilisation. MSRSGC is a reliable classification in our population, and it was best with category IVA lesions in our study. [ABSTRACT FROM AUTHOR]

Rationale: This study presents the first comprehensive analysis and mapping of scientific research on point‐of‐care testing (POCT) in infectious diseases, filling a gap in understanding the evolving landscape of this field. The identification of research themes and global contributions offers valuable insights. Aims and Objectives: This manuscript aims to analyse and map scientific research on POCT in the context of infectious diseases. Methods: The study employed a comprehensive search strategy using terms related to POCT and infectious diseases. The search was conducted on the Scopus database, refining results based on inclusion and exclusion criteria. The dataset of 1719 research articles was then subjected to descriptive analysis and mapping using VOSviewer. Results: The research findings indicate an exponential growth in POCT‐related publications, with 46.8% published post the COVID‐19 pandemic. Plos One journal led in publication frequency, and Biosensors and Bioelectronics received the highest citations per article. North America and Western Europe dominated contributions, with notable participation from China, South Africa, and India. The research landscape revealed the following research themes: detection technologies, human immunodeficiency virus (HIV)/sexually transmitted infection (STI) diagnosis, antibiotic optimisation, and schistosomiasis. Clinical trials focused on antibiotic prescribing, HIV, STIs, and specific infections. The findings suggest a shifting landscape towards POCT, emphasising the need for future planning and investment in healthcare systems. The research identifies areas for future exploration, such as the impact of POCT on antibiotic prescribing and its role in combating infectious diseases in low‐ and middle‐income countries. Conclusion: Implementation of POCT has the potential to revolutionise infectious disease management, improve patient outcomes, and reduce the global burden of diseases. Better public awareness, healthcare team management, and planning for POCT at entry points are crucial for societal benefit. Results demonstrated the evolving role of POCT in infectious disease management and prevention. [ABSTRACT FROM AUTHOR]

Background: Touch imprint cytology (TIC) of core needle biopsy specimen is an easy method of rapid on-site evaluation (ROSE) which aids in the rapid diagnosis of breast lumps by cytological analysis. Objective: To evaluate the efficacy of touch imprint cytology in predicting the adequacy of needle core biopsy of breast lumps and its diagnostic accuracy for malignancy. Materials and Methods: This study was done in Burdwan Medical College over a period of two years on 80 patients who had presented with breast lumps and had given consent for core needle biopsy for diagnosis. Results: Out of 80 cases, satisfactory materials on touch imprint were obtained in 79 cases. Only one case did not yield satisfactory material and hence was excluded from the analysis. A total of 43 cases were malignant, and 36 cases were either benign or inflammatory on core needle biopsy. Thirty-seven cases were accurately diagnosed as malignant by TIC, and 35 cases were accurately diagnosed as benign by TIC. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of TIC were 86.05%, 97.22%, 97.37%, and 85.36%, respectively, and the overall accuracy was 90%. Conclusion: TIC of core needle biopsy is a rapid, reliable, and accurate method for early cytological diagnosis of symptomatic breast lesions. It can be used routinely at the site of biopsy to evaluate the adequacy of materials obtained during core needle biopsy and to plan for further workup in case of malignant breast lesions. [ABSTRACT FROM AUTHOR]

Background: Health-care professionals routinely measure blood glucose of all critically ill patients in intensive care unit (ICU). The traditional reference standard, venous blood glucose requires venipuncture, and laboratories usually return the test results after 60 min. We wondered if a point of care (POC) capillary glucose measured by glucometer could be as accurate and reliable as blood venous glucose. Methods: We studied consecutive patients admitted to an ICU between May 1, 2009, and May 10, 2009. We compared the diagnostic accuracy of two-POC glucometers with laboratory venous glucose, the reference standard. We used Bland–Altman plots and the Clark error grid method to analyze the results. Results: This study included a total of 110 patients 38 (34%) women; mean age 52.1 years (standard deviation [SD] =17.3); range = 14–85 years. Fourteen patients (12%) were known to have diabetes. The mean glucose value (glucometer 1) was 152.9 mg/dL (SD = 83.1); range = 48–501 mg/dL; that by glucometer 2 was 152.2 mg/dL (SD = 76.2); range = 30–458 mg/dL and by the laboratory was 148.6 mg/dL (SD = 81.5); range = 52–480 mg/dL. Of the 110 subjects, 2 (2%) had blood glucose below 70 mg/dL; 85 (77%) between 70 and 180 mg/dL; and 23 (21%) had blood glucose exceeding 180 mg/dL. The Bland–Altman plot showed a bias of 4 mg% (95% confidence intervals = −9.8–+1.1); and the limits of agreement were −63 and +54 mg%. The area under the receiver operating characteristic curve for the two glucometers was 0.92 and 0.93, respectively. The error grid analysis showed that 80% (78/110) of samples lay within Zone A, 22 (110) in Zone B, and 1% (1/110) in Zone C. Conclusions: POC glucose, measured by glucometers was in agreement with the venous glucose estimation. Both glucometers were equally accurate and performed uniformly well across the wide range of blood glucose values. [ABSTRACT FROM AUTHOR]

Background: Anemia poses a significant health challenge for pregnant women (PW), and accurate and timely diagnosis is essential for effective management. Objective: The objective was to assess the diagnostic validity of the new digital hemoglobinometer for hemoglobin against laboratory-based hematology autoanalyzer among PW. Methodology: The study was conducted at a secondary-level healthcare facility among 204 pregnant women to be sampled conveniently, their sociodemographic and iron intake data collected, and hemoglobin levels assessed using a digital hemoglobinometer (Device A) and a hematology analyzer. Specificity, sensitivity, PPV, NPV, diagnostic accuracy, and method agreement were evaluated via Bland-Altman analysis and Lin's concordance correlation coefficient. Results: The proportion of anemia using the Device A was 64.7% while the hematology analyzer reported a proportion of 52.9%. Device A showed a sensitivity of 97.22%, specificity of 80.30%, and diagnostic accuracy of 86.3%, with substantial agreement indicated by Cohen's kappa coefficient (kappa = 0.72) and the weighted kappa coefficient for different grades of anemia was 0.67. Bland-Altman analysis revealed a mean difference (bias) of -0.28 (± 0.5) between the two methods, with limits of agreement at -1.24 and 0.68. Lin's concordance correlation coefficient of absolute agreement was 0.91. Conclusion: The DH showed high sensitivity and diagnostic accuracy for anemia detection in PW, with substantial agreement with the hematology analyzer. It offers a convenient and rapid alternative for POC hemoglobin estimation in resource-constrained settings. [ABSTRACT FROM AUTHOR]

Background: The policy attention to primary health care has seen a global upswing in recent years, including in India. Earlier assessments had shown that a very small proportion of Indian population used the government primary health facilities. Starting in 2018, Indian government has established more than 100,000 Health and Wellness Centres (HWCs) to increase rural population's access to primary health care. It is crucial to know how useful people find the services of HWCs. Methods: A qualitative inquiry was made to understand the perceptions, experiences and expectations of the rural communities regarding HWCs in Chhattisgarh state. Fourteen focus group discussions were conducted with community members. The study areas were chosen to include both the central and remote districts of the state. The study used accessibility, availability, acceptability and quality (AAAQ) framework to assess HWCs. Results: Community members felt that the most important change brought about by HWCs was to offer a wider range of curative services than previously available. Services for noncommunicable diseases such as hypertension and diabetes were seen as a key value addition of HWCs. People felt improvements in services for acute ailments also. The services people found missing in HWCs were for injuries, dental care and mental health. In people's experience, the availability of essential medicines and point-of-care tests at HWCs was satisfactory and the treatment was effective. People appreciated the supportive behaviour of health workers in HWCs. They did not find the referrals from HWCs as excessive but often faced difficulties in receiving necessary services at higher facilities. Conclusions: The assessment based on community perceptions showed that the services of HWCs matched well with people's needs of curative primary care. It shows that people are willing to use the government facilities for primary health care if the services are relevant, adequately functional and accessible. [ABSTRACT FROM AUTHOR]

India continues to grapple with a significant burden of HIV infections. Despite notable progress in prevention and treatment efforts, multiple challenges, such as high-risk populations, inadequate testing facilities, and limited access to healthcare in remote areas, persist. Though the Government of India offers HIV-1 plasma viral load testing at various medical centers, aiding treatment decisions and monitoring antiretroviral therapy effectiveness, enhancing care for individuals living with HIV under the National AIDS Control Program (NACP), the nation's large population and diverse demographics further complicate its outreach and response. Hence, strategic interventions and alternative methods of testing remain crucial to curbing HIV transmission and improving the quality of life for those affected. Dried blood spot (DBS) sampling has emerged as a convenient and cost-effective alternative for HIV-1 viral load testing, revolutionizing the landscape of diagnostic and monitoring strategies for HIV infection. Though the plasma-based viral load remains the gold standard for monitoring HIV-1, DBS-based HIV-1 viral load testing holds immense promise for improving access to care, particularly in resource-limited settings where traditional plasma-based methods may be logistically challenging. DBS entails the collection of a small volume of blood onto filter paper, followed by drying and storage. This approach offers numerous advantages, including simplified sample collection, transportation, and storage, reducing the need for cold-chain logistics. Recent studies have demonstrated the feasibility and accuracy of DBS-based HIV-1 viral load testing, revealing a strong correlation between DBS and plasma measurements. Its implementation can enhance the early detection of treatment failure, guide therapeutic decisions, and ultimately contribute to better clinical outcomes for HIV-infected individuals. Hence, this review explores the principles, advancements, feasibility, and implications of DBS-based HIV-1 viral load testing. [ABSTRACT FROM AUTHOR]

Background: Endotracheal intubation is an essential resuscitative procedure in the emergency setting. Airway assessment parameters such as the Mallampati classification are difficult to perform in an emergency setting. As point-of-care ultrasound (POCUS) assessment of airway parameters does not require patients to perform any mandatory action, ultrasound may become the potential first-line noninvasive airway assessment tool in the emergency department (ED). The use of POCUS in the ED has not been sufficiently studied. Using POCUS in airway assessment for predicting difficult intubation may be the next step in successful airway management. Methodology: The study was an observational study conducted at the ED of the All India Institute of Medical Sciences (Rishikesh). The treating emergency physician recorded the patient history and systemic examination along with an indication for intubation. The POCUS assessment of airway parameters pre-epiglottis to epiglottic vocal cord ratio (Pre-E/E-VC), tongue thickness, hyomental distance, and distance from skin to the hyoid bone was performed by the study investigator. During laryngoscopy, Cormack-Lehane (CL) grading was assessed. The data was entered and analyzed. Results: Seventy patients who required intubation in the ED were enrolled in the study. Among the study population, 48.6%, 28.6%, 14.3%, 1.4%, and 7.1% were classified with the following CL grading: 1, 2a, 2b, 3a, and 3b, respectively. At a cutoff of ≥ 1.86, Pre-E/E-VC predicts difficult laryngoscopy (AUC 0.835) with a sensitivity of 83% and a specificity of 94%. At a cutoff of ≥ 5.98 cm, tongue thickness predicts difficult laryngoscopy (AUC 0.78) with a sensitivity of 83% and a specificity of 88%. At a cutoff of hyomental distance ≤ 6 cm, it predicts difficult laryngoscopy with a sensitivity of 83% and a specificity of 88%. All parameters can act as a promising tool for predicting difficult laryngoscopy, with the single best parameter being Pre-E/E-VC. Conclusion: Assessment of the airway with POCUS may be helpful to the emergency physician when the clinical airway assessment parameters fail to predict difficult laryngoscopy as most patients requiring intubation are uncooperative. Assessment of the parameters in our study Pre-E/E-VC, tongue thickness, and hyomental distance can act as a promising tool for predicting difficult laryngoscopy in the emergency scenario. [ABSTRACT FROM AUTHOR]

Introduction In high-burden settings, low-complexity screening tests for tuberculosis (TB) could expand the reach of community-based case-finding efforts. The potential costs and cost-effectiveness of approaches incorporating these tests are poorly understood. Methods We developed a microsimulation model assessing 3 approaches to community-based case-finding in hypothetical populations (India-, South Africa-, The Philippines-, Uganda-, and Vietnam-like settings) with TB prevalence 4 times that of national estimates: (1) screening with a point-of-care C-reactive protein (CRP) test, (2) screening with a more sensitive "Hypothetical Screening test" (95% sensitive for Xpert Ultra-positive TB, 70% specificity; equipment/labor costs similar to Xpert Ultra, but using a $2 cartridge) followed by sputum Xpert Ultra if positive, or (3) testing all individuals with sputum Xpert Ultra. Costs are expressed in 2023 US dollars and include treatment costs. Results Universal Xpert Ultra was estimated to cost a mean $4.0 million (95% uncertainty range: $3.5 to $4.6 million) and avert 3200 (2600 to 3900) TB-related disability-adjusted life years (DALYs) per 100 000 people screened ($670 [The Philippines] to $2000 [Vietnam] per DALY averted). CRP was projected to cost $550 (The Philippines) to $1500 (Vietnam) per DALY averted but with 44% fewer DALYs averted. The Hypothetical Screening test showed minimal benefit compared to universal Xpert Ultra, but if specificity were improved to 95% and per-test cost to $4.5 (all-inclusive), this strategy could cost $390 (The Philippines) to $940 (Vietnam) per DALY averted. Conclusions Screening tests can meaningfully improve the cost-effectiveness of community-based case-finding for TB but only if they are sensitive, specific, and inexpensive. [ABSTRACT FROM AUTHOR]

Background: One significant cause of morbidity and mortality in patients undergoing endotracheal intubation is the aspiration of gastric contents. Its prevalence is more in the emergency than in elective settings. Point-of-care gastric ultrasound (GUS) is a non-invasive bedside ultrasonogram that provides both qualitative and quantitative information about the stomach contents. The diagnostic accuracy of GUS in terms of gastric parameters (measured antral diameters, antral cross-sectional area, and calculated gastric volume) to predict aspiration is yet unknown. We aim to determine this in the patients undergoing urgent emergency intubation (UEI) in the emergency department. Methodology: A prospective observational study was conducted at the emergency department of a tertiary healthcare center in India. Patients requiring UEI were identified and a bedside gastric ultrasound was done in the right lateral decubitus position using low frequency curved array probe. The qualitative data and the antral diameters (anteroposterior and craniocaudal) were assessed. The patient's clinical parameters and history regarding the last meal were noted. The cross-sectional area of gastric antrum was calculated using CSA = (AP × CC) π/4. The gastric volume is estimated using Perla's formula: GV = 27.0 + 14.6(RLD CSA) –1.28(age). Results: A hundred patients requiring urgent endotracheal intubation were enrolled in the study. Visible aspiration was more in participants with a distended gastric status (χ2 = 16.880, p = < 0.001). The median gastric volume in the patients who aspirated was 146.37 mL, and it ranged from 111.59 mL-201.01 mL. Using ROC analysis, a cut-off of CC diameter ≥ 2.35 cm (sensitivity 88%, specificity 91%) and AP diameter ≥ 5.15 cm (sensitivity 88%, specificity 87%) predicts aspiration. A calculated USG CSA cut-off ≥ 9.27cm2 (sensitivity 100%, specificity 87%) and an USG gastric volume ≥ 111.594 mL (sensitivity 100%, a specificity 92%) predicts aspiration. Conclusion: Point-of-care gastric ultrasound is an useful non-invasive bedside tool for risk stratification for aspiration in busy emergency rooms. We present threshold gastric antral parameters that can be used to predict aspiration along with its diagnostic accuracy. This can help the treating ED physician take adequate precautions, decide on intubation techniques and treatment modifications to aid in better patient management. [ABSTRACT FROM AUTHOR]

Simple Summary: The early detection of oral cancer is essential for improving patient outcomes. A conventional oral examination by specialists is the clinical standard for detecting oral lesions. However, many high-risk individuals in middle- and low-income countries lack access to specialists. Therefore, there is a need to develop an easy-to-use, non-invasive oral screening tool that enhances the existing system for detecting precancerous lesions. This study explores artificial intelligence (AI)-based techniques to identify precancerous lesions using photographic images of oral cavities in the Indian population. The high performance of deep learning models suggests that an AI-based solution can be deployed for community screening programs in low-resource settings after further improvement and validation. The prevalence of oral potentially malignant disorders (OPMDs) and oral cancer is surging in low- and middle-income countries. A lack of resources for population screening in remote locations delays the detection of these lesions in the early stages and contributes to higher mortality and a poor quality of life. Digital imaging and artificial intelligence (AI) are promising tools for cancer screening. This study aimed to evaluate the utility of AI-based techniques for detecting OPMDs in the Indian population using photographic images of oral cavities captured using a smartphone. A dataset comprising 1120 suspicious and 1058 non-suspicious oral cavity photographic images taken by trained front-line healthcare workers (FHWs) was used for evaluating the performance of different deep learning models based on convolution (DenseNets) and Transformer (Swin) architectures. The best-performing model was also tested on an additional independent test set comprising 440 photographic images taken by untrained FHWs (set I). DenseNet201 and Swin Transformer (base) models show high classification performance with an F1-score of 0.84 (CI 0.79–0.89) and 0.83 (CI 0.78–0.88) on the internal test set, respectively. However, the performance of models decreases on test set I, which has considerable variation in the image quality, with the best F1-score of 0.73 (CI 0.67–0.78) obtained using DenseNet201. The proposed AI model has the potential to identify suspicious and non-suspicious oral lesions using photographic images. This simplified image-based AI solution can assist in screening, early detection, and prompt referral for OPMDs. [ABSTRACT FROM AUTHOR]

Point-of-care ultrasound (PoCUS) has a potentially vital role to play in emergency medicine (EM), whether it be in high-, medium-, or low-resourced settings. However, numerous barriers are present which impede EM PoCUS implementation nationally and globally: (i) lack of a national practice guideline or scope of practice for EM PoCUS, (ii) resistance from non-PoCUS users of ultrasound imaging (USI) and lack of awareness from those who undertake parallel or post-EM patient care, and (iii) heterogeneous pattern of resources available in different institutes and settings. When combined with the Indian Preconception and Prenatal Diagnostic Techniques (PCPNDT) Act, this has led to the majority of India's 1.4 billion citizens being unable to access EM PoCUS. In order to address these barriers (globally as well as with specific application to India), this article outlines the three core principles of EM PoCUS: (i) the remit of the EM PoCUS USI must be well defined a priori, (ii) the standard of EM PoCUS USI must be the same as that of non-PoCUS users of USI, and (iii) the imaging performed should align with subsequent clinical decision-making and resource availability. These principles are contextualized using an integrated PoCUS framework approach which is designed to provide a robust foundation for consolidation and expansion across different PoCUS specialisms and health-care settings. Thus, a range of mechanisms (from optimization of clinical practice through to PoCUS educational reform) are presented to address such barriers. For India, these are combined with specific mechanisms to address the PCPNDT Act, to provide the basis for influencing national legislation and instigating an addendum to the Act. By mapping to the recent Lancet Commission publication on transforming access to diagnostics, this provides a global and cross-discipline perspective for the recommendations. [ABSTRACT FROM AUTHOR]

Background: Comprehensive reviews on the use and utility of point-of-care tests (POCs) in public health programs in relation to infectious disease and nutrition are limited. Point-of-care technologies have potential to improve the management of infectious diseases particularly in settings where healthcare infrastructure and timely access to quality medical care are limited., Methods: We aim to describe POC tests currently used or under evaluation in the Indian national programs for communicable diseases and nutrition, and to identify the barriers and facilitators. Scoping review methodology was followed to search databases such as MEDLINE, EPPI (evidence for policy and practice information), CINAHL (Cumulative Index to Nursing and Allied Health Literature), JBI Evidence Synthesis, and Google Scholar. Descriptive statistics were applied to identify the utility, barriers, and facilitators of POCs in context of Indian public health program from patients' and physicians' perspectives., Conclusion: Rapid results, appropriate case management, and accuracy of testing in remote areas are perceived to be the major benefits of using POCs. Lack of awareness about POCs and lack of regulations leading to spurious products on the market are obstacles to their optimal use., (© Journal of The Association of Physicians of India 2024.)

Bedside Aphasia Battery in Tamil (BAB T) was developed for assessing the linguistic abilities of Tamil speaking individuals following an acquired brain injury. Method: The conception of the test took place in two phases: Phase 1 was the development of the Bedside Aphasia Battery in Tamil (BAB T) and phase 2 administration of the test battery in neurotypical adults and patients with aphasia. A Delphi panel was constructed based on selected experts from the field of neuro communication disorders and linguistics majors in the Tamil language. Recruited participants were surveyed using a modified Delphi method to establish opinions. A three round Delphi process derived consensus among the experts regarding the components and subdomains employed in the construction of BAB in Tamil. A pilot study was also conducted on nine participants (six neurotypical and three patients with stroke) to content validate the constructed BAB in Tamil. Outcomes and Results: BAB T and its subdomains were identified to have excellent internal consistency, test retest and interrater reliability. BAB T takes approximately 15-20 min to administer and can be employed in busy wards. This tool is especially useful in low resource countries like India, where professional specialized speech and language services are scarce. The BAB T significantly differentiates performance between neurotypical adults and patients with aphasia. Additionally, differences among the patient group also reflect the type of fluent and non fluent aphasia. [ABSTRACT FROM AUTHOR]

Population-based surveys commonly use point-of-care (POC) methods with capillary blood samples for estimating Hb concentrations; these estimates need to be validated by comparison with reference methods using venous blood. In a cross-sectional study in 748 participants (17–86 years, 708 women, Hb: 5·1 to 18·2 g/dl) from Hyderabad, India, we validated Hb measured from a pooled capillary blood sample by a POC autoanalyser (Horiba ABX Micros 60OT, Hb-C-AA) by comparison with venous blood Hb measured by two reference methods: POC autoanalyser (Hb-V-AA) and cyanmethemoglobin method (Hb-V-CM). These comparisons also allowed estimation of blood sample-related and equipment-related differences in the Hb estimates. We also conducted a longitudinal study in 426 participants (17–21 years) to measure differences in the Hb response to iron folate (IFA) treatment by the capillary blood POC method compared with the reference methods. In the cross-sectional study, Bland–Altman analyses showed trivial differences between source of blood (Hb-C-AA and Hb-V-AA; mean difference, limits of agreement: 0·1, −0·8 to 1·0 g/dl) and between analytical methods (Hb-V-AA and Hb-V-CM; mean difference, limits of agreement: < 0·1, −1·8 to 1·8 g/dl). Cross-sectional anaemia prevalence estimated using Hb-C-AA did not differ significantly from Hb-V-CM or Hb-V-AA. In the longitudinal study, the Hb increment in response to IFA intervention was not different when using Hb-C-AA (1·6 ± 1·7 g/dl) compared with Hb-V-AA (1·7 ± 1·7 g/dl) and Hb-V-CM (1·7 ± 1·7 g/dl). The pooled capillary blood–autoanalyzer method (Hb-C-AA) offers a practical and accurate way forward for POC screening of anaemia. [ABSTRACT FROM AUTHOR]

Background Blood-based biomarkers for diagnosing active tuberculosis (TB), monitoring treatment response, and predicting risk of progression to TB disease have been reported. However, validation of the biomarkers across multiple independent cohorts is scarce. A robust platform to validate TB biomarkers in different populations with clinical end points is essential to the development of a point-of-care clinical test. NanoString nCounter technology is an amplification-free digital detection platform that directly measures mRNA transcripts with high specificity. Here, we determined whether NanoString could serve as a platform for extensive validation of candidate TB biomarkers. Methods The NanoString platform was used for performance evaluation of existing TB gene signatures in a cohort in which signatures were previously evaluated on an RNA-seq dataset. A NanoString codeset that probes 107 genes comprising 12 TB signatures and 6 housekeeping genes (NS-TB107) was developed and applied to total RNA derived from whole blood samples of TB patients and individuals with latent TB infection (LTBI) from South India. The TBSignatureProfiler tool was used to score samples for each signature. An ensemble of machine learning algorithms was used to derive a parsimonious biomarker. Results Gene signatures present in NS-TB107 had statistically significant discriminative power for segregating TB from LTBI. Further analysis of the data yielded a NanoString 6-gene set (NANO6) that when tested on 10 published datasets was highly diagnostic for active TB. Conclusions The NanoString nCounter system provides a robust platform for validating existing TB biomarkers and deriving a parsimonious gene signature with enhanced diagnostic performance. [ABSTRACT FROM AUTHOR]

Background: A false-negative rapid antigen test of COVID-19 in healthcare settings not only causes delays in diagnosis, isolation and treatment but also leads to failures in the infection prevention and control practices of the hospital. Objectives: The study objective was to assess the diagnostic performance of ID NOW (Rapid polymerase chain reaction [PCR]) as a COVID-19 triage tool for medical admissions from the emergency room (ER) of our medium-sized tertiary hospital. Methodology: Molecular laboratory data with valid ID NOW and reverse transcription-PCR (RT-PCR) real time results were collected from February to September 2022 of patients presenting with symptoms of influenza-like illness and severe acute respiratory infections at ER. The diagnostic accuracy of ID NOW (sensitivity, specificity, positive predictive value and negative predictive value) was calculated against the laboratory's reference standard RT-PCR test. Results: A total of 153 patients were tested both by ID NOW and RT-PCR. The sensitivity and specificity of the ID NOW assay were 96% (95% confidence interval [CI] 92.49% to 98.92%) and 96.7% (95% CI 91.71% to 98.56%), respectively. Conclusion: ID NOW provided a rapid and reliable adjunct for the safe triage of patients with COVID-19 at our centre and can work effectively when integrated into a COVID-19 triage algorithm of the hospital. Diagnostic stewardship can pave the way for better infection control practices of hospitals. [ABSTRACT FROM AUTHOR]

Early detection of oral cancer in low-resource settings necessitates a Point-of-Care screening tool that empowers Frontline-Health-Workers (FHW). This study was conducted to validate the accuracy of Convolutional-Neural-Network (CNN) enabled m(mobile)-Health device deployed with FHWs for delineation of suspicious oral lesions (malignant/potentially-malignant disorders). The effectiveness of the device was tested in tertiary-care hospitals and low-resource settings in India. The subjects were screened independently, either by FHWs alone or along with specialists. All the subjects were also remotely evaluated by oral cancer specialist/s. The program screened 5025 subjects (Images: 32,128) with 95% (n = 4728) having telediagnosis. Among the 16% (n = 752) assessed by onsite specialists, 20% (n = 102) underwent biopsy. Simple and complex CNN were integrated into the mobile phone and cloud respectively. The onsite specialist diagnosis showed a high sensitivity (94%), when compared to histology, while telediagnosis showed high accuracy in comparison with onsite specialists (sensitivity: 95%; specificity: 84%). FHWs, however, when compared with telediagnosis, identified suspicious lesions with less sensitivity (60%). Phone integrated, CNN (MobileNet) accurately delineated lesions (n = 1416; sensitivity: 82%) and Cloud-based CNN (VGG19) had higher accuracy (sensitivity: 87%) with tele-diagnosis as reference standard. The results of the study suggest that an automated mHealth-enabled, dual-image system is a useful triaging tool and empowers FHWs for oral cancer screening in low-resource settings. [ABSTRACT FROM AUTHOR]

Background: Dyspnea is one of the common symptoms patients present to the emergency department (ED). The broad spectrum of differentials often requires laboratory and radiological testing in addition to clinical evaluation, causing unnecessary delay. Point of care ultrasound (PoCUS) has shown promising results in accurately diagnosing patients with dyspnea, thus, becoming a popular tool in ED while saving time and maintaining safety standards. Our study aimed to determine the utilization of point of care ultrasound in patients with acute dyspnea as an initial diagnostic tool in our settings. Methodology: The study was conducted at the emergency department of a tertiary healthcare center in Northern India. Adult patients presenting with acute dyspnea were prospectively enrolled. They were clinically evaluated and necessarily investigated, and a provisional diagnosis was made. Another EP, trained in PoCUS, performed the scan, blinded to the laboratory investigations (not the clinical parameters), and made a PoCUS diagnosis. Our gold standard was the final composite diagnosis made by two Emergency Medicine consultants (who had access to all investigations). Accuracy and concordance of the ultrasound diagnosis to the final composite diagnosis were calculated. The time to formulate a PoCUS diagnosis and final composite diagnosis was compared. Results: Two hundred thirty-seven patients were enrolled. The PoCUS and final composite diagnosis showed good concordance (κ = 0.668). PoCUS showed a high sensitivity for acute pulmonary edema, pleural effusion, pneumothorax, pneumonia, pericardial effusion, and low sensitivity for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) and acute respiratory distress syndrome (ARDS)/acute lung injury (ALI). High overall specificity was seen. A high positive predictive value for all except left ventricular dysfunction, pericardial effusion, non-cardiopulmonary causes of dyspnea, and a low negative predictive value was seen for pneumonia. The median time to make a PoCUS diagnosis was 16 (5–264) min compared to the 170 (8–1346) min taken for the final composite diagnosis. Thus, time was significantly lower for PoCUS diagnosis (p value <0.001). Conclusion: By combining the overall accuracy of PoCUS, the concordance with the final composite diagnosis, and the statistically significant reduction in time taken to formulate the diagnosis, PoCUS shows immense promise as an initial diagnostic tool that may expedite the decision-making in ED for patients' prompt management and disposition with reliable accuracy. [ABSTRACT FROM AUTHOR]

Background: In India, Drug Information Services (DIS) are well established in general medicine and its related point-of-care (POC) settings; however, there is a service gap and scope for expanding these services in other specialty units. In this context, it is important to understand the expectations of specialty care healthcare professionals (HCPs) on DIS for better outcomes. Objective: To comprehend the perspectives and expectations of DIS among HCPs in India. Methods: An online observational-based survey was conducted among the HCPs from 12 tertiary care hospitals across India. A 27-item questionnaire was developed using the CHERRIES checklist, which was validated for content and reliability, Cronbach's α = 0.7453 and Pearson's r = 0.69. Part A and Part B questions were constructed to comprehend the perceptions and expectations on DIS by the HCPs at the POC settings. Results: A total of 539 responses were received. Overall, 52.6% of the HCPs were not receiving real-time DIS, whereas 78% of them required a drug information pharmacist to assist them at the point-of-care. More than half (52.6%) of respondents believe that DIS should primarily be provided to in-patients. According to 55.7% of HCPs, the preferred mode of the request was mobile application, and search engines were used by 63.9% of the respondents as a source of drug information. Most of the respondents (98.3%) believed that DIS would be beneficial in improving the quality of patient care. Conclusion: Drug information pharmacists play a major role in providing real-time DIS to HCPs and patients at POC and there is scope for improving the competency and productivity of their services. The establishment of centralized drug information centres across the country may minimize irrational drug use and its associated cost burden on patients and healthcare professionals. [ABSTRACT FROM AUTHOR]

Background: Microcirculatory derangement is the primary cause of organ dysfunction in patients with sepsis. Assessment of the microcirculation is usually done by means of indirect parameters (SvO2, transcutaneous PO2, serum lactate). The aim of our study is to understand microcirculatory abnormalities in patients with sepsis by directly visualizing the tiny vessels using hand-held video microscopes (HVMs) and determining the role of this modality in the prediction of sepsis-related mortality. Methods: A longitudinal prospective hospital-based study was carried out in medical ward and ICU of a tertiary care hospital. Patients admitted with the presumed infectious disease were included. Evaluation of sublingual microcirculation was done in these patients from Day 1 to Day 5. Clinical and laboratory variables and microcirculation variables were compared between patients with or without sepsis and between survivors and non-survivors of sepsis. Chi-square test for categorical and Student's t-test or Wilcoxon rank-sum test for continuous variables were applied. Univariate and multivariate regression analyses were performed using the Cox-proportional hazard model. Results and discussion: On admission, microcirculation assessment measure, PPV (small), was significantly reduced in those with sepsis, as compared to those without sepsis. Multivariable models indicate the inverse relationship of PPV small with mortality. [ABSTRACT FROM AUTHOR]

Sickle cell disease (SCD) is a devastating and under‐recognised global child health issue affecting over 300,000 infants annually, with the highest prevalence in India and sub‐Saharan Africa. Most affected infants born in low‐ and middle‐income countries (LMIC) lack access to SCD testing and die from complications in the first years of life without a formal diagnosis. The majority of deaths are preventable with early diagnosis and provision of inexpensive interventions. Despite global recognition of the urgent need, expansion of SCD newborn screening (NBS) programmes beyond the pilot stage has been obstructed by a dependence on an expensive and logistically challenging centralised laboratory testing model. Recently, several point‐of‐care tests (POCT) for SCD have been developed with promising field validation studies. Here, we summarise the state of POCT for SCD, review barriers and unanswered questions, and discuss optimal strategies for utilising POCT to address the growing global burden of SCD. There is an urgent need to prospectively evaluate the ability of POCT to reduce the morbidity and high early mortality of SCD. To impact a sustainable reduction to this end, it is essential to link a diagnosis with comprehensive SCD care, including wide and affordable access to affordable hydroxycarbamide therapy. [ABSTRACT FROM AUTHOR]

Silicosis is an irreversible, incurable and progressive occupational disease caused by prolonged exposure to crystalline-silica dust while working in the relevant industries. Conventionally diagnosis is done by chest radiology, often in an advanced stage as early symptoms often go unnoticed. Early detection and necessary intervention (secondary prevention) could be a realistic possible control strategy for controlling silicosis as no effective treatment is available to stop and/or reverse the pathological process. Additionally, these patients are also vulnerable to pulmonary tuberculosis, which often becomes difficult to treat and with uncertain treatment outcome. Considering India has a huge burden of silicosis and silico-tuberculosis, a rapid and inexpensive screening method was realized to be an urgent need for early detection of silicosis among silica dust exposed workers. Serum club cell protein 16 (CC16) is evidenced to be a useful proxy screening marker for early detection of silicosis as evidenced from the recent research work of ICMR-National Institute of Occupational Health (ICMR-NIOH), India. In this study a lateral-flow assay for semi-quantitative estimation of serum CC16 level was developed. The detection was performed using gold nanoparticles conjugated anti-CC16 monoclonal antibodies. A sum of 106 serum samples was tested to do the performance evaluation of the assay. A concentration of 6 ng/ml or less produced one band, 6.1–9 ng/ml produced two bands, while more than 9 ng/ml produced all the three bands at the test zone. The sensitivity of the assay was 100% while the specificity was 95%. This assay may be used as a sensitive tool for periodic screening of silica dust exposed vulnerable workers for early detection of silicosis in them. [ABSTRACT FROM AUTHOR]

• LAMP technology is isothermal and can be performed in dry bath. • LAMP technology is simple, rapid, highly sensitive and cost effective. • It can be use as point of care diagnostics. • Results can be obtained within 1 h and interpreted by naked eye visualization. Kyasanur forest disease (KFD), a re-emerging tick-borne viral disease, causes severe hemorrhagic fever in humans and nonhuman primates. KFD virus (KFDV) is a member of the genus Flavivirus. KFD is now increasingly reported outside its endemic zone in India. Rapid and specific detection of the KFDV plays a critical role in containment of the outbreak. The diagnosis of KFD currently relies on real-time RT-PCR, nested RT-PCR, end point RT-PCR, and serodiagnostic assay. These assays are tedious, time-consuming, and cannot be used as a routine screening platform. The present study was aimed to develop a one-step reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay for molecular diagnosis of KFD. The gene amplification reaction was accomplished by incubation at a constant temperature of 63 °C for 60 min. The limit of detection of RT-LAMP assay was 10 copies. KFD RT-LAMP assay was successfully evaluated with diverse host samples including humans, monkeys, and tick. The assay correctly picked up different KFD isolates indicating its applicability for divergent strains. Comparative evaluation of RT-LAMP assay with quantitative TaqMan real-time RT-PCR revealed 100% concordance. No cross-reaction with related flavi and other hemorrhagic fever viruses was observed, indicating its high specificity. The RT-LAMP test developed in this study will serve as a rapid, sensitive alternate detection method for KFDV infection and would be useful for high throughput screening of clinical samples in resource limited areas during outbreaks. [ABSTRACT FROM AUTHOR]

Background: Focused assessment with sonography in trauma (FAST) is an important adjunct and an extension of the clinical examination in an emergency setting for the last three decades. e-FAST visualizes the lung bases and injuries related to the lungs in addition to the intraabdominal and pericardial bleed. In trauma patients, time is precious. Noncontrast computed tomography (NCCT) chest is the gold standard for the evaluation of blunt trauma chest. However, it is cumbersome and time-consuming and leads to increased morbidity and mortality. Therefore, evaluation of trauma patients at the trauma bay with e-FAST which is available at all times will not only save time but also the lives of trauma patients. Our endeavor is to find whether e-FAST can be substituted for NCCT for assessing injuries accurately in a stable blunt trauma patient. Patient and methods: Prospective observational study was conducted in a tertiary care trauma center during the period of November 2017 to 2019. Of the 197 patients presenting to the trauma surgeon in the trauma center, 110 were included in the study after satisfying the inclusion criteria. Eighty-seven patients being hemodynamically unstable were excluded from the study. Results: There was no statistical significance in the comparative data between the groups and all with "p" values more than 0.05. This accepts the null hypothesis and establishes the fact that there is no difference between NCCT chest which is the gold standard for chest blunt trauma and e-FAST. Conclusion: We conclude that e-FAST is a better adjunct to the diagnosis and management of blunt trauma chest patients. [ABSTRACT FROM AUTHOR]

Background: Screening for anemia among tribal school children has been a challenge. Objectives: To validate a point-of-care (POC) device (mission® plus hemoglobinometer) to the gold standard method, spectrophotometry. Study Design: Cross-sectional study. Participants: The representative sample of 953 tribal adolescents from the residential schools of Odisha. Methods: Hemoglobin was measured simultaneously by the POC and gold standard method during January to July 2019. The validity of the POC device was measured by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). The area under the curve was calculated using receiver operating characteristic (ROC) analysis. Concordance of the POC device with the gold standard method was determined by the Bland--Altman plot. The intraclass correlation coefficient (ICC), precision (ρ), a bias correction factor (Cb), and the concordance correlation coefficient were also calculated. Deming regression analysis was performed, and a linear equation was established. Results: The mean age of the study participants was 13.07 (±1.48) years. The prevalence of anemia was 45.54% by the gold standard method. The sensitivity and specificity of the POC device were 94.9% and 56.1%, respectively. PPV and NPVs were 64.4% and 93.0%, respectively. The area under the ROC curve was found to be 0.856. The ICC was 0.887 (95% confidence interval: 0.872-0.901). Conclusions: Very good reliability/absolute agreement for hemoglobin measurements existed between the POC device and the gold standard method making it suitable as a screening device. [ABSTRACT FROM AUTHOR]

COVID-19 testing across India uses a mix of two types of tests. Rapid Antigen Tests (RATs) are relatively inexpensive point-of-care lateral-flow-assay tests, but they are also less sensitive. The reverse-transcriptase polymerase-chain-reaction (RT-PCR) test has close to 100% sensitivity and specificity in a laboratory setting, but delays in returning results, as well as increased costs relative to RATs, may vitiate this advantage. India-wide, about 49% of COVID-19 tests are RATs, but some Indian states, including the large states of Uttar Pradesh (pop. 227.9 million) and Bihar (pop. 121.3 million) use a much higher proportion of such tests. Here we show, using simulations based on epidemiological network models, that the judicious use of RATs can yield epidemiological outcomes comparable to those obtained through RT-PCR-based testing and isolation of positives, provided a few conditions are met. These are (a) that RAT test sensitivity is not too low, (b) that a reasonably large fraction of the population, of order 0.5% per day, can be tested, (c) that those testing positive are isolated for a sufficient duration, and that (d) testing is accompanied by other non-pharmaceutical interventions for increased effectiveness. We assess optimal testing regimes, taking into account test sensitivity and specificity, background seroprevalence and current test pricing. We find, surprisingly, that even 100% RAT test regimes should be acceptable, from both an epidemiological as well as a economic standpoint, provided the conditions outlined above are met. Author summary: Using network models, we study optimal ways of combining low sensitivity, relatively inexpensive point-of-care rapid antigen tests for COVID-19 with higher sensitivity but more expensive laboratory RT-PCR tests. We take into account background seroprevalence and current test pricing for such tests in India, finding that even purely rapid antigen test-based regimes can produce the same reduction in overall infections that pure RT-PCR tests are capable of. This is provided one can test at scale and isolate those testing positive effectively, that the sensitivity of the rapid test is not too low and that non-pharmaceutical interventions proceed in parallel for increased effectiveness. [ABSTRACT FROM AUTHOR]

Introduction: Viral hepatitis is a crucial public health problem in India. Hepatitis C virus (HCV) elimination is a national priority and a key strategy has been adopted to strengthen the HCV diagnostics services to ensure early and accurate diagnosis. Methods: To conduct an economic evaluation of implementing a rapid point-of-care screening test for the identification of HCV among the selected key population under the National Viral Hepatitis Control Programme in Tamil Nadu, South India. Economic evaluation of a point-of-care screening test for HCV diagnosis among the key population attending the primary health care centers. A combination of decision tree and Markov model was developed to estimate cost-effectiveness of point-of-care screening test for HCV diagnosis at the primary health care centers. Total costs, quality-adjusted life years (QALYs) of the intervention and comparator, and incremental cost-effectiveness ratio (ICER) were calculated. The model parameter uncertainties which would influence the cost-effectiveness outcome has been evaluated by one-way sensitivity analysis and probabilistic sensitivity analysis. Results: When compared to the tertiary level diagnostic strategy for HCV, the point-of-care screening for selected key population at primary health care level results in a gain of 57 undiscounted QALYs and 38 discounted QALYs, four undiscounted life years and two discounted life years. The negative ICER of the new strategy indicates that it is less expensive and more effective compared with the current HCV diagnosis strategy. Conclusions: The proposed strategy for HCV diagnosis in the selected key population in Tamil Nadu is dominant and cost-saving compared to the current strategy. [ABSTRACT FROM AUTHOR]

• Kyasanur forest disease (KFD) is an emerging public health problem in India. • A point of care test was evaluated for its performance for KFD diagnosis. • The test was highly sensitive and specific with a significant limit of detection. • The test can be used in field and remote settings for rapid diagnosis of KFD. Due to the remote forest area locations of sporadic cases and outbreaks of Kyasanur forest disease (KFD), rapid diagnosis poses a significant challenge. This study aimed to evaluate the diagnostic performance of Truenat KFD, a simple, rapid and user-friendly point-of-care test for detection of KFD and compare diagnostic accuracy with conventional real-time reverse transcription-polymerase chain reaction (RT-PCR) testing. Truenat KFD can be deployed in a field laboratory setting. The study involved 145 clinical specimens, including human serum, monkey necropsy tissues and tick pool, to validate Truenat KFD (Molbio Diagnostics Pvt.Ltd.) for KFD diagnosis. We have optimized and validated the microchip-based Truenat KFD (Molbio Diagnostics Pvt.Ltd.) for KFD diagnosis. Point-of-care testing was highly sensitive and specific, with a detection limit of up to 10 copies of KFD viral RNA. Results were comparable with the gold-standard TaqMan and commercially available Altona RealStar AHFV / KFDV real-time RT-PCR assays. Screening results for human, monkey and tick specimens were 100% concordant across the assays. Truenat KFD(Molbio Diagnostics Pvt.Ltd.) was found to be highly sensitive and specific with a significant limit of detection. This point-of-care test would be useful in rapid diagnosis of KFD in remote and/or field settings, quick patient management and control of virus spread. [ABSTRACT FROM AUTHOR]

Introduction: Globally around 47.4% of children and in India, 58% of children aged 6-59 months are anemic. Diagnosis of anemia in children using accurate technologies and providing adequate treatment is essential to reduce the burden of anemia. Point-of-care testing (POCT) devices is a potential option for estimation of hemoglobin in peripheral and field settings were the hematology analyzer and laboratory services are not available.Objectives: To access the validity of the POCTs (invasive and non-invasive devices) for estimation of hemoglobin among children aged 6-59 months compared with hematology analyzer.Methods: The study participants were enrolled from the pediatric outpatient department in Haryana, India, from November 2019 to January 2020. Hemoglobin levels of the study participants were estimated in Sahli's hemoglobinometer and invasive digital hemoglobinometers (DHs) using capillary blood samples. Hemoglobin levels in non-invasive DH were assessed from the finger/toe of the children. Hemoglobin levels measured in POCTs were compared against the venous blood hemoglobin estimated in the hematology analyzer.Results: A total of 120 children were enrolled. The mean (SD) of hemoglobin (g/dl) estimated in auto-analyzer was 9.4 (1.8), Sahli's hemoglobinometer was 9.2 (1.9), invasive DH was 9.7 (1.9), and non-invasive DH was 11.9 (1.5). Sahli's hemoglobinometer (95.5%) and invasive DH (92.2%) had high sensitivity for the diagnosis of anemia compared with non-invasive DH (24.4%). In contrast, non-invasive DH had higher specificity (96.7%) compared with invasive DH (83.3%) and Sahli's hemoglobinometer (70%). Invasive DH took the least time (2-3 min) for estimation of hemoglobin per participant, followed by Sahli's (4-5 min) and non-invasive DH (5-7 min).Conclusion: All three POCT devices used in this study are reasonable and feasible for estimating hemoglobin in under-5 children. Invasive DHs are potential POCT devices for diagnosis of anemia among under-5 children, while Sahli's can be considered as a possible option, where trained and skilled technicians are available. Further research and development are required in non-invasive DH to improve accuracy. Lay summaryIn India, anemia is a serious public health problem, where 58% of the children aged 6-59 months are anemic. Point-of-care testing (POCT) using digital hemoglobinometers (DHs) has been recommended as one of the key interventions by the Anemia Mukt Bharat program since 2018 in India. These POCT devices are easy to use, less invasive, can be carried to field, require minimal training and results are available immediately. Therefore this study assessed the validity of POCT devices-invasive DH, non-invasive DH and Sahli's hemoglobinometer among 6-59 months children in facility setting compared with the gold standard hematology analyzer. A total of 120 children under 6-59 months of age were enrolled from the pediatric outpatient department in Haryana, India, from November 2019 to January 2020. The (mean hemoglobin in g/dl) invasive (9.7) and non-invasive DH (11.9) overestimated hemoglobin value, while Sahli's (9.2) underestimated hemoglobin compared with hematology analyzer (9.4). Invasive DH (92.2%) and Sahli's hemoglobinometer (95.5%) reported high ability to correctly identify those with anemia compared with non-invasive DH (24.4%). In contrast, non-invasive DH (96.73%) had higher ability to correctly identify those without the anemia compared with invasive DH (83.3%) and Sahli's (70%). [ABSTRACT FROM AUTHOR]

In a developing country like India, with limited resources and access to healthcare facilities, dealing with massive hemorrhage is a major challenge. This challenge gets compounded by pre-existing anemia, hemostatic disorders, and logistic issues of timely transfer of such patients from peripheral hospitals to centers with adequate resources and management expertise. Despite the awareness amongst healthcare providers regarding management modalities of bleeding patients, no uniform Patient Blood Management (PBM) or perioperative bleeding management protocols have been implemented in India, yet. In light of this, an interdisciplinary expert group came together, comprising of experts working in transfusion medicine, hematology, obstetrics, anesthesiology and intensive care, to review current practices in management of bleeding in Indian healthcare institutions and evaluating the feasibility of implementing uniform PBM guidelines. The specific intent was to perform a gap analysis between the ideal and the current status in terms of practices and resources. The expert group identified interdisciplinary education in PBM and bleeding management, bleeding history, viscoelastic and platelet function testing, and the implementation of validated, setting-specific bleeding management protocols (algorithms) as important tools in PBM and perioperative bleeding management. Here, trauma, major surgery, postpartum hemorrhage, cardiac and liver surgery are the most common clinical settings associated with massive blood loss. Accordingly, PBM should be implemented as a multidisciplinary and practically applicable concept in India in a timely manner in order to optimize the use the precious resource blood and to increase patients' safety. [ABSTRACT FROM AUTHOR]

Objective: To determine the performance of a glycosylated fibronectin (GlyFn) point-of-care (POC) test for pre-eclampsia (PE) in a large Southeast Asian cohort (India) in comparison to previously described biomarkers.Design: A total of 798 pregnant women at ≥20 weeks of gestation were enrolled in a prospective case-control study. Study participants included 469 normotensive women with urinary mg protein/mmol creatinine ratio <0.3, 135 with PE (hypertension with urinary mg protein/mmol creatinine ratio ≥0.3) and 194 with gestational hypertension (hypertension with urinary mg protein/mmol creatinine ratio <0.3).Methods: GlyFn levels were determined using a POC device and PIGF, sFlt-1 and PAPPA2 levels were determined by immunoassay. Performance was assessed using logistic regression modelling and receiver-operating characteristic (ROC) curves. Classification performance and positive and negative predictive values are reported at specific thresholds.Results: Increased levels of GlyFn, soluble fms-like tyrosine kinase-1 (sFlt-1) and pregnancy-associated placental protein A2 (PAPPA2), and decreased levels of placental growth factor (PlGF) were significantly associated (P < 0.01) with clinically defined PE. Area under the ROC (AUROC) values with 95% confidence intervals were: GlyFn, 0.99 (0.98-0.99); PlGF, 0.96 (0.94-0.98); sFlt-1, 0.86 (0.83-0.89); and PAPPA2, 0.96 (0.94-0.97). Of subjects with GH, 48% were positive for more than two PE biomarkers, and 70% of these delivered preterm.Conclusions: The Lumella™ GlyFn POC test has been validated in a low/middle-income country setting for PE diagnosis and may be a useful adjunctive tool for early identification, appropriate triage, and improved outcomes.Tweetable Abstract: The Lumella™ point-of-care test had excellent performance in diagnosing PE in a large Southeast Asian cohort. [ABSTRACT FROM AUTHOR]

Introduction: India has launched Anemia Mukt Bharat (AMB) strategy in 2018, to deal with the high burden of anemia in the country. Point-of-care testing (POCT) of anemia using digital hemoglobinometers and treatment is one of the primary interventions under AMB. This study aimed to determine the diagnostic validity of digital hemoglobinometers (TrueHb and HemoCue 301) for screening of anemia compared to hematology analyzer. Methodology: A hospital-based, cross-sectional study was conducted among pregnant women attending antenatal clinics of a selected primary health center and subdivisional hospital of Haryana, India, during January 2019. Hemoglobin (Hb) levels of the pregnant women were estimated in digital hemoglobinometers using capillary blood samples and hematology analyzer using venous blood samples. Bias, limits of agreement (LOA), and validity of digital hemoglobinometers were assessed against a hematology analyzer. Results: A total of 110 pregnant women were included. Bias (LOA) in Hb values estimated using digital hemoglobinometers was -0.09 g/dL (-1.97 to 1.80 ) for HemoCue301 and -0.04 g/dL (-1.69 to 1.60) for TrueHb compared to the hematology analyzer. HemoCue® 301 (sensitivity: 86% and specificity: 83%) had relatively higher sensitivity and specificity compared to TrueHb (sensitivity: 78.9% and specificity: 81%). Conclusions: Digital hemoglobinometers have high sensitivity and specificity. Thus, these can be a potential POCTs for screening of anemia in peripheral health facilities. Further studies are required to establish the validity of the digital hemoglobinometers at community settings. [ABSTRACT FROM AUTHOR]

Background: The present study was undertaken to investigate imaging features of emerging coronavirus disease 2019 (COVID-19) pneumonia by chest ultrasound point-of-care ultrasonography (POCUS) and digital radiographs (chest radiograph [CXR]) and their correlation with clinical manifestation and severity of the disease. Methods: The present ongoing single-center study assessed patients admitted from April 20 to May 15, 2020, with laboratory-confirmed COVID-19 pneumonia at SMS Medical College Hospital, Jaipur, India. The clinical features, laboratory investigations, CXR, and POCUS findings were evaluated and compared. Results: Fifty-two patients with a manifestation of COVID-19 pneumonia were studied. Most of the patients were in the fifth and sixth decade of age group with a mean age of 56.57 years. There was an overall male preponderance (80% men and only 20% women). All pneumonitis patients were symptomatic with fever (88.46%), cough (82.69%), and dyspnea (55.77%) being the major symptoms. Thirty-four patients had underlying comorbid conditions. The digital radiograph-chest findings of 55.77% patients exhibited classic COVID-19 pneumonia findings. The ultrasonography of the chest findings revealed pleural and lungs changes in 94% of patients with COVID-19-positive pneumonia. CURB-65 score for the severity of pneumonia had a positive correlation with POCUS severity score and CXR visual score with P = 0.0013 and 0.0018, respectively. The duration of some major symptoms for COVID-19 pneumonia also had a positive correlation with the POCUS severity score and CXR visual score. Conclusion: The spectrum of COVID-19 pneumonia has a predilection for advancing age and male gender. Although both POCUS and CXR are important tools to detect severity of pneumonia, POCUS has higher sensitivity as compared to that of CXR to detect characteristics of COVID-19 pneumonia, especially interstitial involvement or acute respiratory distress syndrome. [ABSTRACT FROM AUTHOR]

Background: India is facing a serious burden of anemia where majority of the women (51%) of reproductive age suffer from anemia. Though there are many programs being run for decades to fight anaemia, it still persist to be a major health challenge in Odisha where around half of the women and children are anemic (children age 6-59 months; 44.6%, pregnant women of age 15-49; 47.6%, all women of age 15-49 years; 51.0%). Objectives: AIIMS Bhubaneswar, in partnership with Govt. of Odisha and UNICEF aimed to assess the burden of anaemia in the state. Methods: This cross-sectional study was conducted amongst 3974 beneficiaries between March to July 2016. Hemoglobin estimation was done using Hemocue 201. Results: Prevalence of mild, moderate and severe anemia was observed to be 39-58%, 7-20% and 1-3%, respectively in 4 districts. Coverage of iron folic acid tablets amongst adolescent girls, adolescent boys, pregnant women, lactating mothers, and women of reproductive age groups were 38%, 16%, 73%, 46%, 11% respectively. Conclusion: The study has shown that prevalence of severe and moderate anaemia has decreased to a greater extent, however the prevalence of mild anaemia is still very high. [ABSTRACT FROM AUTHOR]

Coronavirus disease-2019 (COVID-19) and the associated pathophysiological perturbations continue to bewilder the fraternity at large. In this context, the thromboembolic predisposition in COVID-19 has particularly emerged as a matter of an ardent debate. The index commentary aims to present an account of the recent developments in the understanding of the immunothrombosis in the enigmatical setting of COVID-19. [ABSTRACT FROM AUTHOR]

Effusive pneumothorax is an abnormal collection of air and fluid within the pleural space: blood, pus, or serous fluid. Thus, effusive pneumothorax can be categorized as hemopneumothorax, pyopneumothorax, or hydropneumothorax, depending on the type of fluid accumulation. Hydropneumothorax is a clinical condition defined by the presence of air and serous fluid within the pleura space. Hydropneumothorax is one of the common respiratory emergencies encountered in the emergency department in India. Etiologies can be classified into infectious and non‐infectious causes, among which tuberculosis being the most common one. Point of care ultrasound (POCUS) can help diagnose hydropneumothorax at the bedside rather than shift the patient for an X‐ray. Here, we describe a case of hydropneumothorax, which was diagnosed using POCUS by characteristic sonographic signs, namely "Hydro‐point" and "barcode‐hydro point‐sinusoidal sign." Sonographic hydro‐point is the transition zone of the air‐fluid interface, which is seen in hydropneumothorax. Targhetta et al., in 1992, introduced the term "Hydro‐point" in lung ultrasound for diagnosing hydropneumothorax but has been under‐reported/unspoken much in the literature. With the use of POCUS, we diagnosed and stabilized the patient in the Emergency Department. [ABSTRACT FROM AUTHOR]

Introduction: Noncommunicable diseases (NCDs) are a major cause of disease burden. NCDs are a global epidemic and India is no exception. Risk factors contributing to NCDs can be detected before symptoms occur. Screening is an effective tool. Real-time teleconsultation during screening is a value-added service. This preliminary report documents the process and observations during teleconsultations provided in NCD screening camps, across multiple locations in India. That real-time teleconsultations in camp mode make a difference and are relevant in India is discussed. Materials and Methods: To provide awareness about risk factors of common NCDs such as diabetes, cardiovascular diseases, and anemia, screening camps were conducted. A 22-member field team organizes internet-enabled camps using point-of-care diagnostics. Software was developed to capture participant details and provide decision support to the field team. This resulted in identification of participants eligible for teleconsultations. Participants with risk factors of the targeted NCDs (hyperglycemia and dyslipidemia) were offered teleconsultations during screening. Currently, the program is active across six locations (Bengaluru, Coimbatore, Delhi National Capital Region, Kolkata, Pune, and Vijayawada) in India. Results: Since program inception from August 27, 2015 to October 31, 2018, a total of 757,325 participants have been screened. Twenty-seven thousand three hundred fifty-three participants were eligible for teleconsultations. Thirteen thousand six hundred fifteen availed onsite teleconsultations; 99.8% of the 1409 teleconsultation beneficiaries surveyed were "extremely satisfied and very happy." Conclusion: Providing real-time teleconsultations to 13,615 individuals "at risk" of specific NCDs from six centers across India is doable and well received by beneficiaries. [ABSTRACT FROM AUTHOR]

Background: HemoCue point of care devices has been extensively used in screening for anemia in blood banking. HemoCue can estimate hemoglobin (Hb) both from venous as well as capillary blood. However, the suitability of HemoCue Hb estimation in donor selection is unclear. Aims: The aims of this study were to evaluate variance of difference in Hb measurement in capillary HemoCue estimation as compared to venous HemoCue estimation from automated cell counter and to assess accuracy of two different HemoCue models (201 and 301) against automated cell counter Hb measurements in both capillary as well as venous blood. Materials and Methods: HemoCue 201 and 301 were evaluated by a comparison of methods study against Sysmex XP-100 three-part analyzer at a blood bank of a tertiary care hospital in Uttarakhand, India, in 2017. Assessment for anemia of 115 donors was done initially by capillary Hb by a convenience sampling to 2 instruments from 2 different models of HemoCue (total of 4 instruments). Venous blood collected was analyzed by Sysmex XP-100 and all HemoCue analyzers. Results: For capillary method, bias ranged from −0.97 to −0.37 g/dL, upper limit of agreement (LOA) ranged from 0.72 to −1.06 g/dL, and lower LOA ranged from −2.65 to −1.79 g/dL. For venous method, bias ranged from −0.03 to −0.24 g/dL, the upper LOA ranged from 0.81 to −1.07 g/dL, and lower LOA ranged from −1.04 to −0.57 g/dL. Thus, capillary HemoCue estimation exhibited greater bias as well as wider LOA. Variance of the differences from automated counter was significantly lower for venous HemoCue comparison compared to capillary HemoCue estimation (P < 0.001 for each instrument). Conclusion: Errors in capillary sampling of blood show the extent to which preanalytical errors can influence results in point-of-care devices. We suggest augmentation of any blood bank-based Hb screening process based just on capillary sampling to be augmented by a properly selected venous sampling to reduce deferral for a false-positive screen of anemia. [ABSTRACT FROM AUTHOR]

Objectives: Sickle cell anemia is the commonest genetic disorder in India, and the frequency of the sickle cell gene is very high in the remote tribal areas where facilities are generally limited. Therefore, a rapid and affordable point-of-care test for sickle cell disease is needed.Methods: The diagnostic accuracy of HemoTypeSC was evaluated against automated high-performance liquid chromatography (HPLC) as the gold standard for its efficacy in a newborn screening program.Results: A total of 1,559 individuals (980 newborns and 579 adults) from four participating centers were analyzed by both methods. HemoTypeSC correctly identified 209 of 211 total hemoglobin (Hb) SS cases, for a 99.1%/99.9% total HbSS sensitivity/specificity. Overall, HemoTypeSC exhibited sensitivity and specificity of 98.1% and 99.1% for all possible phenotypes (HbAA, HbAS, and HbSS) detected. HPLC is relatively expensive and not available in most laboratories in remote tribal areas.Conclusions: We conclude that the rapid, point-of-care testing device HemoTypeSC test is suitable for population and newborn screening for the HbS phenotype. [ABSTRACT FROM AUTHOR]

Background Visceral leishmaniasis (VL), caused by the Leishmania donovani complex, is a fatal, neglected tropical disease that is targeted for elimination in India, Nepal, and Bangladesh. Improved diagnostic tests are required for early case detection and for monitoring the outcomes of treatments. Previous investigations using Leishmania lysate antigen demonstrated that the immunoglobulin (Ig) G1 response is a potential indicator of a patient's clinical status after chemotherapy. Methods IgG1 or IgG enzyme-linked immunosorbent assays (ELISAs) with rK39 or lysate antigens and novel IgG1 rK39 rapid diagnostic tests (RDTs) were assessed with Indian VL serum samples from the following clinical groups: paired pre- and postchemotherapy (deemed cured); relapsed; other infectious diseases; and endemic, healthy controls. Results With paired pre- and post-treatment samples (n = 37 pairs), ELISAs with rK39- and IgG1-specific conjugates gave a far more discriminative decrease in post-treatment antibody responses when compared to IgG (P <.0001). Novel IgG1 rK39 RDTs provided strong evidence for decreased IgG1 responses in patients who had successful treatment (P <.0001). Furthermore, both IgG1 rK39 RDTs (n = 38) and ELISAs showed a highly significant difference in test outcomes between cured patients and those who relapsed (n = 23; P <.0001). RDTs were more sensitive than corresponding ELISAs. Conclusions We present strong evidence for the use of IgG1 in monitoring treatment outcomes in VL, and the first use of an IgG1-based RDT using the rK39 antigen for the discrimination of post-treatment cure versus relapse in VL. Such an RDT may have a significant role in monitoring patients and in targeted control and elimination of this devastating disease. [ABSTRACT FROM AUTHOR]

Anemia is an important public health challenge and accurate prevalence estimates are needed for program planning and tracking progress. While venous blood assessed by automated hematology analyzers is considered gold standard, most population‐based surveys use point‐of‐care diagnostics and capillary blood to estimate population prevalence of anemia. Several factors influence hemoglobin (Hb) concentration, including human and analytic error, analysis method, and type of instrument, but it is unclear whether biological variability exists between venous and capillary blood. The objective of this paper was to systematically review sources of Hb variability and the potential biological basis for venous and capillary differences. We use data from a recent survey in the state of Uttar Pradesh, India, to illustrate the implications on anemia prevalence estimates. Significant differences in Hb concentration between capillary and venous blood samples are common. Most but not all find capillary Hb concentration to be higher than venous. Instrument/method variability and human error play an important role, but cannot fully explain these differences. A normative guide to data collection, analysis, and anemia diagnosis is needed to ensure consistent and appropriate interpretation. Further research is needed to fully understand the biological implications of venous and capillary Hb variability. [ABSTRACT FROM AUTHOR]

Background: Truenat is a novel molecular assay that rapidly detects tuberculosis (TB) and rifampicin-resistance. Due to the portability of its battery-powered testing platform, it may be valuable in peripheral healthcare settings in India. Methods: Using a microsimulation model, we compared four TB diagnostic strategies for HIV-negative adults with presumptive TB: (1) sputum smear microscopy in designated microscopy centers (DMCs) (SSM); (2) Xpert MTB/RIF in DMCs (Xpert); (3) Truenat in DMCs (Truenat DMC); and (4) Truenat for point-of-care testing in primary healthcare facilities (Truenat POC). We projected life expectancy, costs, incremental cost-effectiveness ratios (ICERs), and 5-year budget impact of deploying Truenat POC in India’s public sector. We defined a strategy “cost-effective” if its ICER was

Abstract Background Early detection of Atrial Fibrillation (AF) is a public health priority across the globe because AF-related strokes are preventable. Despite an ongoing stroke epidemic in India, a public health strategy for AF screening and treatment is missing because the epidemiology of AF in India remains poorly defined. Methods This population-based study used mobile technology to derive age and sex-stratified AF prevalence by screening 7 participants in each of six age and sex strata (age 40–55, 56–65, 65+, and male and female) from 50 villages (2100 participants). A health worker from each village used a handheld digital electrocardiogram (iECG) device (Kardia) to screen for AF on 3 separate days, and administered a questionnaire. All abnormal (AF or unclassified) iECGs were reviewed by the Indian cardiologist and AF determination confirmed by a US-based cardiac electrophysiologist. Results Of the 2100 individuals enrolled, iECGs were collected from 2074 participants (98.8%) and 1947 (92.7%) participants responded to the questionnaire. AF was identified in 33 participants (1.6%), two-thirds on the first iECG. AF prevalence was higher among males (2.3% vs 1.0%, p = 0.03) and in older people (0.6%, 0.9%, 2.1%, 5.6%; p < 0.01). Conclusions The prevalence of AF observed in our population-based sample is comparable to rates found in studies from North America and Western Europe and increases similarly with age. AF screening using village health workers in rural India is feasible and presents an opportunity for a strategy to address the stroke epidemic in India through primary prevention. Highlights • Prevalence of atrial fibrillation found in our study (1.6%) is at least 3-fold higher than previously reported in India. • Community Health Workers are capable of performing AF screening using mobile point-of-care technologies. • Multiple screenings, even over a short span of time, helps identify people with paroxysmal AF. • Older people were more likely to have AF in comparison to younger people, mirroring trends observed in western countries. [ABSTRACT FROM AUTHOR]

Abstract There is need for rapid and cost-effective diagnostic test for tuberculosis. The present study was carried out to design a Loop-mediated isothermal amplification (LAMP) assay combined with lateral flow dipstick (LFD) as a point-of-care method for diagnosis of TB. LAMP assay targeting sdaA gene combined with LFD for sequence specific detection was standardized in user friendly and rapid format. It does not require sophisticated instruments and shows visual results instantly. The LAMP-LFD assay was validated using culture confirmed specimens. The assay was evaluated in a cross-sectional study using respiratory specimens collected from patients in Delhi, India and it showed high concordance with GeneXpert MTB/RIF assay. Lateral flow dipstick method has provided an excellent detection format with LAMP method. The LAMP-LFD assay showed high diagnostic accuracy in comparison to other methods and can be used as a point-of-care test in cost-effective manner. Graphical abstract Unlabelled Image Highlights • Rapid and sensitive detection of Mycobacterium tuberculosis. • No need for sophisticated instruments. • Naked eye visualization of results using Lateral flow dipstick. • Sequence specific method for high specificity. • Potential point of care diagnostic test for resource limited settings. [ABSTRACT FROM AUTHOR]

Background There is no experience of point-of-care (POC) microbiological confirmation for TB in India in field settings. Methods Under the TB-Free Haryana project, a mobile van-mounted digital x-ray and portable GeneXpert system screened all presumptive TB patients with strong clinic-radiological suspicion for TB. Results Of 1673 x-rays, 215 (13%) had findings suggestive of TB, 109 had strong clinical suspicion and were eligible for POC GeneXpert, in whom a test was performed in 82 (75%) cases; 59 (72%) tested positive and were initiated on treatment within 24 h. Conclusions A mobile van equipped with digital x-ray and POC GeneXpert is feasible and has a good success rate with potential for replication. [ABSTRACT FROM AUTHOR]

Introduction: In 2002, the Government of Chhattisgarh initiated a Community Health Worker program called the Mitanin Program, to strengthen the health system of Chhattisgarh. The current study was conducted with the twin objectives to assess morbidity pattern and health-seeking behavior in urban slums of Durg and Bhilai to understand the role of Mitanins in health seeking of their slum population. Methods: Ten urban slums, five each from Durg and Bhilai were selected through simple random sampling for the study. Household survey was done using prestructured questionnaire. A total of 1025 households representing 4997 family members were surveyed. Results: The study found that diseases which were most prevalent in the urban slums of Durg and Bhilai are blood pressure and diabetes mellitus. Diseases such as diarrhea, typhoid, hepatitis, tuberculosis, leprosy, and filariasis which have strong association with safe drinking water and sanitation are prevalent. For chronic communicable disease and reproductive and child health (RCH), people from both cities prefer going to public health-care facilities. About a fourth of the population came in contact with the Mitanins to seek health care mostly in relation to chronic communicable diseases and RCH. Conclusion: The study shows an increase in the prevalence of chronic lifestyle diseases among the slum population. There is a case for inclusion of chronic conditions, as specified under Comprehensive Primary Health Care. There is a need to reprioritize Mitanin's role in early diagnosis through point-of-care diagnostics and ensuring prompt referrals and follow-up. [ABSTRACT FROM AUTHOR]

Objective: To introduce the implementation of point of care INR monitoring service by community pharmacists for optimizing the therapy outcomes of Warfarin, used widely for its anticoagulant activity both as a treatment and prophylaxis. Methods: This prospective, controlled, staggered parallel design study was conducted in selected community pharmacies associated with general practitioners. The patients in the intervention arm received point of care INR measurement and anticoagulant management including assessment of clinical and quality of life endpoints by their pharmacists in collaboration with their general practitioners. Result: 82 patients were recruited into the study in 5 community pharmacies and all these patients were under the medical care of 7 general medical practitioners. About 44 % (n = 36) of the patients recruited into the intervention group submitted their retrospective INR reports which was considered as pre intervention data and used to compare the clinical outcome against post intervention phases. It was found that the patients in the post intervention group had a statistically significant (p < 0.05) control in the INR values than the pre intervention group. A statistically significant difference (p = 0.025) was observed in the quality of life of patients at pre and post intervention groups. There was also a significant (p = 0.016) increase in patient's knowledge about anticoagulant therapy between pre and post intervention. Conclusion: The community pharmacists and medical practitioners managed anticoagulant service is feasible and acceptable to patients and pharmacist involved in the study. [ABSTRACT FROM AUTHOR]