Magnetic smartphone microflow cytometry enables rapid CD4/CD8 T cell quantification.

ABSTRACTIntroduction: Syphilis remains an important and preventable cause of stillbirth and neonatal mortality. About 1 million women with active syphilis become pregnant each year. Without treatment, 25% of them will deliver a stillborn baby and 33% a low birth weight baby with an increased chance of dying in the first month of life. Adverse pregnancy outcomes due to syphilis can be prevented by screening pregnant women, and treating those who test positive with a single dose of penicillin before 28 weeks’ gestation.Areas covered: This manuscript covers the impact of syphilis on pregnancy outcome, the diagnosis of syphilis, with a special focus on point of care (POC) tests, and challenges to the introduction of POC tests, and their potential impact on the control and prevention of syphilis in resource limited settings.Expert commentary: POC tests for syphilis are available which meet the ASSURED criteria, and could make syphilis screening accessible to all women anywhere in the world who attend an antenatal clinic. High quality dual POC tests for HIV and syphilis could ensure that well-funded programmes for the prevention of mother to child transmission of HIV can contribute towards increased coverage of antenatal syphilis screening, and prevent more than 300,000 adverse pregnancy outcomes due to syphilis annually. Alongside investment to increase availability of syphilis POC tests, operational research is needed to understand how best to improve screening of pregnant women and to translate test availability into improved pregnancy outcomes.

BackgroundAnaemia and malaria are both major contributors to maternal and child mortality, and morbidity, with some of the worst outcomes occurring in sub-Saharan Africa. Point of care tests (POCT), if used appropriately, provide a simple, inexpensive form of diagnostic testing, as a reliable alternative when laboratory tests are not readily available. In such resource limited settings, clinical staff tend to rely on symptom-based diagnosis and presumptive treatment. This study uses qualitative methods to identify the current practice of POCT use for malaria and anaemia, to explore the enablers and barriers to effective implementation of these POCT, and to determine how relationships between each of the stakeholder groups may impact on POCT use.MethodsStaff (clinical and laboratory) and patients (pregnant women) at three antenatal care facilities within the Ashanti Region of Ghana participated in interviews and focus group discussions (FGDs). An initial coding framework was developed based on the pre-defined objectives of the study. Thematic analysis was used to identify subthemes and categories within each of the key themes.ResultsAt the time data were collected all three facilities used malaria POCT either as an adjunct to microscopy, or as their only form of malaria testing. Although all three facilities were familiar with haemoglobin colour scale (HCS), none of the facilities used them routinely. Clinical staff perceived symptom-based diagnosis was a quick way to diagnosis because access to POCT during consultations was unreliable, but recognized disadvantages associated with symptom-based diagnosis.Perceived advantages of malaria and anaemia POCT were user-friendliness, improved diagnosis and opportunity for patient engagement, as well as lower cost implication for patients. Perceived disadvantages included likelihood of missed diagnosis of mild anaemia, as well as likelihood of human error leading to in accurate diagnosis which could impact on patient trust. Poor communication and lack of trust between staff groups was also identified as a barrier to effective uptake of POCT.ConclusionsConsistent supply of POCT as well as staff training and staff and patient engagement, are fundamental to successful uptake of POCT for effective malaria and anaemia management.

Haemophilia Rapid Card Test in Community Outreach Initiatives: Insights from a Single Centre in Kerala

The rise and fall of the health technology startup Theranos is emblematic of the promise and peril of point-of-care testing (POCT). Instruments that deliver immediate results from minimally invasive samples at the location of collection can provide powerful tools to deliver health data in clinical and public health contexts. Yet, POCT availability is driven largely by market interests, which limits the development of inexpensive tests for diverse health conditions that can be used in resource-limited settings. These constraints, combined with complex regulatory hurdles and substantial ethical challenges, have contributed to the underutilization of POCT in human biology research. We evaluate current POCT capabilities and limitations, discuss promising applications for POCT devices in resource-limited settings, and discuss the future of POCT. As evidenced by publication trends, POCT platforms have rapidly advanced in recent years, gaining traction among clinicians and health researchers. We highlight POCT devices of potential interest to population-based researchers and present specific examples of POCT applications in human biology research. Several barriers can limit POCT applications, including cost, lack of regulatory approval for non-clinical use, requirements for expensive equipment, and the dearth of validation in remote field conditions. Despite these issues, we see immense potential for emerging POCT technology capable of analyzing new sample types and used in conjunction with increasingly common technology (e.g., smart phones). We argue that the fallout from Theranos may ultimately provide an opportunity to advance POCT, leading to more ethical data collection and novel opportunities in human biology research.

BackgroundAffordable and reliable point of care (POC) tests to diagnose urogenital chlamydia infections (POC-Ct) are needed, especially in resource limited settings. WHO has formulated standards that POC tests have to...

BackgroundInfant HIV diagnosis by HIV DNA polymerase chain reaction (PCR) testing at the standard 6 weeks of age is often late to mitigate the mortality peak that occurs in HIV positive infants’ first 2–3 months of life. Kenya recently revised their early infant diagnosis (EID) guidelines to include HIV DNA PCR testing at birth (pilot only), 6 weeks, 6 months, and 12 months postnatal and a final 18-month antibody test. The World Health Organization (WHO) approved point-of-care (POC) diagnostic platforms for infant HIV testing in resource-limited countries that could simplify logistics and expedite infant diagnosis. Sustainable scale-up and optimal utility in Kenya and other high-prevalence countries depend on robust implementation studies in diverse clinical settings.MethodsWe will pilot the implementation of birth testing by HIV DNA PCR, as well as two POC testing systems (Xpert HIV-1 Qual [Xpert] and Alere q HIV-1/2 Detect [Alere q]), on specimens collected from Kenyan infants at birth (0 to 2 weeks) and 6 weeks (4 to < 24 weeks) postnatal. The formative phase will inform optimal implementation of birth testing and two POC testing technologies. Qualitative interviews with stakeholders (providers, parents of HIV-exposed infants, and community members) will assess attitudes, barriers, and recommendations to optimize implementation at their respective sites. A non-blinded pilot study at four Kenyan hospitals (n = 2 Xpert, n = 2 Alere q platforms) will evaluate infant HIV POC testing compared with standard of care HIV DNA PCR testing in both the birth and 6-week windows. Objectives of the pilot are to assess uptake, efficiency, quality, implementation variables, user experiences of birth testing with both POC testing systems or with HIV DNA PCR, and costs.DiscussionThis study will generate data on the clinical impact and feasibility of adding HIV testing at birth utilizing POC and traditional PCR HIV testing strategies in resource-limited settings. Data from this pilot will inform the optimal implementation of Kenya’s birth testing guidelines and of POC testing systems for the improvement of EID outcomes.Trial registrationClinicalTrials.gov, NCT03435887. Registered 26 February 2018.

Introduction. Anemia remains a significant global health challenge, particularly among children in resource-limited settings, with substantial impacts on morbidity, mortality, and socioeconomic development. Point-of-care testing (POCT) devices for hemoglobin (Hb) measurement offer a promising alternative to automated hematology analyzers in resource-limited settings, but their diagnostic accuracy and implementation challenges require systematic evaluation. Material and method. This systematic review adhered to PRISMA 2020 guidelines, analyzing studies published between 2020-2025 that evaluated POCT devices for Hb measurement in children (0-18 years) in resource-limited settings. Five studies met inclusion criteria, assessing four POCT devices (HemoCue Hb301, Aptus, Sahli’s hemoglobinometer, and Masimo Rad-67). Data on sensitivity, specificity, measurement differences (bias), and the range of variation in those differences (Limits of Agreement, LOA) were extracted, and quality assessment was performed using Joanna Briggs Institute (JBI) tools. Results. Of 483 records screened, only five studies met inclusion criteria, encompassing four POCT devices. Due to substantial heterogeneity in design and outcome reporting, a meta-analysis could not be performed. POCT devices demonstrated variable diagnostic accuracy: sensitivity ranged from 24.4% to 100%, and specificity from 70% to 100%. The HemoCue Hb301 was the most widely used device (80% of studies) but showed inconsistent performance, with mean bias ranging from −0.27 to 2.5 g/dL and wide LOA (−3.68 to 5.2 g/dL). Non-invasive devices like the Masimo Rad-67 had lower sensitivity (24.4–95.5%) and high specificity (89.1–96.7%). Key challenges included over/underestimation of Hb levels, environmental sensitivity (temperature, altitude), high costs, and the need for trained personnel. Conclusion. While POCT devices provide rapid, portable solutions for anemia screening in resource-limited settings, their accuracy varies significantly, potentially leading to misclassification. Standardized protocols, improved device robustness, and cost-effective innovations are urgently needed to enhance reliability. Future research should prioritize validation studies and meta-analyses to guide optimal POCT implementation in pediatric populations.

IntroductionGlobally, the incidence of HIV and syphilis can be reduced by the use of validated point of care tests (POCTs). As part of the WHO PRoSPeRo Network, we aimed to evaluate the performance, acceptability, and operational characteristics of two dual HIV/syphilis POCTs (Bioline HIV/Syphilis Duo (Abbott) and DPP® HIV-Syphilis assay (Chembio) for the screening of HIV and syphilis amongst men who have sex with men (MSM).Method and analysesA cross sectional study of 2,577 MSM in Italy, Malta, Peru, and the United Kingdom (UK) presenting to seven clinic sites, were enrolled. Finger prick blood was collected to perform POCTs and results compared with standard laboratory investigations on venepuncture blood. Acceptability and operational characteristics were assessed using questionnaires. Diagnostic meta-analysis was used to combine data from the evaluation sites.ResultsBased on laboratory tests, 23.46% (n = 598/2549) of participants were confirmed HIV positive, and 35.88% of participants (n = 901/2511) were positive on treponemal reference testing. Of all participants showing evidence of antibodies to Treponema pallidum, 50.56% (n = 455/900) were Rapid Plasma Reagin (RPR) test reactive. Of HIV positive individuals, 60.62% (n = 354/584) had evidence of antibodies to T. pallidum, and of these 60.45% (n = 214/354) exhibited reactive RPR tests indicating probable (co)infection. For Bioline POCT, pooled sensitivities and specificities for HIV were 98.95% and 99.89% respectively, and for syphilis were 73.79% and 99.57%. For Chembio pooled sensitivities and specificities for HIV were 98.66% and 99.55%, and for syphilis were 78.60% and 99.48%. Both tests can detect greater than 90% of probable active syphilis cases, as defined by reactive RPR and treponemal test results. These dual POCTs were preferred by 74.77% (n = 1,926) of participants, due to their convenience, and the operational characteristics made them acceptable to health care providers (HCPs).ConclusionsBoth the Bioline and the Chembio dual POCT for syphilis and HIV had acceptable performance, acceptability and operational characteristics amongst MSM in the PRoSPeRo network. These dual POCTs could serve as a strategic, more cost effective, patient and healthcare provider (HCP) friendly alternative to conventional testing; in clinical and other field settings, especially those in resource-limited settings.

Objectives: To develop awareness of benefits of point-of-care testing (POCT) education in schools of public health, to identify learning objectives for teaching POCT, to enable public health professionals and emergency responders to perform evidence-based diagnosis and triage effectively and efficiently at points of need, and to better improve future standards of care for public health practice, including in limited-resource settings and crisis situations.Methods: We surveyed all U.S. schools of public health, colleges of public health, and public health schools accredited by the Council on Education in Public Health (CEPH). We included accredited public health programs, so that all states offering public health education were represented. We analyzed survey data, public health books, and board certification guidelines. We used PubMed to identify public health curriculum papers, and assessed 2019 CEPH accreditation requirements. We merged POCT knowledge bases to design a new curriculum for teaching public health students and practitioners the principles and practice of POCT.Results: Public health curricula, certification requirements, and textbooks generally do not include POCT instruction. Only one book, Global Point of Care: Strategies for Disasters, Emergencies, and Public Health Resilience, and one online course on public health preparedness address POCT and public health intervention issues. The topic, POC HIV/HCV ED testing, appeared in one course and POC diagnostics in local clinics, in another. Papers on public health curriculum have not incorporated POCT. No curriculum addresses POCT in isolation units during quarantine, despite evidence that recent Ebola virus disease cases in the U.S. and elsewhere proved unequivocally the need for POCT. The modular learning objectives identified in this paper were customized for public health students. Public health graduates can use boot camps, online credentialing, and self-study to acquire POCT skills.Conclusions: Enhancing accreditation requirements, academic training, board certification, and field experience will generate public health healthcare professionals who will rely upon evidence-based medical decision making at points of care, including during crises when time is of the essence. A POCT-enabled public health workforce can help prevent and stop outbreaks. Public health-based medical professionals urgently need the skills necessary to perform POCT and prepare America and other nations for threats portending significant adverse medical, economic, social, and cultural impact.

BackgroundRapid and point-of-care (POC) tests for syphilis are an invaluable screening tool, yet inadequate evaluation of their diagnostic accuracy against best reference standards limits their widespread global uptake. To fill this gap, a systematic review and meta-analysis was conducted to evaluate the sensitivity and specificity of rapid and POC tests in blood and serum samples against Treponema pallidum (TP) specific reference standards.MethodsFive electronic databases (1980–2012) were searched, data was extracted from 33 articles, and Bayesian hierarchical models were fit.ResultsIn serum samples, against a TP specific reference standard point estimates with 95% credible intervals (CrI) for the sensitivities of popular tests were: i) Determine, 90.04% (80.45, 95.21), ii) SD Bioline, 87.06% (75.67, 94.50), iii) VisiTect, 85.13% (72.83, 92.57), and iv) Syphicheck, 74.48% (56.85, 88.44), while specificities were: i) Syphicheck, 99.14% (96.37, 100), ii) Visitect, 96.45% (91.92, 99.29), iii) SD Bioline, 95.85% (89.89, 99.53), and iv) Determine, 94.15% (89.26, 97.66). In whole blood samples, sensitivities were: i) Determine, 86.32% (77.26, 91.70), ii) SD Bioline, 84.50% (78.81, 92.61), iii) Syphicheck, 74.47% (63.94, 82.13), and iv) VisiTect, 74.26% (53.62, 83.68), while specificities were: i) Syphicheck, 99.58% (98.91, 99.96), ii) VisiTect, 99.43% (98.22, 99.98), iii) SD Bioline, 97.95%(92.54, 99.33), and iv) Determine, 95.85% (92.42, 97.74).ConclusionsRapid and POC treponemal tests reported sensitivity and specificity estimates comparable to laboratory-based treponemal tests. In resource limited settings, where access to screening is limited and where risk of patients lost to follow up is high, the introduction of these tests has already been shown to improve access to screening and treatment to prevent stillbirths and neonatal mortality due to congenital syphilis. Based on the evidence, it is concluded that rapid and POC tests are useful in resource limited settings with poor access to laboratories or screening for syphilis.

Background:According to the World Health Organization, 6 million cases of syphilis occur every year. Serological tests for syphilis form the mainstay of diagnosis for syphilis. We evaluated the performance of point-of-care test (POCT) against other specific treponemal test for confirming the diagnosis of syphilis.Materials and Methods:Does performance and operational superiority of POCT make it the investigation of choice in confirming syphilis? Retrospectively, data were analyzed of 599 serum samples from Apex Regional sexually transmitted disease centre, Safdarjung Hospital, New Delhi, received for testing by syphilis treponemal assays (both nontreponemal reactive and nonreactive). These samples underwent treponemal testing for syphilis by the Treponema pallidum hemagglutination (TPHA), fluorescent treponemal antibody absorption test (FTA-ABS), and POCT. Performance characteristics (sensitivity, specificity, positive predictive value [PPV], negative predictive value [NPV], and diagnostic accuracy), and operational characteristics of POCT and TPHA were evaluated against the gold standard FTA-ABS.Results:A total of 599 samples were evaluated, of which 61.76% were positive by FTA-ABS. On analysis, the sensitivity was 91.08% and 91.89%, specificity was 89.08% and 87.34%, PPV was 93.09% and 92.14%, NPV was 86.08% and 86.96%, and diagnostic accuracy was 90.32% and 90.15% for POCT and TPHA, respectively. The lower cost, shorter turnaround time, lesser infrastructure and workforce need, and easy availability make the POCT operationally superior to TPHA.Conclusion:Owing to its operational superiority and higher specificity POCT can replace TPHA for confirming the diagnosis of Syphilis. POCT are affordable, equipment free, have room temperature storage, and yield result within 15 minutes, enabling same day testing and treatment. It can be used in a resource limited setting, for community setup or even self-testing.

This review examines the challenges and strategies of implementing Point-of-Care Testing (POCT) in remote and resource-limited settings. POCT, a critical advancement in healthcare, offers timely diagnosis and treatment, especially crucial in areas with limited access to centralized laboratory facilities. However, its integration faces several challenges, including operational complexities, reduced analytical precision compared to traditional lab tests, the necessity for integration with electronic medical records, and significant financial considerations. The review highlights the importance of quality management systems, staff training, and maintenance schedules to ensure the accuracy and reliability of POCT. Innovations such as microfluidic-based systems and smartphone technology are discussed as potential solutions to overcome operational and analytical limitations. These technologies promise greater accuracy, efficiency, and portability, making them suitable for use in varied healthcare environments. The paper emphasizes the need for a balanced approach in adopting POCT, considering both its benefits in enhancing patient care and the associated costs and complexities. Overall, POCT emerges as a pivotal tool in improving healthcare accessibility and outcomes in challenging settings.

A biomarker for risk stratification and disease severity assessment in SARS-CoV-2 infections has not yet been established. Point of care testing (POCT) of butyrylcholinesterase (BChE) enables early detection of systemic inflammatory responses and correlates with disease severity in sepsis and burns. In acute care or resource-limited settings, POCT facilitates rapid clinical decision making, a particularly beneficial aspect in the management of pandemic situations. In this prospective observational study, POCT-measured BChE activity was assessed in 52 critically ill COVID-19 patients within 24 h of ICU admission and on the third and seventh day after ICU admission. Forty (77%) of these patients required venovenous extracorporeal membrane oxygenation (vvECMO). In critically ill COVID-19 patients, BChE activity is significantly decreased compared with healthy subjects, but also compared with other inflammatory conditions such as sepsis, burns, or trauma. POCT BChE activity reflects the severity of organ dysfunction and allows prediction of 28-day mortality in critically ill COVID-19 patients. Implementing early POCT BChE measurement could facilitate risk stratification and support admission and transfer decisions in resource-limited settings.

BackgroundPoint-of-care testing (POCT) has numerous potential benefits to improve health care service, especially in resource-limited settings. We aim to identify which POC-tests (POCTs) of laboratory parameters are known, employed, and rated as useful by general practitioners (GPs).MethodsA questionnaire with 27 POCTs was posted to a random selection of GPs (n = 451) in Saxony, Germany.ResultsA total of 208 GPs replied (response rate 46.1%). Out of 27 POCTs, each GP knew an average of 20.3 as laboratory parameters and 9.2 as POCTs. Urine test strips (99.0%), blood glucose test (98.1%), and Troponin I/T (86.4%) were the best-known, followed by INR/Quick (82.5%), Microalbumin (79.1%), and D-dimer (78.6%) POCTs. Yet, solely 0 to 13 POC tests were actually used (mean value 4.6). Urine test strips were employed most frequently (97.6%), followed by blood glucose test (94.7%), Troponin I/T (57.8%), Microalbumin (57.3%), and INR/Quick POCTs (41.7%). Heart fatty binding protein (H-FABP), Syphilis, Coeliac disease, and Malaria appeared as the least frequently used POCTs. The majority of the GPs declared 14 of the 27 POCTs to be useful.Discussion/conclusionThe most recurrently employed POCTs are those for diagnosing or monitoring diabetes mellitus, ensued by POCTs addressing acute cardiovascular diseases (Troponin I/T, D-dimer) or monitoring the therapy of infectious diseases or the anticoagulant therapy. POCTs most often rated as useful by GPs are also widely known and frequently used. Nonetheless, the majority of GPs rate only a very limited number of POCTs as useful. Frequent concerns might be low economic benefit, over-reliance, and test accuracy coming along with the complex implementation of the tests requiring technical skills, accurate storage, and the correct interpretation of test results.Trial registrationIn accordance with the (Model) Professional Code for Physicians in Germany, neither human body materials nor data that can be assigned to a specific human being are used in our study. A declaration of no objection from the Ethics Committee of the Martin-Luther University Halle-Wittenberg (Medical Faculty) confirms no professional or ethical concerns due to completely anonymized data collection and analysis. Our study was therefore not registered in a corresponding registry.

Imaging flow cytometry documents incomplete resistance of human sickle F-cells to ex vivo hypoxia-induced sickling