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Deriving the optimal limit of detection for an HCV point-of-care test for viraemic infection: analysis of a global dataset

Morgan Freiman J, Wang J, Easterbrook PJ, Robert Horsburgh C, Marinucci F, White LF, et al.

J Hepatol, 2019 Feb 20.
PMID: 30797050 DOI: 10.1016/j.jhep.2019.02.011

BACKGROUND & AIMS: Affordable point-of-care (POC) tests for hepatitis C (HCV) viraemia are needed to improve access to treatment in low and middle income countries (LMICs). Our aims were to determine the target limit of detection (LOD) necessary to diagnose the majority of persons with HCV eligible for treatment, and identify characteristics associated with low-level viraemia (LLV) (defined as the lowest 3% of the distribution of HCV RNA) to understand those at risk of being mis-diagnosed.
METHODS: We established a multi-country cross-sectional dataset of first available quantitative HCV RNA linked to demographic and clinical data. We excluded individuals on HCV treatment. We analyzed the distribution of HCV RNA and determined critical thresholds for detection of HCV viraemia. We then performed logistic regression to evaluate factors associated with LLV, and derived relative sensitivities for significant covariates.
RESULTS: The dataset included 66,640 individuals with HCV viraemia from Georgia (44.4%), Canada (40.9%), India (8.1%), Cambodia (2.6%), Egypt (1.6%), Pakistan (1.3%), Cameroon (0.4%), Indonesia (0.2%), Thailand (0.2%), Vietnam (0.1%), Malaysia (0.05%), and Mozambique (0.02%). The 97% LOD was 1,318 IU/mL (95% CI 1298.4, 1322.3). Factors associated with LLV were younger age 18-30 vs. 51-64 years (OR 2.56 95% CI 2.19, 2.99), female vs. male sex (OR 1.32, 95% CI 1.18, 1.49), and advanced fibrosis stage F4 vs. F0-1 (OR 1.44, 95%CI 1.21, 1.69). Only the younger age group had a decreased relative sensitivity below 95% at 93.3%.
CONCLUSIONS: In this global dataset, a test with an LOD of 1,318 IU/mL would identify 97% of viraemic HCV infections among almost all populations. This LOD will help guide manufacturers in the development of affordable POC diagnostics to expand HCV testing and linkage to care in LMICs.
LAY SUMMARY: We created and analyzed a dataset from 12 countries with 66,640 participants with chronic hepatitis C virus infection. We determined that about 97% of those with viraemic infection had 1300 International Units/mL or more of circulating virus at the time of diagnosis. While current diagnostic tests can detect as little as 12 International Units/mL of virus, our findings suggest that increasing the level of detection closer to 1300 would maintain good test accuracy and will likely allow for more affordable portable tests to be developed for use in low and middle income countries.

Matched MeSH terms: Point-of-Care Systems
Fulltext Combining parasite lactate dehydrogenase-based and histidine-rich protein 2-based rapid tests to improve specificity for diagnosis of malaria Due to Plasmodium knowlesi and other Plasmodium species in Sabah, Malaysia

Grigg MJ, William T, Barber BE, Parameswaran U, Bird E, Piera K, et al.

J Clin Microbiol, 2014 Jun;52(6):2053-60.
PMID: 24696029 DOI: 10.1128/JCM.00181-14

Plasmodium knowlesi causes severe and fatal malaria in Malaysia. Microscopic misdiagnosis is common and may delay appropriate treatment. P. knowlesi can cross-react with "species-specific" parasite lactate dehydrogenase (pLDH) monoclonal antibodies used in rapid diagnostic tests (RDTs) to detect P. falciparum and P. vivax. At one tertiary-care hospital and two district hospitals in Sabah, we prospectively evaluated two combination RDTs for malaria diagnosis by using both a pan-Plasmodium-pLDH (pan-pLDH)/P. falciparum-specific-pLDH (Pf-pLDH) RDT (OptiMAL-IT) and a non-P. falciparum VOM-pLDH/Pf-HRP2 RDT (CareStart). Differential cross-reactivity among these combinations was hypothesized to differentiate P. knowlesi from other Plasmodium monoinfections. Among 323 patients with PCR-confirmed P. knowlesi (n = 193), P. falciparum (n = 93), and P. vivax (n = 37) monoinfections, the VOM-pLDH individual component had the highest sensitivity for nonsevere (35%; 95% confidence interval [CI], 27 to 43%) and severe (92%; CI, 81 to 100%) P. knowlesi malaria. CareStart demonstrated a P. knowlesi sensitivity of 42% (CI, 34 to 49%) and specificity of 74% (CI, 65 to 82%), a P. vivax sensitivity of 83% (CI, 66 to 93%) and specificity of 71% (CI, 65 to 76%), and a P. falciparum sensitivity of 97% (CI, 90 to 99%) and specificity of 99% (CI, 97 to 100%). OptiMAL-IT demonstrated a P. knowlesi sensitivity of 32% (CI, 25 to 39%) and specificity of 21% (CI, 15 to 29%), a P. vivax sensitivity of 60% (CI, 42 to 75%) and specificity of 97% (CI, 94 to 99%), and a P. falciparum sensitivity of 82% (CI, 72 to 89%) and specificity of 39% (CI, 33 to 46%). The combination of CareStart plus OptiMAL-IT for P. knowlesi using predefined criteria gave a sensitivity of 25% (CI, 19 to 32%) and specificity of 97% (CI, 92 to 99%). Combining two RDT combinations was highly specific for P. knowlesi malaria diagnosis; however, sensitivity was poor. The specificity of pLDH RDTs was decreased for P. vivax and P. falciparum because of P. knowlesi cross-reactivity and cautions against their use alone in areas where P. knowlesi malaria is endemic. Sensitive P. knowlesi-specific RDTs and/or alternative molecular diagnostic tools are needed in areas where P. knowlesi malaria is endemic.

Matched MeSH terms: Point-of-Care Systems*
Fulltext Detection of Tuberculosis (TB) using gold standard method, direct sputum smears microscopy, PCR, qPCR and electrochemical DNA sensor: a mini review

Che Engku Noramalina Che-Engku-Chik, Siti Sarah Othman, Helmi Wasoh, Nor Azah Yusof, Jaafar Abdullah, Mohd Hazani Mat Zaid

Journal of Biochemistry, Microbiology and Biotechnology, 2016;4(2):16-21.
MyJurnal

Despite the continued effort globally made to control the growing case of Tuberculosis (TB), it
continues to be regarded as the second deadliest disease after the HIV. There are various
methods developed to diagnose TB, most of which having the criteria of sensitive, selective,
cheap and portable to be used in robust applications. Even with the advancement in medication,
the important keys including early stage diagnosis is yet to be considered. In diagnosing TB, the
only technique remained as the gold standard method is the culturing method, which is the Acid
Fast Bacilli (AFB) staining. On the other hand, molecular technique utilising Polymerase Chain
Reaction (PCR) assay is preferred as a non-culturing method. Additionally, as molecular
techniques become advanced, real-time PCR or quantitative PCR (qPCR) using multiple probes
in one shot has raised interest among researchers, because it can skip the process of gel
electrophoresis. Recently, researchers have been working on electrochemical DNA sensors
which are sensitive, selective, rapid, cheap and can meet with point of care (POC) testing
requirements to diagnose TB.

Matched MeSH terms: Point-of-Care Systems
Accutome PachPen handheld ultrasonic pachymeter: intraobserver repeatability and interobserver reproducibility by personnel of different training grades

Peyman M, Tai LY, Khaw KW, Ng CM, Win MM, Subrayan V

Int Ophthalmol, 2015 Oct;35(5):651-5.
PMID: 25189684 DOI: 10.1007/s10792-014-9989-6

To assess the intra-observer repeatability and inter-observer reproducibility of central corneal thickness (CCT) measurements of PachPen (Accutome, Inc., Pennsylvania, USA), a hand-held, portable ultrasonic pachymeter when used by an ophthalmic nurse compared to an ophthalmologist. Ophthalmology Clinic, University of Malaya Medical Center In this prospective study, CCT was measured in 184 eyes of 92 healthy subjects, first by a corneal surgeon experienced in ultrasound pachymetry (Observer 1) followed by an ophthalmic nurse new to the procedure (Observer 2). Nine measurements were obtained from each eye by each observer, independently. Measurements were compared between the observers. Coefficients of repeatability and reproducibility were calculated. The Bland-Altman plot was used to assess agreement between observers. Mean age of the study population was 54.3 ± 15.2 years old and consisted of 43.5% male. Mean CCT as measured by Observers 1 and 2 were 528.3 ± 32.9 and 530.7 ± 33.3 µm, respectively. Observer 1 showed higher repeatability of measurements compared to that of Observer 2 (coefficient of repeatability 3.46 vs. 5.55%). The measurements by both observers showed high correlation (0.96) and good agreement (mean difference -2.4 µm; 95% limits of agreement -21.4, 16.7 µm). Coefficient of reproducibility of measurements between observers was 5.08%. Accutome PachPen hand-held ultrasound pachymeters gives excellent intra-observer repeatability and inter-observer reproducibility by personnel of different training grades.

Matched MeSH terms: Point-of-Care Systems*
Comparing effectiveness of two anticoagulation management models in a Malaysian tertiary hospital

Thanimalai S, Shafie AA, Hassali MA, Sinnadurai J

Int J Clin Pharm, 2013 Oct;35(5):736-43.
PMID: 23715759 DOI: 10.1007/s11096-013-9796-6

BACKGROUNDS: Limited evidence is available regarding pharmacist managed anticoagulation clinic in the Southeast Asian region where there is marked difference in terms of care model, genetic composition and patient demographics.

OBJECTIVES: This study aimed at comparing the anticoagulation clinic managed by the pharmacist with physician advisory and the usual medical care provided in Kuala Lumpur Hospital (KLH) in terms of anticoagulation control and adverse outcomes.

SETTING: A 2,302 bedded government tertiary referral hospital in Malaysia.

METHODS: A 6-month retrospective cohort study of the effectiveness of two models of anticoagulation care, the pharmacist managed anticoagulation clinic which is known as warfarin medication therapy adherence clinic (WMTAC) and usual medical clinic (UMC) in KLH was conducted, where a random number generator was used to recruit patients. The UMC patients received standard medical care where they are managed by rotational medical officers in the physicians' clinic. As for the WMTAC with physician advisory, the pharmacist will counsel and review the patients internationalised normalization ratio at each clinic visit and also adjust the patients' warfarin dose accordingly. Patients are referred to physicians if immediate attention is required.

MAIN OUTCOME MEASURE: The main therapeutic outcome is time in therapeutic range (TTR) both actual and expanded TTR and thromboembolic and bleeding complications.

RESULTS: Each of the WMTAC and usual medical care recruited 92 patients, which totals to 184 patients. The patient demographics in terms of age, race and indication of treatment were comparable. At the end of the 6 months follow-up, patients in the WMTAC group had significantly higher actual-TTR (65.1 vs. 48.3 %; p < 0.05) compared to those in usual medical care group. Rates of admission were 6.5 versus 28.2 events per 100 person-years for the WMTAC and UMC groups, respectively. Though the bleeding incidences were not significantly different, it was reduced.

CONCLUSIONS: These findings will impact local warfarin patient management services and policies because there was no available evidence supporting the role of pharmacists in the management of warfarin patients prior to this study.

Matched MeSH terms: Point-of-Care Systems
Fulltext Clinical knowledge management at the point of care

Teng CL

International e-Journal of Science, Medicine & Education, 2012;6 Suppl 1:S137-S141.
MyJurnal

In the developing world, clinical knowledge management in primary care has a long way to go. Clinical decision support systems, despite its promise to revolutionise healthcare, is slow in its implementation due to the lack of financial investment in information technology. Point-of-care resources, such as comprehensive electronic textbooks delivered via the web or mobile devices, have yet to be fully utilised by the healthcare organisation or individual clinicians. Increasing amount of applicable knowledge of good quality (e.g. clinical practice guidelines and other pre-appraised resources) are now available via the internet. The policy makers and clinicians need to be more informed about the potential benefits and
limitations of these new tools and resources and make the necessary budgetary provision and learn how best to harness them for patient care.

Matched MeSH terms: Point-of-Care Systems
Fulltext The 'analysis of gene expression and biomarkers for point-of-care decision support in Sepsis' study; temporal clinical parameter analysis and validation of early diagnostic biomarker signatures for severe inflammation andsepsis-SIRS discrimination

Szakmany T, Fitzgerald E, Garlant HN, Whitehouse T, Molnar T, Shah S, et al.

Front Immunol, 2023;14:1308530.
PMID: 38332914 DOI: 10.3389/fimmu.2023.1308530

INTRODUCTION: Early diagnosis of sepsis and discrimination from SIRS is crucial for clinicians to provide appropriate care, management and treatment to critically ill patients. We describe identification of mRNA biomarkers from peripheral blood leukocytes, able to identify severe, systemic inflammation (irrespective of origin) and differentiate Sepsis from SIRS, in adult patients within a multi-center clinical study.
METHODS: Participants were recruited in Intensive Care Units (ICUs) from multiple UK hospitals, including fifty-nine patients with abdominal sepsis, eighty-four patients with pulmonary sepsis, forty-two SIRS patients with Out-of-Hospital Cardiac Arrest (OOHCA), sampled at four time points, in addition to thirty healthy control donors. Multiple clinical parameters were measured, including SOFA score, with many differences observed between SIRS and sepsis groups. Differential gene expression analyses were performed using microarray hybridization and data analyzed using a combination of parametric and non-parametric statistical tools.
RESULTS: Nineteen high-performance, differentially expressed mRNA biomarkers were identified between control and combined SIRS/Sepsis groups (FC>20.0, p<0.05), termed 'indicators of inflammation' (I°I), including CD177, FAM20A and OLAH. Best-performing minimal signatures e.g. FAM20A/OLAH showed good accuracy for determination of severe, systemic inflammation (AUC>0.99). Twenty entities, termed 'SIRS or Sepsis' (S°S) biomarkers, were differentially expressed between sepsis and SIRS (FC>2·0, p-value<0.05).
DISCUSSION: The best performing signature for discriminating sepsis from SIRS was CMTM5/CETP/PLA2G7/MIA/MPP3 (AUC=0.9758). The I°I and S°S signatures performed variably in other independent gene expression datasets, this may be due to technical variation in the study/assay platform.

Matched MeSH terms: Point-of-Care Systems
Serological and molecular rapid diagnostic tests for Toxoplasma infection in humans and animals

Khan AH, Noordin R

Eur J Clin Microbiol Infect Dis, 2020 Jan;39(1):19-30.
PMID: 31428897 DOI: 10.1007/s10096-019-03680-2

Infection by Toxoplasma gondii is prevalent worldwide. The parasite can infect a broad spectrum of vertebrate hosts, but infection of fetuses and immunocompromised patients is of particular concern. Easy-to-perform, robust, and highly sensitive and specific methods to detect Toxoplasma infection are important for the treatment and management of patients. Rapid diagnostic methods that do not sacrifice the accuracy of the assay and give reproducible results in a short time are highly desirable. In this context, rapid diagnostic tests (RDTs), especially with point-of-care (POC) features, are promising diagnostic methods in clinical microbiology laboratories, especially in areas with minimal laboratory facilities. More advanced methods using microfluidics and sensor technology will be the future trend. In this review, we discuss serological and molecular-based rapid diagnostic tests for detecting Toxoplasma infection in humans as well as animals.

Matched MeSH terms: Point-of-Care Systems
Performance of emergency physicians in point-of-care echocardiography following limited training

Bustam A, Noor Azhar M, Singh Veriah R, Arumugam K, Loch A

Emerg Med J, 2014 May;31(5):369-73.
PMID: 23428721 DOI: 10.1136/emermed-2012-201789

OBJECTIVES: The aim of this study was to evaluate if emergency medicine trainees with a short duration of training in echocardiography could perform and interpret bedside-focused echocardiography reliably on emergency department patients.
METHODS: Following a web-based learning module and 3 h of proctored practical training, emergency medicine trainees were evaluated in technical and interpretative skills in estimating left ventricular function, detection of pericardial effusion and inferior vena cava (IVC) diameter measurements using bedside-focused echocardiography on emergency department patients. An inter-rater agreement analysis was performed between the trainees and a board-certified cardiologist.
RESULTS: 100 focused echocardiography examinations were performed by nine emergency medicine trainees. Agreement between the trainees and the cardiologist was 93% (K=0.79, 95% CI 0.773 to 0.842) for visual estimation of left ventricular function, 92.9% (K=0.80, 95% CI 0.636 to 0.882) for quantitative left ventricular ejection fraction by M-mode measurements, 98% (K=0.74, 95% CI 0.396 to 1.000) for the detection of pericardial effusion, and 64.2% (K=0.45, 95% CI 0.383 to 0.467) for IVC diameter assessment. The Bland-Altman limits of agreement for left ventricular function was -9.5% to 13.7%, and a Pearson's correlation yielded a value of 0.82 (p<0.0001, 95% CI 0.734 to 0.881). The trainees detected pericardial effusion with a sensitivity of 60%, specificity of 100%, positive predictive value of 100% and negative predictive value of 97.9%.
CONCLUSIONS: Emergency medicine trainees were found to be able to perform and interpret focused echocardiography reliably after a short duration of training.
Study site: Trauma and emergency department, University of Malaya Medical Centre, Kuala Lumpur

Matched MeSH terms: Point-of-Care Systems*
Fulltext Utilization of Point-of-Care Ultrasound to Detect Splenic Microabscesses in Pediatric Melioidosis

Sakulchit T, Ngu L, Chor YK, Ong GY

Cureus, 2021 Mar 08;13(3):e13760.
PMID: 33842136 DOI: 10.7759/cureus.13760

Melioidosis is an infectious disease most commonly found in places with tropical climates. Definitive diagnosis can be confirmed by culture or pathological results of blood or infected organ. However, imaging study is helpful in providing early provisional diagnosis and guiding therapy. Point-of-care ultrasound can be currently performed bedside by non-radiological staff such as emergency physicians or intensivists. We present the case of a pediatric patient who got diagnosed with melioidosis after detection of multiple splenic and hepatic abscesses by point-of-care ultrasound, leading to early diagnosis and appropriate empirical antibiotic selection, resulting in good treatment outcome.

Matched MeSH terms: Point-of-Care Systems
Biosensing based on surface-enhanced Raman spectroscopy as an emerging/next-generation point-of-care approach for acute myocardial infarction diagnosis

Low JSY, Thevarajah TM, Chang SW, Goh BT, Khor SM

Crit Rev Biotechnol, 2020 Dec;40(8):1191-1209.
PMID: 32811205 DOI: 10.1080/07388551.2020.1808582

Cardiovascular disease is a major global health issue. In particular, acute myocardial infarction (AMI) requires urgent attention and early diagnosis. The use of point-of-care diagnostics has resulted in the improved management of cardiovascular disease, but a major drawback is that the performance of POC devices does not rival that of central laboratory tests. Recently, many studies and advances have been made in the field of surface-enhanced Raman scattering (SERS), including the development of POC biosensors that utilize this detection method. Here, we present a review of the strengths and limitations of these emerging SERS-based biosensors for AMI diagnosis. The ability of SERS to multiplex sensing against existing POC detection methods are compared and discussed. Furthermore, SERS calibration-free methods that have recently been explored to minimize the inconvenience and eliminate the limitations caused by the limited linear range and interassay differences found in the calibration curves are outlined. In addition, the incorporation of artificial intelligence (AI) in SERS techniques to promote multivariate analysis and enhance diagnostic accuracy are discussed. The future prospects for SERS-based POC devices that include wearable POC SERS devices toward predictive, personalized medicine following the Fourth Industrial Revolution are proposed.

Matched MeSH terms: Point-of-Care Systems
Fulltext Multi-organ point-of-care ultrasound for COVID-19 (PoCUS4COVID): international expert consensus

Hussain A, Via G, Melniker L, Goffi A, Tavazzi G, Neri L, et al.

Crit Care, 2020 12 24;24(1):702.
PMID: 33357240 DOI: 10.1186/s13054-020-03369-5

COVID-19 has caused great devastation in the past year. Multi-organ point-of-care ultrasound (PoCUS) including lung ultrasound (LUS) and focused cardiac ultrasound (FoCUS) as a clinical adjunct has played a significant role in triaging, diagnosis and medical management of COVID-19 patients. The expert panel from 27 countries and 6 continents with considerable experience of direct application of PoCUS on COVID-19 patients presents evidence-based consensus using GRADE methodology for the quality of evidence and an expedited, modified-Delphi process for the strength of expert consensus. The use of ultrasound is suggested in many clinical situations related to respiratory, cardiovascular and thromboembolic aspects of COVID-19, comparing well with other imaging modalities. The limitations due to insufficient data are highlighted as opportunities for future research.

Matched MeSH terms: Point-of-Care Systems/standards*
Fulltext A point-of-care test for measles diagnosis: detection of measles-specific IgM antibodies and viral nucleic acid

Warrener L, Slibinskas R, Chua KB, Nigatu W, Brown KE, Sasnauskas K, et al.

Bull World Health Organ, 2011 Sep 01;89(9):675-82.
PMID: 21897488 DOI: 10.2471/BLT.11.088427

OBJECTIVE: To evaluate the performance of a newly developed point-of-care test (POCT) for the detection of measles-specific IgM antibodies in serum and oral fluid specimens and to assess if measles virus nucleic acid could be recovered from used POCT strips.
METHODS: The POCT was used to test 170 serum specimens collected through measles surveillance or vaccination programmes in Ethiopia, Malaysia and the Russian Federation: 69 were positive for measles immunoglobulin M (IgM) antibodies, 74 were positive for rubella IgM antibodies and 7 were positive for both. Also tested were 282 oral fluid specimens from the measles, mumps and rubella (MMR) surveillance programme of the United Kingdom of Great Britain and Northern Ireland. The Microimmune measles IgM capture enzyme immunoassay was the gold standard for comparison. A panel of 24 oral fluids was used to investigate if measles virus haemagglutinin (H) and nucleocapsid (N) genes could be amplified by polymerase chain reaction directly from used POCT strips.
FINDINGS: With serum POCT showed a sensitivity and specificity of 90.8% (69/76) and 93.6% (88/94), respectively; with oral fluids, sensitivity and specificity were 90.0% (63/70) and 96.2% (200/208), respectively. Both H and N genes were reliably detected in POCT strips and the N genes could be sequenced for genotyping. Measles virus genes could be recovered from POCT strips after storage for 5 weeks at 20-25 °C.
CONCLUSION: The POCT has the sensitivity and specificity required of a field-based test for measles diagnosis. However, its role in global measles control programmes requires further evaluation.

Matched MeSH terms: Point-of-Care Systems/standards*
Current aspects in immunosensors

Gopinath SC, Tang TH, Citartan M, Chen Y, Lakshmipriya T

Biosens Bioelectron, 2014 Jul 15;57:292-302.
PMID: 24607580 DOI: 10.1016/j.bios.2014.02.029

Sensing applications can be used to report biomolecular interactions in order to elucidate the functions of molecules. The use of an analyte and a ligand is a common set-up in sensor development. For several decades, antibodies have been considered to be potential analytes or ligands for development of so-called "immunosensors." In an immunosensor, formation of the complex between antibody and antigen transduces the signal, which is measurable in various ways (e.g., both labeled and label-free based detection). Success of an immunosensor depends on various factors, including surface functionalization, antibody orientation, density of the antibody on the sensor platform, and configuration of the immunosensor. Careful optimization of these factors can generate clear-cut results for any immunosensor. Herein, current aspects, involved in the generated immunosensors, are discussed.

Matched MeSH terms: Point-of-Care Systems
Advances in paper-based point-of-care diagnostics

Hu J, Wang S, Wang L, Li F, Pingguan-Murphy B, Lu TJ, et al.

Biosens Bioelectron, 2014 Apr 15;54:585-97.
PMID: 24333570 DOI: 10.1016/j.bios.2013.10.075

Advanced diagnostic technologies, such as polymerase chain reaction (PCR) and enzyme-linked immunosorbent assay (ELISA), have been widely used in well-equipped laboratories. However, they are not affordable or accessible in resource-limited settings due to the lack of basic infrastructure and/or trained operators. Paper-based diagnostic technologies are affordable, user-friendly, rapid, robust, and scalable for manufacturing, thus holding great potential to deliver point-of-care (POC) diagnostics to resource-limited settings. In this review, we present the working principles and reaction mechanism of paper-based diagnostics, including dipstick assays, lateral flow assays (LFAs), and microfluidic paper-based analytical devices (μPADs), as well as the selection of substrates and fabrication methods. Further, we report the advances in improving detection sensitivity, quantification readout, procedure simplification and multi-functionalization of paper-based diagnostics, and discuss the disadvantages of paper-based diagnostics. We envision that miniaturized and integrated paper-based diagnostic devices with the sample-in-answer-out capability will meet the diverse requirements for diagnosis and treatment monitoring at the POC.

Matched MeSH terms: Point-of-Care Systems*
Diagnostics on acute myocardial infarction: Cardiac troponin biomarkers

Fathil MF, Md Arshad MK, Gopinath SC, Hashim U, Adzhri R, Ayub RM, et al.

Biosens Bioelectron, 2015 Aug 15;70:209-20.
PMID: 25841117 DOI: 10.1016/j.bios.2015.03.037

Acute myocardial infarction or myocardial infarction (MI) is a major health problem, due to diminished flow of blood to the heart, leads to higher rates of mortality and morbidity. Data from World Health Organization (WHO) accounted 30% of global death annually and expected more than 23 million die annually by 2030. This fatal effects trigger the need of appropriate biomarkers for early diagnosis, thus countermeasure can be taken. At the moment, the most specific markers for cardiac injury are cardiac troponin I (cTnI) and cardiac troponin T (cTnT) which have been considered as 'gold standard'. Due to higher specificity, determination of the level of cardiac troponins became a predominant indicator for MI. Several ways of diagnostics have been formulated, which include enzyme-linked immunosorbent assay, chemiluminescent, fluoro-immunoassays, electrical detections, surface plasmon resonance, and colorimetric protein assay. This review represents and elucidates the strategies, methods and detection levels involved in these diagnostics on cardiac superior biomarkers. The advancement, sensitivity, and limitations of each method are also discussed. In addition, it concludes with a discussion on the point-of care (POC) assay for a fast, accurate and ability of handling small sample measurement of cardiac biomarker.

Matched MeSH terms: Point-of-Care Systems*
Paper microfluidic device for early diagnosis and prognosis of acute myocardial infarction via quantitative multiplex cardiac biomarker detection

Lim WY, Thevarajah TM, Goh BT, Khor SM

Biosens Bioelectron, 2019 Mar 01;128:176-185.
PMID: 30685097 DOI: 10.1016/j.bios.2018.12.049

The early detection of acute myocardial infarction (AMI) upon the onset of chest pain symptoms is crucial for patient survival. However, this detection is challenging, particularly without a persistent elevation of ST-segment reflected in an electrocardiogram or in blood tests. A majority of the available point-of-care testing devices allow accurate and rapid diagnosis of AMI. However, AMI diagnosis is reliable only at intermediate and later stages, with myocardial injury (> 6 h) and MI, based on the expression of specific cardiac biomarkers including troponin I or T (cTnI or cTnT), creatine kinase-MB (CK-MB), and myoglobin. Diagnosis at the early myocardial ischemia stage is not possible. To overcome this limitation, a sensitive and rapid microfluidic paper-based device (µPAD) was developed for the simultaneous detection of multiple cardiac biomarkers for the early and late diagnosis of AMI. The glycogen phosphorylase isoenzyme BB (GPBB) was detected during early (within first 4 h) ischemic myocardial injury. On the same µPAD platform, detection of prolonged elevation of levels of cTnT and CK-MB, which are only produced 6 h after the onset of chest pain in human serum, was possible. Sandwich immunoassay performed on the µPAD achieved reproducibility (RSD approximately 10% and intra-and inter-day precision (CV 10-20%, 99th percentile), as well as consistently stable test results for 28 days, with strong correlation (r2= 0.962), using the standard Siemens Centaur XPT Immunoassay system. The present findings indicate the potential of the µPAD platform as a point-of-care device for the early diagnosis and prognosis of AMI.

Matched MeSH terms: Point-of-Care Systems
A signal-amplified electrochemical DNA biosensor incorporated with a colorimetric internal control for Vibrio cholerae detection using shelf-ready reagents

Low KF, Zain ZM, Yean CY

Biosens Bioelectron, 2017 Jan 15;87:256-263.
PMID: 27567251 DOI: 10.1016/j.bios.2016.08.064

A novel enzyme/nanoparticle-based DNA biosensing platform with dual colorimetric/electrochemical approach has been developed for the sequence-specific detection of the bacterium Vibrio cholerae, the causative agent of acute diarrheal disease in cholera. This assay platform exploits the use of shelf-stable and ready-to-use (shelf-ready) reagents to greatly simplify the bioanalysis procedures, allowing the assay platform to be more amenable to point-of-care applications. To assure maximum diagnosis reliability, an internal control (IC) capable of providing instant validation of results was incorporated into the assay. The microbial target, single-stranded DNA amplified with asymmetric PCR, was quantitatively detected via electrochemical stripping analysis of gold nanoparticle-loaded latex microspheres as a signal-amplified hybridization tag, while the incorporated IC was analyzed using a simplified horseradish peroxidase enzyme-based colorimetric scheme by simple visual observation of enzymatic color development. The platform showed excellent diagnostic sensitivity and specificity (100%) when challenged with 145 clinical isolate-spiked fecal specimens. The limits of detection were 0.5ng/ml of genomic DNA and 10 colony-forming units (CFU)/ml of bacterial cells with dynamic ranges of 0-100ng/ml (R(2)=0.992) and log10 (1-10(4) CFU/ml) (R(2)=0.9918), respectively. An accelerated stability test revealed that the assay reagents were stable at temperatures of 4-37°C, with an estimated ambient shelf life of 200 days. The versatility of the biosensing platform makes it easily adaptable for quantitative detection of other microbial pathogens.

Matched MeSH terms: Point-of-Care Systems
Fulltext Quartz crystal microbalance-based biosensors as rapid diagnostic devices for infectious diseases

Lim HJ, Saha T, Tey BT, Tan WS, Ooi CW

Biosens Bioelectron, 2020 Nov 15;168:112513.
PMID: 32889395 DOI: 10.1016/j.bios.2020.112513

Infectious diseases are the ever-present threats to public health and the global economy. Accurate and timely diagnosis is crucial to impede the progression of a disease and break the chain of transmission. Conventional diagnostic techniques are typically time-consuming and costly, making them inefficient for early diagnosis of infections and inconvenient for use at the point of care. Developments of sensitive, rapid, and affordable diagnostic methods are necessary to improve the clinical management of infectious diseases. Quartz crystal microbalance (QCM) systems have emerged as a robust biosensing platform due to their label-free mechanism, which allows the detection and quantification of a wide range of biomolecules. The high sensitivity and short detection time offered by QCM-based biosensors are attractive for the early detection of infections and the routine monitoring of disease progression. Herein, the strategies employed in QCM-based biosensors for the detection of infectious diseases are extensively reviewed, with a focus on prevalent diseases for which improved diagnostic techniques are in high demand. The challenges to the clinical application of QCM-based biosensors are highlighted, along with an outline of the future scope of research in QCM-based diagnostics.

Matched MeSH terms: Point-of-Care Systems
Fulltext Evaluation of the Diagnostic Accuracy of a New Biosensors-Based Rapid Diagnostic Test for the Point-Of-Care Diagnosis of Previous and Recent Dengue Infections in Malaysia

Chong ZL, Soe HJ, Ismail AA, Mahboob T, Chandramathi S, Sekaran SD

Biosensors (Basel), 2021 Apr 22;11(5).
PMID: 33921935 DOI: 10.3390/bios11050129

Dengue is a major threat to public health globally. While point-of-care diagnosis of acute/recent dengue is available to reduce its mortality, a lack of rapid and accurate testing for the detection of previous dengue remains a hurdle in expanding dengue seroepidemiological surveys to inform its prevention, especially vaccination, to reduce dengue morbidity. This study evaluated ViroTrack Dengue Serostate, a biosensors-based semi-quantitative anti-dengue IgG (immunoglobulin G) immuno-magnetic agglutination assay for the diagnosis of previous and recent dengue in a single test. Blood samples were obtained from 484 healthy participants recruited randomly from two communities in Petaling district, Selangor, Malaysia. The reference tests were Panbio Dengue IgG indirect and capture enzyme-linked immunosorbent assays, in-house hemagglutination inhibition assay, and focus reduction neutralization test. Dengue Serostate had a sensitivity and specificity of 91.1% (95%CI 87.8-93.8) and 91.1% (95%CI 83.8-95.8) for the diagnosis of previous dengue, and 90.2% (95%CI 76.9-97.3) and 93.2% (95%CI 90.5-95.4) for the diagnosis of recent dengue, respectively. Its positive predictive value of 97.5% (95%CI 95.3-98.8) would prevent most dengue-naïve individuals from being vaccinated. ViroTrack Dengue Serostate's good point-of-care diagnostic accuracy can ease the conduct of dengue serosurveys to inform dengue vaccination strategy and facilitate pre-vaccination screening to ensure safety.

Matched MeSH terms: Point-of-Care Systems

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