Efficacy of Loop-Mediated Isothermal Amplification for H. pylori Detection as Point-of-Care Testing by Noninvasive Sampling

For targeted eradication of Helicobacter pylori (H. pylori) to reduce gastric cancer burden, a convenient approach is definitely needed. The purpose of this study was to evaluate the LAMP assay for H. pylori detection using samples collected by noninvasive and self-sampling methods. The available LAMP assay for H. pylori detection was appraised and verified using reference and clinically isolated H. pylori strains. In addition, a clinical study was conducted to assess the LAMP assay on 51 patients, from whom saliva, oral brushing samples, feces, corpus, and antrum specimens were available. Clarithromycin resistance was also analysed through detection of A2143G mutation using the LAMP-RFLP method. The validation and verification analysis demonstrated that the LAMP assay had an acceptable result in terms of specificity, sensitivity, reproducibility, and accuracy for clinical settings. The LAMP assay showed a detection limit for H. pylori down to 0.25 fg/µL of genomic DNA. An acceptable consensus was observed using saliva samples (sensitivity 58.1%, specificity 84.2%, PPV 85.7%, NPV 55.2%, accuracy 68%) in comparison to biopsy sampling as the gold standard. The performance testing of different combinations of noninvasive sampling methods demonstrated that a combination of saliva and oral brushing could achieve a sensitivity of 74.2% and a specificity of 57.9%. A2143G mutation detection by LAMP-RFLP showed perfect consensus with Sanger sequencing results. It appears that the LAMP assay in combination with noninvasive and self-sampling as a point-of-care testing (POCT) approach has potential usefulness to detect H. pylori infection in clinic settings and screening programs.

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How I use fibrinogen replacement therapy in acquired bleeding

Blood ◽

10.1182/blood-2014-08-552000 ◽

2015 ◽

Vol 125 (9) ◽

pp. 1387-1393 ◽

Cited By ~ 69

Author(s):

Jerrold H. Levy ◽

Lawrence T. Goodnough

Keyword(s):

Replacement Therapy ◽

Cardiovascular Surgery ◽

Point Of Care ◽

Critical Role ◽

Clinical Settings ◽

Point Of Care Testing ◽

Hemostatic Therapy ◽

Transfusion Guidelines ◽

Fibrinogen Replacement Therapy

Abstract Fibrinogen is a critical protein for hemostasis and clot formation. However, transfusion guidelines have variable recommendations for maintaining fibrinogen levels in bleeding patients. An increasing number of studies support the practice of fibrinogen replacement therapy for acquired coagulopathies, and additional studies are underway. Fibrinogen therapy can be administered with cryoprecipitate or fibrinogen concentrates, and clinical practice varies according to their availability and licensing status. Fibrinogen concentrate therapy has been studied in animal models and clinical trials and supports the critical role of fibrinogen repletion in bleeding patients. Point-of-care testing will have an important role in guiding fibrinogen replacement for hemostatic therapy in clinical settings such as cardiovascular surgery, postpartum hemorrhage, and trauma. Fibrinogen therapy is an important component of a multimodal strategy for the treatment of coagulopathic bleeding.

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Application of Loop-Mediated Isothermal Amplification combined with colorimetric and lateral flow dipstick visualization as the potential point-of-care testing for diphtheria

10.21203/rs.2.14953/v1 ◽

2019 ◽

Author(s):

Aleksandra Anna Zasada ◽

Aldona Wiatrzyk ◽

Urszula Czajka ◽

Klaudia Brodzik ◽

Kamila Formińska ◽

...

Keyword(s):

Detection Limit ◽

Sensitivity And Specificity ◽

Point Of Care ◽

Lamp Assay ◽

Corynebacterium Diphtheriae ◽

Lateral Flow ◽

Isothermal Amplification ◽

Suspected Case ◽

Point Of Care Testing ◽

Loop Mediated Isothermal Amplification

Abstract Background Diphtheria outbreaks occurred in endemic areas and imported and indigenous cases are reported in UE/EEA. Because of the high infectiveness and severity of the disease, early and accurate diagnosis of each suspected case is essential for the treatment and management of the case and close contacts. The aim of the study was to establish simple and rapid testing methods based on Loop-Mediated Isothermal Amplification (LAMP) assay for the detection of Corynebacterium diphtheriae and differentiation between toxigenic and non-toxigenic strains.Methods Corynebacterium diphtheriae and Corynebacterium ulcerans isolates from the National Institute of Public Health-National Institute of Hygiene collection were used for the development of LAMP assay for the diagnosis of diphtheria and nontoxigenic C. diphtheriae infections. Various colorimetric methods for visualization of results were investigated. Sensitivity and specificity of the assay were examined using a collection of DNA samples from various gram-positive and gram-negative bacteria.Results The LAMP assay for tox and dtxR genes was developed. The sensitivity and specificity of the assay were calculated as 100%. The detection limit was estimated as 1.42 pg/µl concentration of DNA template when the reaction was conducted for 60 min. However, the detection limit was lowered 10 times for every 10 minutes of reduction in the time of incubation during the reaction. Positive results were successfully detected colorimetrically using hydroxynaphthol blue, calcein, QuantiFluor, and lateral flow Milenia HybriDetect dipsticks.Conclusion The assay developed in the study might be applied for point-of-care testing of diphtheria and other C. diphtheriae infections. It is highly sensitive, specific, inexpensive, easy to use, and suitable for low-resource settings.

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Analysis: Investigating the quality of POCT devices for HbA1c, what are our next steps?

Journal of Diabetes Science and Technology ◽

10.1177/1932296819850838 ◽

2019 ◽

Vol 13 (6) ◽

pp. 1154-1157 ◽

Cited By ~ 2

Author(s):

Erna Lenters-Westra ◽

Emma English

Keyword(s):

Point Of Care ◽

Performance Evaluations ◽

Clinical Settings ◽

Point Of Care Testing ◽

Performance History ◽

Future Studies ◽

Wide Range ◽

Need To Evaluate ◽

Number Of Publications

There are a growing number of publications evaluating the performance of HbA1c point-of-care testing (POCT) devices when compared to routine laboratory instruments, but is this what we need from future studies? Here we describe the current understanding of the performance of POCT for HbA1c, which areas need further studies, and the key requirements for future publications based on performance evaluations of these devices. These include studies in clinical settings, performance measured against internationally standardized reference methods, and the need to evaluate new to the market devices that do not currently have a detailed performance history. In addition we highlight the need for external quality assessment schemes that are designed to support POCT in a wide range of clinical settings.

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All-in-one in situ colorimetric RT-LAMP assay for point-of-care testing of SARS-CoV-2

The Analyst ◽

10.1039/d1an01043c ◽

2021 ◽

Author(s):

yugan he ◽

liqing wang ◽

xiaoping an ◽

Yigang Tong

Keyword(s):

Severe Acute Respiratory Syndrome ◽

Global Health ◽

Point Of Care ◽

Lamp Assay ◽

Point Of Care Testing

The ongoing outbreaks of the coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have resulted in unprecedented challenges to global health. To effectively contain...

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Current Point-of-Care testing in cancer and future perspectives: a systematic review

European Journal of Public Health ◽

10.1093/eurpub/ckaa040.033 ◽

2020 ◽

Vol 30 (Supplement_2) ◽

Cited By ~ 1

Author(s):

M Rodrigues ◽

I Andrade ◽

R Cruz

Keyword(s):

Systematic Review ◽

Early Detection ◽

Point Of Care ◽

Low Cost ◽

Rapid Test ◽

Point Of Care Testing ◽

Screening Programs ◽

Low Resource ◽

Resource Limited ◽

Prevalent Disease

Abstract Introduction Cancer is the most prevalent disease worldwide, causing a major impact on society. Early detection and monitorization of the tumour can provide a more effective treatment. Point-of-care (POC) testing allows the patient to have a handheld test that gives the results rapidly. No expertise or special knowledge is required which is vital namely when carried out in low-resource areas. Recent studies analysed established and emerging biomarkers and how to incorporate them into POC devices, but a systematic review reporting the existing POC platforms for cancer is still not available. Objectives This systematic review aims to report current and recent advances for point-of-care testing in cancer. Methodology A literature review was conducted through research in the databases “PubMed” and “B-On” for relevant reviews published in the last ten years, using the keywords “Point-of-care testing” AND “Cancer” AND “Rapid Test” AND “Cancer detection”. Results In 2015 there were eight commercially available POC tests for prostate, bladder, colorectal, cervical, HPV-causing head and neck cancer, liver, breast and lung cancer. After 2018 a small number of POC devices were tested in screening programs and multicentric studies, and more recently, promising novel POC prototypes for early detection of cancer, namely a 3D prototype micro device for multiple singleplex RNA expression analysis in liver cancer and a POC microscopy prototype for digital diagnostics of breast cancer lymph node metastases, with potential to be used in resource-limited settings. Conclusion The use of POC testing can deliver accurate, fast results, and in the case of cancer it is no exception, contributing to the progression of treatment and reduction in cancer-related deaths. In low-resource settings a POC test is fundamental and it should be simple and low-cost. But there are limitations in the tests which is a challenge for improvement and investigation in the future.

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Reliability analysis of GEM® Premier™ technology: a multicenter study

Emergency Care Journal ◽

10.4081/ecj.2015.4795 ◽

2015 ◽

Vol 11 (2) ◽

Author(s):

Francesco Faggiano ◽

Tiziana Franchin ◽

Matteo Ritrovato ◽

Pietro Derrico

Keyword(s):

Patient Safety ◽

Point Of Care ◽

Clinical Settings ◽

Blood Gas ◽

Gas Analyzer ◽

Performance Measurements ◽

Point Of Care Testing ◽

Data Set ◽

High Level ◽

Blood Gas Analyzer

<p>This paper describes how specific blood gas analyzer characteristics can support the emerging clinical and organizational user’s needs while ensuring patient safety. A oneyear data set from two Italian hospitals was analyzed from 10 different blood gas analyzers. Performance measurements in terms of mean down time (MDT) were calculated to show how technical characteristics declared by the manufacturer compare to the analyzer availability in real clinical settings. Results show a high level of reliability for the analyzed technology, associated with very low MDT of each sensor integrated in the cartridge. Moreover, results show a high level of efficiency in cartridge usage. Such results are consistent with the specification of the GEM<sup>®</sup> Premier™ maintenance- free technology and are particularly relevant in the point-of-care testing setting.</p>

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Application of Loop-Mediated Isothermal Amplification combined with colorimetric and lateral flow dipstick visualization as the potential point-of-care testing for Corynebacterium diphtheriae

10.21203/rs.2.14953/v4 ◽

2020 ◽

Author(s):

Aleksandra Anna Zasada ◽

Aldona Wiatrzyk ◽

Urszula Czajka ◽

Klaudia Brodzik ◽

Kamila Formińska ◽

...

Keyword(s):

Detection Limit ◽

Sensitivity And Specificity ◽

Point Of Care ◽

Lamp Assay ◽

Corynebacterium Diphtheriae ◽

Lateral Flow ◽

Isothermal Amplification ◽

Suspected Case ◽

Point Of Care Testing ◽

Loop Mediated Isothermal Amplification

Abstract Background Diphtheria outbreaks occurred in endemic areas and imported and indigenous cases are reported in UE/EEA. Because of the high infectiveness and severity of the disease, early and accurate diagnosis of each suspected case is essential for the treatment and management of the case and close contacts.The aim of the study was to establish simple and rapid testing methods based on Loop-Mediated Isothermal Amplification (LAMP) assay for the detection of Corynebacterium diphtheriae and differentiation between toxigenic and non-toxigenic strains.Methods Corynebacterium diphtheriae and Corynebacterium ulcerans isolates from the National Institute of Public Health-National Institute of Hygiene collection were used for the development of LAMP assay for the diagnosis of diphtheria and nontoxigenic C. diphtheriae infections. Various colorimetric methods for visualization of results were investigated. Sensitivity and specificity of the assay were examined using a collection of DNA samples from various gram-positive and gram-negative bacteria.Results The LAMP assay for tox and dtxR genes was developed. The sensitivity and specificity of the assay were calculated as 100%. The detection limit was estimated as 1.42 pg/µl concentration of DNA template when the reaction was conducted for 60 min. However, the detection limit was lowered 10 times for every 10 minutes of reduction in the time of incubation during the reaction. Positive results were successfully detected colorimetrically using hydroxynaphthol blue, calcein, QuantiFluor, and lateral flow Milenia HybriDetect dipsticks.Conclusion The assay developed in the study might be applied for point-of-care testing of diphtheria and other C. diphtheriae infections as well as for other infections caused by diphtheria-toxin producing Corynebacterium species. It is highly sensitive, specific, inexpensive, easy to use, and suitable for low-resource settings.

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A Real-World Setting Study: Which Glucose Meter Could Be the Best for POCT Use? An Easy and Applicable Protocol During the Hospital Routine

Journal of Diabetes Science and Technology ◽

10.1177/1932296818774077 ◽

2018 ◽

Vol 12 (5) ◽

pp. 1053-1060

Author(s):

Alessio Mancini ◽

Giampaolo Esposto ◽

Silvana Manfrini ◽

Silvia Rilli ◽

Gessica Tinti ◽

...

Keyword(s):

Point Of Care ◽

Venous Blood ◽

Blood Analysis ◽

Clinical Settings ◽

Point Of Care Testing ◽

Laboratory Reference ◽

Glucose Meter ◽

Reliability And Robustness ◽

Error Grid ◽

Venous Blood Sampling

The aim of this retrospective study is to evaluate the reliability and robustness of six glucose meters for point-of-care testing in our wards using a brand-new protocol. During a 30-days study period a total of 50 diabetes patients were subjected to venous blood sampling and glucose meter blood analysis. The results of six glucose meters were compared with our laboratory reference assay. GlucoMen Plus (Menarini) with the 82% of acceptable results was the most robust glucose meter. Even if the Passing-Bablok analysis demonstrates the presence of constant systematic errors and the Bland-Altman test highlighted a possible overestimation, the surveillance error grid analysis showed that this glucose meter can be used safely. We proved that portable glucose meters are not always reliable in routinely clinical settings.

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Identification and Management of Glucocorticoid-Induced Hyperglycemia on an Inpatient Malignant Hematology Ward: A Quality Improvement Initiative

Blood ◽

10.1182/blood.v124.21.6004.6004 ◽

2014 ◽

Vol 124 (21) ◽

pp. 6004-6004

Author(s):

Andrew Aw ◽

Heidi Dutton ◽

Janine Malcolm ◽

Erin Keely ◽

Jason Tay

Keyword(s):

Quality Improvement ◽

Adverse Events ◽

Hospital Stay ◽

Fasting Glucose ◽

Point Of Care ◽

Point Of Care Testing ◽

Screening Programs ◽

Common Diagnosis ◽

History Of ◽

Capillary Glucose

Abstract Background: Hyperglycemia in malignant hematology inpatients has been associated with increased adverse events. Glucocorticoids (GC) are commonly used to treat hematologic malignancies, increasing the likelihood of hyperglycemia even in patients who do not have a history of diabetes. In particular, glucocorticoids may contribute to postprandial hyperglycemia. Studies identifying quality interventions in this setting are lacking. Methods: We performed a retrospective review of all admissions to the malignant hematology ward at The Ottawa Hospital between September 1 to November 30, 2012 to document current practices for identifying and managing GC-induced hyperglycemia. Admissions were included if at least one dose of GC was given during hospital stay. We assessed glucose monitoring strategies, glycemic control quality and hyperglycemia therapies during the first 7 days of GC use, and up to 24 hours post discontinuation. Associations between adverse events of infection, readmission or Emergency Room visit within 30 days of GC initiation were assessed using regression analyses. Results: We identified 77 encounters: the most common diagnosis was acute leukemia (27%), and the most frequent reason for admission to the hematology ward was for autologous hematopoietic stem cell transplantation (14%). Median patient age was 57, median body mass index was 23.6 kg/m2, proportion of male patients was 54.5% and median length of stay was 12 days. Of the 77 encounters, 26% of patients were on GC prior to admission, 40% were discharged with a prescription for GC, and 5% had a previous history of GC-induced hyperglycemia. Only 19% of admissions had scheduled point-of-care testing of capillary glucose ordered during the first 7 days of glucocorticoid therapy, while 95% of admissions had at least one glucose measurement performed during hospital stay. Correctional scale insulin and scheduled basal or prandial insulin were only ordered in 14% and 3% of admissions respectively. One patient was assessed by the Diabetic Nurse Educator, and 3 patients were assessed through formal consultation by Endocrinology. Average fasting glucose was < 110 mg/dl in 38%, 110 – 180 mg/dl in 57%, 181 – 252 mg/dl in 3%, and > 252 mg/dl in 2%. At least one extreme hyperglycemic (>252 mg/dl) event occurred in 10% of cases. In the 48 admissions with at least one glucose measured in the non-fasting state, 10% had an average non-fasting glucose greater than 180 mg/dl. No associations between fasting glucose and adverse events were identified. Conclusion: GC-induced hyperglycemia is common in malignant hematology inpatients. Only 19% of cases had scheduled qid point of care testing of capillary glucose. The American and Canadian Diabetes Associations recommend glycemic monitoring for at least 48 hours in those started on GC, with or without diabetes, identifying a practice gap. Our local needs assessment provides a foundation for future quality improvement interventions to enhance patient care through the development of appropriate screening programs and referral pathways. Disclosures No relevant conflicts of interest to declare.

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Point-of-care testing and counseling at community pharmacies

European Journal of Public Health ◽

10.1093/eurpub/ckaa166.545 ◽

2020 ◽

Vol 30 (Supplement_5) ◽

Author(s):

A Sevikyan ◽

I Kazaryan ◽

L Vardanyan ◽

A Amirkhanyan

Keyword(s):

Public Health ◽

Continuing Education ◽

Health Information ◽

General Health ◽

Diabetes Management ◽

Point Of Care ◽

Community Pharmacies ◽

Point Of Care Testing ◽

Screening Programs ◽

Number Of Patients

Abstract An increasing number of patients seek advice at community pharmacies in terms of prevention, detection and initial management of certain conditions and diseases. Some countries have introduced pharmacy-based screening programs and counseling. The objective of this work was to analyze the situation on providing screening and counseling at community pharmacies in Armenia. The staff of randomly selected community pharmacies located in various regions of Armenia was asked to complete pre-tested questionnaire. The data were analysed with SPSS statistical software, version 22.0. 62.9% of 353 responded professionals reported availability of conditions for monitoring blood pressure, 14.4% - for monitoring glucose level, 11.3% - for doing pregnancy test, 9.6% - for testing cholesterol, 2.0% - for monitoring asthma using peak flow meter. 86.7% indicated accessibility of conditions for private discussion with patients. Small number of pharmacy professionals reported that during the last year they were engaged in diabetes management (10.2%) and HIV/AIDS/TB management (7.9%). 7.4% of respondents were involved in family planning activity. 97.5% of pharmacy professionals considers that being active in providing general health information to patients is important and 89.2% reported about being active. The number of professionals who are active in providing general health information to patients is significantly higher among those who attended continuing education courses than among those who did not (p = 0.003). Only part of community pharmacies is able to provide point-of-care testing. Professionals are rarely involved in disease management. They are active in providing general health information. Continuing education improves situation with engagement of pharmacy professionals in public health activity. Key messages There is need to improve the situation with providing point-of-care testing at community pharmacies. Training increases involvement of community pharmacists in public health.

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