Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction

Background: Medical practices face challenges of time and cost pressures with scarce resources. Point-of-care testing (POCT) has the potential to accelerate processes compared to central laboratory testing and can increase satisfaction of physicians, staff members, and patients. The objective of this study was to evaluate the effects of introducing HbA1c POCT in practices specialized in diabetes. Method: Three German practices that manage 400, 550, and 950 diabetes patients per year participated in this evaluation. The workflow and required time before and after POCT implementation (device: Alere Afinion AS100 Analyzer) was evaluated in each practice. Physician (n = 5), staff (n = 9), and patient (n = 298) satisfaction was assessed with questionnaires and interviews. Results: After POCT implementation the number of required visits scheduled was reduced by 80% (88% vs 17.6%, P < .0001), the number of venous blood collections by 75% (91% vs 23%, P < .0001). Of patients, 82% (vs 13% prior to POCT implementation) were able to discuss their HbA1c values with treating physicians immediately during their first visit ( P < .0001). In two of the practices the POCT process resulted in significant time savings of approximately 20 and 22 working days per 1000 patients per year (95% CI 2-46; 95% CI 10-44). All physicians indicated that POCT HbA1c implementation improved the practice workflow and all experienced a relief of burden for the office and the patients. All staff members indicated that they found the POCT measurement easy to perform and experienced a relief of burden. The majority (61.3%) of patients found the capillary blood collection more pleasant and 83% saw an advantage in the immediate availability of HbA1c results. Conclusions: The implementation of HbA1c POCT leads to an improved practice workflow and increases satisfaction of physicians, staff members and patients.

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Point-of-Care Testing Using Invasive and Non-Invasive Hemoglobinometers: Reliable and Valid Method for Estimation of Hemoglobin among Children 6–59 Months

Journal of Tropical Pediatrics ◽

10.1093/tropej/fmaa111 ◽

2020 ◽

Author(s):

Gomathi Ramaswamy ◽

Kashish Vohra ◽

Kapil Yadav ◽

Ravneet Kaur ◽

Tripti Rai ◽

...

Keyword(s):

Point Of Care ◽

Venous Blood ◽

Public Health Problem ◽

Outpatient Department ◽

Point Of Care Testing ◽

Adequate Treatment ◽

Non Invasive ◽

Hematology Analyzer ◽

The Mean ◽

Study Participants

Abstract 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 summary In 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%).

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Comprehensive bedside point of care testing in critical ED patients: a before and after study

The American Journal of Emergency Medicine ◽

10.1016/j.ajem.2015.03.034 ◽

2015 ◽

Vol 33 (6) ◽

pp. 776-780 ◽

Cited By ~ 21

Author(s):

Adam J. Singer ◽

Justin Williams ◽

Maria Taylor ◽

Deborah Le Blanc ◽

Henry C. Thode

Keyword(s):

Point Of Care ◽

Point Of Care Testing ◽

Before And After ◽

Before And After Study

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Measurement accuracy of two professional-use systems for point-of-care testing of blood glucose

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2019-0549 ◽

2020 ◽

Vol 58 (3) ◽

pp. 445-455

Author(s):

Annette Baumstark ◽

Nina Jendrike ◽

Ulrike Kamecke ◽

Christina Liebing ◽

Stefan Pleus ◽

...

Keyword(s):

Blood Glucose ◽

Point Of Care ◽

Venous Blood ◽

Laboratory Method ◽

Sample Type ◽

Point Of Care Testing ◽

Blood Samples ◽

Testing Procedures ◽

Grid Analysis ◽

Error Grid

AbstractBackgroundThe professional-use systems HemoCue® Glucose 201+ (HC201+) and HemoCue® Glucose 201 RT (HC201RT) are widely used for point-of-care testing (POCT) of blood glucose (BG). HC201RT utilizes unit-use microcuvettes which can be stored at room temperature, whereas HC201+ microcuvettes have to be stored at <8 °C. In this study, system accuracy of HC201+ and HC201RT was evaluated using capillary and venous blood samples.MethodsFor each system, two reagent system lots were evaluated within a period of 2 years based on testing procedures of ISO 15197:2013, a standard applicable for self-monitoring of blood glucose (SMBG) systems. For each reagent system lot, the investigation was performed by using 100 capillary and 95 to 99 venous blood samples. Comparison measurements were performed with a hexokinase laboratory method. Accuracy criteria of ISO 15197:2013 and POCT12-A3 were applied. In addition, bias was analyzed according to Bland and Altman, and error grid analysis was performed.ResultsWhen measuring capillary samples, both systems fulfilled accuracy requirements of ISO 15197:2013 and POCT12-A3 with the investigated reagent system lots. When measuring venous samples, only HC201+ fulfilled these requirements. Bias between HC201+ and reference measurements was more consistent over venous and capillary samples and microcuvette lots than for HC201RT. Error grid analysis showed that clinical actions might have been different depending on which system was used.ConclusionsIn this study, HC201+ showed a high level of accuracy irrespective of the sample type (capillary or venous). In contrast, HC201RT measurement results were markedly affected by the type of sample.

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P295 Comparative Assessment of Infliximab Trough Levels between Point-of-Care Testing and current Standard of Care (enzyme linked immunosorbent assay) in patients with Inflammatory Bowel Disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.419 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S325-S325

Author(s):

D Maniero ◽

G Lorenzon ◽

I Marsilio ◽

A Rigo ◽

R Cardin ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Whole Blood ◽

Point Of Care ◽

Enzyme Linked Immunosorbent Assay ◽

Blood Collection ◽

Point Of Care Testing ◽

Deming Regression ◽

Inflammatory Bowel ◽

Trough Levels

Abstract Background Infliximab (IFX) is a monoclonal antibody that targets cytokine tumor necrosis factor; it is used for the treatment of patients with active inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC). IFX induces and maintains remission and mucosal healing in patients with IBD. Measurement of trough levels (TL) of IFX is important to assess if the drug is within its therapeutic concentrationand to explain lack/loss of response. Standard laboratory tests to assess IFX trough levels (enzyme linked immunosorbent assays, ELISA) present some downsides, related to the long turnaround (about 3 hours), and the need of specialized equipment and laboratory personnel. For this reason, point-of care testing (POCT) was developed to provide results within a few minutes from blood collection, leading to a decision-making approach. Aim To determine the degree of analytical correlation between a recently developed POCT (ProciseDx) IFX assay which analyze capillary whole blood and the comparative ELISA from serum. Methods From October 2020 to January 2021, patients (aged≥18 years) taking IFX were recruited at Gastroenterology Unit, Padua University Hospital. In each patient, IFX levels from capillary whole blood collected by finger stick were performed using the ProciseDx IFX assay with reportable range between 1.7-77.2 µg/mL; at the same time, a serum sample from venous blood was collected to carry out Grifols’ Promonitor ELISA test (range 0.035–14.4 µg/mL). A Deming regression test was used to identify the correlation between the two methods. Results Eighty-seven patients were enrolled (63% males; mean age of 44±16), with 52% of them having CD, 45% UC and 3% an undetermined-Inflammatory Bowel Disease. The assessment with ProciseDx POCT was feasible in each patient and only in three cases blood collection from finger prick was repeated. Moreover, from blood collection to results we needed about 3±0.5 minutes, while serum ELISA analysis required the collection of at least 40 samples (around three weeks at our centre) and 3 hours to be performed. 39 patients (59% males; mean age of 44±16) had TL as assessed by ProciseDx IFX assay lower than 1.7 or greater than 14.4 µg/mL, in accordance with ELISA assessment. Among the remaining 48 patients (67% males with mean age of 45±17), The correlation between the two tests was high (the total results showed an R squared of 0.691 (95% CI 0.717-0.902). Conclusion The ProciseDx POCT has good accuracy but was more rapid and easy to be performed in providing the results of Therapeutic Drug Monitoring in outpatients taking IFX. This could lead to a more effective optimization of the biological drug, thus avoiding treatment failure.

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Patient acceptability of targeted risk-based detection of non-communicable diseases in a dental and pharmacy setting

BMC Public Health ◽

10.1186/s12889-020-09649-7 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Zehra Yonel ◽

Asma Yahyouche ◽

Zahra Jalal ◽

Alistair James ◽

Thomas Dietrich ◽

...

Keyword(s):

Vitamin D ◽

Community Pharmacy ◽

Healthcare Professionals ◽

Point Of Care ◽

Communicable Diseases ◽

Blood Collection ◽

Point Of Care Testing ◽

Patient Acceptability ◽

Non Communicable Diseases ◽

Finger Prick

Abstract Background Non-communicable diseases [NCDs] are the major cause of mortality globally and are increasing in prevalence. Different healthcare professionals’ access different population groups; and engaging allied healthcare professionals in risk-driven early case detection of certain NCDs may be beneficial, especially those who have not been tested for NCDs within the previous 12 months. The objectives of this study were to determine: whether NCD case finding in dental/community pharmacy settings is feasible in terms of patient acceptability, barriers to recruitment, impact on the existing service. Determine time taken to test for: type 2 diabetes risk [T2DM], chronic obstructive pulmonary disease [COPD], hypertension, vitamin D deficiency and chronic kidney disease [CKD]. Determine whether there is added benefit of point of care testing [POCT] to identify diabetes risk compared to a validated screening questionnaire alone. Methods An exploratory study was undertaken to explore issues associated with NCD assessment in one dental practice and one community pharmacy within the West-Midlands, UK. Fifty patients > 40 years-of-age were recruited per site. Participants undertook: a questionnaire providing demographic data, any previous NCD diagnosis or positive family history. Validated questionnaires for determining NCD risk [T2DM/COPD]. Chair-side capillary blood [finger-prick] samples for HbA1C, creatinine/eGFR, Vitamin-D. Prior work had been undertaken to measure the agreement between point of care testing [POCT] devices and a central laboratory method, and to gauge the opinions of participants regarding discomfort experienced using venous (antecubital fossa) and capillary (finger-prick) blood collection, via a 10 cm Visual-Analogue-Scale. The POCT devices demonstrated good concordance with laboratory testing and were acceptable methods of blood collection for participants. Results Recruitment rates demonstrated that 8 days were needed to recruit 50 participants and 60% of those approached opted to participate. The principal barrier to participation was time, with average time taken to test being 19mins. Utilising dental and pharmacy settings identified potential cases of previously undiagnosed disease. Conclusions Risk-targeted testing for NCDs in high street dental and community pharmacies is both attractive and acceptable to patients.

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Common cold in Team Finland during 2018 Winter Olympic Games (PyeongChang): epidemiology, diagnosis including molecular point-of-care testing (POCT) and treatment

British Journal of Sports Medicine ◽

10.1136/bjsports-2018-100487 ◽

2019 ◽

Vol 53 (17) ◽

pp. 1093-1098 ◽

Cited By ~ 9

Author(s):

Maarit Valtonen ◽

Matti Waris ◽

Tytti Vuorinen ◽

Erkki Eerola ◽

Antti J Hakanen ◽

...

Keyword(s):

Respiratory Syncytial Virus ◽

Common Cold ◽

Olympic Games ◽

Point Of Care ◽

Influenza B ◽

Point Of Care Testing ◽

Staff Members ◽

Winter Olympic Games ◽

The Common ◽

Syncytial Virus

ObjectivesThe common cold is the main cause of medical time loss in elite sport. Rapid diagnosis has been a challenge that may be amenable to molecular point-of-care testing (POCT).MethodsWe performed a prospective observational study of the common cold in Team Finland during the 2018 Winter Olympic Games. There were 44 elite athletes and 68 staff members. The chief physician recorded the symptoms of the common cold daily on a standardised form. Two nasal swabs were taken at the onset of symptoms. One swab was analysed within 45 min using a molecular POCT for respiratory syncytial virus and influenza A and B viruses. After the Games, the other swab was tested for 16 possible causative respiratory viruses using PCR in laboratory-based testing.Results20 out of 44 (45%) athletes and 22 out of 68 (32%) staff members experienced symptoms of the common cold during a median stay of 21 days. Eleven (26%) samples tested virus-positive using POCT. All subjects with influenza (n=6) and 32 close contacts were treated with oseltamivir. The aetiology of the common cold was finally detected in 75% of the athletes and 68 % of the staff members. Seven virus clusters were identified. They were caused by coronaviruses 229E, NL63 and OC43, influenza B virus, respiratory syncytial virus A, rhinovirus and human metapneumovirus. The virus infections spread readily within the team, most commonly within the same sport discipline.ConclusionsThe cold was indeed a common illness in Team Finland during the Winter Olympic Games. POCT proved to be clinically valuable, especially for influenza. The aetiology of the common cold was identified in most cases.

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