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

Author(s):  
Gomathi Ramaswamy ◽  
Kashish Vohra ◽  
Kapil Yadav ◽  
Ravneet Kaur ◽  
Tripti Rai ◽  
...  

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%).

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3360-3360
Author(s):  
Anja B Drebes ◽  
Paul Priest ◽  
Shaila Bates ◽  
Lida Moghaddam ◽  
Edward GD Tuddenham ◽  
...  

Abstract Abstract 3360 Background: Point-of-care testing (POCT) is widely used for monitoring of the international normalized ratio (INR) in patients on oral anticoagulation with a vitamin-K antagonist (VKA) and numerous clinical studies have assessed the accuracy of this method in comparison with INR results from venous blood samples analysed in the laboratory. There is however a paucity of clinical data to support the use of POCT in patients on dual anticoagulation with low molecular weight heparin (LMWH) and a VKA during initiation of anticoagulation or bridging after a surgical procedure. Aim: To test the hypothesis whether therapeutic doses of LMWH interfere with INR measurements when using a POCT system during times of dual anticoagulation with LMWH and a VKA. To further investigate whether the effect is most pronounced once LMWH has reached peak plasma levels and less evident 10 hours and more after administration of LMWH. Methods: We prospectively collected 160 consecutive venous blood samples from patients on therapeutic doses of LMWH - Tinzaparin (175 IU/kg once daily) and a VKA commonly warfarin for INR testing in our laboratory. At the same time all patients had their INR determined on capillary blood collected by finger prick using a CoaguChek XS Pro and INR test strips with the same lot number (Roche Diagnostics Ltd, UK). 60 blood samples were collected within 3–6 hours after administration of LMWH (group 1) and 100 samples were collected 10 hours or more after the last injection of LMWH (group 2). For each sample the dose and time of the last injection of LMWH was recorded along with the time of the venepuncture and the result of the capillary INR. To ensure that we had a wide variation in the plasma concentrations of LMWH we carried out anti-Xa testing on a cross-section of venous samples The dosing advice for Warfarin was based on the INR result of the venous blood sample processed in the laboratory. Results: The correlation coefficient between the POCT INR and the laboratory INR was 0.98 in group 1 and 0.97 in group 2. In the Bland Altman analysis for group 1 the mean 95% confidence interval (CI) was 0.03 (range+/− 1.96 SD: −0.26 to +0.32) and for group 2 the mean 95% CI was 0.00 (range −0.28 to +0.29). These results are comparable to results of our internal quality control between POCT INR and laboratory INR in patients on VKA alone with a mean 95% CI of −0.02 (range −0.26 to +0.29). The mean INR was 1.8 by both methods in group 1 and 1.7 by both methods in group 2 and anti-Xa levels ranged from 0 to1.19 U/mL. A variation in the result of the POCT INR and laboratory INR of 0.5 or greater is thought to affect dosing decisions for Warfarin. Such a variation was observed in 3% (2/60) in group 1 and 2% (2/100) in group 2. Conclusion: There was good accuracy of the INR obtained with the POCT system used and this was not affected by the timing of the administration of LMWH in relation to testing. Disclosures: No relevant conflicts of interest to declare.


2018 ◽  
Vol 42 (5) ◽  
pp. 189-193
Author(s):  
Tevfik Honca ◽  
Mehtap Honca

AbstractBackgroundThe aim of the present study was to compare hemoglobin (Hb) levels determined by point-of-care testing (POCT) HemoCue® and arterial blood gas analyzer using an automated hematology analyzer in critically ill geriatric patients.MethodsForty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemoCue® (HemoCue®; Hb 201+, Angelholm, Sweden) (HbHemoCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series, Japan) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbott Laboratories, USA) (HbLab) as a reference method. Capillary blood measurements were performed (HbHemoCueCapillary) using HemoCue® at bedside. Bland-Altman analysis was applied to the results.ResultsWe found a positive correlation between the Hb measurements of HemoCueCapillary, HemoCueArterial and automated hematology analyzer (r-values were 0.799 and 0.922, respectively) and p<0.001. There was also a positive correlation between the Hb measurements of blood gas analyzer and automated hematology analyzer (r = 0.878) and p<0.001. The bias and limits of agreement were 0.32 and −2.5±3.14 g/dL for the HbHemoCueCapillary, 0.64 and −1.03±2.31 g/dL for the HbHemoCueArterial and −1.2 and −4.45±2.05 g/dL for the HbBGA. Inotropic agent administration did not affect the Hb values in all groups.ConclusionsBoth HemoCueCapillary and HemoCueArterial are sufficiently accurate and correlated with automated hematology analyzer in geriatric critically ill patients if used correctly. In terms of Hb levels, arterial and capillary blood sample measurements with HemoCue® provided more clinically acceptable accuracy than blood gas analysis system.


2018 ◽  
Vol 12 (3) ◽  
pp. 687-694 ◽  
Author(s):  
Karl-Heinz Patzer ◽  
Payam Ardjomand ◽  
Katharina Göhring ◽  
Guido Klempt ◽  
Andreas Patzelt ◽  
...  

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.


2020 ◽  
Vol 58 (3) ◽  
pp. 445-455
Author(s):  
Annette Baumstark ◽  
Nina Jendrike ◽  
Ulrike Kamecke ◽  
Christina Liebing ◽  
Stefan Pleus ◽  
...  

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.


The Analyst ◽  
2015 ◽  
Vol 140 (21) ◽  
pp. 7399-7406 ◽  
Author(s):  
Lin Zhang ◽  
Wentao Yang ◽  
Yuankui Yang ◽  
Hong Liu ◽  
Zhongze Gu

Here we report a smartphone-based potentiometric biosensor for point-of-care testing of salivary α-amylase (sAA), which is one of the most sensitive indices of autonomic nervous system activity, and therefore a promising non-invasive biomarker for mental health.


PLoS ONE ◽  
2020 ◽  
Vol 15 (10) ◽  
pp. e0239931
Author(s):  
Stefan A. Nass ◽  
Ilias Hossain ◽  
Chilel Sanyang ◽  
Bakary Baldeh ◽  
Dora I. A. Pereira

2020 ◽  
Vol 66 (6) ◽  
pp. 630-636
Author(s):  
Bhargavi Kamineni ◽  
Anusha Tanniru ◽  
Venkateshwarlu Vardhelli ◽  
Deepak Sharma ◽  
Dinesh Pawale ◽  
...  

Abstract Introduction Early diagnosis and appropriate management of neonatal jaundice is crucial in avoiding severe hyperbilirubinemia and brain injury. A low-cost, minimally invasive, point-of-care (PoC) tool for total bilirubin (TB) estimation which can be useful across all ranges of bilirubin values and all settings is the need of the hour. Objective To assess the accuracy of Bilistick system, a PoC device, for measurement of TB in comparison with estimation by spectrophotometry. Design/methods In this cross-sectional clinical study, in infants who required TB estimation, blood samples in 25-µl sample transfer pipettes were collected at the same time from venous blood obtained for laboratory bilirubin estimation. The accuracy of Bilistick in estimating TB within ±2 mg/dl of bilirubin estimation by spectrophotometry was the primary outcome. Results Among the enrolled infants, 198 infants were eligible for study analysis with the mean gestation of 36 ± 2.3 weeks and the mean birth weight of 2368 ± 623 g. The median age at enrollment was 68.5 h (interquartile range: 48–92). Bilistick was accurate only in 54.5% infants in measuring TB within ±2 mg/dl difference of TB measured by spectrophotometry. There was a moderate degree of correlation between the two methods (r = 0.457; 95% CI: 0.339–0.561, p value &lt; 0.001). Bland–Altman analysis showed a mean difference of 0.5 mg/dl (SD ± 4.4) with limits of agreement between −8.2 and +9.1 mg/dl. Conclusion Bilistick as a PoC device is not accurate to estimate TB within the clinically acceptable difference (±2 mg/dl) of TB estimation by spectrophotometry and needs further improvement to make it more accurate.


2017 ◽  
Vol 53 (2) ◽  
pp. 101-106
Author(s):  
Aleksandra Charchut ◽  
Magdalena Wójcik ◽  
Barbara K. Kościelniak ◽  
Przemysław J. Tomasik

Fecal occult blood testing (FOBT) is a non-invasive and easy-to-carry, self-performed assay. It is often conducted in the diagnosis of various gastrointestinal diseases, especially as a screening test for colorectal cancer. This test is aimed at detecting blood which is not visible macroscopically in a stool sample. The purpose of this paper is to discuss various types of FOB tests: chemical, immunochroma- tographic and DNA tests. Despite the similarity in their performance, these tests use different methods and thus differ in their ability to detect blood from different parts of the gastrointestinal tract. In addition, the interfering factors in the various assays and the proper preparation of the patient before the test are discussed in detail. The knowledge of the differences between these tests will allow to correct performance and interpretation of the results obtained with each tests.


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