Invasive and non-invasive point-of-care testing and point-of-care monitoring of the hemoglobin concentration in human blood – how accurate are the data?

2019 ◽  
Vol 64 (5) ◽  
pp. 495-506
Author(s):  
Frank Dietzel ◽  
Peter Dieterich ◽  
Frank Dörries ◽  
Hartmut Gehring ◽  
Philipp Wegerich

Abstract In this review, scientific investigations of point-of-care testing (POCT) and point-of-care monitoring (POCM) devices are summarized with regard to the measurement accuracy of the hemoglobin concentration. As a common basis, information according to the Bland and Altman principle [bias, limits of agreement (LOA)] as well as the measurement accuracy and precision are considered, so that the comparability can be mapped. These collected data are subdivided according to the manufacturers, devices and procedures (invasive and non-invasive). A total of 31 devices were identified. A comparability of the scientific investigations in particular was given for 23 devices (18 invasive and five non-invasive measuring devices). In terms of measurement accuracy, there is a clear leap between invasive and non-invasive procedures, while no discernible improvement can be derived in the considered time frame from 2010 to 2018. According to the intended use, strict specifications result from the clinical standards, which are insufficiently met by the systems. More stringent requirements can be derived both in the area of blood donation and in the treatment of patients.

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%).


Author(s):  
Yogesh Kumar ◽  
Ayush Dogra ◽  
Vikash Shaw ◽  
Ajeet Kaushik ◽  
Sanjeev Kumar

Background: Hemoglobin is essential biomolecule for the transportation of oxygen therefore; its assessment is also obligatory very frequently in innumerable clinical practices. Traditional invasive techniques have concomitant shortcomings e.g. time delay, onset of infections and discomfort, which necessitates a non-invasive hemoglobin estimating solution to get rid of these constraints in health informatics. Currently various techniques are underway in allied domain and scanty products are also feasible in the market but due to low satisfaction rate, invasive solutions are still assumed as gold standard. Recently introduced technologies are effectively evolved as optical spectroscopy and digital photographic concepts on different sensing spots e.g. fingertip, palpebral conjunctiva, bulbar conjunctiva and fingernail. Productive sensors utilize more than eight wavelengths to compute hemoglobin concentration and four wavelengths to display only Hb-index (trending of hemoglobin) either in disposable adhesive or reusable clip type sensor’s configuration. Objective: This study aims an optimistic optical spectroscopic technique to measure hemoglobin concentration and conditional usability of non-invasive blood parameters’ diagnostics at point-of-care. Methods: Two distinguishable light emitting sources (810nm & 1300nm) are utilized at isosbestic points with single photodetector (800-1700nm). With this purpose, reusable finger probe assembly is facilitated in transmittance mode based on newly offered sliding mechanism to block ambient light. Results: Investigation with proposed design presents correlation coefficients between reference hemoglobin and every individual feature, multivariate linear regression model for highly correlated independent features. Moreover, principal component analytical model with multivariate linear regression offers mean bias of 0.036 & -0.316 g/dL, precision of 0.878 & 0.838 and limits of agreement from -1.685 to 1.758 g/dL & -1.790 to 1.474 g/dL for 18 & 21 principle components respectively. Conclusion: The encouraging readouts emphasize favorable precision therefore proposed sensing system is amenable to assess hemoglobin in settings with limited resources and strengthening future routes for point of care applications.


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.


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.


Biosensors ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 200
Author(s):  
Jin Wang ◽  
Xiangmei Li ◽  
Xing Shen ◽  
Ang Zhang ◽  
Jinxiu Liu ◽  
...  

Aflatoxin B1 (AFB1), a mycotoxin, is hepatotoxic, carcinogenic, and nephrotoxic in humans and animals, and contaminate a wide range of maize. In this study, an immunochromatographic assay (ICA) based on polystyrene microspheres (PMs) was developed for sensitive and quantitative detection of AFB1 in maize. The amounts of PMs, the condition for activating carboxyl groups of PMs, the amount of monoclonal antibody (mAb), and the volume of the immune probe were optimized to enhance the performance PMs-ICA for point-of-care testing of AFB1 in maize. The PMs-ICA showed the cut-off value of 1 ng/mL in phosphate buffer (PB) and 6 µg/kg in maize samples, respectively. The quantitative limit of detection (qLOD) was 0.27 and 1.43 µg/kg in PB and maize samples, respectively. The accuracy and precision of the PMs-ICA were evaluated by analysis of spiked maize samples with recoveries of 96.0% to 107.6% with coefficients of variation below 10%. In addition, the reliability of PMs-ICA was confirmed by the liquid chromatography-tandem mass spectrometry method. The results indicated that the PMs-ICA could be used as a sensitive, simple, rapid point-of-care testing of AFB1 in maize.


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