Fingerstick Capillary Blood Research Articles

Evaluation of Specimen Types for Pima CD4 Point-of-Care Testing: Advantages of Fingerstick Blood Collection into an EDTA Microtube.

IntroductionEffective point-of-care testing (POCT) is reliant on optimal specimen collection, quality assured testing, and expedited return of results. Many of the POCT are designed to be used with fingerstick capillary blood to simplify the blood collection burden. However, fingerstick blood collection has inherent errors in sampling. An evaluation of the use of capillary and venous blood with CD4 POCT was conducted.MethodsThree different specimen collection methods were evaluated for compatibility using the Alere Pima CD4 assay at 5 HIV/AIDS healthcare sites in Dar es Salaam, Tanzania. At each site, whole blood specimens were collected from enrolled patients by venipuncture and fingerstick. Pima CD4 testing was performed at site of collection on venipuncture specimens (Venous) and fingerstick blood directly applied to a Pima CD4 cartridge (Capillary-Direct) and collected into an EDTA microtube (Capillary-Microtube). Venous blood was also tested at the laboratory by the reference CD4 method and Pima for comparison analysis.ResultsAll three specimen collection methods were successfully collected by healthcare workers for use with the Pima CD4 assay. When compared to the reference CD4 method, Pima CD4 testing with the Capillary-Microtube method performed similarly to Venous, while Pima CD4 counts with the Capillary-Direct method were slightly more biased (-20 cells/μL) and variable (-229 to +189 cells/μL limit of agreement). Even though all three collection methods had similar invalid Pima testing rates (10.5%, 9.8%, and 8.3% for Capillary-Direct, Capillary-Microtube, and Venous respectively), the ability to perform repeat testing with Capillary-Microtube and Venous specimens increased the likelihood of acquiring a valid CD4 result with the Pima assay.ConclusionsCapillary blood, either directly applied to Pima CD4 cartridges or collected in an EDTA microtube, and venous blood are suitable specimens for Pima CD4 testing. The advantages of capillary blood collection in an EDTA microtube are that it uses fingerstick collection which mimics venous blood and allows extra testing without additional blood collection.

Phosphorylated histone 2AX foci determination in capillary blood mononuclear cells

Background: One of the most severe variants of DNA lesions is the DNA double-strand break (DSB). Generally, non-physiological DSBs occur as a result of ionizing radiation, oxidative or mechanical stress and chemical effects. DSBs can be detected by phosphorylated histone 2AX (γH2AX) foci analysis using indirect immunofluorescence assay (IFA). Peripheral blood mononuclear cells (PBMCs) obtained by venipuncture and density gradient centrifugation have mainly been used for DSB assessment applying IFA but capillary blood mononuclear cells (CBMCs) could be an alternative facilitating DSB analysis. Methods: CBMCs and PBMCs were isolated from capillary and venous blood of ten human volunteers. Nuclear characteristics and DSBs induced by etoposide were determined by IFA using an automated microscopy interpretation system for DNA damage assessment. Results: The number of isolated PBMCs and CBMCs, their nuclear characteristics as well as the number and characteristics of etoposide-induced DSBs were not significantly different in capillary and venous cells (P>0.05). Conclusions: CBMCs isolated from capillary finger stick blood can be used for DSB analysis by γH2AX foci assessment instead of PBMCs obtained by venipuncture. The use of CBMCs could enhance the implementation of γH2AX as a biomarker for individual diagnostics in precision medicine.

Correlations between gingival crevicular blood glucose and capillary blood glucose: A preliminary report.

INTRODUCTION:Oral health plays an important role for screening of many systemic diseases. Hence, dentists play an important role in screening for systemic diseases as well. Early diagnosis of any systemic diseases can prevent long-term complications. Diabetic is one of the common chronic diseases. Hence, the study had been undertaken to evaluate whether gingival crevicular blood (GCB) can be used to screen for diabetes during routine oral health checkups.MATERIALS AND METHODS:This analytical study included thirty participants who visited the Department of Periodontics, who fulfilled inclusion criteria and were willing to participate. Blood samples were collected by finger stick method and periodontal probing. The glucose levels of both the samples were estimated using glucometer and correlated the levels from both the methods.RESULTS:Correlation between capillary finger stick blood glucose and GCB glucose was high (0.97) and was significant at 0.01 level.CONCLUSION:Blood oozing during routine periodontal examination can be used for diabetes mellitus screening in dental office.

Wearable physiological systems and technologies for metabolic monitoring.

Wearable sensors allow continuous monitoring of metabolites for diabetes, sports medicine, exercise science, and physiology research. These sensors can continuously detect target analytes in skin interstitial fluid (ISF), tears, saliva, and sweat. In this review, we will summarize developments on wearable devices and their potential applications in research, clinical practice, and recreational and sporting activities. Sampling skin ISF can require insertion of a needle into the skin, whereas sweat, tears, and saliva can be sampled by devices worn outside the body. The most widely sampled metabolite from a wearable device is glucose in skin ISF for monitoring diabetes patients. Continuous ISF glucose monitoring allows estimation of the glucose concentration in blood without the pain, inconvenience, and blood waste of fingerstick capillary blood glucose testing. This tool is currently used by diabetes patients to provide information for dosing insulin and determining a diet and exercise plan. Similar technologies for measuring concentrations of other analytes in skin ISF could be used to monitor athletes, emergency responders, warfighters, and others in states of extreme physiological stress. Sweat is a potentially useful substrate for sampling analytes for metabolic monitoring during exercise. Lactate, sodium, potassium, and hydrogen ions can be measured in sweat. Tools for converting the concentrations of these analytes sampled from sweat, tears, and saliva into blood concentrations are being developed. As an understanding of the relationships between the concentrations of analytes in blood and easily sampled body fluid increases, then the benefits of new wearable devices for metabolic monitoring will also increase.

Performance evaluation of BD FACSPresto™ point of care CD4 analyzer to enumerate CD4 counts for monitoring HIV infected individuals in Nigeria.

BackgroundDespite the upsurge in support and intervention of donor agencies in HIV care and treatment programing in Sub-Sahara African, antiretroviral (ART) programs are still confronted with access and coverage challenges which influence enrolment of new patients. This study investigated the validity of point of care BD FACSPresto™ CD4 analyzer for CD4+ cell count, overall agreement, correlation, sensitivity, and specificity in comparison to a reference standard flow cytometry method. We also assessed the feasibility of use among non-laboratorians.MethodsBlood samples from 300 HIV infected individuals were analyzed for CD4+ T cell and CD4%, using finger prick capillary sample from 150 PMTCT clients and 150 ART clients at Murtala Mohammed Specialist Hospital, Kano, Nigeria. Their venous samples were compared on a flow cytometry reference method using BD FACSCount CD4+ count system. The accuracy of the BD FACSPresto machine in comparison to BD FACSCount was evaluated. Statistical analysis was carried out using STATA (version 12). Bland-Altman method and correlation analysis were used to analyze agreement between both measurements. In addition, sensitivity and specificity of both measurements were determined. Statistical significance was set at p-value <0.05.ResultsThe mean bias and limit of agreement for CD4+ count between BD FACSPresto and BD FACS count machine were 7.49 (95% CI: 2.44 to 12.54) and -8.14 to 96.39 respectively. Further analysis revealed close agreement between BD FACSPresto and BD FACSCount with no significant difference between the two methods (p = .0.95). Using a threshold of 500 cells/μL, sensitivity and specificity of BD FACSPresto were 95.1% and 97.1% respectively, compared to BD FACSCount. There was no statistically significant difference in the misclassification between BD FACSPresto and BD FACSCount results (p = 0.23). Furthermore, sensitivity and specificity were similar when BD FACSPresto machine was operated by a nurse or laboratory scientist, there was no substantial difference in testing variability observed between laboratory and non-laboratory operators using the BD FACSPresto analyzer.ConclusionsOverall, BD FACSPresto Point of Care CD4+ count finger stick capillary blood results is a reliable method in comparison to venous sample cytometry method and no significant difference variability observed between laboratory personnel and non-laboratory operators. The BD FACSPresto is simple, more robust and easy to use equipment without significant variability in reliability by non-laboratory health care workers hence will be a valuable instrument in increasing access and coverage of CD4 estimations in developing countries. The introduction of the BD FACSPresto POC analyzer has a high potential in reducing patients waiting time and improving the overall quality of ART service and clients’ satisfaction especially in rural settings.

The Effects of a 36-Hour Mixed Task Ultraendurance Race on Mucosal Immunity Markers and Pulmonary Function

The present study was conducted to assess the changes in mucosal immunity and pulmonary function among participants in a 36-hour mixed task ultraendurance race. Thirteen of the 20 race participants volunteered for the investigation (age 34±5 y). The event consisted of a mixture of aerobic, strong man, and military-style exercise. Participants had a pulmonary function test and gave a finger stick capillary blood sample and unstimulated saliva samples both before the event and upon dropout or completion. The blood sample was analyzed for hematocrit, and the saliva sample was analyzed for salivary flow rate, salivary alpha amylase, salivary immunoglobulin A (IgA), and IgA type 1. Significant differences were noted among the finishers and those who dropped out in salivary flow rate (P = .026), salivary IgA (P = .017), and peak expiratory flow (P = .05) measurements. Salivary flow rate and IgA for the race finishers were reduced from pre- to postrace, whereas the nonfinishers showed no change or small increases. No significant differences emerged for other variables. Based on the results of the present investigation, finishing a 36-hour mixed task ultra-endurance event results in a decline in both pulmonary function and mucosal immunity compared with competitors who do not finish.

The end of the hepatitis C burden: Really?

The end of the hepatitis C burden: Really?

The use of finger-stick blood to assess lactate in critically ill surgical patients

BackgroundUsing finger-stick capillary blood to assess lactate from the microcirculation may have utility in treating critically ill patients. Our goals were to determine how finger-stick capillary lactate correlates with arterial lactate levels in patients from the surgical intensive care unit, and to compare how capillary and arterial lactate trend over time in patients undergoing resuscitation for shock.MethodsCapillary whole blood specimens were obtained from finger-sticks using a lancet, and assessed for lactate via a handheld point-of-care device as part of an “investigational use only” study. Comparison was made to arterial blood specimens that were assessed for lactate by standard laboratory reference methods.Results40 patients (mean age 68, mean APACHEII 18, vasopressor use 62%) were included. The correlation between capillary and arterial lactate levels was 0.94 (p < 0.001). Capillary lactate measured slightly higher on average than paired arterial values, with a mean difference 0.99 mmol/L. In patients being resuscitated for septic and hemorrhagic shock, capillary and arterial lactate trended closely over time: rising, peaking, and falling in tandem. Clearance of capillary and arterial lactate mirrored clinical improvement, normalizing in all patients except two that expired.ConclusionFinger-stick capillary lactate both correlates and trends closely with arterial lactate in critically ill surgical patients, undergoing resuscitation for shock.

Performance Evaluation of the Becton Dickinson FACSPresto™ Near-Patient CD4 Instrument in a Laboratory and Typical Field Clinic Setting in South Africa.

BackgroundThe BD-FACSPresto™ CD4 is a new, point-of-care (POC) instrument utilising finger-stick capillary blood sampling. This study evaluated its performance against predicate CD4 testing in South Africa.MethodsPhase-I testing: HIV+ patient samples (n = 214) were analysed on the Presto™ under ideal laboratory conditions using venous blood. During Phase-II, 135 patients were capillary-bled for CD4 testing on FACSPresto™, performed according to manufacturer instruction. Comparative statistical analyses against predicate PLG/CD4 method and industry standards were done using GraphPad Prism 6. It included Bland-Altman with 95% limits of agreement (LOA) and percentage similarity with coefficient of variation (%CV) analyses for absolute CD4 count (cells/μl) and CD4 percentage of lymphocytes (CD4%).ResultsIn Phase-I, 179/217 samples yielded reportable results with Presto™ using venous blood filled cartridges. Compared to predicate, a mean bias of 40.4±45.8 (LOA of -49.2 to 130.2) and %similarity (%CV) of 106.1%±7.75 (7.3%) was noted for CD4 absolute counts. In Phase-2 field study, 118/135 capillary-bled Presto™ samples resulted CD4 parameters. Compared to predicate, a mean bias of 50.2±92.8 (LOA of -131.7 to 232) with %similarity (%CV) 105%±10.8 (10.3%), and 2.87±2.7 (LOA of -8.2 to 2.5) with similarity of 94.7±6.5% (6.83%) noted for absolute CD4 and CD4% respectively. No significant clinical differences were indicated for either parameter using two sampling methods.ConclusionThe Presto™ produced remarkable precision to predicate methods, irrespective of venous or capillary blood sampling. A consistent, clinically insignificant over-estimation (5–7%) of counts against PLG/CD4 and equivalency to FACSCount™ was noted. Further field studies are awaited to confirm longer-term use.

Development and validation of HILIC-ESI/MS/MS methods for simultaneous quantitation of several antipsychotics in human plasma and blood.

Knowledge of antipsychotic drug levels at point of care (POC) may significantly aid therapeutic decision-making. To support the development of future POC devices and to validate the use of fingerstick capillary blood sampling, two robust hydrophilic interaction LC-ESI/MS/MS methods were developed and validated. Two PK studies were completed evaluating the correlation between fingerstick blood and plasma concentrations with corresponding venous blood and plasma concentrations for several commonly prescribed atypical antipsychotics and selected metabolites. Sensitive and reliable LC-MS/MS bioanalytical assays were developed to support these studies. Three methods, requiring only 25-μl matrix volumes, were developed using supported liquid extraction with hydrophilic interaction LC-MS/MS detection and validated according to regulatory guidance. Robust and efficient LC-MS/MS assays were established and were effective in providing antipsychotic drug matrix comparator results in the intended clinical studies.

DOP039. Point-of-care monitoring of infliximab trough levels in capillary fingerstick blood of patients with inflammatory bowel disease (IBD)

DOP039. Point-of-care monitoring of infliximab trough levels in capillary fingerstick blood of patients with inflammatory bowel disease (IBD)

Prospective assessment of rapid diagnostic tests for the detection of antibodies to hepatitis C virus, a tool for improving access to care

Large-scale hepatitis C screening is required to prevent further spread of the infection, improve access to care in the context of new hepatitis C virus (HCV) drug regimens without interferon-alpha and subsequently reduce the risk of long-term complications of chronic liver disease. Rapid diagnostic tests (RDTs) represent an attractive alternative to enzyme immunoassay using blood from venepuncture. The aim of the present study was to prospectively assess the clinical performance of CE-marked RDTs detecting anti-HCV antibodies in fingerstick capillary whole blood and/or oral fluid. A total of 513 individuals, including 318 patients with chronic HCV infection, 25 patients with resolved HCV infection and 170 HCV-seronegative individuals, were prospectively enrolled. The specificity of RDTs with fingerstick whole blood varied from 98.8% to 100%. The clinical sensitivity was high for the OraQuick® and Toyo® tests (99.4% and 95.8%, respectively), but low for the Labmen® test (63.1%). The specificity and clinical sensitivity in crevicular fluid were both satisfactory for the OraQuick® test (100% and 97.6%, respectively). HCV antibody RDTs were easy and rapid to perform in the context of patient care. They were highly specific. Both the OraQuick® and Toyo® tests reached the expected level of performance for wide-scale use, with a performance advantage for the OraQuick® HCV test. RDTs appear to be a promising new tool for wide-scale screening of HCV infection in high-risk to medium-risk populations. Hence, careful assessment of the performance of HCV RDTs must be recommended before they can be implemented in clinical practice.

Developing a chair side, safe and non-invasive procedure for assessment of blood glucose level using gingival crevicular bleeding in dental clinics.

Aim:To study the accessibility of chair side blood glucose non-invasive screening method for diabetes mellitus during routine periodontal examination.Materials and Methods:Fifteen non-diabetics and 15 newly onset type 2 diabetics patients with moderate to severe periodontitis were selected after meeting inclusion and exclusion criteria. Periodontal pocket probing was performed using a Williams Graduated periodontal probe. Blood oozing from gingival sulcus of anterior teeth following periodontal pocket probing was collected with stick of a glucose self-monitoring device. As control, finger stick capillary blood was taken.Results:A statistically significant correlation was observed between the blood glucose level of gingival crevicular blood (GCB) and peripheral fasting blood (PFB) of diabetic subjects. The mean GCB glucose level of the subjects in diabetic group was 172.27 ± 5.02 mg/dl while mean PFB glucose was 167.80 ± 8.87 mg/dl. The correlation coefficient of diabetic and non-diabetic subjects were r = +0.715 and r = +0.619, respectively.Conclusion:The results suggested that blood oozing during routine periodontal examination may be used for diabetic mellitus screening in a dental office setting without the need for any extra procedure.

Diagnostic Efficacy of Gingival Crevicular Blood for Assessment of Blood Glucose Levels in Dental Office: A cross Sectional Study

Objectives: The gingival crevicular blood (GCB) obtained during routine periodontal probing may be a source for blood glucose measurements. The aim of this study was to compare gingival crevicular blood and fingerstick blood glucose measurements using a glucometer against the conventional laboratory methods. Materials and Methods: The study group comprised of three groups. In the first group 30 patients with periodontitis and positive bleeding on probing were chosen. Blood samples of two sites intraorally were analyzed using a glucose self-monitoring device. The second and third group comprised of 50 diabetic and 50 non-diabetic patients. After testing fasting plasma glucose (FPG), fasting glucose levels in gingival crevicular blood (GCBG), and fasting capillary fingerstick blood (CFBG) samples were analyzed using same device. Results: Significant correlation (r= 0.93, p<0.001) was found between gingival crevicular blood glucose levels and capillary finger stick blood glucose levels. Considerable correlation (r=0.75, p<0.001) was found between levels of fasting gingival crevicular blood glucose and fasting blood glucose both in diabetic patients and the normal population. Conclusion: It is evident that the blood obtained during routine periodontal probing can be used for estimation of blood glucose levels. GCB can be used as a marker for blood glucose estimation using glucometer. The technique described is safe, easy to perform and helps to increase the frequency of diabetes screening in dental office.

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Introduction: Growing interest in the application of capillary whole blood lactate to clinical medicine has come with the development of handheld point-of-care (POC) devices that use test strip technology similar to glucometers. These POC devices can process tiny aliquots of blood from patient fingersticks, with rapid result turnaround time at the bedside. As such, use of capillary whole blood may have advantages over arterial blood in lactate determination, including speed, ease, and less-invasive specimen acquisition. However, greater understanding of the correlation between capillary whole blood and arterial blood lactate is needed, prior to the use of capillary lactate becoming standard of care in the intensive care unit (ICU). Methods: The study took place in the surgical ICU of an urban teaching hospital. Capillary whole blood specimens were obtained from fingersticks using a lancet, and assessed for lactate using a portable handheld POC lactate analyzer (Nova StatStrip Lactate Point-of-Care Analyzer, Nova Biomedical Corporation, Waltham, MA) as part of an "investigational use only" study. Comparison was made to concurrently drawn arterial blood specimens that were assessed for lactate both by the portable POC device, and by standard reference methods including a blood gas analyzer (BGA) and core lab (CL). Correlation between the various methods was assessed statistically by calculating the Pearson correlation coefficient. Results: Twenty-two patients were included from July to August, 2013. The group had an average age 66 years, mean APACHE II score 15, 50% on vasopressors, and 32% with septic shock. Lactate concentrations ranged from 1 to 20 mmol/L, with a mean lactate concentration of 5 mmol/L. The correlation between POC-capillary and POC-arterial lactate levels was 0.93 (p < 0.001), while the correlation between POC-capillary and BGA-arterial lactate levels was 0.90 (p<0.001). Capillary whole blood lactate trended on average 1.5 mmol/L higher than paired arterial samples run on a BGA. The correlations between POC-arterial and BGA-arterial, and between POC-arterial and CL-arterial lactate levels were both 0.99 (p < 0.001). Conclusions: Fingerstick capillary whole blood lactate measured by a handheld POC device correlated strongly with arterial lactate levels, measured both by the handheld POC device and by BGA. The study group included ICU patients with a high degree of acuity and septic shock. Furthermore, the handheld POC device performed as well as reference methods in calculating arterial lactate in the ICU. Research is underway to determine whether capillary whole blood lactate could be used as a novel biomarker for assessment and resuscitation of critically ill patients.

Development of noninvasive procedure for monitoring blood glucose level using gingival crevicular bleeding

Introduction. Diabetes mellitus (DM) and chronic periodontitis are common chronic diseases in adults. It is usually necessary to provide a sample of capillary blood to measure blood glucose level in diabetics. However, it is possible to obtain blood during periodontal probing without any discomfort. The aim of the study was to evaluate accessibility of chair side noninvasive screening method for blood glucose level in DM during routine periodontal examination. Material and Methods. 15 non diabetics and 15 newly onset type 2 diabetic patients with moderate to severe periodontitis were selected for the study after meeting inclusion and exclusion criteria. Periodontal pocket probing was performed using Williams Graduated periodontal probe. Blood oozing from gingival sulcus of anterior teeth following periodontal pocket probing was collected with a stick of glucose self monitoring device. As control, finger stick capillary blood was taken. Results. Statistically significant correlation was observed between the blood glucose level in gingival crevicular blood (GCB) and peripheral fasting blood (PFB) in diabetic subjects. The mean GCB glucose level in diabetic subjects was 172.27?5.02 mg/dL while mean PFB glucose level was 167.80?8.87 mg/dL. The correlation coefficients for diabetic and non diabetic subjects were r=0.715 and r=0.619, respectively. Conclusion The results suggested that blood oozing during routine periodontal examination may be used for DM screening in dental office without the need for any extra procedure.

Direct-to-Consumer Disease Screening with Finger-Stick Testing: Online Patient Safety Risks

The direct-to-consumer (DTC)6 medical industry (i.e., medical testing and treatment outside of physician oversight) is growing rapidly as the Internet becomes more accessible globally. As several studies have highlighted, this industry offers unproven medical testing, provides testing for unapproved indications, and uses suspect advertising claims (1,–,5). Furthermore, given the prevalence of illicit pharmaceutical marketing (6), consumers are confronted with systemic online self-diagnosis and self-treatment risks that have emerged as a global patient safety and public health issue. One particularly troubling practice DTC companies commonly use is finger-stick (capillary blood) testing for disease screening and diagnosis. Although useful in some clinical point-of-care applications, finger-stick testing carries substantial risks when offered to the consumer for screening, diagnosis, or disease monitoring without professional oversight. Although other nonvenipuncture alternative-site testing carries many of the same risks, we focus specifically on the dangers of finger-stick testing because of its widespread use by DTC vendors. Because of the present situation and the unique patient safety risks we outline below (e.g., low diagnostic sensitivity, strip factors, logistics of testing), creating a regulatory framework for finger-stick testing could ensure legitimate evidence-based applications, patient safety protections, and responsible advertising that accurately reflects risks and utility. Offering DTC finger-stick medical testing in conjunction with information suggesting potentially abnormal results may in fact constitute unauthorized medical practice. According to the Federation of State Medical Boards, medical practice includes “offering or undertaking to prevent or diagnose … by any means … or devices any disease, illness, pain, … or abnormal physical condition of any person … .” (7). Many DTC medical-testing companies seem to fit squarely within this definition. Indeed, a simple Google search for “home testing kits” yields a panoply of DTC finger-stick tests: lipids (total, LDL, and HDL cholesterol; triglycerides), high-sensitivity C-reactive protein (hs-CRP), aspartate …

Screening for Type 2 diabetes mellitus using gingival crevicular blood with self monitoring blood glucose meter

BackgroundThe number of people with Type 2 diabetes mellitus is increasing globally and there is a large group of undiagnosed diabetes mellitus patients. Since the dental practitioners are extremely likely to encounter undiagnosed diabetes mellitus patients, they could play an important role in detecting diabetes in these patients to avoid long term macrovascular and microvascular complications. AimsTo compare the gingival crevicular blood glucose and fingerstick capillary blood glucose levels, and to evaluate the ability of gingival crevicular blood to be used as non-invasive screening test for diabetes mellitus. Material and methods60 patients with chronic periodontitis were recruited for the study. 30 patients were non-diabetic healthy controls and 30 were Type 2 diabetic patients. The gingival crevicular blood and fingerstick capillary blood were evaluated for blood glucose levels by using the Onetouch Ultra blood glucose self monitoring system. Linear relationship between gingival crevicular blood glucose and fingerstick blood glucose were assessed by Pearson's correlation analysis. ResultsA high degree of intra patient correlation was observed between gingival crevicular blood glucose and fingerstick capillary blood glucose in both non-diabetic (r = 0.88) and diabetic group (r = 0.94). There was no significant difference observed between Type 2 diabetic and non-diabetic patients with regard to age, gender, probing pocket depth and clinical attachment level. ConclusionsThe results of this study indicate that gingival crevicular blood can be used for screening of Type 2 diabetes mellitus. However, further studies are needed to confirm these findings with a larger sample size.

Performance Evaluation and Labeling Comprehension of a New Blood Glucose Monitoring System with Integrated Information Management

This study evaluated performance and product labeling of CONTOUR® USB, a new blood glucose monitoring system (BGMS) with integrated diabetes management software and a universal serial bus (USB) port, in the hands of untrained lay users and health care professionals (HCPs). Subjects and HCPs tested subject's finger stick capillary blood in parallel using CONTOUR USB meters; deep finger stick blood was tested on a Yellow Springs Instruments (YSI) glucose analyzer for reference. Duplicate results by both subjects and HCPs were obtained to assess system precision. System accuracy was assessed according to International Organization for Standardization (ISO) 15197:2003 guidelines [within ±15 mg/dl of mean YSI results (samples <75 mg/dl) and ±20% (samples ≥75 mg/dl)]. Clinical accuracy was determined by Parkes error grid analysis. Subject labeling comprehension was assessed by HCP ratings of subject proficiency. Key system features and ease-of-use were evaluated by subject questionnaires. All subjects who completed the study (N = 74) successfully performed blood glucose measurements, connected the meter to a laptop computer, and used key features of the system. The system was accurate; 98.6% (146/148) of subject results and 96.6% (143/148) of HCP results exceeded ISO 15197:2003 criteria. All subject and HCP results were clinically accurate (97.3%; zone A) or associated with benign errors (2.7%; zone B). The majority of subjects rated features of the BGMS as "very good" or "excellent." CONTOUR USB exceeded ISO 15197:2003 system performance criteria in the hands of untrained lay users. Subjects understood the product labeling, found the system easy to use, and successfully performed blood glucose testing.

Screening of gingival crevicular blood glucose and capillary finger blood glucose in the diagnosis of diabetes

Aim: The study aimed at obtaining glucose readings using gingival crevicular blood (GCB) to screen for undiagnosed diabetes during routine dental visits. Materials and Methods: The present study included 50 patients who were divided into two groups, i.e. Group A and Group B, based on bleeding on probing at the site of collection of GCB. Group A participants had blood collected from sites having adequate bleeding on probing, whereas Group B participants had blood collected from sites with little bleeding on probing. GCB and capillary finger-stick blood (CFB] glucose readings were obtained using a self-monitoring glucometer. Statistical Analysis: Correlations between both the samples were done using Pearson's correlation. Results: Group A patients' correlations between GCB and CFB glucose readings were high, whereas in Group B patients, correlations between glucose readings were low. Conclusion: GCB can be an excellent source for screening diabetes during routine dental visits.