Accuracy, Ease of Use, Safety, and Acceptability of a 23-?L Conical Cup Blood Transfer Device for Use with Rapid Diagnostic Tests.
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ABSTRACT:
SUBMITTER: Incardona S
PROVIDER: S-EPMC6169173 | biostudies-literature | 2018 Sep
REPOSITORIES: biostudies-literature
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Accuracy, Ease of Use, Safety, and Acceptability of a 23-μL Conical Cup Blood Transfer Device for Use with Rapid Diagnostic Tests.
Incardona Sandra S Kyabayinze Daniel J DJ Bell David D Ndawula Bbale B Kanyago Marvis C MC Mwancha-Kwasa Magoma C MC González Iveth J IJ
The American journal of tropical medicine and hygiene 20180712 3
Devices to safely transfer fixed amounts of finger prick blood to rapid diagnostic tests (RDTs) pose a significant challenge, especially in non-laboratory settings. Following the success of an "inverted cup device" for transfer of 5 μL blood, a prototype with a conical cup shape was developed for transfer of 20 μL blood, the amount needed for human immunodeficiency virus or human African trypanosomiasis (HAT) RDTs. This study determined the volume of blood transferred by this new blood transfer ...[more]
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Project description:BackgroundMalaria rapid diagnostic tests (RDTs) are increasingly used by remote health personnel with minimal training in laboratory techniques. RDTs must, therefore, be as simple, safe and reliable as possible. Transfer of blood from the patient to the RDT is critical to safety and accuracy, and poses a significant challenge to many users. Blood transfer devices were evaluated for accuracy and precision of volume transferred, safety and ease of use, to identify the most appropriate devices for use with RDTs in routine clinical care.MethodsFive devices, a loop, straw-pipette, calibrated pipette, glass capillary tube, and a new inverted cup device, were evaluated in Nigeria, the Philippines and Uganda. The 227 participating health workers used each device to transfer blood from a simulated finger-prick site to filter paper. For each transfer, the number of attempts required to collect and deposit blood and any spilling of blood during transfer were recorded. Perceptions of ease of use and safety of each device were recorded for each participant. Blood volume transferred was calculated from the area of blood spots deposited on filter paper.ResultsThe overall mean volumes transferred by devices differed significantly from the target volume of 5 microliters (p < 0.001). The inverted cup (4.6 microliters) most closely approximated the target volume. The glass capillary was excluded from volume analysis as the estimation method used is not compatible with this device. The calibrated pipette accounted for the largest proportion of blood exposures (23/225, 10%); exposures ranged from 2% to 6% for the other four devices. The inverted cup was considered easiest to use in blood collection (206/226, 91%); the straw-pipette and calibrated pipette were rated lowest (143/225 [64%] and 135/225 [60%] respectively). Overall, the inverted cup was the most preferred device (72%, 163/227), followed by the loop (61%, 138/227).ConclusionsThe performance of blood transfer devices varied in this evaluation of accuracy, blood safety, ease of use, and user preference. The inverted cup design achieved the highest overall performance, while the loop also performed well. These findings have relevance for any point-of-care diagnostics that require blood sampling.
| S-EPMC3041722 | biostudies-literature
Project description:BackgroundAntigen-detecting rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 are important diagnostic tools. We assessed clinical performance and ease-of-use of seven Ag-RDTs in a prospective, manufacturer-independent, multi-centre cross-sectional diagnostic accuracy study to inform global decision makers.MethodsUnvaccinated participants suspected of a first SARS-CoV-2 infection were recruited at six sites (Germany, Brazil). Ag-RDTs were evaluated sequentially, with collection of paired swabs for routine reverse transcription polymerase chain reaction (RT-PCR) testing and Ag-RDT testing. Performance was compared to RT-PCR overall and in sub-group analyses (viral load, symptoms, symptoms duration). To understandusability a System Usability Scale (SUS) questionnaire and ease-of-use (EoU) assessment were performed.Findings7471 participants were included in the analysis. Sensitivities across Ag-RDTs ranged from 70·4%-90·1%, specificities were above 97·2% for all Ag-RDTs but one (93·1%).Ag-RDTs, Mologic, Bionote, Standard Q, showed diagnostic accuracy in line with WHO targets (> 80% sensitivity, > 97% specificity). All tests showed high sensitivity in the first three days after symptom onset (≥87·1%) and in individuals with viral loads≥ 6 log10SARS-CoV2 RNA copies/mL (≥ 88·7%). Usability varied, with Rapigen, Bionote and Standard Q reaching very good scores; 90, 88 and 84/100, respectively.InterpretationVariability in test performance is partially explained by variable viral loads in population evaluated over the course of the pandemic. All Ag-RDTs reach high sensitivity early in the disease and in individuals with high viral loads, supporting their role in identifying transmission relevant infections. For easy-to-use tests, performance shown will likely be maintained in routine implementation.FundingMinistry of Science, Research and Arts, State of Baden-Wuerttemberg, Germany, internal funds from Heidelberg University Hospital, University Hospital Charité - Universitätsmedizin Berlin, UK Department of International Development, WHO, Unitaid.
| S-EPMC8702380 | biostudies-literature
Project description:BackgroundGirls and women need effective, safe, and affordable menstrual products. Single-use products are regularly selected by agencies for resource-poor settings; the menstrual cup is a less known alternative. We reviewed international studies on menstrual cup leakage, acceptability, and safety and explored menstrual cup availability to inform programmes.MethodsIn this systematic review and meta-analysis, we searched PubMed, Cochrane Library, Web of Science, Popline, Cinahl, Global Health database, Emerald, Google Scholar, Science.gov, and WorldWideScience from database inception to May 14, 2019, for quantitative or qualitative studies published in English on experiences and leakage associated with menstrual cups, and adverse event reports. We also screened the Manufacturer and User Facility Device Experience database from the US Food and Drug Administration for events related to menstrual cups. To be eligible for inclusion, the material needed to have information on leakage, acceptability, or safety of menstrual cups. The main outcome of interest was menstrual blood leakage when using a menstrual cup. Safety outcomes of interest included serious adverse events; vaginal abrasions and effects on vaginal microflora; effects on the reproductive, digestive, or urinary tract; and safety in poor sanitary conditions. Findings were tabulated or combined by use of forest plots (random-effects meta-analysis). We also did preliminary estimates on costs and environmental savings potentially associated with cups. This systematic review is registered on PROSPERO, number CRD42016047845.FindingsOf 436 records identified, 43 studies were eligible for analysis (3319 participants). Most studies reported on vaginal cups (27 [63%] vaginal cups, five [12%] cervical cups, and 11 [25%] mixed types of cups or unknown) and 15 were from low-income and middle-income countries. 22 studies were included in qualitative or quantitative syntheses, of which only three were of moderate-to-high quality. Four studies made a direct comparison between menstrual cups and usual products for the main outcome of leakage and reported leakage was similar or lower for menstrual cups than for disposable pads or tampons (n=293). In all qualitative studies, the adoption of the menstrual cup required a familiarisation phase over several menstrual cycles and peer support improved uptake (two studies in developing countries). In 13 studies, 73% (pooled estimate: n=1144; 95% CI 59-84, I2=96%) of participants wished to continue use of the menstrual cup at study completion. Use of the menstrual cup showed no adverse effects on the vaginal flora (four studies, 507 women). We identified five women who reported severe pain or vaginal wounds, six reports of allergies or rashes, nine of urinary tract complaints (three with hydronephrosis), and five of toxic shock syndrome after use of the menstrual cup. Dislodgement of an intrauterine device was reported in 13 women who used the menstrual cup (eight in case reports, and five in one study) between 1 week and 13 months of insertion of the intrauterine device. Professional assistance to aid removal of menstrual cup was reported among 47 cervical cup users and two vaginal cup users. We identified 199 brands of menstrual cup, and availability in 99 countries with prices ranging US$0·72-46·72 (median $23·3, 145 brands).InterpretationOur review indicates that menstrual cups are a safe option for menstruation management and are being used internationally. Good quality studies in this field are needed. Further studies are needed on cost-effectiveness and environmental effect comparing different menstrual products.FundingUK Medical Research Council, Department for International Development, and Wellcome Trust.
| S-EPMC6669309 | biostudies-literature
Project description:PurposeRapid antigen-detecting tests (Ag-RDTs) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can transform pandemic control. Thus far, sensitivity (≤ 85%) of lateral-flow assays has limited scale-up. Conceivably, microfluidic immunofluorescence Ag-RDTs could increase sensitivity for SARS-CoV-2 detection.MethodsThis multi-centre diagnostic accuracy study investigated performance of the microfluidic immunofluorescence LumiraDx™ assay, enrolling symptomatic and asymptomatic participants with suspected SARS-CoV-2 infection. Participants collected a supervised nasal mid-turbinate (NMT) self-swab for Ag-RDT testing, in addition to a professionally collected nasopharyngeal (NP) swab for routine testing with reverse transcriptase polymerase chain reaction (RT-PCR). Results were compared to calculate sensitivity and specificity. Sub-analyses investigated the results by viral load, symptom presence and duration. An analytical study assessed exclusivity and limit-of-detection (LOD). In addition, we evaluated ease-of-use.ResultsThe study was conducted between November 2nd 2020 and 4th of December 2020. 761 participants were enrolled, with 486 participants reporting symptoms on testing day. 120 out of 146 RT-PCR positive cases were detected positive by LumiraDx™, resulting in a sensitivity of 82.2% (95% CI 75.2-87.5%). Specificity was 99.3% (CI 98.3-99.7%). Sensitivity was increased in individuals with viral load ≥ 7 log10 SARS-CoV2 RNA copies/ml (93.8%; CI 86.2-97.3%). Testing against common respiratory commensals and pathogens showed no cross-reactivity and LOD was estimated to be 2-56 PFU/mL. The ease-of-use-assessment was favourable for lower throughput settings.ConclusionThe LumiraDx™ assay showed excellent analytical sensitivity, exclusivity and clinical specificity with good clinical sensitivity using supervised NMT self-sampling.Trial registration number and registration dateDRKS00021220 and 01.04.2020.
| S-EPMC8358901 | biostudies-literature
Project description:To prevent transmission in Ebola Virus Disease (EVD) outbreaks, it is recommended to disinfect living things (hands and people) with 0.05% chlorine solution and non-living things (surfaces, personal protective equipment, dead bodies) with 0.5% chlorine solution. In the current West African EVD outbreak, these solutions (manufactured from calcium hypochlorite (HTH), sodium dichloroisocyanurate (NaDCC), and sodium hypochlorite (NaOCl)) have been widely used in both Ebola Treatment Unit and community settings. To ensure solution quality, testing is necessary, however test method appropriateness for these Ebola-relevant concentrations has not previously been evaluated. We identified fourteen commercially-available methods to test Ebola-relevant chlorine solution concentrations, including two titration methods, four DPD dilution methods, and six test strips. We assessed these methods by: 1) determining accuracy and precision by measuring in quintuplicate five different 0.05% and 0.5% chlorine solutions manufactured from NaDCC, HTH, and NaOCl; 2) conducting volunteer testing to assess ease-of-use; and, 3) determining costs. Accuracy was greatest in titration methods (reference-12.4% error compared to reference method), then DPD dilution methods (2.4-19% error), then test strips (5.2-48% error); precision followed this same trend. Two methods had an accuracy of <10% error across all five chlorine solutions with good precision: Hach digital titration for 0.05% and 0.5% solutions (recommended for contexts with trained personnel and financial resources), and Serim test strips for 0.05% solutions (recommended for contexts where rapid, inexpensive, and low-training burden testing is needed). Measurement error from test methods not including pH adjustment varied significantly across the five chlorine solutions, which had pH values 5-11. Volunteers found test strip easiest and titration hardest; costs per 100 tests were $14-37 for test strips and $33-609 for titration. Given the ease-of-use and cost benefits of test strips, we recommend further development of test strips robust to pH variation and appropriate for Ebola-relevant chlorine solution concentrations.
| S-EPMC4887006 | biostudies-literature
Project description:BackgroundAccurate cup placement during total hip arthroplasty (THA) is difficult because the intraoperative pelvic position changes even in supine patient position. We developed a device known as HipPointer; it corrects pelvic rotation and creates a functional pelvic plane as a reference. The aim of this study was to determine the device placement accuracy and investigate causes of error.Material and methodsHipPointer was used for cup placement in 353 hips of 308 patients who underwent direct-anterior-approach THA in supine position. The mean age at surgery and body mass index were 63.9 (17-90) years and 24.9 (16.6-42.0) kg/m2, respectively. The mean observation period was 40.5 (12-73) months. To investigate the accuracy of HipPointer, preoperative planning and postoperative cup placement angles relative to the functional pelvic plane were evaluated using a three-dimensional analysis software, and absolute errors were determined.ResultsThe means ± standard deviations of radiographic inclination (RI) and radiographic anteversion (RA) were 40.2 ± 3.0° and 15.8 ± 3.6°, respectively. The absolute errors of RI and RA were 2.2 ± 2.0° and 2.7 ± 2.3°, respectively. The ratio of the cup placement angle for which both RI and RA are ≤10° in the target zone was 99% (350/353 hips), and the ratio of the absolute errors for which both RI and RA are ≤5° was 80.4% (284/353 hips).ConclusionsHipPointer is simple in structure, easy to use, and useful for direct-anterior-approach THA in supine position. It provides good cup placement accuracy.
| S-EPMC9133511 | biostudies-literature
Project description:ObjectivesSelf-collection of cervico-vaginal samples for human papillomavirus (HPV) testing has the potential to make cervical cancer screening more accessible to underscreened women. We evaluated the acceptability and ease of use of home-based HPV self-collection within a diverse population of low-income, infrequently screened women.MethodsParticipants were low-income women from North Carolina who had not received Pap testing in 4 or more years. Eligible women received a self-collection kit containing instructions and a brush for home-based sample collection. A total of 227 women returned a self-collected sample by mail and completed a questionnaire to assess their experiences with HPV self-collection. We described acceptability measures and used logistic regression to identify predictors of overall positive thoughts about the self-collection experience.ResultsNearly all women were willing to perform HPV self-collection again (98%) and were comfortable receiving the self-collection kit in the mail (99%). Overall, 81% of participants reported positive thoughts about home-based self-collection. Women with at least some college education and those who were divorced, separated or widowed were more likely to report overall positive thoughts. Aspects of self-collection that participants most commonly reported liking included convenience (53%), ease of use (32%) and privacy (23%). The most frequently reported difficulties included uncertainty that the self-collection was done correctly (16%) and difficulty inserting the self-collection brush (16%).ConclusionsHome-based self-collection for HPV was a highly acceptable screening method among low-income, underscreened women and holds the promise to increase access to cervical cancer screening in this high-risk population.
| S-EPMC5831249 | biostudies-literature
Project description:Introduction:It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but only approximately 11% of prevalent dialysis patients use this modality. Connection-assist devices can overcome the challenges posed by decreased manual dexterity and/or visual acuity, and can allow more patients to be treated with home-based therapies. As part of the CE marking authorization, a connection device has been evaluated for safety and ease of use in a usability study. Methods:Fifteen patients and nine carers volunteered in this study, ranging from 23 to 86 years in age and from 0.3 to 24 years in experience in the PD therapy. The operating cycle consisted of eight tasks, each having several handling steps. The data analysis focused on the task effectiveness and the subjects' subjective feedback from the NASA task load index (N-TLX) questionnaire and semi-structured interviews. Results:Of 1248 handling steps performed in total, 38 use errors were observed and discussed with the subjects. This equates to 97% of all handling steps being performed safely and easily. In all six dimensions of the N-TLX, more than 50 percent of subjects rated the task load 50 points or less on the scale. Regarding the handling of the device, 13 of 15 of the patients and 8 of 9 of the carers gave positive feedback. Discussion:Safety and ease of use was demonstrated by evaluating task effectiveness (97% SU), interviews and N-TLX. Additionally the study provided valuable individual user feedback, which will inform the final design of the system for PD. The majority of patients and carers gave positive feedback regarding use and handling of this connection device. Innovative connection devices in general promise to reduce the barriers to using this home-based dialysis treatment.
| S-EPMC6825503 | biostudies-literature
Project description:Our objective was to compare the diagnostic accuracies of and to determine the correlations between the disc damage likelihood scale (DDLS) and anatomical and functional tests used for glaucoma detection. A total of 54 healthy subjects (54 eyes) and 47 primary open-angle glaucoma patients (47 eyes) were included in this cross-sectional observational study. DDLS scores and cup-to-disc (C/D) ratios were evaluated. Subjects underwent standard automated perimetry (SAP), optic disc and retinal nerve fiber layer (RNFL) imaging with time and spectral-domain optical coherence tomography (TD and SD-OCT), Heidelberg Retina Tomograph (HRT II), and scanning laser polarimetry (GDx-VCC). Areas under the receiver operating characteristic curves (AROCs) for DDLS and diagnostic tests parameters were calculated. DDLS correlations (Spearman's rank) among these parameters were analyzed. Fifty-four eyes were healthy and 47 had glaucoma, including 16 preperimetric glaucoma. DDLS, vertical and horizontal C/D ratios had the largest AROCs (0.92, 0.94 and 0.91, respectively). DDLS diagnostic accuracy was better than the accuracies of HRT II parameters, TD and SD-OCT RNFL thicknesses, and SAP mean deviation (MD) index. There were no significant differences between the accuracies of the DDLS and the C/D ratios, TD-OCT vertical (0.89) and horizontal (0.86) C/D ratios, TD-OCT C/D area ratio (0.89), and GDx-VCC NFI (0.81). DDLS showed significant strong correlations with vertical (r = 0.79) and horizontal (0.74) C/D ratios, and with the parameters vertical C/D ratio and C/D area ratio from HRT II (both 0.77) and TD-OCT (0.75 and 0.72, respectively). DDLS had significant moderate correlations with most of the other structural measurements and SAP MD. The optic disc clinical evaluation with DDLS system and C/D ratio demonstrated excellent accuracy in distinguishing glaucomatous from healthy eyes. DDLS had moderate to strong correlations with most structural and functional parameters. These findings stress the importance of optic disc clinical examination to detect glaucoma in a clinical scenario.
| S-EPMC5519156 | biostudies-literature
Project description:BackgroundThe fecal immunochemical test (FIT) is widely used in colorectal cancer (CRC) screening, but limited data exist for its application in individuals at above-average risk for CRC who complete surveillance colonoscopies.AimTo assess the accuracy, acceptability, and effectiveness of FIT in the interval between surveillance colonoscopies, for predicting advanced neoplasia (advanced adenoma or CRC) at the next colonoscopy.MethodsIndividuals enrolled in an Australian surveillance program were included. Diagnostic accuracy was determined for 614 individuals completing a two-sample FIT (OC-Sensor) ≤ 3 months preceding surveillance colonoscopy. 386 Individuals were surveyed to assess acceptability of interval FIT. Additionally, a retrospective analysis was performed on 7331 individuals offered interval FIT between colonoscopies, where a positive FIT (≥ 20 µg hemoglobin/g feces) triggered an early colonoscopy. Associations between interval FIT results and advanced neoplasia were determined using regression analysis.ResultsFIT detected CRC and advanced adenoma with sensitivities of 60.0% (3/5) and 27.1% (35/129), respectively. Most (89.1%, 344/386) survey respondents preferred completing interval FIT every 1-2 years. The detection rate of interval FIT for advanced neoplasia decreased with increasing FIT completion. Individuals returning a positive FIT had a higher risk of advanced neoplasia than those who did not complete FIT. Positive interval FIT reduced time-to-diagnosis for CRC and advanced adenoma by a median of 30 and 20 months, respectively.ConclusionInterval FIT was well accepted and enabled earlier detection of advanced neoplasia in individuals at above-average risk of CRC. Given that interval FIT predicts advanced neoplasia, it may be used to personalize surveillance colonoscopy intervals.
| S-EPMC11258152 | biostudies-literature