Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization.
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ABSTRACT:
SUBMITTER: Hong K
PROVIDER: S-EPMC8226604 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundDecentralized clinical trials offer the promise of reduced patient burden, faster and more diverse recruitment, and have received regulatory support during the COVID-19 pandemic. However, lack of data accuracy or data validation poses a challenge for fully decentralized trials. A mixed data collection modality where onsite measurements are collected at key time points and decentralized measurements are taken at intermediate time points is attractive operationally. To date, the impact of decentralized measurements (which could presumably be less accurate) taken at intermediate time points on statistical inference on the primary or other key time points has not been evaluated.MethodsIn this article we evaluate the estimation and statistical inference for three scenarios: (1) all onsite measurements, (2) a mixture of onsite and decentralized measurements, and (3) all decentralized measurements, in the setting of a chronic weight management trial. We consider scenarios where decentralized measurements have additional within- and between-subject variabilities and/or bias.ResultsIn the mixed modality setting, simulation studies showed that the estimation and inference for the key time points with onsite measurements have good properties and are not impacted by the additional variability and bias from intermediate decentralized measurements. However, estimates for intermediate decentralized time points for the mixed modality and estimates for the all decentralized modality measurements have increased variability and bias.ConclusionMixed modality trials can help achieve the benefits of decentralized clinical trials by reducing the number of onsite visits with little impact on statistical inferences for various estimands, compared to traditional (all onsite) clinical trials.
| S-EPMC9128333 | biostudies-literature
Project description:Blood plasma separation is a prerequisite in numerous biomedical assays involving low abundance plasma-borne biomarkers and thus is the fundamental step before many bioanalytical steps. High-capacity refrigerated centrifuges, which have the advantage of handling large volumes of blood samples, are widely utilized, but they are bulky, non-transportable, and prohibitively expensive for low-resource settings, with prices starting at $1,500. On the other hand, there are low-cost commercial and open-source micro-centrifuges available, but they are incapable of handling typical clinical amounts of blood samples (2-10mL). There is currently no low-cost CE marked centrifuge that can process large volumes of clinical blood samples on the market. As a solution, we customised the rotor of a commercially available low-cost micro-centrifuge (~$125) using 3D printing to enable centrifugation of large clinical blood samples in resource poor-settings. Our custom adaptor ($15) can hold two 9 mL S-Monovette tubes and achieve the same separation performance (yield, cell count, hemolysis, albumin levels) as the control benchtop refrigerated centrifuge, and even outperformed the control in platelet separation by at least four times. This low-cost open-source centrifugation system capable of processing clinical blood tubes could be valuable to low-resource settings where centrifugation is required immediately after blood withdrawal for further testing.
| S-EPMC9269434 | biostudies-literature
Project description:BacT/Alert Virtuo is an advanced, automated blood culture system incorporating improved automation and an enhanced detection algorithm to shorten time to detection. A multicenter study of the investigational Virtuo system (bioMérieux, Inc., Durham, NC) compared to BacT/Alert 3D (BTA3D) for detection of bacteremia/fungemia in four bottle types, SA and FA Plus (aerobic) and SN and FN Plus (anaerobic), was performed in a clinical setting with patient samples in a matched system design clinical trial. Blood was added to paired aerobic or anaerobic bottles, with the volume in each bottle in each pair required to be ?10 ml and with the volumes required to be within 30% of each other. Of 5,709 bottle sets (52.5% aerobic pairs and 47.5% anaerobic pairs), 430 (7.5%) were positive for bacterial or fungal growth, with 342 (6.0%) clinically significant and 83 (1.5%) contaminated. A total of 3,539 sets (62.0%) were volume compliant, with 203 sets (5.7%) clinically significant. The positivity rates for volume-compliant bottle pairs determined by the two systems were comparable, with 68.7% of clinically significant isolates detected by both instruments, 15.7% by Virtuo only, and 15.7% by BTA3D only. Virtuo detected microbial growth nearly 2 h sooner overall than BTA3D (mean, 15.9 h versus 17.7 h). Shorter time to detection by Virtuo was related to organism group, with the time to detection being significantly shorter for enteric Gram-negative bacilli and enterococci (means, 3.6 h and 2.3 h shorter, respectively). This large clinical study demonstrated that the Virtuo blood culture system produced results comparable to those seen with the long-established BTA3D system, with significantly shorter time to detection.
| S-EPMC5527419 | biostudies-literature
Project description:Expanding whole blood sample collection for transcriptome analysis beyond traditional phlebotomy clinics will open new frontiers for remote immune research and telemedicine. Determining the stability of RNA in blood samples exposed to high ambient temperatures (>30°C) is necessary for deploying home-sampling in settings with elevated temperatures (e.g., studying physiological response to natural disasters that occur in warm locations or in the summer). Recently, we have developed homeRNA, a technology that allows for self-blood sampling and RNA stabilization remotely. homeRNA consists of a lancet-based blood collection device, the Tasso-SST™ which collects up to 0.5 ml of blood from the upper arm, and a custom-built stabilization transfer tube containing RNAlater™. In this study, we investigated the robustness of our homeRNA kit in high temperature settings via two small pilot studies in Doha, Qatar (no. participants = 8), and the Western and South Central USA during the summer of 2021, which included a heatwave of unusually high temperatures in some locations (no. participants = 11). Samples collected from participants in Doha were subjected to rapid external temperature fluctuations from being moved to and from air-conditioned areas and extreme heat environments (up to 41°C external temperature during brief temperature spikes). In the USA pilot study, regions varied in outdoor temperature highs (between 25°C and 43.4°C). All samples that returned a RNA integrity number (RIN) value from the Doha, Qatar group had a RIN ≥7.0, a typical integrity threshold for downstream transcriptomics analysis. RIN values for the Western and South Central USA samples (n = 12 samples) ranged from 6.9-8.7 with 9 out of 12 samples reporting RINs ≥7.0. Overall, our pilot data suggest that homeRNA can be used in some regions that experience elevated temperatures, opening up new geographical frontiers in disseminated transcriptome analysis for applications critical to telemedicine, global health, and expanded clinical research. Further studies, including our ongoing work in Qatar, USA, and Thailand, will continue to test the robustness of homeRNA.
| S-EPMC9405416 | biostudies-literature
Project description:Key messageThe new NB scope aids in better visualization of the scalp and blood collection and analysis at bed side.ObjectiveCaesarean section rates and inherent complications are on the rise all over the world. One way to avoid a caesarean is to measure fetal scalp blood lactate levels. The methods available to visualize fetal scalp, obtain the blood sample and perform the blood test are separate, cumbersome and expensive, needing a certain level of expertise. We propose a device that incorporates all the steps of obtaining a fetal scalp blood lactate into one sleek, easy to use device.MethodsThe initial design, 3-D print and was tried on mannequin. After ethics committee approval, the prototype was experimented on patients in labour with singleton live fetus in cephalic presentation with no evidence of distress.ResultsThere were (n = 9) patients recruited. There were (n = 5) primigravida and (n = 4) multigravida all of whom were in active labour. Parity did not seem to influence ease of instrumentation. Of the (n = 9) mothers (n = 2) had meconium-stained liquor and the rest (n = 7) had clear liquor, meconium-stained liquor did not affect visualization. The mean time taken to collect the sample was 184.11(± 33.04) seconds.ConclusionThe Neeraj-Bhaskar (NB) scope is an easy to use, affordable device that can be used time and again to decide on cases where emergency caesarean section can be avoided due to fetal distress.
| S-EPMC7239983 | biostudies-literature
Project description:Background: The aim of this study was to evaluate the clinical performance of VersaTrek 528 compared to BACTEC FX 400 blood culture (BC) systems. Materials and Methods: Simulated and clinically obtained BCs were used in the study. Confirmed bacterial species (n = 78), including 43 Gram-positives, 30 Gram-negatives, and 5 Candida albicans strains, were each inoculated into BC bottles. Clinically obtained BCs were subdivided into two groups, A and B. In group A were 72 BC sets (pair: aerobic and anaerobic) in which a set inoculated with 5 ml blood was processed in the VersaTrek BC system, whilst the one inoculated with 10 ml blood was processed in the FX BC system. In group B, 76 BC sets (pairs) corresponding to 152 VersaTrek bottles and 152 FX bottles were inoculated with the same volume (10 ml) of blood, and processed in each system. Results: In the simulated BC study, 90% (63/70) of the VersaTrek aerobic bottles were positive, which was higher than that of FX 400 (59/70, 84%), but was not statistically significant (P = 0.423). In contrast, FX 400 anaerobic bottles had a higher positive rate than the other BC system (84 vs. 77%), although it was statistically insignificant (P = 0.267). Time to detection of organisms in the two BCs was comparable for both aerobic (P = 0.131) and anaerobic bottles (P = 0.104). In clinical BCs of group A, FX BC system had slightly higher positive rates for both aerobic (11.1 vs. 9.7%, P = 0.312) and anaerobic (8.3 vs. 6.9%, P = 0.375) bottles. However, the difference was not statistically significant. In group B, VersaTrek aerobic bottles had a higher positive rate compared to the other BC system (10.5 vs. 5.2%, P = 0.063). In terms of positive rates of sub-studies A and B, VersaTrek and FX BC systems were comparable. Conclusion: There was no significant difference between the two BC systems in the detection of bacteria and fungi in simulated BCs. In clinical BCs, the performance of the VersaTrek BC system, with inoculation of 5 or 10 ml patient's blood, was comparable to the FX system with inoculation of 10 ml patient's blood.
| S-EPMC6120971 | biostudies-literature
Project description:To facilitate future pharmacokinetic studies of combination treatments against leishmaniasis in remote regions in which the disease is endemic, a simple cheap sampling method is required for miltefosine quantification. The aims of this study were to validate a liquid chromatography-tandem mass spectrometry method to quantify miltefosine in dried blood spot (DBS) samples and to validate its use with Ethiopian patients with visceral leishmaniasis (VL). Since hematocrit (Ht) levels are typically severely decreased in VL patients, returning to normal during treatment, the method was evaluated over a range of clinically relevant Ht values. Miltefosine was extracted from DBS samples using a simple method of pretreatment with methanol, resulting in >97% recovery. The method was validated over a calibration range of 10 to 2,000 ng/ml, and accuracy and precision were within ±11.2% and ?7.0% (?19.1% at the lower limit of quantification), respectively. The method was accurate and precise for blood spot volumes between 10 and 30 ?l and for Ht levels of 20 to 35%, although a linear effect of Ht levels on miltefosine quantification was observed in the bioanalytical validation. DBS samples were stable for at least 162 days at 37°C. Clinical validation of the method using paired DBS and plasma samples from 16 VL patients showed a median observed DBS/plasma miltefosine concentration ratio of 0.99, with good correlation (Pearson'sr= 0.946). Correcting for patient-specific Ht levels did not further improve the concordance between the sampling methods. This successfully validated method to quantify miltefosine in DBS samples was demonstrated to be a valid and practical alternative to venous blood sampling that can be applied in future miltefosine pharmacokinetic studies with leishmaniasis patients, without Ht correction.
| S-EPMC4808221 | biostudies-literature
Project description:Within the Internet of Things (IoT) and blockchain research, there is a growing interest in decentralizing health monitoring systems, to provide improved privacy to patients, without relying on trusted third parties for handling patients' sensitive health data. With public blockchain deployments being severely limited in their scalability, and inherently having latency in transaction processing, there is room for researching and developing new techniques to leverage the security features of blockchains within healthcare applications. This paper presents a solution for patients to share their biomedical data with their doctors without their data being handled by trusted third party entities. The solution is built on the Ethereum blockchain as a medium for negotiating and record-keeping, along with Tor for delivering data from patients to doctors. To highlight the applicability of the solution in various health monitoring scenarios, we have considered three use-cases, namely cardiac monitoring, sleep apnoea testing, and EEG following epileptic seizures. Following the discussion about the use cases, the paper outlines a security analysis performed on the proposed solution, based on multiple attack scenarios. Finally, the paper presents and discusses a performance evaluation in terms of data delivery time in comparison to existing centralized and decentralized solutions.
| S-EPMC7146265 | biostudies-literature
Project description:Dried blood spot (DBS) is a minimally invasive sampling method suitable for sample collection, storage and transportation in resource limited areas. Aim of this study was to compare the diagnostic utility of DBS with plasma sample for HCV RNA quantitation and genotyping using commercial systems. Plasma and DBS card spotted samples were collected from 95 HCV seropositive patients. Both types of samples were subjected to HCV RNA by real-time PCR (Abbott m2000rt, USA). Genotyping was performed using Abbott HCV genotype II kit (Abbott diagnostics, USA) in samples with viral load > 3 log10 IU/ml. In both plasma and DBS, 14 (14.7%) samples were negative and 81 (85.3%) were positive for HCV RNA. Median viral load in plasma (3.78; range 0-7.43) log10 IU/ml was comparable to DBS (3.93; range 0-7.24) log10 IU/ml. DBS demonstrated sensitivity and specificity of 97.5 and 85.7% respectively, with positive predictive value (PPV) of 97.5% and negative predictive value (NPV) of 85.7%. DBS showed good correlation (r2 = 0.866) and agreement (93.5%) with plasma. Genotyping in 20 patients showed 100% concordance between DBS and plasma samples. DBS showed good sensitivity and specificity as a sampling method for HCV RNA quantitation and genotyping.
| S-EPMC6003055 | biostudies-literature
Project description:Peripheral blood is a highly accessible biofluid providing a rich source of information about human physiology and health status. However, for studies of the blood transcriptome with RNA sequencing (RNA-Seq) techniques, high levels of hemoglobin mRNAs (hgbRNA) present in blood can occupy valuable sequencing space, impacting detection and quantification of non-hgbRNAs. In this study, we evaluated two methods for preparing ribosomal RNA (rRNA)-depleted sequencing libraries for RNA-Seq of whole blood, one of which is also designed to deplete hgbRNAs. Two experiments were performed: one evaluating library performance across 6 human blood samples and the other examining library reproducibility and performance in a two-subject subset. We find that addition of hgbRNA depletion to the rRNA-depletion protocol for library preparation from blood RNA effectively reduces highly abundant hgbRNA reads; however, it does not result in a statistically significant increase in differentially expressed genes in our patient-control study. Bioinformatic removal of globin gene counts in non-hgbRNA depleted libraries provides improvement in overall performance of these libraries. We conclude that use of a standard ribosomal RNA depletion method for library preparation coupled with bioinformatic removal of globin gene counts is sufficient for reproducible and sensitive measurement of both coding and noncoding RNAs in the blood transcriptome.
| S-EPMC7156519 | biostudies-literature