A New Detection Chamber Design on Centrifugal Microfluidic Platform to Measure Hemoglobin of Whole Blood

2021 ◽  
pp. 247263032098545
Author(s):  
Ehsan Mahmodi Arjmand ◽  
Maryam Saadatmand ◽  
Manouchehr Eghbal ◽  
Mohammad Reza Bakhtiari ◽  
Sima Mehraji
Keyword(s):  
Driving Forces ◽  
Focal Point ◽  
Point Of Care ◽  
Hemoglobin Concentration ◽  
Turnaround Time ◽  
Air Bubbles ◽  
Final Solution ◽  
Blood Samples ◽  
Detection Chamber ◽  
Hemoglobin Measurement

Undoubtedly, microfluidics has been a focal point of interdisciplinary science during the last two decades, resulting in many developments in this area. Centrifugal microfluidic platforms have good potential for use in point-of-care devices because they take advantage of some intrinsic forces, most notably centrifugal force, which obviates the need to any external driving forces. Herein, we introduce a newly designed detection chamber for use on microfluidic discs that can be employed as an absorbance readout step in cases where the final solution has a very low viscosity and surface tension. In such situations, our chamber easily eliminates the air bubbles from the final solution without any interruption. One microfluidic disc for measuring the hemoglobin concentration was designed and constructed to verify the correct functioning of this detection chamber. This disc measured the hemoglobin concentration of the blood samples via the HiCN method. Then, the hemoglobin concentration of 11 blood samples was quantified and compared with the clinic’s data using the hemoglobin measurement disc, which included four hemoglobin measurement sets, and each set contained two inlets for the blood sample and the reagent, one two-part mixing chamber, and one bubble-free detection chamber. The measured values of the disc had good linearity and conformity compared with the clinic’s data, and there were no air bubbles in the detection step. In this study, the standard deviation and the turnaround time were ± 0.51 g/dL and 68 s, respectively.

scholarly journals Validation of the BD FACSPresto system for the measurement of CD4 T-lymphocytes and hemoglobin concentration in HIV-negative and HIV-positive subjects

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Xiaofan Lu ◽  
Hanxiao Sun ◽  
Haicong Li ◽  
Wei Xia ◽  
Hao Wu ◽  
...  
Keyword(s):  
Point Of Care ◽  
Venous Blood ◽  
Method Comparison ◽  
Hemoglobin Concentration ◽  
Hiv Positive ◽  
Reference Standard ◽  
Blood Samples ◽  
Deming Regression ◽  
Hematology Analyzer ◽  
Hiv Negative

Abstract This study aimed to compare the performance of the BD FACSPresto system with the conventional standard-of-care technologies for the measurement of absolute CD4 count (AbsCD4), CD4 percentage (CD4%) and total hemoglobin concentration (Hb) in capillary and venous blood samples of HIV-negative and HIV-positive subjects. A total of 1304 participants were included in this prospective cohort study. Both venous and capillary blood samples were analyzed using the BD FACSPresto system and the results were compared against the BD FACSCalibur for enumerating AbsCD4 and CD4% and Sysmex XT-4000i hematology analyzer for determining Hb levels. Method comparison studies were performed using Deming regression and Bland–Altman plots. The Deming regression analyses comparing the accuracy of the BD FACSPresto system with the reference standard technologies demonstrated a significant linear correlation between the AbsCD4, CD4%, and Hb values generated by the two platforms. The 95% CI of the slopes for AbsCD4, CD4%, and Hb levels were 0.94–0.99, 0.99–1.01 and 0.86–0.93, respectively (P < 0.001). Bland–Altman plots for AbsCD4, CD4%, and Hb levels demonstrated close agreement between the BD FACSPresto system and the reference standards for all study participants. The performance and accuracy of BD FACSPresto system was comparable to the reference standard technologies. The BD FACSPresto system can be used interchangeably with BD FACSCalibur platform for CD4 and Sysmex XT-4000i hematology analyzer for Hb concentrations in resource-limited settings thus, improving accessibility to point-of-care testing services.

scholarly journals Comparison of the Accuracy of Noninvasive Hemoglobin Monitoring by Spectrophotometry (SpHb) and HemoCue® with Automated Laboratory Hemoglobin Measurement

2011 ◽  
Vol 115 (3) ◽  
pp. 548-554 ◽  
Author(s):  
Lionel Lamhaut ◽  
Roxana Apriotesei ◽  
Xavier Combes ◽  
Marc Lejay ◽  
Pierre Carli ◽  
...  
Keyword(s):  
Clinical Study ◽  
Linear Regression ◽  
Point Of Care ◽  
Reference Method ◽  
Hemoglobin Concentration ◽  
Automated Analysis ◽  
Laboratory Measurement ◽  
Altman Analysis ◽  
Simultaneous Measurements ◽  
Hemoglobin Measurement

Background The reference method for hemoglobin concentration measurement remains automated analysis in the laboratory. Although point-of-care devices such as the HemoCue® 201+ (HemoCue, Ängelholm, Sweden) provide immediate hemoglobin values, a noninvasive, spectrophotometry-based technology (Radical-7®; Masimo Corp., Irvine, CA) that provides continuous online hemoglobin (SpHb) measurements has been introduced. This clinical study aimed to test the hypothesis that SpHb monitoring was equivalent to that of HemoCue® (the automated hemoglobin measurement in the laboratory taken as a reference method) during acute surgical hemorrhage. Methods Blood for laboratory analysis was sampled after induction of anesthesia, during surgery according to the requirements of the anesthesiologist, and finally after the transfer of the patient to the recovery room. When each blood sample was taken, capillary samples were obtained for analysis with HemoCue®. SpHb monitoring was performed continuously during surgery. Using the automated hemoglobin measurement in the laboratory as a reference method, the authors tested the hypothesis that SpHb monitoring is equivalent to that of HemoCue®. The agreement between two methods was evaluated by linear regression and Bland and Altman analysis. Results Eighty-five simultaneous measurements from SpHb, HemoCue®, and the laboratory were obtained from 44 patients. Bland and Altman comparison of SpHb and HemoCue® with the laboratory measurement showed, respectively, bias of -0.02 ± 1.39 g · dl(-1) and -0.17 ± 1.05 g · dl(-1), and a precision of 1.11 ± 0.83 g · dl(-1) and 0.67 ± 0.83 g · dl(-1). Considering an acceptable difference of ± 1.0 g · dl(-1) with the laboratory measurement, the percentage of outliers was significantly higher for SpHb than for HemoCue® (46% vs. 16%, P &lt; 0.05). Conclusions Taking automated laboratory hemoglobin measurement as a reference, the study shows that SpHb monitoring with Radical-7® gives lower readings than does the HemoCue® for assessment of hemoglobin concentration during hemorrhagic surgery.

scholarly journals Making sense of rapid antigen testing in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostics

Diagnosis ◽  
2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Camilla Mattiuzzi ◽  
Brandon M. Henry ◽  
Giuseppe Lippi
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Point Of Care ◽  
Turnaround Time ◽  
Molecular Testing ◽  
Upper Respiratory Tract ◽  
Making Sense ◽  
Skilled Personnel ◽  
Potential Benefits ◽  
Antigen Testing ◽  
Care Availability

AbstractAlthough the most effective strategy for preventing or containing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreaks relies on early diagnosis, the paramount and unprecedented number of tests needed to fully achieve this target is overwhelming worldwide testing supply and capacity. Molecular detection of SARS-CoV-2 RNA in nasopharyngeal swabs is still considered the reference diagnostic approach. Nonetheless, identification of SARS-CoV-2 proteins in upper respiratory tract specimens and/or saliva by means of rapid (antigen) immunoassays is emerging as a promising screening approach. These tests have some advantages compared to molecular analysis, such as point of care availability, no need of skilled personnel and dedicated instrumentation, lower costs and short turnaround time. However, these advantages are counterbalanced by lower diagnostic sensitivity compared to molecular testing, which would only enable to identifying patients with higher SARS-CoV-2 viral load. The evidence accumulated to-date has hence persuaded us to develop a tentative algorithm, which would magnify the potential benefits of rapid antigen testing in SARS-CoV-2 diagnostics.

scholarly journals A 3D-printed magnetic digital microfluidic diagnostic platform for rapid colorimetric sensing of carbapenemase-producing Enterobacteriaceae

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Pojchanun Kanitthamniyom ◽  
Pei Yun Hon ◽  
Aiwu Zhou ◽  
Mohammad Yazid Abdad ◽  
Zhi Yun Leow ◽  
...  
Keyword(s):  
Point Of Care ◽  
Resistance Mechanism ◽  
Turnaround Time ◽  
World Health ◽  
Colorimetric Sensing ◽  
Resource Limited ◽  
Reaction Chambers ◽  
Technological Platform ◽  
Health Organization ◽  
Digital Microfluidic

AbstractCarbapenemase-producing Enterobacteriaceae (CPE) are a group of drug-resistant Gram-negative pathogens that are classified as a critical threat by the World Health Organization (WHO). Conventional methods of detecting antibiotic-resistant pathogens do not assess the resistance mechanism and are often time-consuming and laborious. We have developed a magnetic digital microfluidic (MDM) platform, known as MDM Carba, for the identification of CPE by measuring their ability to hydrolyze carbapenem antibiotics. MDM Carba offers the ability to rapidly test CPE and reduce the amount of reagents used compared with conventional phenotypic testing. On the MDM Carba platform, tests are performed in droplets that function as reaction chambers, and fluidic operations are accomplished by manipulating these droplets with magnetic force. The simple droplet-based magnetic fluidic operation allows easy system automation and simplified hands-on operation. Because of the unique “power-free” operation of MDM technology, the MDM Carba platform can also be operated manually, showing great potential for point-of-care testing in resource-limited settings. We tested 27 bacterial isolates on the MDM Carba platform, and the results showed sensitivity and specificity that were comparable to those of the widely used Carba NP test. MDM Carba may shorten the overall turnaround time for CPE identification, thereby enabling more timely clinical decisions for better clinical outcomes. MDM Carba is a technological platform that can be further developed to improve diagnostics for other types of antibiotic resistance with minor modifications.

scholarly journals Design and experimental investigation of a novel spiral microfluidic chip to separate wide size range of micro-particles aimed at cell separation

2021 ◽  
pp. 095441192110297
Author(s):  
Seyed Ali Tabatabaei ◽  
Mohammad Zabetian Targhi
Keyword(s):  
Point Of Care ◽  
Diagnostic System ◽  
Average Diameter ◽  
Microfluidic System ◽  
Microfluidic Chips ◽  
Medical Sciences ◽  
Blood Samples ◽  
Micro Particles ◽  
Monodisperse Polystyrene ◽  
Device Size

Isolation of microparticles and biological cells on microfluidic chips has received considerable attention due to their applications in numerous areas such as medical and engineering fields. Microparticles separation is of great importance in bioassays due to the need for smaller sample and device size and lower manufacturing costs. In this study, we first explain the concepts of separation and microfluidic science along with their applications in the medical sciences, and then, a conceptual design of a novel inertial microfluidic system is proposed and analyzed. The PDMS spiral microfluidic device was fabricated, and its effects on the separation of particles with sizes similar to biological particles were experimentally analyzed. This separation technique can be used to separate cancer cells from the normal ones in the blood samples. These components required for testing were selected, assembled, and finally, a very affordable microfluidic kit was provided. Different experiments were designed, and the results were analyzed using appropriate software and methods. Separator system tests with polydisperse hollow glass particles (diameter 2–20 µm), and monodisperse Polystyrene particles (diameter 5 & 15 µm), and the results exhibit an acceptable chip performance with 86% of efficiency for both monodisperse particles and polydisperse particles. The microchannel collects particles with an average diameter of 15.8, 9.4, and 5.9 μm at the proposed reservoirs. This chip can be integrated into a more extensive point-of-care diagnostic system to test blood samples.

scholarly journals COVID-19 Biomarkers and Advanced Sensing Technologies for Point-of-Care (POC) Diagnosis

2021 ◽  
Vol 8 (7) ◽  
pp. 98
Author(s):  
Ernst Emmanuel Etienne ◽  
Bharath Babu Nunna ◽  
Niladri Talukder ◽  
Yudong Wang ◽  
Eon Soo Lee
Keyword(s):  
Response Times ◽  
Rna Virus ◽  
Point Of Care ◽  
Protein Detection ◽  
Turnaround Time ◽  
Quantitative Detection ◽  
Rt Pcr ◽  
Specificity And Sensitivity ◽  
Small Market ◽  
Multiple Biomarkers

COVID-19, also known as SARS-CoV-2 is a novel, respiratory virus currently plaguing humanity. Genetically, at its core, it is a single-strand positive-sense RNA virus. It is a beta-type Coronavirus and is distinct in its structure and binding mechanism compared to other types of coronaviruses. Testing for the virus remains a challenge due to the small market available for at-home detection. Currently, there are three main types of tests for biomarker detection: viral, antigen and antibody. Reverse Transcription-Polymerase Chain Reaction (RT-PCR) remains the gold standard for viral testing. However, the lack of quantitative detection and turnaround time for results are drawbacks. This manuscript focuses on recent advances in COVID-19 detection that have lower limits of detection and faster response times than RT-PCR testing. The advancements in sensing platforms have amplified the detection levels and provided real-time results for SARS-CoV-2 spike protein detection with limits as low as 1 fg/mL in the Graphene Field Effect Transistor (FET) sensor. Additionally, using multiple biomarkers, detection levels can achieve a specificity and sensitivity level comparable to that of PCR testing. Proper biomarker selection coupled with nano sensing detection platforms are key in the widespread use of Point of Care (POC) diagnosis in COVID-19 detection.

scholarly journals Antibody Responses in Cats Following Primary and Annual Vaccination against Feline Immunodeficiency Virus (FIV) with an Inactivated Whole-Virus Vaccine (Fel-O-Vax® FIV)

Viruses ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 470
Author(s):  
Mark Westman ◽  
Dennis Yang ◽  
Jennifer Green ◽  
Jacqueline Norris ◽  
Richard Malik ◽  
...  
Keyword(s):  
Antibody Response ◽  
Virus Vaccine ◽  
Point Of Care ◽  
Primary Vaccination ◽  
Antibody Responses ◽  
Blood Samples ◽  
Study Results ◽  
Elisa Testing ◽  
Primary Antibody Response ◽  
Residual Blood

Although the antibody response induced by primary vaccination with Fel-O-Vax® FIV (three doses, 2–4 weeks apart) is well described, the antibody response induced by annual vaccination with Fel-O-Vax® FIV (single dose every 12 months after primary vaccination) and how it compares to the primary antibody response has not been studied. Residual blood samples from a primary FIV vaccination study (n = 11), and blood samples from cats given an annual FIV vaccination (n = 10), were utilized. Samples from all 21 cats were tested with a commercially available PCR assay (FIV RealPCRTM), an anti-p24 microsphere immunoassay (MIA), an anti-FIV transmembrane (TM; gp40) peptide ELISA, and a range of commercially available point-of-care (PoC) FIV antibody kits. PCR testing confirmed all 21 cats to be FIV-uninfected for the duration of this study. Results from MIA and ELISA testing showed that both vaccination regimes induced significant antibody responses against p24 and gp40, and both anti-p24 and anti-gp40 antibodies were variably present 12 months after FIV vaccination. The magnitude of the antibody response against both p24 and gp40 was significantly higher in the primary FIV vaccination group than in the annual FIV vaccination group. The differences in prime versus recall post-vaccinal antibody levels correlated with FIV PoC kit performance. Two FIV PoC kits that detect antibodies against gp40, namely Witness® and Anigen Rapid®, showed 100% specificity in cats recently administered an annual FIV vaccination, demonstrating that they can be used to accurately distinguish vaccination and infection in annually vaccinated cats. A third FIV PoC kit, SNAP® Combo, had 0% specificity in annually FIV-vaccinated cats, and should not be used in any cat with a possible history of FIV vaccination. This study outlines the antibody response to inactivated Fel-O-Vax® FIV whole-virus vaccine, and demonstrates how best to diagnose FIV infection in jurisdictions where FIV vaccination is practiced.

scholarly journals Evaluation of mobile real-time polymerase chain reaction tests for the detection of severe acute respiratory syndrome coronavirus 2

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Chukwunonso Onyilagha ◽  
Henna Mistry ◽  
Peter Marszal ◽  
Mathieu Pinette ◽  
Darwyn Kobasa ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Real Time ◽  
Point Of Care ◽  
Middle Eastern ◽  
Turnaround Time ◽  
Cross Reactivity ◽  
Clinical Samples ◽  
Diarrhea Virus ◽  
Highly Sensitive ◽  
Transmissible Gastroenteritis

AbstractThe coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), calls for prompt and accurate diagnosis and rapid turnaround time for test results to limit transmission. Here, we evaluated two independent molecular assays, the Biomeme SARS-CoV-2 test, and the Precision Biomonitoring TripleLock SARS-CoV-2 test on a field-deployable point-of-care real-time PCR instrument, Franklin three9, in combination with Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0 (M1) manual extraction system for rapid, specific, and sensitive detection of SARS-COV-2 in cell culture, human, and animal clinical samples. The Biomeme SARS-CoV-2 assay, which simultaneously detects two viral targets, the orf1ab and S genes, and the Precision Biomonitoring TripleLock SARS-CoV-2 assay that targets the 5′ untranslated region (5′ UTR) and the envelope (E) gene of SARS-CoV-2 were highly sensitive and detected as low as 15 SARS-CoV-2 genome copies per reaction. In addition, the two assays were specific and showed no cross-reactivity with Middle Eastern respiratory syndrome coronavirus (MERS-CoV), infectious bronchitis virus (IBV), porcine epidemic diarrhea virus (PEDV), transmissible gastroenteritis (TGE) virus, and other common human respiratory viruses and bacterial pathogens. Also, both assays were highly reproducible across different operators and instruments. When used to test animal samples, both assays equally detected SARS-CoV-2 genetic materials in the swabs from SARS-CoV-2-infected hamsters. The M1 lysis buffer completely inactivated SARS-CoV-2 within 10 min at room temperature enabling safe handling of clinical samples. Collectively, these results show that the Biomeme and Precision Biomonitoring TripleLock SARS-CoV-2 mobile testing platforms could reliably and promptly detect SARS-CoV-2 in both human and animal clinical samples in approximately an hour and can be used in remote areas or health care settings not traditionally serviced by a microbiology laboratory.

scholarly journals Evaluation of the performance of sysmex XN-3100 automated hematology analyzer regarding the sysmex XE-2100 and microscopic examination

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Said Incir ◽  
Kerim Erhan Palaoglu
Keyword(s):  
Comparative Method ◽  
Reference Method ◽  
Turnaround Time ◽  
Analytical Sensitivity ◽  
Biological Variability ◽  
Comparison Analysis ◽  
Blood Samples ◽  
Hematology Analyzer ◽  
Quality Control Materials ◽  
Automated Hematology Analyzer

AbstractObjectivesWe performed a verification study of the Sysmex XN-3100 hematology analyzer in comparison with the XE-2100 according to the guidelines of the Clinical and Laboratory Standards Institute (CLSI) and the International Council for Standardization in Hematology (ICSH).Materials and methodsBlood samples and quality control materials were used for precision. For comparison, we used the current XE-2100 as the comparative method and analyzed 540 blood samples. The Passing-Bablok and Bland-Altman tests were performed according to the CLSI EP09-A3 and a carryover study was performed according to the CLSI H26-A2 guidelines. The flagging performance of the two analyzers was compared, using two experienced laboratory technicians as the reference method.ResultsThe Sysmex XN-3100 demonstrated high levels of precision for most parameters. For the comparison analysis, all parameters, except for MCHC, monocytes and basophils were within the systematic error limits of desirable biological variability criterion (SeDBV). The carryover was less than 0.4% for all parameters. The flagging performance of the XN-3100 was satisfactory and the overall efficiency was high.ConclusionsThe XN-3100 not only showed a strong correlation and agreement with the XE-2100 but also displayed a comparable analytical sensitivity, and increased specificity, which may result in an improved turnaround time and throughpu.

Requiem for the STAT Test: Automation and Point of Care Testing

2019 ◽  
Author(s):  
Gurmukh Singh ◽  
Natasha M Savage ◽  
Brandy Gunsolus ◽  
Kellie A Foss
Keyword(s):  
Point Of Care ◽  
Turnaround Time ◽  
Test Automation ◽  
Test Results ◽  
Point Of Care Testing ◽  
Tube System ◽  
Front End ◽  
Laboratory Test Results ◽  
Batch Testing ◽  
Pneumatic Tube System

Abstract Objective Quick turnaround of laboratory test results is needed for medical and administrative reasons. Historically, laboratory tests have been requested as routine or STAT. With a few exceptions, a total turnaround time of 90 minutes has been the usually acceptable turnaround time for STAT tests. Methods We implemented front-end automation and autoverification and eliminated batch testing for routine tests. We instituted on-site intraoperative testing for selected analytes and employed point of care (POC) testing judiciously. The pneumatic tube system for specimen transport was expanded. Results The in-laboratory turnaround time was reduced to 45 minutes for more than 90% of tests that could reasonably be ordered STAT. With rare exceptions, the laboratory no longer differentiates between routine and STAT testing. Having a single queue for all tests has improved the efficiency of the laboratory. Conclusion It has been recognized in manufacturing that batch processing and having multiple queues for products are inefficient. The same principles were applied to laboratory testing, which resulted in improvement in operational efficiency and elimination of STAT tests. We propose that the target for in-laboratory turnaround time for STAT tests, if not all tests, be 45 minutes or less for more than 90% of specimens.

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