New procalcitonin point-of-care test meets analytical performances to stratification of infectious syndrome
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PROVIDER: S-EPMC10907192 | biostudies-literature | 2024 Feb
REPOSITORIES: biostudies-literature
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Project description:ObjectivesWe report the analytical performances of a new point-of-care (POC) procalcitonin (PCT) fluorescence immunoassay that uses the AFIAS-6© system from Boditech and its concordance with results of the standard method Kryptor Compact plus from the central laboratory.Designand methods: Analytical performances including imprecision studies, limit of blank (LoB), limit of detection (LoD) and limit of quantification (LOQ) were determined. The method comparison was performed using plasma vs. whole blood for Kryptor CompactPlus© vs. AFIAS-6©, respectively.ResultsThe total imprecision was far from the CV of 4.5% claimed by the manufacturer and close to 10%, for levels of PCT at 0.4 and 8.3 μg/L. The LoD of this novel PCT assay was found to close to the LoD provided by the manufacturer at 0.04 μg/L. The LOQ was higher than that claimed by the manufacturer (0.1 vs 0.002, respectively). The equation of linearity in the lower range was found to be y = 1.056x - 0.039 with r2 = 0.993 with a mean recovery percentage of 86 ± 15%. Correlation studies showed a good correlation between PCT measurements using plasma on Kryptor system and on corresponding whole blood with POC reaching a bias of -0.04 in the range from 0.02 to 2 μg/L.ConclusionThe novel PCT assay on AFIAS-6© is an acceptable POC alternative for the diagnosis and management of sepsis at EDs to improve the flow of patients, as results are consistent with those of the standard PCT Kryptor Compact Plus© assay, despite its higher imprecision.
| S-EPMC6838538 | biostudies-literature
Project description:Many Point-of-Care devices have been released over the past decade. However, data regarding their analytical performances in real-world situations remains scarce. Herein, we aimed to assess the analytical performances of the i-STAT Alinity system. We conducted an analytical performances study with the i-STAT Alinity device using cartridges CG4+ (pH, Pco2, Po2, lactate, bicarbonate and base excess); CHEM8+ (Na, K, Cl, ionized Ca, urea, creatinine, glucose, hematocrit and hemoglobin) and PT/INR (prothrombin time and international normalized ratio). We assessed the imprecision and compared the results to those obtained on existing instruments in the central laboratory. We found that the within-lab coefficients of variation (CV) were very low (<2%) or low (2-5%), except for creatinine and PT (CV = 5.2% and CV = 6.3%, respectively). For almost all the parameters, the results were strongly (R2 = 90-95%) or very strongly (R2 > 95%) correlated with those of the existing laboratory instruments, and the biases were very low (<2%) or low (2-5%). However, correlations of the PT and INR measurements with existing instruments were lower (R2 = 86.0% and 89.7%), and biases in the Po2 (7.9%), creatinine (5.4%) and PT (-6.6%) measurements were higher. The i-STAT Alinity appeared as a convenient device for measurements of numerous parameters. However, clinicians should interpret Po2, creatinine and PT results with caution.
| S-EPMC9857650 | biostudies-literature
Project description:BackgroundThe National Institute for Health and Care Excellence (NICE) have called for research into the role of biomarkers, and specifically procalcitonin (PCT), for the early diagnosis of serious bacterial infections (SBI) in children. The aim of this study was to compare the diagnostic test accuracy of C-reactive protein (CRP) and PCT for the diagnosis of SBI in children.MethodsData was collected prospectively from four UK emergency departments (ED) between November 2017 and June 2019. Consecutive children under 18 years of age with fever and features of possible sepsis and/or meningitis were eligible for inclusion. The index tests were PCT and CRP and the reference standard was the confirmation of SBI.Results213 children were included in the final analysis. 116 participants (54.5%) were male, and the median age was 2 years, 9 months. Parenteral antibiotics were given to 100 (46.9%), three (1.4%) were admitted to a paediatric intensive care unit and there were no deaths. There were ten (4.7%) confirmed SBI. The area under the curve for PCT and CRP for the detection of SBI was identical at 0.70.ConclusionsThere was no difference in the performance of PCT and CRP for the recognition of SBI in this cohort.Trial registrationRegistered at https://www.clinicaltrials.gov (trial registration: NCT03378258 ) on the 19th of December 2017.
| S-EPMC7576699 | biostudies-literature
Project description:BackgroundThis study was conducted to investigate whether point-of-care (POC) procalcitonin (PCT) measurement can reduce redundant antibiotic treatment in patients hospitalized with acute exacerbation of COPD (AECOPD).MethodsOne-hundred and twenty adult patients admitted with AECOPD were enrolled in this open-label randomized trial. Patients were allocated to either the POC PCT-guided intervention arm (n=62) or the control arm, in which antibiotic therapy followed local guidelines (n=58).ResultsThe median duration of antibiotic exposure was 3.5 (interquartile range [IQR] 0-10) days in the PCT-arm vs 8.5 (IQR 1-11) days in the control arm (P=0.0169, Wilcoxon) for the intention-to-treat population. The proportion of patients using antibiotics for ≥5 days within the 28-day follow-up was 41.9% (PCT-arm) vs 67.2% (P=0.006, Fisher's exact) in the intention-to-treat population. For the per-protocol population, the proportions were 21.1% (PCT-arm) vs 73.9% (P<0.00001, Fisher's exact). Within 28-day follow-up, one patient died in the PCT-arm and two died in the control arm. A composite harm end point consisting of death, rehospitalization, or intensive care unit admission, all within 28 days, showed no apparent difference.ConclusionOur study shows that the implementation of a POC PCT-guided algorithm can be used to substantially reduce antibiotic exposure in patients hospitalized with AECOPD, with no apparent harm.
| S-EPMC4922826 | biostudies-literature
Project description:BackgroundEbola virus disease (EVD) is a severe viral illness caused by Ebola virus (EBOV). The 2013-2016 EVD outbreak in West Africa is the largest recorded, with >11 000 deaths. Development of the ReEBOV Antigen Rapid Test (ReEBOV RDT) was expedited to provide a point-of-care test for suspected EVD cases.MethodsRecombinant EBOV viral protein 40 antigen was used to derive polyclonal antibodies for RDT and enzyme-linked immunosorbent assay development. ReEBOV RDT limits of detection (LOD), specificity, and interference were analytically validated on the basis of Food and Drug Administration (FDA) guidance.ResultsThe ReEBOV RDT specificity estimate was 95% for donor serum panels and 97% for donor whole-blood specimens. The RDT demonstrated sensitivity to 3 species of Ebolavirus (Zaire ebolavirus, Sudan ebolavirus, and Bundibugyo ebolavirus) associated with human disease, with no cross-reactivity by pathogens associated with non-EBOV febrile illness, including malaria parasites. Interference testing exhibited no reactivity by medications in common use. The LOD for antigen was 4.7 ng/test in serum and 9.4 ng/test in whole blood. Quantitative reverse transcription-polymerase chain reaction testing of nonhuman primate samples determined the range to be equivalent to 3.0 × 105-9.0 × 108 genomes/mL.ConclusionsThe analytical validation presented here contributed to the ReEBOV RDT being the first antigen-based assay to receive FDA and World Health Organization emergency use authorization for this EVD outbreak, in February 2015.
| S-EPMC5050482 | biostudies-literature
Project description: Not available
| S-EPMC5711404 | biostudies-literature
Project description:The soluble urokinase plasminogen activator receptor (suPAR) has been proposed as a biomarker for risk stratification of patients presenting with acute infections. However, most studies evaluating suPAR have used platform-based assays, the accuracy of which may differ from point-of-care tests capable of informing timely triage in settings without established laboratory capacity. Using samples and data collected during a prospective cohort study of 425 patients presenting with moderate Covid-19 to two hospitals in India, we evaluated the analytical performance and prognostic accuracy of a commercially-available rapid diagnostic test (RDT) for suPAR, using an enzyme-linked immunosorbent assay (ELISA) as the reference standard. Our hypothesis was that the suPAR RDT might be useful for triage of patients presenting with moderate Covid-19 irrespective of its analytical performance when compared with the reference test. Although agreement between the two tests was limited (bias = -2.46 ng/mL [95% CI = -2.65 to -2.27 ng/mL]), prognostic accuracy to predict supplemental oxygen requirement was comparable, whether suPAR was used alone (area under the receiver operating characteristic curve [AUC] of RDT = 0.73 [95% CI = 0.68 to 0.79] vs. AUC of ELISA = 0.70 [95% CI = 0.63 to 0.76]; p = 0.12) or as part of a published multivariable prediction model (AUC of RDT-based model = 0.74 [95% CI = 0.66 to 0.83] vs. AUC of ELISA-based model = 0.72 [95% CI = 0.64 to 0.81]; p = 0.78). Lack of agreement between the RDT and ELISA in our cohort warrants further investigation and highlights the importance of assessing candidate point-of-care tests to ensure management algorithms reflect the assay that will ultimately be used to inform patient care. Availability of a quantitative point-of-care test for suPAR opens the door to suPAR-guided risk stratification of patients with Covid-19 and other acute infections in settings with limited laboratory capacity.
| S-EPMC10441780 | biostudies-literature
Project description:IntroductionThis study was conducted to assess the efficacy of point-of-care (POC) procalcitonin (PCT) serial measurement in determining the antibiotic treatment duration in patients with ventilator-associated pneumonia (VAP).Material and methodsOne hundred patients were randomly recruited and then further randomly divided into two groups of 50 patients each. The first group used the POC PCT test along with the standard sepsis parameter monitoring, while the second group had the standard monitoring only (C-reactive protein [CRP] level, total white count, temperature and tracheal aspirate culture). Serial PCT test results and CRP levels were monitored on days 1, 3, 7 and 9. The patients were followed up for 28-day mortality.ResultsEighty-five patients completed the trial, of whom 43 were in the PCT group and 42 were in the control group. The PCT group had a significantly lower mean (SD) antibiotic treatment duration (10.28 [2.68] days) than the control group (11.52 [3.06]). The mean (SD) difference was -1.25 (95% confidence interval [CI], -2.48 to 0.01; t-statistic [df] = -1.997 [83]; P = 0.049). The PCT group also had a higher number of antibiotic-free days alive during the 28 days after VAP onset than the control group (mean [SD], 10.79 [7.61] vs. 8.72 [6.41]). The Sequential Organ Failure Assessment score was the sole factor for the decrease in duration after VAP onset (regression coefficient β [95% CI], -0.70 [-1.19 to -0.20]; P = 0.006).ConclusionsThe POC procalcitonin test can reduce the antibiotic treatment duration in patients with VAP.
| S-EPMC10158486 | biostudies-literature
Project description:Diabetes mellitus is a worldwide-spread chronic metabolic disease that occurs when the pancreas fails to produce enough insulin levels or when the body fails to effectively use the secreted pancreatic insulin, eventually resulting in hyperglycemia. Systematic glycemic control is the only procedure at our disposal to prevent diabetes long-term complications such as cardiovascular disorders, kidney diseases, nephropathy, neuropathy, and retinopathy. Glycated albumin (GA) has recently gained more and more attention as a control biomarker thanks to its shorter lifespan and wider reliability compared to glycated hemoglobin (HbA1c), currently the "gold standard" for diabetes screening and monitoring in clinics. Various techniques such as ion exchange, liquid or affinity-based chromatography and immunoassay can be employed to accurately measure GA levels in serum samples; nevertheless, due to the cost of the lab equipment and complexity of the procedures, these methods are not commonly available at clinical sites and are not suitable to home monitoring. The present review describes the most up-to-date advances in the field of glycemic control biomarkers, exploring in particular the GA with a special focus on the recent experimental analysis techniques, using enzymatic and affinity methods. Finally, analysis steps and fundamental reading technologies are integrated into a processing pipeline, paving the way for future point-of-care testing (POCT). In this view, we highlight how this setup might be employed outside a laboratory environment to reduce the time from measurement to clinical decision, and to provide diabetic patients with a brand-new set of tools for glycemic self-monitoring.
| S-EPMC9496022 | biostudies-literature
Project description:We report a simple droplet fluidic point-of-care test (POCT) that uses gravity to manipulate the sequence, timing, and motion of droplets on a surface. To fabricate this POCT, we first developed a surface coating toolbox of nine different coatings with three levels of wettability and three levels of slipperiness that can be independently tailored. We then fabricated a device that has interconnected fluidic elements-pumps, flow resistors and flow guides-on a highly slippery solid surface to precisely control the timing and sequence of motion of multiple droplets and their interactions on the surface. We then used this device to carry out a multi-step enzymatic assay of a clinically relevant analyte-lactate dehydrogenase (LDH)-to demonstrate the application of this technology for point-of-care diagnosis.
| S-EPMC10588563 | biostudies-literature