Utility of the Cobas® Plasma Separation Card as a Sample Collection Device for Serological and Virological Diagnosis of Hepatitis C Virus Infection

Velásquez-Orozco, Fernando; Rando-Segura, Ariadna; Martínez-Campreciós, Joan; Salmerón, Paula; Najarro-Centeno, Adrián; Esteban, Angels; Quer, Josep; Buti, Marı́a; Pumarola-Suñe, Tomás; Rodríguez‐Frías, Francisco

doi:10.3390/diagnostics11030473

Cited by 8 publications

(14 citation statements)

References 17 publications

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“…A current prospective study compares the performance of dried plasma spots (DPS), prepared by using the Cobas ® plasma separation card (PSC), to plasma and serum collected from venipuncture blood of HCV infected patients in Barcelona, Spain. The study findings demonstrate the comparable performance of DPS for the serological and virological markers of HCV infection to that of the conventional specimen types, albeit the LLOD for DPS was noticeably higher in the study [ 105 ]. Another study (i.e., HepCdetect II Study) deciphers the usefulness of plasma and/or DBS to characterize acute HCV infection kinetics and transmission networks in individuals who recently inject drugs in Catalonia, Spain based on next-generation sequencing (NGS) of HCV nonstructural protein (i.e., NS5B) in 220 viremic PWIDs [ 106 ].…”

Section: The Real-world Clinical Performance Of Current Hcv Diagnostic Algorithmsmentioning

confidence: 72%

Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises

et al. 2021

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The simplification of current hepatitis C diagnostic algorithms and the emergence of digital diagnostic devices will be very crucial to achieving the WHO’s set goals of hepatitis C diagnosis (i.e., 90%) by 2030. From the last decade, hepatitis C diagnosis has been revolutionized by the advent and approval of state-of-the-art HCV diagnostic platforms which have been efficiently implemented in high-risk HCV populations in developed nations as well as in some low-to-middle income countries (LMICs) to identify millions of undiagnosed hepatitis C-infected individuals. Point-of-care (POC) rapid diagnostic tests (RDTs; POC-RDTs), RNA reflex testing, hepatitis C self-test assays, and dried blood spot (DBS) sample analysis have been proven their diagnostic worth in real-world clinical experiences both at centralized and decentralized diagnostic settings, in mass hepatitis C screening campaigns, and hard-to-reach aboriginal hepatitis C populations in remote areas. The present review article overviews the significance of current and emerging hepatitis C diagnostic packages to subvert the public health care burden of this ‘silent epidemic’ worldwide. We also highlight the challenges that remain to be met about the affordability, accessibility, and health system-related barriers to overcome while modulating the hepatitis C care cascade to adopt a ‘test and treat’ strategy for every hepatitis C-affected individual. We also elaborate some key measures and strategies in terms of policy and progress to be part of hepatitis C care plans to effectively link diagnosis to care cascade for rapid treatment uptake and, consequently, hepatitis C cure.

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Section: The Real-world Clinical Performance Of Current Hcv Diagnostic Algorithmsmentioning

confidence: 72%

Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises

et al. 2021

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“…The Novilytic DUO card includes a spreading layer beneath the PSM to distribute cell-free plasma to two precut paper discs; however, the maximum output volume is only 3.8 μL per disc and may preclude quantitation of analytes in low abundance (e.g., hormones, cytokines, and circulating nucleic acids). Both the Novilytic DUO cards and Cobas PSCs utilize only vertical separation to store plasma directly beneath the separation material, which can result in contamination due to hemolysis (from shearing or upon drying) or leakage of RBCs through the PSM . Alternatively, the “volume-defined DPS card” provides consistent metering of plasma utilizing lateral flow channels and overflow control for samples with a low hematocrit by inclusion of a water-soluble poly(vinyl alcohol) film.…”

Section: Introductionmentioning

confidence: 99%

“…Both the Novilytic DUO cards and Cobas PSCs utilize only vertical separation to store plasma directly beneath the separation material, which can result in contamination due to hemolysis (from shearing or upon drying) or leakage of RBCs through the PSM. 34 Alternatively, the "volume-defined DPS card" provides consistent metering of plasma utilizing lateral flow channels and overflow control for samples with a low hematocrit by inclusion of a water-soluble poly(vinyl alcohol) film. This device functions well as a stand-alone plasma separator unit but requires a complete seal for separation, has an open structure, and may not be amenable to multiplexing to produce multiple unique samples of plasma.…”

Section: ■ Introductionmentioning

confidence: 99%

Direct Processing and Storage of Cell-Free Plasma Using Dried Plasma Spot Cards

et al. 2022

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Plasma separation cards represent a viable approach for expanding testing capabilities away from clinical settings by generating cell-free plasma with minimal user intervention. These devices typically comprise a basic structure of the plasma separation membrane, unconstrained porous collection pad, and utilize either (i) lateral or (ii) vertical fluidic pathways for separating plasma. Unfortunately, these configurations are highly susceptible to (i) inconsistent sampling volume due to differences in the patient hematocrit or (ii) severe contamination due to leakage of red blood cells or release of hemoglobin (i.e., hemolysis). Herein, we combine the enhanced sampling of our previously reported patterned dried blood spot cards with an assembly of porous separation materials to produce a patterned dried plasma spot card for direct processing and storage of cell-free plasma. Linking both vertical separation and lateral distribution of plasma yields discrete plasma collection zones that are spatially protected from potential contamination due to hemolysis and an inlet zone enriched with blood cells for additional testing. We evaluate the versatility of this card by quantitation of three classes of analytes and techniques including (i) the soluble transferrin receptor by enzyme-linked immunosorbent assay, (ii) potassium by inductively coupled plasma atomic emission spectroscopy, and (iii) 18S rRNA by reverse transcriptase quantitative polymerase chain reaction. We achieve quantitative recovery of each class of analyte with no statistically significant difference between dried and liquid reference samples. We anticipate that this sampling approach can be applied broadly to improve access to critical blood testing in resource-limited settings or at the point-of-care.

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“…[23][24][25] The cobas ® Plasma Separation Card (PSC) offers another option; whilst currently approved only for the purpose of human immunodeficiency virus (HIV) viral load monitoring, 26 the utility of the PSC for HCV testing has been recently demonstrated. 27,28 The PSC has three sample collection 'spots' that allow three different tests to be performed with one card. Furthermore, the PSC separates serum from blood cells and can be collected at patients' homes immediately after a positive anti-HCV test.…”

Section: Introductionmentioning

confidence: 99%

Assessing the potential cost-effectiveness of centralized vs point-of-care testing for hepatitis C virus in Pakistan: a model-based comparison

Babigumira

Karichu

Clark

et al. 2022

Preprint

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Background Pakistan has a hepatitis C virus (HCV) infection prevalence of 6-9% and aims to achieve World Health Organization (WHO) targets for elimination of HCV by the year 2030 through scaling HCV diagnosis and accelerating access to care. The clinical and economic benefits of various HCV testing strategies have not yet been evaluated in Pakistan. Objective To evaluate the potential cost-effectiveness of a reference laboratory-based (CEN) confirmatory testing approach vs a molecular near-patient point-of-care (POC) confirmatory approach to screen the general population for HCV in Pakistan. Methods We developed a decision-analytic model comparing HCV testing under two scenarios: screening with an anti-HCV antibody test (Anti-HCV) followed by either POC nucleic acid testing (NAT) (Anti-HCV-POC), or reference laboratory NAT (Anti-HCV-CEN), using data from published literature, the Pakistan Ministry of Health, and expert judgment. Outcome measures included: number of HCV infections identified per year, percentage of individuals correctly classified, total costs, average costs per individual tested, and cost-effectiveness. Sensitivity analysis was also performed. Results At a national level for a tested population of 25 million, the Anti-HCV-CEN strategy would identify 142,406 more HCV infections in one year and increase correct classification of individuals by 0.57% compared with the Anti-HCV-POC strategy. The total annual cost of HCV testing was reduced using the Anti-HCV-CEN strategy by $7.68 million ($0.31 per person). Thus, incrementally, the Anti-HCV-CEN strategy costs less and identifies more HCV infections than Anti-HCV-POC. Conclusions Anti-HCV-CEN would provide the best value for money when scaling up HCV testing in Pakistan.

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Utility of the Cobas® Plasma Separation Card as a Sample Collection Device for Serological and Virological Diagnosis of Hepatitis C Virus Infection

Cited by 8 publications

References 17 publications

Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises

Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises

Direct Processing and Storage of Cell-Free Plasma Using Dried Plasma Spot Cards

Assessing the potential cost-effectiveness of centralized vs point-of-care testing for hepatitis C virus in Pakistan: a model-based comparison

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