Reflex viral load testing in dried blood spots generated by plasma separation card allows the screening and diagnosis of chronic viral hepatitis

Martínez-Campreciós, Joan; Rando-Segura, Ariadna; Buti, María; Rodrigo-Velásquez, Fernando; Riveiro‐Barciela, Mar; Barreira‐Díaz, Ana; Álvarez-López, Patricia; Salmerón, Paula; Tabernero, David; Palomo, Nieves; Nindia, Arlete; Barbosa, Gisela; López, E. Cerezo; Ferreira, Vicelma; Saiago, Nelsa; Kuchta, Alison; Ferrer-Costa, Roser; Esteban, Rafael; Molina, Israel; Rodríguez‐Frías, Francisco

doi:10.1016/j.jviromet.2020.114039

Cited by 20 publications

(16 citation statements)

References 23 publications

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“…PSCs were left to dry and later transported to Vall d’Hebron University Hospital Laboratory (Barcelona) for analysis 1–5 days after being collected. Sensitivity and specificity of the PSC are very high (> 95%) and previously described 20 .…”

Section: Methodssupporting

confidence: 74%

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A novel model of care for simplified testing of HBV in African communities during the COVID-19 pandemic in Spain

Picchio

Nomah

Araujo

et al. 2021

Sci Rep

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Chronic hepatitis B virus (HBV) infection is a major public health threat for migrant populations in Spain and efforts to scale up testing are needed to reach the WHO elimination targets. The Hepatitis B Virus Community Screening and Vaccination in Africans (HBV-COMSAVA) study aims to use point-of-care testing and simplified diagnostic tools to identify, link to care, or vaccinate African migrants in Barcelona during the COVID-19 pandemic. From 21/11/20 to 03/07/2021, 314 study participants were offered HBV screening in a community clinic. Rapid tests for HBsAg screening were used and blood samples were collected with plasma separation cards. Patients received results and were offered: linkage to specialist care; post-test counselling; or HBV vaccination in situ. Sociodemographic and clinical history were collected and descriptive statistics were utilized. 274 patients were included and 210 (76.6%) returned to receive results. The HBsAg prevalence was 9.9% and 33.2% of people had evidence of past resolved infection. Overall, 133 required vaccination, followed by post-test counselling (n = 114), and linkage to a specialist (n = 27). Despite the COVID-19 pandemic, by employing a community-based model of care utilizing novel simplified diagnostic tools, HBV-COMSAVA demonstrated that it was possible to diagnose, link to care, and vaccinate African migrants in community-based settings.

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Section: Methodssupporting

confidence: 74%

“…However, this limitation would not have an impact on selection of patients eligible for HBV therapy; that is, those with HBV-DNA levels > 2000 IU/Ml. In this situation, the sensitivity of PSC increased to almost 96% and showed a high correlation with conventional venous blood testing 20 .…”

Section: Discussionmentioning

confidence: 89%

A novel model of care for simplified testing of HBV in African communities during the COVID-19 pandemic in Spain

Picchio

Nomah

Araujo

et al. 2021

Sci Rep

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“…Nowadays there is a lack of validated commercial assays for DBS workflow. However, according to various studies, the detection of HCV antibodies and quantification of HCV RNA using DBS samples can be very reliable [17,25]. Several studies have focused on the consistency of DBS as an analyte for HCV diagnosis.…”

Section: Discussionmentioning

confidence: 99%

“…Twenty-six samples were tested using 1000 µL of eluted DBS (1 spot eluted in 1000 µL of PBS during 60 min at 37 • C). The adjusted HCV viral load in plasma was calculated as previously described [17,18], taking into account the dilution factor of the elution process, the usual hematocrit values (42% for women and 47% for men), and considering that 70 µL of blood was collected per spot. The lower limit of RNA quantification following this methodology was estimated at 860 IU/mL of eluted DBS.…”

Section: Inno-lia Hcv Scorementioning

confidence: 99%

HCV Diagnosis and Sequencing Using Dried Blood Spots from Patients in Kinshasa (DRC): A Tool to Achieve WHO 2030 Targets

et al. 2021

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The World Health Organization has established an elimination plan for hepatitis C virus (HCV) by 2030. In Sub-Saharan Africa (SSA) access to diagnostic tools is limited, and a number of genotype 4 subtypes have been shown to be resistant to some direct-acting antivirals (DAAs). This study aims to analyze diagnostic assays for HCV based on dried blood spots (DBS) specimens collected in Kinshasa and to characterize genetic diversity of the virus within a group of mainly HIV positive patients. HCV antibody detection was performed on 107 DBS samples with Vidas® anti-HCV and Elecsys anti-HCV II, and on 31 samples with INNO-LIA HCV. Twenty-six samples were subjected to molecular detection. NS3, NS5A, and NS5B regions from 11 HCV viremic patients were sequenced. HCV seroprevalence was 12.2% (72% with detectable HCV RNA). Both Elecsys Anti-HCV and INNO-LIA HCV were highly sensitive and specific, whereas Vidas® anti-HCV lacked full sensitivity and specificity when DBS sample was used. NS5B/NS5A/NS3 sequencing revealed exclusively GT4 isolates (50% subtype 4r, 30% 4c and 20% 4k). All 4r strains harbored NS5A resistance-associated substitutions (RAS) at positions 28, 30, and 31, but no NS3 RAS was detected. Elecsys Anti-HCV and INNO-LIA HCV are reliable methods to detect HCV antibodies using DBS. HCV subtype 4r was the most prevalent among our patients. RASs found in subtype 4r in NS5A region confer unknown susceptibility to DAA.

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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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Reflex viral load testing in dried blood spots generated by plasma separation card allows the screening and diagnosis of chronic viral hepatitis

Cited by 20 publications

References 23 publications

A novel model of care for simplified testing of HBV in African communities during the COVID-19 pandemic in Spain

A novel model of care for simplified testing of HBV in African communities during the COVID-19 pandemic in Spain

HCV Diagnosis and Sequencing Using Dried Blood Spots from Patients in Kinshasa (DRC): A Tool to Achieve WHO 2030 Targets

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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