| Title: |
Real-Life Diagnostic Accuracy and Clinical Utility of Hepatitis B Virus (HBV) Nucleic Acid Testing Using the GeneXpert Point-of-Care Test System from Fresh Plasma and Dry Blood Spot Samples in The Gambia |
| Authors: |
Ceesay, Amie; Drammeh, Sainabou; Ndow, Gibril; Jallow, Alpha Omar A.; Nyang, Haddy; Bittaye, Baboucarr; Mendy, Francis, S; Secka, Ousman; D’alessandro, Umberto; Shimakawa, Yusuke; Vo-Quang, Erwan; Testoni, Barbara; Thursz, Mark; Lemoine, Maud; Chemin, Isabelle |
| Contributors: |
London School of Hygiene and Tropical Medicine Fajara, Gambia; London School of Hygiene and Tropical Medicine (LSHTM); Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL); Centre Léon Bérard Lyon -Université Claude Bernard Lyon 1 (UCBL); Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS); Université de Gambie; Epidémiologie des Maladies Emergentes - Emerging Diseases Epidemiology; Institut Pasteur Paris (IP)-Université Paris Cité (UPCité); Institut Mondor de Recherche Biomédicale (IMRB); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12); Imperial College London; PROLIFICA has received funding and support from the MRC Unit The Gambia, the Gambian Ministry of Health, the European Union (FP7 grant 265994), MRC UKRI (MR/011117/1). WeA. Ceesay is a PhD candidate supported by an Islamic Development Bank (IsDB) postgraduate scholarship funding ID (No: 600036461).; European Project: 265994,EC:FP7:HEALTH,FP7-AFRICA-2010,PROLIFICA(2011) |
| Source: |
ISSN: 2076-2607 ; Microorganisms ; https://hal.science/hal-05021476 ; Microorganisms, 2024, 12 (11), pp.2273. ⟨10.3390/microorganisms12112273⟩. |
| Publisher Information: |
CCSD; MDPI |
| Publication Year: |
2024 |
| Subject Terms: |
diagnosis; clinical; HBV; utility; settings; scale-up; resource limited; GeneXpert; monitoring; [SDV]Life Sciences [q-bio]; [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology; [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology |
| Description: |
International audience ; The GeneXpert HBV Viral Load test is a simplified tool to scale up screening and HBV monitoring in resource-limited settings, where HBV is endemic and where molecular techniques to quantify HBV DNA are expensive and scarce. However, the accuracy of field diagnostics compared to gold standard assays in HBV-endemic African countries has not been well understood. We aim to validate the diagnostic performance of the GeneXpert HBV Viral Load test in freshly collected and stored plasma and dried blood spot (DBS) samples to assess turn-around-time (TAT) for sample processing and treatment initiation, to map GeneXpert machines and to determine limitations to its use in The Gambia. Freshly collected paired plasma and DBS samples (n = 56) were analyzed by the GeneXpert test. Similarly, stored plasma and DBS samples (n = 306, n = 91) were analyzed using the GeneXpert HBV test, in-house qPCR and COBAS TaqMan Roche. The correlation between freshly collected plasma and DBS is r = 0.88 with a mean bias of −1.4. The GeneXpert HBV test had the highest quantifiable HBV DNA viremia of 81.4% (n = 249/306), and the lowest was detected by in-house qPCR at 37.9% (n = 116/306) for stored plasma samples. Bland–Altman plots show strong correlation between GeneXpert and COBAS TaqMan and between GeneXpert and in-house qPCR with a mean bias of +0.316 and −1.173 log10 IU/mL, respectively. However, paired stored plasma and DBS samples had a lower mean bias of 1.831 log10 IU/mL, which is almost significant (95% limits of agreement: 0.66–3.001). Patients (n = 3) were enrolled in the study within a TAT of 6 days. The GeneXpert HBV test displayed excellent diagnostic accuracy by detecting HBV viremia in less than 10 IU/mL. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/39597662; info:eu-repo/grantAgreement/EC/FP7/265994/EU/Prevention of Liver Fibrosis and Cancer in Africa/PROLIFICA; PUBMED: 39597662; PUBMEDCENTRAL: PMC11596281 |
| DOI: |
10.3390/microorganisms12112273 |
| Availability: |
https://hal.science/hal-05021476; https://hal.science/hal-05021476v1/document; https://hal.science/hal-05021476v1/file/Ceesay_microorganisms-12-02273.pdf; https://doi.org/10.3390/microorganisms12112273 |
| Rights: |
http://creativecommons.org/licenses/by/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.86D0C19B |
| Database: |
BASE |