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
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...
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2024-11-01
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| author | Amie Ceesay Sainabou Drammeh Gibril Ndow Alpha Omar A. Jallow Haddy Nyang Baboucarr Bittaye Francis S. Mendy Ousman Secka Umberto D’Alessandro Yusuke Shimakawa Erwan Vo-Quang Barbara Testoni Mark Thursz Maud Lemoine Isabelle Chemin |
| author_facet | Amie Ceesay Sainabou Drammeh Gibril Ndow Alpha Omar A. Jallow Haddy Nyang Baboucarr Bittaye Francis S. Mendy Ousman Secka Umberto D’Alessandro Yusuke Shimakawa Erwan Vo-Quang Barbara Testoni Mark Thursz Maud Lemoine Isabelle Chemin |
| author_sort | Amie Ceesay |
| collection | DOAJ |
| description | 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 log<sub>10</sub> IU/mL, respectively. However, paired stored plasma and DBS samples had a lower mean bias of 1.831 log<sub>10</sub> 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. |
| format | Article |
| id | doaj-art-3fa41425f9d74f4a8d93c861c48d4df9 |
| institution | OA Journals |
| issn | 2076-2607 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | MDPI AG |
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| spelling | doaj-art-3fa41425f9d74f4a8d93c861c48d4df92025-08-20T01:53:54ZengMDPI AGMicroorganisms2076-26072024-11-011211227310.3390/microorganisms12112273Real-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 GambiaAmie Ceesay0Sainabou Drammeh1Gibril Ndow2Alpha Omar A. Jallow3Haddy Nyang4Baboucarr Bittaye5Francis S. Mendy6Ousman Secka7Umberto D’Alessandro8Yusuke Shimakawa9Erwan Vo-Quang10Barbara Testoni11Mark Thursz12Maud Lemoine13Isabelle Chemin14Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The GambiaDisease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The GambiaDisease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The GambiaDisease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The GambiaDisease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The GambiaDisease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The GambiaDisease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The GambiaDisease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The GambiaDisease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The GambiaUnité d’Épidémiologie des Maladies Émergentes, Institut Pasteur, Université Paris Cité, 75015 Paris, FranceDisease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The GambiaCancer Research Center of Lyon, INSERM U1052, CNRS UMR 5286, 69008 Lyon, FranceDivision of Digestive Diseases, Section of Hepatology, Department of Metabolism, Digestion and Reproduction, Imperial College London, London W2 1NY, UKDisease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The GambiaCancer Research Center of Lyon, INSERM U1052, CNRS UMR 5286, 69008 Lyon, FranceThe 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 log<sub>10</sub> IU/mL, respectively. However, paired stored plasma and DBS samples had a lower mean bias of 1.831 log<sub>10</sub> 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.https://www.mdpi.com/2076-2607/12/11/2273monitoringGeneXpertdiagnosisresource limitedscale-upsettings |
| spellingShingle | Amie Ceesay Sainabou Drammeh Gibril Ndow Alpha Omar A. Jallow Haddy Nyang Baboucarr Bittaye Francis S. Mendy Ousman Secka Umberto D’Alessandro Yusuke Shimakawa Erwan Vo-Quang Barbara Testoni Mark Thursz Maud Lemoine Isabelle Chemin 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 Microorganisms monitoring GeneXpert diagnosis resource limited scale-up settings |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | monitoring GeneXpert diagnosis resource limited scale-up settings |
| url | https://www.mdpi.com/2076-2607/12/11/2273 |
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