Performance evaluation of Xpert HBV viral load (VL) assay: Point-of-care molecular test to strengthen and decentralize management of chronic hepatitis B (CHB) infection

Gupta, Ekta; Khodare, Arvind; Rani, Nitiksha; Singh, Gaurav; Kavita, Aggarwal; Sharma, Manoj Kumar

doi:10.1016/j.jviromet.2021.114063

Cited by 8 publications

(6 citation statements)

References 9 publications

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“…Although real-time polymerase chain reaction (RT–qPCR)-based detection methods have been widely used for HBV DNA detection with superior performance [ 5 ], they have shortcomings. These limitations are mainly associated with the much longer turnaround time for the results, the requirement for large-scale equipment and a shortage of professional and technical personnel [ 6 , 7 ]. Furthermore, studies have shown that low awareness of the disease and the high cost of testing contribute to the lack of HBV testing in low- and middle-income countries [ 8 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

CRISPR/Cas13a-assisted rapid and portable HBV DNA detection for low-level viremia patients

Tian

Fan

et al. 2023

Emerging Microbes & Infections

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Background & Aims: The WHO declared to eliminate hepatitis B virus (HBV) by 2030. However, an increasing number of patients are presenting with low-level viremia (LLV) with the widespread use of antiviral medications. The diagnostic efficiency and coverage area of HBV infection are low. Hence, this study intended to drive the HBV infection detection to effectively adaptable for any small to medium-sized laboratory or field survey. Methods: We established, optimized, and evaluated a colloidal gold test strip for detection of HBV DNA based on CRISPR/Cas13a combined with recombinase-aided amplification (RAA) technology. Furthermore, 180 HBV-infected patients (including patients with different viral loads, LLV patients and dynamic plasma samples of patients on antiviral therapy) were enrolled for clinical validation. Results: The strip detection of HBV DNA was established based on RAA-CRISPR-Cas13a technology with a sensitivity of 10 1 copies/μL and a specificity of 100%. HBV DNA gradient concentration plasmids and clinical samples were effectively identified by this approach. The positive coincidence rate for LLV patients was 87%, while the negative coincidence rate was 100%. The positive coincidence rate reached 100% in LLV patients (viral loading >100 IU/mL). The sensitivity, specificity, positive predictive agreement (PPA) and negative predictive agreement (NPA) values of dynamic plasma detection in patients on antiviral therapy were 100%, 92.15%, 93.75%, and 100%, respectively. Conclusions: We develop rapid and portable RAA-CRISPR/Cas13a-based strip of HBV DNA detection for LLV patients. This study provides a visual and faster alternative to current PCR-based diagnosis for HBV infection.

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Section: Introductionmentioning

confidence: 99%

CRISPR/Cas13a-assisted rapid and portable HBV DNA detection for low-level viremia patients

Tian

Fan

et al. 2023

Emerging Microbes & Infections

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“… 22 , 27 Our findings suggest an urgent need for simplified clinical algorithms in sSA that would enable a reduction in the number of tests and visits required and therefore minimise loss to follow-up. The development of ALT POC tests 28 and the use of HBV DNA POC tests 29 , 30 or alternative serological markers 31 , 35 and simple biochemical markers of liver fibrosis might overcome these barriers. 13 We did not assess liver fibrosis using the AST-to-platelet ratio index (APRI) in this study because it has been shown to have poor diagnostic performance in previous studies in Africa.…”

Section: Discussionmentioning

confidence: 99%

HBV continuum of care using community- and hospital-based screening interventions in Senegal: Results from the PROLIFICA programme

Sow¹,

Lemoine²,

Touré³

et al. 2022

JHEP Reports

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“…The Xpert HBV VL assay has been evaluated against multiple conventional quantitative nucleic acid platforms, such as the Roche Cobas, and Abbott RealTime HBV assays and has shown very good concordance (77,78). Assessment of the platform within a tertiary care hospital clinic in Addis Ababa, Ethiopia, demonstrated utility of the Xpert HBV VL to identify patients requiring initiation of treatment, with an Xpert cutoff of 4,190 IU/mL and 35,800 IU/mL equivalent to ≥ 2,000 IU/mL and ≥20,000 IU/mL, as determined by a high-throughput LBT method (79).…”

Section: Nucleic-acid-based Rdtmentioning

confidence: 99%

Rapid Diagnostics for Hepatitis B and C Viruses in Low- and Middle-Income Countries

Shenge¹,

Osiowy

2021

Front.Virol.

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The global health challenge posed by hepatitis B virus (HBV) and hepatitis C virus (HCV) persists, especially in low-and-middle-income countries (LMICs), where underdiagnosis of these viral infections remains a barrier to the elimination target of 2030. HBV and HCV infections are responsible for most liver-related mortality worldwide. Infected individuals are often unaware of their condition and as a result, continue to transmit these viruses. Although conventional diagnostic tests exist, in LMIC they are largely inaccessible due to high costs or a lack of trained personnel, resulting in poor linkage to care and increased infections. Timely and accurate diagnosis is needed to achieve elimination of hepatitis B and C by the year 2030 as set out by the World Health Organization Global Health Sector Strategy. In this review rapid diagnostic tests allowing for quick and cost-effective screening and diagnosis of HBV and HCV, are discussed, as are their features, including suitability, reliability, and applicability in LMIC, particularly those within Africa.

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Performance evaluation of Xpert HBV viral load (VL) assay: Point-of-care molecular test to strengthen and decentralize management of chronic hepatitis B (CHB) infection

Cited by 8 publications

References 9 publications

CRISPR/Cas13a-assisted rapid and portable HBV DNA detection for low-level viremia patients

CRISPR/Cas13a-assisted rapid and portable HBV DNA detection for low-level viremia patients

HBV continuum of care using community- and hospital-based screening interventions in Senegal: Results from the PROLIFICA programme

Rapid Diagnostics for Hepatitis B and C Viruses in Low- and Middle-Income Countries

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