Monitoring hepatitis B by using point-of-care testing: biomarkers, current technologies, and perspectives

Xu, Ruidong; Feng, Ailing; Li, Xiaodong; Hu, Jie; Lin, Min

doi:10.1080/14737159.2021.1876565

Cited by 7 publications

(2 citation statements)

References 111 publications

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“…The presence of these serological biomarkers will not only determine the infection, but also the clinical phase, either acute or chronic infection, in patients [ 39 ]. The biomarkers of HBV consist of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HbsAb or Anti-HBs), hepatitis B envelop antigen (HbeAg), hepatitis B envelop antibody (HbeAb), hepatitis B core antigen (HbcAg) and hepatitis B core antibody (HbcAb or Anti-HBc) [ 30 , 40 ]. HBV DNA measurement is a direct indicator of the viral load.…”

Section: Diagnosis Of Hbvmentioning

confidence: 99%

Lateral Flow Assay for Hepatitis B Detection: A Review of Current and New Assays

2023

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From acute to chronic hepatitis, cirrhosis, and hepatocellular cancer, hepatitis B infection causes a broad spectrum of liver diseases. Molecular and serological tests have been used to diagnose hepatitis B-related illnesses. Due to technology limitations, it is challenging to identify hepatitis B infection cases at an early stage, particularly in a low- and middle-income country with constrained resources. Generally, the gold-standard methods to detect hepatitis B virus (HBV) infection requires dedicated personnel, bulky, expensive equipment and reagents, and long processing times which delay the diagnosis of HBV. Thus, lateral flow assay (LFA), which is inexpensive, straightforward, portable, and operates reliably, has dominated point-of-care diagnostics. LFA consists of four parts: a sample pad where samples are dropped; a conjugate pad where labeled tags and biomarker components are combined; a nitrocellulose membrane with test and control lines for target DNA-probe DNA hybridization or antigen-antibody interaction; and a wicking pad where waste is stored. By modifying the pre-treatment during the sample preparation process or enhancing the signal of the biomarker probes on the membrane pad, the accuracy of the LFA for qualitative and quantitative analysis can be improved. In this review, we assembled the most recent developments in LFA technologies for the progress of hepatitis B infection detection. Prospects for ongoing development in this area are also covered.

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Section: Diagnosis Of Hbvmentioning

confidence: 99%

Lateral Flow Assay for Hepatitis B Detection: A Review of Current and New Assays

2023

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“…Recently, with the aim of performing real-time PCR tests more efficiently, rapid real-time PCR devices have attracted considerable attention ( Romsos and Vallone, 2015 ; White et al, 2015 ; Federici et al, 2018 ) and are of great significance for rapid pathogen detection and on-site diagnosis ( Qian et al, 2018 ). Although some rapid PCR devices have been designed for point-of-care testing (POCT), some technical challenges are still faced, such as complex hardware system design, insufficient miniaturization, and complicated preprocessing ( Luppa et al, 2016 ; Kazuya et al, 2020 ; Rong et al, 2021 ). The GeneXpert, developed by Cepheid, is a popular POC device that has been endorsed by the WHO ( Heidebrecht et al, 2016 ), and however it still needs 45–60 min for the test to complete due to one single temperature module conducting the thermal cycle through repeated heating and cooling processes ( Stime et al, 2018 ).…”

Section: Introductionmentioning

confidence: 99%

Performance Evaluation of a Novel Ultrafast Molecular Diagnostic Device Integrated With Microfluidic Chips and Dual Temperature Modules

Lin

Song

Shao³

et al. 2022

Front. Bioeng. Biotechnol.

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Ultrafast, portable, and inexpensive molecular diagnostic platforms are critical for clinical diagnosis and on-site detection. There are currently no available real-time polymerase chain reaction (PCR) devices able to meet the demands of point-of-care testing, as the heating and cooling processes cannot be avoided. In this study, the dual temperature modules were first designed to process microfluidic chips automatically circulating between them. Thus, a novel ultrafast molecular diagnostic real-time PCR device (approximately 18 and 23 min for DNA and RNA detection, respectively) with two channels (FAM and Cy5) for the detection of 12 targets was developed. The device contained three core functional components, including temperature control, optics, and motion, which were integrated into a portable compact box. The temperature modules accurately control temperature in rapid thermal cycles with less than ±0.1 °C, ±1 °C and ±0.5 °C for the temperature fluctuation, uniformity, and error of indication, respectively. The average coefficient of variation (CV) of the fluorescence intensity (FI) for all 12 wells was 2.3% for FAM and 2.7% for Cy5. There was a good linear relationship between the concentrations of fluorescent dye and the FIs of FAM and Cy5(R2 = 0.9990 and 0.9937), and the average CVs of the Ct values calculated by the embedded software were 1.4% for FAM and Cy5, respectively. The 100 double-blind mocked sputum and 249 clinical stool samples were analyzed by the ultrafast real-time PCR device in comparison with the DAAN Gene SARS-CoV-2 kit run on the ABI 7500 instrument and Xpert C. difficile/Epi, respectively. Among the 249 stool samples, the ultrafast real-time PCR device detected toxigenic C. difficile in 54 samples (54/249, 21.7%) with a specificity and positive predictive values of 99.0 and 96.3%, which were higher than the Xpert C. difficile/Epi values of 94.4 and 88.1% (p > 0.05). The ultrafast real-time PCR device detected 15 SARS-CoV-2 positive samples, which has a 100% concordance with that obtained by the DAAN Gene SARS-CoV-2 kit. This study demonstrated that the ultrafast real-time PCR device integrated with microfluidic chips and dual temperature modules is an ultrafast, reliable, easy-to-use, and cost-effective molecular diagnostic platform for clinical diagnosis and on-site testing, especially in resource-limited settings.

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Portable Paper‐Based Nucleic Acid Enrichment for Field Testing

et al. 2023

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Point-of-care testing (POCT) can be the method of choice for detecting infectious pathogens; these pathogens are responsible for not only infectious diseases such as COVID-19, but also for certain types of cancers. For example, infections by human papillomavirus (HPV) or Helicobacter pylori (H. pylori) are the main cause of cervical and stomach cancers, respectively. COVID-19 and many cancers are treatable with early diagnoses using POCT. A variety of nucleic acid testing have been developed for use in resource-limited environments. However, questions like unintegrated nucleic acid extraction, open detection systems increase the risk of cross-contamination, and dependence on expensive equipment and alternating current (AC) power supply, significantly limit the application of POCT, especially for on-site testing. In this paper, a simple portable platform is reported capable of rapid sample-to-answer testing within 30 min based on recombinase polymerase amplification (RPA) at a lower temperature, to detect SARS-CoV-2 virus and H. pylori bacteria with a limit of detection as low as 4 × 10 2 copies mL −1 . The platform used a battery-powered portable reader for on-chip one-pot amplification and fluorescence detection, and can test for multiple (up to four) infectious pathogens simultaneously. This platform can provide an alternative method for fast and reliable on-site diagnostic testing.

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Monitoring hepatitis B by using point-of-care testing: biomarkers, current technologies, and perspectives

Cited by 7 publications

References 111 publications

Lateral Flow Assay for Hepatitis B Detection: A Review of Current and New Assays

Lateral Flow Assay for Hepatitis B Detection: A Review of Current and New Assays

Performance Evaluation of a Novel Ultrafast Molecular Diagnostic Device Integrated With Microfluidic Chips and Dual Temperature Modules

Portable Paper‐Based Nucleic Acid Enrichment for Field Testing

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