Sansure Biotech

Emerging Clinical Significance of HBV RNA: A New Hepatitis B Viral Marker

yang, rongchang — Sun, 28 Jul 2024 01:41:47 +0000

Hepatitis B virus (HBV) poses an enduring global health dilemma, with current therapeutic strategies falling short of total viral eradication, even with the advent of nucleos(t)ide analogues (NAs) and pegylated interferon (Peg-IFN) (Deng et al., 2022). The enigmatic persistence of HBV is predominantly attributed to the tenacious presence of covalently closed circular DNA (cccDNA) within hepatocytes, which acts as a resilient template for viral replication and transcription.

Traditionally, assessing intrahepatic HBV activity hinged on the use of liver biopsies, an invasive approach that is fraught with risks and not amenable to routine monitoring (Mak et al., 2021). This has precipitated an urgent quest for non-invasive, efficacious surrogate markers capable of monitoring intrahepatic HBV activity, a pursuit that has garnered significant momentum in recent years. While conventional serological markers such as serum HBV DNA, hepatitis B e antigen (HBeAg), and hepatitis B surface antigen (HBsAg) have been used to reflect viral replication activity during the natural course of infection, they may not accurately represent cccDNA transcriptional activity in patients receiving NA treatment (Li et al. 2021).

In the quest for non-invasive alternatives, circulating HBV RNA has emerged as a beacon of hope, heralding a new era in the surrogate markers for intrahepatic cccDNA (Deng et al., 2022). This biomarker has captured the scientific community’s attention for its potential in monitoring the progression of chronic hepatitis B (CHB) in patients, irrespective of their antiviral treatment status (Deng et al. 2022). Importantly, HBV RNA allows for the monitoring of viral activity even in patients where serum HBV DNA is undetectable, providing a more sensitive measure of ongoing viral replication.

Circulating HBV RNA primarily consists of full-length, spliced, and 3′-truncated pregenomic RNA (pgRNA). In the blood of CHB patients, it circulates mainly in the form of virus-like particles, including enveloped viral particles and naked capsids (often as capsid-antibody complexes in patient serum) (Deng et al. 2022). The exact mechanism by which these RNA-containing particles are released from hepatocytes remains elusive, highlighting the complex biology of HBV RNA.

The relationship between circulating HBV RNA and intrahepatic viral activity is of particular interest. Theoretically, circulating HBV RNA correlates well with intrahepatic HBV RNA, reflecting both the quantity and transcriptional activity of nuclear cccDNA, independent of NA treatment (Mak et al. 2021). This characteristic makes HBV RNA a potentially valuable biomarker for assessing the efficacy of antiviral therapies and predicting treatment outcomes.

It’s important to note that the reverse transcription of HBV pgRNA occurs intracellularly. To accurately reflect reverse transcription efficiency, the ratio of intrahepatic HBV pgRNA to intrahepatic relaxed circular DNA (rcDNA) would be ideal. However, quantifying intracellular HBV pgRNA and distinguishing it from other HBV RNA species within hepatocytes remains challenging (Li et al. 2021). These other species include precore region RNA, internally spliced RNA, and 3′-end truncated pgRNA.

Moreover, cytoplasmic full-length pgRNA has three main fates: (1) translation into viral proteins, (2) direct secretion after encapsidation, and (3) reverse transcription into rcDNA (Li et al. 2021). This complexity underscores the potential of serum HBV RNA as a biomarker of viral activity, while also highlighting the need for further research to determine whether the serum HBV RNA/DNA ratio can accurately reflect intracellular pgRNA reverse transcription efficiency.

Another biomarker that has shown promise in reflecting cccDNA levels and transcriptional activity is the hepatitis B core-related antigen (HBcrAg). HBcrAg comprises three related proteins sharing a 149 amino acid sequence: HBeAg, hepatitis B core antigen, and a truncated 22 kDa precore protein (Mak et al. 2021). Studies in Chinese populations have shown that serum levels of HBV RNA and HBcrAg change dynamically during the natural course of CHB infection, with good correlation between these two biomarkers in patients.

Interestingly, the persistent detectability of serum HBV RNA and HBcrAg in patients who have achieved HBsAg seroclearance suggests that these individuals still require monitoring of viral biomarkers and liver-related complications (Mak et al. 2021). This finding underscores the potential of HBV RNA as a more sensitive marker of residual viral activity compared to traditional serological markers.

A study published in 2022 titled “Clinical Research on Serum HBV RNA Quantitative Detection in Antiviral Therapy of Chronic Hepatitis B Patients” utilized an HBV RNA quantitative detection kit (Sansure Biotech) to evaluate the efficacy of antiviral therapy in CHB patients (Sun et al. 2022). The results indicated that serum HBV RNA levels more accurately reflected and monitored the efficacy of NA antiviral therapy in CHB patients, suggesting its potential use in assessing the safety of discontinuing antiviral treatment.

However, it’s crucial to acknowledge that due to the complex biological nature of circulating HBV RNA, quantitative analyses using different technologies and amplification targets may detect HBV RNA species with varying sensitivities, potentially leading to inconsistent clinical results (Deng et al. 2022). This variability highlights the need for standardization of HBV RNA detection methods to ensure consistent and comparable results across different clinical settings and research studies.

In summation, HBV RNA stands out as a groundbreaking biomarker with the potential to revolutionize the monitoring of HBV infection and treatment efficacy. Its capacity to mirror intrahepatic cccDNA levels and transcriptional activity, even in scenarios where serum HBV DNA remains undetectable, positions it as an invaluable asset in the clinical management of CHB. The forthcoming research must focus on standardizing HBV RNA detection methods and unraveling the biological nuances of its various species to harness its full clinical potential. The integration of HBV RNA testing into clinical practice could significantly improve the monitoring and management of CHB patients, potentially leading to more personalized treatment strategies and better long-term outcomes.

Works Cited

Deng R, Liu S, Shen S, Guo H, Sun J. “Circulating HBV RNA: From Biology to Clinical Applications.” Hepatology, vol. 76, no. 5, 2022, pp. 1520-1530.

Li W, Deng R, Liu S, Guo H, Sun J. “Letter to the Editor: Can the Ratio of Serum HBV RNA to DNA Reflect the Reverse-Transcription Efficiency of Viral pgRNA?” Hepatology, vol. 74, no. 1, 2021, pp. 532-533.

Mak, LY, Cloherty G, Wong DK, Gersch J, Seto WK, Fung J, Yuen MF. “HBV RNA Profiles in Patients With Chronic Hepatitis B Under Different Disease Phases and Antiviral Therapy.” Hepatology, vol. 73, no. 6, 2021, pp. 2167-2179.

Sun, Huabao, Meiqi Li, Qinan Lai, et al. “Clinical Research on Serum HBV RNA Quantitative Detection in Antiviral Therapy of Chronic Hepatitis B Patients.” Experimental and Laboratory Medicine, vol. 40, no. 3, 2022, pp. 306-309.

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admin@sansure2021 — Sun, 30 Jun 2024 05:21:23 +0000

Sansure Celebrates Acquisition of MDSAP Certification

yang, rongchang — Thu, 14 Mar 2024 10:33:54 +0000

From December 19th to 22nd, 2023, Sansure underwent a three-and-a-half-day MDSAP quantity management system certification audit. Through the close collaboration and joint efforts of various departments within the company, Sansure successfully passed this stringent audit and obtained the certification.

The MDSAP certification is not only a significant achievement for Sansure but also a key milestone in its internationalization strategy. This certification is a project jointly initiated by member countries of the International Medical Device Regulators Forum (IMDRF), aimed at enabling medical device manufacturers to meet the quality management system (QMS) and good manufacturing practice (GMP) requirements of participating countries through a single audit. Possessing the MDSAP certification means that Sansure’s products will gain access to key markets such as the United States, Canada, Brazil, and Australia without the need for additional system certifications. This not only greatly simplifies the process of entering these markets but also significantly enhances market access efficiency.

Under the organization of the Quality Management Department, all departments of the company demonstrated a high degree of unity and collaboration, giving full attention to the audit work. In preparation for this certification, the Quality Management Department began meticulous preparations at the end of 2022, established a special project team, and carried out extensive collection and interpretation of regulations. Based on an in-depth understanding of the regulations, a differential analysis of the quality management system was conducted, and a comprehensive revision of documents and system optimization followed. Through two internal audits in August and November, all preparations were ensured to be foolproof. On this well-prepared foundation, Sansure successfully passed the first and second certification audits in October and December, respectively.

The smooth acquisition of the MDSAP international system certification not only fully proves the completeness and effectiveness of Sansure’s quality management system but also significantly enhances Sansure’s competitiveness in the international market.

Looking ahead, Sansure will continue to commit to strengthening and improving its quality management system, continuously enhancing product quality and service levels, and is dedicated to providing global customers with higher quality products and services. We firmly believe that the MDSAP certification will help Sansure win more opportunities and trust in the global medical device market.

Stay tuned for more exciting performances by Sansure on the international stage.

HPV Infection in Men: Why Keep Men Involved in HPV and Cervical Cancer Elimination?

yang, rongchang — Wed, 21 Feb 2024 09:36:13 +0000

Human Papillomavirus (HPV) is a widespread infection that not only affects women but also poses a significant threat to men. In recent years, groundbreaking research published in The Lancet Global Health has shed light on the prevalence of HPV infection in men, prompting a crucial discussion about the involvement of men in the efforts to eliminate HPV and prevent cervical cancer.

To comprehend the urgency of involving men in HPV prevention, it’s vital to examine the latest global data on HPV infection in men. According to recent studies, the prevalence of HPV among men is a significant concern, as it contributes to the transmission of the virus and, consequently, the development of multiple HPV-related diseases and cancers in women and men. These findings emphasize the importance of inclusive strategies to combat HPV on a global scale.

What is HPV?

Human Papillomavirus (HPV) is a group of viruses that infect the skin and mucous membranes. It is the most common sexually transmitted infection globally. In recent years, there has been much urge to involve males in the strategy to eradicate HPV infection, considering^[1]:

1. Prevalence: About one in three men over the age of 15 are infected with at least one type of genital HPV. More specifically, one in five are infected with high-risk or oncogenic HPV types, which have a greater potential to cause cancer.

2. Systematic Review and Meta-analysis: The study analyzed data from research conducted between 1995 and 2022. It determined a global pooled prevalence of 31% for any HPV type and 21% for high-risk HPV types. HPV-16 emerged as the most common genotype, affecting 5% of the population, followed by HPV-6 at 4%^[2].

3. Age and Regional Variations: The prevalence of HPV is particularly high in young adults, peaking between the ages of 25 and 29. The prevalence estimates were similar across various global regions, including Europe, Northern America, Sub-Saharan Africa, Latin America, the Caribbean, and Oceania. However, the prevalence in Eastern and South-Eastern Asia was about half that of other regions.

4. Health Impact of HPV: HPV infection in men can cause anogenital warts and is associated with cancers of the penis, anus, and oropharynx, predominantly linked to HPV type 16. The International Agency for Research on Cancer estimated around 69,400 cases of cancer in men caused by HPV in 2018^[3].

HPV is primarily transmitted through intimate skin-to-skin contact, and most individuals contract it at some point in their lives. Often, the body’s immune system clears the infection, but persistent infections can lead to health complications. HPV houses over 200 related viruses and falls into 2 types:

High-risk HPV is the main reason for HPV-related cancers. There are 14 types of high-risk HPV types, with HPV 16 and 18 being the main contributors (70%) to cervical cancer^[4].
Low-risk HPV can cause warts in the genital area, anus, mouth, or throat. The warts developed in the larynx or respiratory tract might lead to a condition known as respiratory papillomatosis, which has the potential to cause difficulties in breathing^[4].

Screening of HPV Infection in Men

Males play a crucial role in HPV transmission, serving as reservoirs for the virus. The transfer of high-risk HPV strains from men to women can result in cervical precancers and cervical cancer. To comprehend the significance of male involvement in HPV prevention, it’s essential to understand the symptoms and risks associated with HPV infection in men.

The introduction of HPV screening in males becomes imperative to identify and manage the infection effectively. Recognizing the symptoms early and understanding the risks are vital steps in controlling the spread of HPV infection in men and women. People in the following groups can follow the testing recommendation:

1. Males who partner with females
This group of males can make their choice whether to do the HPV test.

2. Males with anal/genital warts:

Males with anal/genital warts are the most common sexually transmitted diseases, with over 90% of cases caused by low-risk HPV types 6 and 11. Genital warts caused by HPV are roughly 340,000 to 360,000 people yearly^[5]. It can be diagnosed with the naked eye or microscopic observation and physical examination. HPV testing is not significant for diagnosis and does not affect the treatment of warts. Therefore, HPV testing is not recommended for this group.

3. Recurrent respiratory papillomatosis (RRP)

HPV types 6 and 11 are the main types of HPV infecting the respiratory tract, with occasional infections of HPV types 16 and 18. Studies have shown that HPV typing helps predict the severity of the disease. HPV type 11 is related to distal dissemination in the respiratory tract, and types 16 and 18 are high-risk subtypes associated with malignancy. HPV typing tests are recommended in these patients.

4. Males contract HPV-related cancer

HPV types 16 and 18, which are the cause of almost all cervical cancers in women, are also the main cause of anal, tonsil, and tongue cancers, as well as important risk factors for vulvar, vaginal, penile, laryngeal, and head and neck squamous cell cancers. HPV tests have been proven to be efficient and valuable in making further confirmation and clinical treatment selection and modification.

Sansure’s HPV Detection Solutions

In the pursuit of eliminating HPV and preventing cervical cancer, reliable and efficient detection solutions are paramount. Sansure offers cutting-edge HPV detection solutions designed to provide accurate and timely results.

Sansure has innovated a high-throughput and high-efficiency for HPV PCR testing., also has provided faster and more convenience solution which reduces the time to obtain results from hours (typically 5-6 hours) to less than 30 minutes.

These HPV testing sets are instrumental in early detection, allowing for prompt intervention and treatment. The comprehensive approach of Sansure’s products aligns with the goal of inclusive HPV prevention, emphasizing the importance of both male and female health. Sansure’s commitment to innovation and excellence in HPV detection reflects the urgency and significance of addressing HPV infections in men and women alike.

Conclusion

The global effort to eliminate HPV and prevent cervical cancer necessitates the active involvement of men. The latest research on HPV prevalence in males emphasizes the urgency of expanding our focus beyond female-centric strategies. By understanding the role of men as carriers of the virus and recognizing the symptoms and risks associated with HPV infection in men, we pave the way for comprehensive prevention and control.
Our advanced HPV detection solutions serve as our effort to eradicate HPV infections in men and women. Creating a world free from the threat of cervical cancer requires a collective strategy to safeguard the health of both men and women. Visit our website for more information about HPV.

Reference

[1] https://www.who.int/news/item/01-09-2023-one-in-three-men-worldwide-are-infected-with-genital-human-papillomavirus

[2] https://medicalxpress.com/news/2023-09-men-worldwide-infected-genital-human.html

[3] Bruni L, Albero G, Rowley J, Alemany L, Arbyn M, Giuliano AR, Markowitz LE, Broutet N, Taylor M. Global and regional estimates of genital human papillomavirus prevalence among men: a systematic review and meta-analysis. Lancet Glob Health. 2023 Sep;11(9):e1345-e1362. doi: 10.1016/S2214-109X(23)00305-4. PMID: 37591583; PMCID: PMC10447222.

[4] https://www.medicalnewstoday.com/articles/high-risk-hpv#types-of-hpv

[5] https://www.cdc.gov/std/hpv/stdfact-hpv-and-men.htm

A Quick Review of Sansure at Medlab 2024

yang, rongchang — Thu, 08 Feb 2024 06:31:58 +0000

As the healthcare industry gears up for one of the most anticipated events of the year, Medlab 2024 aims to provide groundbreaking innovations and cutting-edge technology. From February 5th to 8th, 2024, the Dubai World Trade Centre in Dubai, UAE, transformed into a haven for medical professionals and industry leaders alike.

Located at the crossroads of innovation and necessity, Medlab serves as a catalyst for industry-wide transformation. This year, we, Sansure, a key player in the world of in vitro diagnostic industry, offer diagnostic solutions that are poised to revolutionize the healthcare landscape.

Sansure’s Showcase at Medlab 2024

Sansure serves as a provider of in vitro diagnostic solutions, integrating diagnostic reagents, instruments, and independent clinical laboratory services, all centered around our innovative gene technology. For years, we have been developing our technologies, forging a series of diagnostic products that fit the market demands, helping to resolve community screening and clinical laboratory diagnosis, and relieving the clinical burden by providing rapid and accurate diagnostic results to support treatment decisions. And at Medlab 2024, as one of the Platinum Partners, we presented the potential of diagnostic solutions to attendees.

Sansure’s Exhibits at the Event

1. iPonatic III Portable Molecular Workstation:

The groundbreaking POCT instrument, iPonatic III, is designed to bring molecular diagnostics to the forefront of point-of-care testing. Its compact design and powerful capabilities make it a game-changer in delivering rapid and accurate results.

2. Surelite Automated CLIA System:

Sansure also showcased the Surelite series, an automated Chemiluminescence Immunoassay (CLIA) system. Surelite 8 and Surelite 16 exemplify compact automated CLIA systems, providing swift and accurate diagnostic results in as fast as 15 minutes. Their intelligent design, encompassing an all-in-one cartridge and a comprehensive array of assays, seamlessly aligns with diverse clinical demands, eliminating the need for additional consumables and minimizing waste.

3. Automated Nucleic Acid Extraction System:

Since 2012, Sansure has been at the forefront of advancing automated nucleic acid extraction instruments. In that pivotal year, the company successfully introduced a high-throughput, high-precision, and exceptionally efficient system. This advanced technology enables a smooth workflow encompassing sample preprocessing and nucleic acid extraction, reflecting Sansure’s commitment to innovation in molecular diagnostics.

4. Automated Electrochemiluminescence Analyzer:

YnY 2050 was another exhibit that has won much attention. The YnY 2050 analyzers utilize cutting-edge, fully automated technology with Enhanced ElectroChemiLuminescence (EECL) for immunoassay analysis. The signaling antibody/antigen is labeled with an electronically Neutral Ruthenium Complex (NRC), while the capturing antibody/antigen is coated with magnetic microbeads. When combined with a clinical sample, a sandwich immunocomplex forms on the microbeads, which are then precisely captured in an ElectroChemiLuminescence measuring cell using a movable magnet.

A TPA-containing buffer ensures analysis purity by eliminating undesired substances and creating a favorable chemical environment for NRC units to undergo electrochemical reactions, resulting in a luminescent excited state. The light signal is quantitatively analyzed by a Photomultiplier Tube (PMT).

5. Real-Time Quantitative Thermal Cycler:

The MA-6000 Real-Time Quantitative Thermal Cycler, after years of dedicated research and development, stands as a testament to its worth. This advanced technology promises to enhance patient care and reduce waiting times by processing up to 96 samples simultaneously. Our Real-Time fluorescence quantitative PCR system, MA-6000, features innovative hardware, structure, and optimized software to ensure superior quality results.

Professionals and experts from all around the globe were “allured” by our presentation, being drawn into an insightful discussion on the applications, efficiency, and strengths of our offerings. This provided us with a valuable opportunity to gauge market tendencies and allowed attendees to gain a deeper understanding of Sansure.

Honors, Thanks & Wish

As we reflect on this prestigious event, we express our gratitude to Medlab 2024 for the platform provided to engage with industry leaders and experts. The positive reception and insightful discussions have fueled our enthusiasm to push the boundaries of diagnostic technologies further.

Looking ahead, we are excited about the future possibilities and the impact our solutions can have on the global healthcare landscape. Sansure remains dedicated to advancing genetic technology, bridging gaps in diagnostics, and contributing to the collective efforts to improve patient outcomes. Let’s look forward to the future of IVD.

Understanding Occult Hepatitis B Infection (OBI): Insights and Diagnostic Solutions

yang, rongchang — Sun, 04 Feb 2024 06:15:28 +0000

Occult hepatitis B virus (HBV) infection (OBI) refers to the presence of HBV DNA in the absence of detectable hepatitis B surface antigen^[1]. This enigmatic condition poses a considerable challenge for clinicians, as the virus remains hidden, making its detection and subsequent management a complex task.

This article will explore Occult Hepatitis B Infection, its key characteristics, clinical significance, and the challenges associated with its detection.

Key Characteristics of Occult Hepatitis B Infection

Occult Hepatitis B Infection (OBI) presents a perplexing challenge to healthcare professionals due to its distinct characteristics, which set it apart from more overt forms of hepatitis B. Therefore, further research and exploration are critical. Here is a detailed explanation of the characteristics:

Low-Level HBV DNA

At the heart of Occult Hepatitis B Infection lies its elusive nature, primarily characterized by low levels of hepatitis B virus (HBV) DNA circulating in the bloodstream. Unlike typical hepatitis B infections where the viral DNA is abundant and easily detectable, OBI operates stealthily with a minimal viral load. This low-level presence of HBV DNA poses a significant hurdle to traditional diagnostic methods, contributing to the underdiagnosis of Occult Hepatitis B Infection. The subtlety of this infection makes it imperative for healthcare providers to adopt more sensitive tools to identify the virus accurately.

Clinical Significance

Despite its discreet manifestation, OBI holds substantial clinical significance. The persistence of low-level HBV DNA in the liver, even when surface antigen tests indicate negativity, can lead to severe consequences.

Research on the prevalence of Occult Hepatitis B virus infection in adults concludes that a substantial proportion of people carry occult HBV infection, especially among high-risk groups^[2]. OBI has been proven to be associated with end-stage liver diseases, hepatocellular carcinoma, in particular. Chronic OBI may lead to cirrhosis and liver cancer. OBI can be reactivated and replicated for the previous HBV infection or carriers who have received immunosuppressive or chemotherapy^[3].

Copyright picture from https://www.journal-of-hepatology.eu/article/S0168-8278%2820%2930357-3/fulltext#gr3

Diagnostic Challenges

Technically, the most direct diagnostic method is the detection of replicative HBV DNA within liver tissue. However, it is hard to manipulate due to the difficulty of obtaining liver tissue specimens and extracting pure HBV DNA fragments in liver tissue for OBI diagnosis, as well as the lack of standardized analytical methods. Therefore, the detection of replicative HBV DNA in liver tissue is not suitable for routine clinical practice.

On the other hand, the presence of HBcAb (antibodies against hepatitis B core antigen) in the blood only indicates that the patient has been infected with HBV. Further, HBV DNA detection is required for the diagnosis of OBI. Additionally, a portion (20%) of OBI patients may have negative HBcAb results. Serum HBcAb testing can only distinguish the majority (but not all) of individuals with prior HBV infections^[4].

Consequently, a common diagnostic method for OBI is the detection of HBV DNA in blood. Since OBI patients typically have very low levels of HBV DNA in their blood, developing highly sensitive nucleic acid testing methods is crucial.

Advanced Diagnostic Solutions for Occult Hepatitis B Infection

In light of these challenges, healthcare providers are increasingly recognizing the importance of advanced diagnostic solutions for the accurate identification of OBI. The limitations of standard methods highlight the critical role played by innovative detection tools, such as the Sansure Hepatitis B Virus DNA QuantitativeFluorescence Diagnostic Kit, in addressing the complexities associated with Occult Hepatitis B Infection diagnosis.

Key Features of Sansure’s Diagnostic Kit:

Sensitivity: The kit adopts advanced magnetic beads technology, allowing its high sensitivity (5 IU/mL) and ensuring a low false negative rate.
Specificity: Sansure’s diagnostic solution is highly specific to HBV DNA, minimizing the risk of false positives or negatives.

Applications of Sansure’s Diagnostic Kit:

Early Detection: Sansure’s kit facilitates the early detection of Occult Hepatitis B Infection, enabling timely intervention and management.
Monitoring Treatment Efficacy: The quantitative analysis allows clinicians to monitor the effectiveness of antiviral treatments and adjust strategies accordingly.

By adopting advanced diagnostic tools, healthcare professionals can better navigate the diagnostic landscape, leading to improved patient outcomes and more effective management of Occult Hepatitis B Infection.

Conclusion

Understanding and effectively managing Occult Hepatitis B Infection requires a nuanced approach. The challenges associated with low-level HBV DNA detection necessitate the adoption of advanced diagnostic solutions. The Sansure Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit emerges as a reliable ally in this endeavor, offering heightened sensitivity, specificity, and quantitative analysis capabilities. By recommending Sansure’s advanced diagnostic solution, healthcare professionals can enhance their ability to diagnose Occult Hepatitis B Infection accurately and take proactive measures to mitigate its clinical impact.

Reference

[1] Kwak MS, Kim YJ. Occult hepatitis B virus infection. World J Hepatol. 2014 Dec 27;6(12):860-9. doi: 10.4254/wjh.v6.i12.860. PMID: 25544873; PMCID: PMC4269905.
[2] Yu Ri Im, MBBChir, Rukmini Jagdish, BMBS, Damien Leith, MBBS, Jin Un Kim, MBBS , Kyoko Yoshida, MD, Amir Majid, MBBS, et al. Prevalence of occult hepatitis B virus infection in adults: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2022; 7:932-942.
[3] Giovanni Raimondo, Stephen Locarnini, Teresa Pollicino, Fabien Zoulim, Anna S. Lok, and theTaormina Workshop on Occult HBV Infection Faculty Members, Update of the statements on biology and clinical impact of occult hepatitis B virus infection. J. Hepatol. 2019; 71:397-408.
[4] Mak LY, Wong DK, Pollicino T, et al. Occult hepatitis B infection and hepatocellular carcinoma: Epidemiology, virology, hepatocarcinogenesis and clinical significance. J Hepatol. 2020 Oct,73(4):952-964.

Sansure’s New Immunoassay Product Kicks off a New Era of Eelectrochemiluminescence Immunoassay

yang, rongchang — Wed, 31 Jan 2024 03:02:23 +0000

Recently, Sansure Biotech officially launched a new immunoassay product – Accucise Enhanced Electrochemiluminescence Platform at its 15^th Anniversary Celebration. Under the joint witness of more than 2,000 attendees, a new era of electrochemiluminescence (ECL) immunoassay was opened.

Dr. Yin Peng, the Senior Vice President and Chief Technology Officer of Sansure Biotech and the Chairman and General Manager of Accucise Diagnostics, unveiled the new immunoassay product.

In contrast to the traditional ECL technology using tris (2,2′‐bipyridine) ruthenium derivatives as markers, Sansure’s Enhanced Electrochemiluminescence (EECL) technology has been improved in three aspects: luminescent markers, magnetic bead coupling method, and electrochemical regulation. The improved EECL technology features more intense luminescent signals, lower noise, more flexible sensitivity, shorter response time, and greater anti-interference capability, yielding a more precise response system.

1. Tris-heteroleptic electronically neutral ruthenium complexes (NRC) are used as luminescent markers

2. The detection process is completely free from interference of biotin and streptavidin antibodies in samples

3. Rapid detection, with a response time of 5 min and the first result within 8 min

Innovation delivers a more precise response system:

In 2023, Sansure Biotech entered the electrochemiluminescence (ECL) immunoassay track with Accucise Diagnostics and launched a series of new products in succession. In the future, Sansure Biotech intends to optimize product performance and customer experience by focusing on its products and brand to open up a new era of ECL immunoassay.

The Latest Development of Mycoplasma Pneumoniae Infection: Things You Wanna Know

yang, rongchang — Wed, 24 Jan 2024 03:00:18 +0000

Mycoplasma pneumoniae infection is a prevalent respiratory disease affecting people worldwide. In 2023, the global scenario of this infection presents compelling facts, shedding light on its widespread nature. On the bright side, advancements in diagnostic methods, such as DNA fluorescence, and cutting-edge testing kits like those provided by Sansure contribute significantly to accurate and timely identification.

Global Prevalence of Mycoplasma pneumoniae Infection

Globally, epidemics of Mycoplasma pneumoniae pneumonia (MPP) materialize at intervals of 3–7 years, accounting for more than 40% of pediatric community-acquired pneumonia (CAP) cases during epidemic years^[1]. An estimated 2 million cases of Mycoplasma pneumoniae occur each year in the United States^[2], not to mention the many undetected. Therefore, the number can be higher than expected. It is also visible that the outbreak of this year is unprecedented.

Number of Infections

On Nov. 23rd, 2023, the report Mycoplasma pneumoniae: delayed re-emergence after COVID-19 pandemic restrictions was published in The Lancet. The report illustrated the emerging trend of Mycoplasma pneumoniae infection, whose prospective surveillance data were obtained from 45 sites in 24 countries from the four UN regions: Europe, Asia, the Americas, and Oceania.

According to the report, the last 6 months met a surge in Mycoplasma pneumoniae infection PCR detection tests compared to those previous testing periods in the mentioned regions since the start of the prospective surveillance [M pneumoniae was detected by PCR in 1067 (0·71%) of 149 980 tests during the 6 months] ^[3].

According to data in Beijing, with the arrival of the school season, the incidence rate saw an increasing trend right after the slight decrease in August. During this epidemic, the positive detection rate (by real-time PCR assay) of M. pneumoniae in outpatient patients can reach 25.4%, inpatients can reach 48.4%, and respiratory patients can reach as high as 61.1%^[4].

Age Distribution

Children and women have a high proportion of M. Pneumoniae infection. The peak age of M. Pneumoniae infection was between 4 and 14 years old^[5].

Seasonal Distribution

Regarding seasonal distribution, April–June and September–November were the peak seasons of M. Pneumoniae infection each year^[5].

Causes of Mycoplasma Pneumoniae Infection Outbreak

Several factors contribute to the outbreak of mycoplasma pneumoniae infection. Recognizing these causes is essential for implementing proactive measures to curb its spread.

Climate Change

Shifts in climate patterns can affect the distribution and behavior of infectious agents like Mycoplasma pneumoniae. Warmer temperatures and altered humidity levels can create environments more favorable for the spread of respiratory infections. Climate change can also influence human behaviors and patterns (like indoor crowding during extreme weather events), indirectly affecting the spread of respiratory diseases.

Population Density

High population density increases the risk of Mycoplasma pneumoniae infections. In crowded areas, such as urban environments, schools, or public transport, the close proximity of individuals facilitates the airborne spread of this bacterium. Respiratory droplets from an infected person can easily be inhaled by others nearby.

Unhealthy Lifestyles

Lifestyle factors such as smoking, poor nutrition, and lack of exercise can weaken the respiratory system, making individuals more susceptible to infections like Mycoplasma pneumoniae. Smoking, in particular, damages the respiratory tract’s natural defenses, making it easier for pathogens to invade and cause infections.

Weakened Immune Systems

Individuals with weakened immune systems, whether due to chronic diseases, stress, age, or other factors, are more vulnerable to infections, including Mycoplasma pneumoniae. It is especially true for most of us who have contracted COVID-19 before. A weakened immune system has a reduced ability to fight off pathogens, leading to a higher risk of infection and potentially more severe illness.

Mycoplasma Pneumoniae Diagnosis Methods

Accurate and timely diagnosis is pivotal in managing mycoplasma pneumoniae infections. Various diagnostic methods play crucial roles in confirming the presence of the pathogen, each offering unique insights into the infection.

Clinical Diagnosis

Clinical diagnosis remains a primary method for identifying mycoplasma pneumoniae infections. Healthcare professionals assess patients based on a constellation of symptoms, including persistent cough, fever, fatigue, and difficulty breathing. While these symptoms are non-specific and can overlap with other respiratory conditions, a careful examination allows for initial identification. It is essential for individuals experiencing such symptoms, especially in the context of an outbreak, to seek medical attention promptly.

Laboratory Testing

Testing for Mycoplasma pneumoniae is performed using a laboratory-developed multiplex real-time polymerase chain reaction (PCR) assay that detects both Mycoplasma pneumoniae and Chlamydia pneumoniae. The assay has >98% sensitivity and 100% specificity for the detection of Mycoplasma pneumoniae^[6].

Sansure provides Mycoplasma pneumoniae DNA Fluorescence Diagnostic Kit, enabling the specific amplification and identification of mycoplasma pneumonia nucleic acids, and Six Respiratory Pathogens Nucleic Acid Diagnostic Kit, to identify the various respiratory tract pathogens for more accurate treatment.

Radiology

Radiological imaging is supplementary in mycoplasma pneumoniae diagnosis, providing valuable information about the extent and severity of lung involvement. Chest X-rays may reveal patchy infiltrates and areas of consolidation, characteristic of mycoplasma pneumoniae infections.

While radiology aids in assessing the impact on the respiratory system, it is not a standalone diagnostic method. Combining clinical findings, laboratory testing, and radiological assessments enhances the accuracy of mycoplasma pneumoniae diagnosis, allowing healthcare professionals to tailor treatment plans to individual patient needs.

A multi-faceted approach to mycoplasma pneumoniae diagnosis, encompassing clinical assessment, advanced laboratory testing with Sansure kits, and radiological evaluation, ensures a comprehensive understanding of the infection. The integration of these methods enables healthcare providers to deliver timely and targeted interventions, ultimately improving patient outcomes and contributing to the effective management of mycoplasma pneumoniae infections.

Prevention Methods for Mycoplasma Pneumoniae Infection

Preventing the spread of mycoplasma pneumoniae infection involves adopting a multi-faceted approach. This section outlines practical preventive measures that individuals can incorporate into their daily lives.

1. Personal Hygiene:

Emphasizing the importance of personal hygiene, such as handwashing and respiratory etiquette, helps reduce the risk of mycoplasma pneumoniae transmission.

2. Physical Exercise:

Maintaining a regular exercise routine contributes to overall health and strengthens the immune system.

3. Balanced Diet:

A balanced diet rich in essential nutrients supports a healthy immune system. Providing dietary recommendations for bolstering immunity is crucial for preventing mycoplasma pneumoniae infection.

4. Avoiding Crowds:

Crowded places facilitate the rapid spread of respiratory infections. Advising individuals to avoid crowded environments, especially during outbreaks, is a key preventive measure.

Conclusion

Mycoplasma pneumoniae infection remains a significant global health concern in 2023. Understanding its prevalence, causes of outbreaks, effective diagnosis methods, and preventive measures is essential for mitigating its impact on individuals and communities.

The advancements in diagnostic technology, particularly the Sansure testing kits, contribute to a more accurate and efficient identification of the infection, paving the way for improved management and control strategies. As we navigate the challenges posed by respiratory infections, a comprehensive and informed approach is crucial to safeguarding public health.

Reference

[1] Song Z, Jia G, Luo G, Han C, Zhang B, Wang X. Global research trends of Mycoplasma pneumoniae pneumonia in children: a bibliometric analysis. Front Pediatr. 2023 Nov 24;11:1306234. doi: 10.3389/fped.2023.1306234. PMID: 38078315; PMCID: PMC10704248.

[2] https://www.cdc.gov/pneumonia/atypical/mycoplasma/surv-reporting.html

[3] Meyer Sauteur PM, Beeton ML; European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Mycoplasma and Chlamydia Infections (ESGMAC), and the ESGMAC Mycoplasma pneumoniae Surveillance (MAPS) study group. Mycoplasma pneumoniae: delayed re-emergence after COVID-19 pandemic restrictions. Lancet Microbe. 2023 Nov 23:S2666-5247(23)00344-0. doi: 10.1016/S2666-5247(23)00344-0. Epub ahead of print. PMID: 38008103.

[4] Yan, C., Xue, GH., Zhao, HQ. et al. Current status of Mycoplasma pneumoniae infection in China. World J Pediatr (2024). https://doi.org/10.1007/s12519-023-00783-x

[5] Meyer Sauteur PM, Beeton ML; European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Mycoplasma and Chlamydia Infections (ESGMAC), and the ESGMAC Mycoplasma pneumoniae Surveillance (MAPS) study group. Mycoplasma pneumoniae: delayed re-emergence after COVID-19 pandemic restrictions. Lancet Microbe. 2023 Nov 23:S2666-5247(23)00344-0. doi: 10.1016/S2666-5247(23)00344-0. Epub ahead of print. PMID: 38008103.

[6] https://www.publichealthontario.ca/laboratory-services/test-information-index/mycoplasma-pneumoniae-respiratory-pcr

Sansure Shanghai Industrial Park Unveils – a New Starting Point for Globalization

yang, rongchang — Mon, 15 Jan 2024 02:50:05 +0000

Minhang District, Shanghai, January 11, 2024 – Prominent officials and industry experts gathered today for the grand opening of Sansure Shanghai Industrial Park. Mr. Huang Zanjia, Secretary of the Party Leadership Group and Director of the Shanghai Office, the People’s Government of Hunan Province, and Mr. Li Rui, Vice Mayor of Minhang District, graced the ceremony alongside other dignitaries and distinguished guests. Together, they joined Mr. Dai Lizhong, Chairman of Sansure Biotech, in the ribbon-cutting ceremony, officially declaring a new era of Sansure’s Globalization Initiative.

Covering a plot area of 22.6 mu (approx. 3.72 acres), Sansure Shanghai Industrial Park, with an investment of nearly CNY 400 million, is a perfect integration of high-end R&D, intelligent manufacturing and offices. The building is designed in the shape of an estuary that echoes the “eagle taking flight” form of Sansure’s Changsha headquarters. This is both an inheritance of Sansure’s core values – “IShare: with shared aspiration and dream for sharing and win-win” and a carrier of Sansure’s dream of serving the country through industry and healthcare for all. The Shanghai Industrial Park will better link up Sansure’s Changsha headquarters, Beijing Industrial Park, its branch and subsidiaries around the globe and overseas organizations to form a powerful network of R&D, innovation and marketing, and to power the company’s global business development.

In a festive atmosphere, the opening ceremony started at 10:08. Mr. Dai Lizhong delivered a welcome speech to all the guests. He said, the spirit of Shanghai – Inclusiveness and Diversity, Pursuit of Excellence, Open Mind and Humility – tallies with Sansure’s strategic development. The city character of Shanghai enriches Sansure’s corporate culture and confirms Sansure’s value orientation and most importantly, complements and supports Sansure’s strategic development. He also added that in the future, Sansure will steadily take root in Shanghai and make unremitting efforts with a focus on its core values. Sansure will accelerate the implementation of its globalization strategy with Shanghai Industrial Park as the center, actively introduce high-quality resources from other countries, further channel the funds to R&D, make more efforts on the introduction of high-caliber people and leading technologies, and boost technological innovations with more prominent advantages in resources and intelligence to build a world-leading technological innovation center. He emphasized that the goal is to make the industrial park a global hub that integrates high-end R&D, intelligent manufacturing, sales and services for growing Sansure into a world-class enterprise.

“Just as the might Changjiang River nourishes both Hunan and Shanghai, so too are we bound together as family”, said Mr. Huang Zanjia when he addressed the meeting on behalf of the Shanghai Office, the People’s Government of Hunan Province. He expressed his warm congratulations on the opening and high hopes for Sansure’s development in Shanghai and stressed that Hunan is actively synergizing with the national strategies such as the construction of the Yangtze River Economic Belt and the integrated development of the Yangtze River Delta. As a leading enterprise headquartered in Hunan, Sansure Biotech, with Sansure Shanghai Industrial Park as a bridge, plays an important role in the integration of science and innovation resources between Shanghai and Hunan, helping break a new ground for cooperation between our two cities, said Mr. Huang.

Mr. Li Rui, Vice Mayor of Minhang District, on behalf of the People’s Government of Minhang District, expressed his congratulations and blessings on the completion of Sansure Shanghai Industrial Park. He said that biomedical industry is one of the pillar industries in the district’s modern industrial layout and also one of the three leading industries in Shanghai to forge the “Shanghai Upland”. He also remarked that Sansure Biotech is a leading domestic player and its arrival will ignite a new era of growth for the biomedical industry in the industrial zone, propelling both economic and social development to new heights. He asserted that Minhang District will unswervingly encourage, support and guide the development of private enterprises and uphold a favorable business environment to realize a mutually beneficial relationship for both enterprises and regional economy.

After the ceremony, the government officials, industrial experts and Sansure’s partners visited the Shanghai Industrial Park and learned about the company’s scientific research strength, industrial pipeline, globalization, and product applications. They profusely praised the company for its strong comprehensive strength and development momentum and spoke highly of the park’s architectural style featuring modern technological advancement, beautiful and trendy environment, high-standard laboratories, open and bright office environment as well as warm and cozy leisure space.

Also present at the ceremony were Ma Hongping, Member of the Party Leadership Group and Deputy Director of the Shanghai Office of the People’s Government of Hunan Province, Prof. Song Haibo, Vice President of the National Association of Health Industry and Enterprise Management and President of the Medical Laboratory Industry Branch, Prof. Pan Baishen of Zhongshan Hospital affiliated to Fudan University, Prof. Wang Hualiang, President of Shanghai Academy of Experimental Medicine, and Prof. Wang Xuefeng from Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, along with representatives from the Shanghai Municipal Commission of Commerce, Hunan Provincial Department of Commerce, French Consulate General in Shanghai, and officials from the district’s departments, including the Development and Reform Commission, Economic Committee, Science and Technology Commission, Investment Promotion Center and Xinzhuang Industrial Zone.

Join Sansure at Medlab Middle East 2024

admin@sansure2021 — Fri, 12 Jan 2024 05:46:32 +0000

Join Sansure at

Medlab Middle East 2024

Date: Feb 5-8, 2024
Location: Dubai World Trade Centre, Dubai, UAE
Booth: Z5.G30