Serve clinical, dedicated to innovation ——Academic summary of Zybio

In the fleeting years, over the course of more than a decade, Zybio has constructed a '9+2+1' product system, with 9 product lines that essentially cover cutting-edge products in various fields of IVD (In Vitro Diagnostics); 2 intelligent networks, the intelligent management system and intelligent middleware, aiding laboratories in improving quality and efficiency; and 1 set of overall laboratory solutions bringing together various advanced equipment and technologies, providing one-stop services to effectively address the challenges faced by medical laboratories.

In 2023, global customers utilizing Zybio's product series have published over 80 SCI academic articles. These publications have been featured in top-tier international journals:

Immunity

Impact Factor: 32.4

Military Medical Research

Impact Factor: 21.1

National Science Review

Impact Factor: 20.7

Journal Of Clinical Microbiology

Impact Factor: 9.4

Journal of Medical Virology

Impact Factor: 12.7

For our customers, providing high-quality products is our eternal pursuit. Every drop of sincerity is dedicated to precision. Let's review some academic achievements of Zybio in 2023 together:

1. Zybio's mass spectrometry EXS2600 system compared to international mainstream mass spectrometry systems, perfectly addressing the challenge of European geographical differences.

Despite the significant importance of MALDI-TOF MS in diagnostics, only two MALDI-TOF MS systems, MALDI Biotyper and Vitek MS, are available in Europe. In this study, Zybio EXS2600 was compared with mainstream mass spectrometry platforms in Europe, using 16sRNA sequencing as the reference gold standard, and tested against 356 clinically challenging bacterial isolates. MALDI Biotyper, EXS2600, and Vitek MS showed equivalent detection rates for all isolates. Among all detection results, the consistency with sequencing data was 98.9%, 98.5%, and 99.7% for MALDI Biotyper, EXS2600, and Vitek MS, respectively. All three mass spectrometers meet the requirements for clinical microbiology testing in Europe. This indicates that the Zybio EXS series mass spectrometry has addressed the geographical differences in bacterial identification.

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2.?Zybio's mass spectrometry EXS3000 demonstrates advantages in routine identification of clinical microbiology in China.

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This study collected a total of 1340 isolates from various clinical specimens in China. Analysis was conducted simultaneously on Zybio EXS3000 and VITEK MS, and 16S rRNA gene or ITS region sequencing was further used to identify strains that showed inconsistencies or were unable to be identified by both systems. The species-level accurate detection rates of EXS3000 and VITEK MS were 95.0% and 96.5%, respectively, and the genus-level accurate detection rates were 99.2% and 98.3%, respectively. There was no significant difference between the two devices in microbial identification performance. However, compared to VITEK MS, the structural design of EXS3000 makes its vacuum chamber smaller, resulting in a shorter time required to reach vacuum state, significantly reducing the identification time. EXS3000 adopts a different spectrum acquisition logic, requiring calibration only once a day without affecting the identification results, and has fewer spectrum acquisitions with high acquisition efficiency. Additionally, the application of cloud databases is also one of the advantages of the EXS3000 platform. The cloud database is continually updated by the manufacturer and can always access the latest version online, without any cost to clinical laboratories.

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3. In this study, the performance of two mainstream microbial mass spectrometry platforms in China, Autof Ms1000 and EXS3000 MALDI-TOF MS, was compared for routine microbial identification in clinical settings.

A total of 209 clinical bacterial strains were used for the first time to compare the performance of these two platforms, including 70 Gram-negative bacteria, 58 Gram-positive bacteria, 15 anaerobic bacteria, and 66 fungi. The overall identification results of clinical strains by EXS3000 and Autof Ms1000 were as follows: EXS3000 had a species-level accurate detection rate of 191 (91.39%) and a genus-level accurate detection rate of 205 (98.09%); Autof Ms1000 had a species-level accurate detection rate of 190 (90.91%) and a genus-level accurate detection rate of 205 (98.09%). Both instruments are easy to operate and have the advantage of fast loading of target plates and vacuum extraction.

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For routine clinical testing, both the EXS3000 and Autof Ms1000 systems are equally good choices. However, for the identification of branching bacteria, the performance of EXS3000 is slightly better than that of Autof Ms1000. It is worth mentioning that the target plate of the EXS3000 instrument is reusable, while the target plate of Autof Ms1000 is disposable, making the cost of EXS3000 lower.

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4. Rapid and Effective Tracking of Emerging Virus Outbreaks through Wastewater Monitoring.

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This study collected wastewater-based epidemiology (WBE) data from the Third People's Hospital of Shenzhen and several community wastewater treatment plants (WWTPs). Virus RNA extraction was performed using the aluminum hydroxide adsorption-precipitation method and Zybio's fully automated nucleic acid extraction and amplification (see Figure 1). The study found that wastewater monitoring can effectively track the local transmission of SARS-CoV-2. Wastewater monitoring over a month-long period consistently detected signals of viral RNA in the wastewater, and the virus concentration showed a significant positive correlation with daily case counts. Overall, the results of this study indicate that wastewater nucleic acid monitoring holds great value and significant potential for combating emerging infectious diseases.

5. Monitoring Changes in Common Respiratory Pathogens among Hospitalized Children in Hainan Using Zybio's CDC Reagent Products.

This study conducted epidemiological investigations of common respiratory viruses among hospitalized children in two hospitals in Hainan, China, during the spring and early summer periods from 2019 to 2021, using Zybio's automated nucleic acid extraction instrument and CDC detection reagent kits. It was found that the incidence of influenza A virus (IFVA) and influenza B virus (IFVB) decreased significantly in 2020 and 2021 compared to 2019, while the incidence of human respiratory syncytial virus (HRSV) increased and became the predominant viral pathogen in 2021. Rhinovirus (RV) was one of the major pathogens during these three years. This study explored the changes in the epidemiology of seasonal respiratory viruses and provided possible measures to address respiratory virus pandemics.

6. Non-invasive Urine Nucleic Acid Extraction Aids in Promoting HPV-DNA Screening in Indonesia.

The primary cause of cervical cancer is persistent infection with high-risk human papillomavirus (HPV). Effective prevention and ultimately the elimination of cervical cancer can be achieved through three levels of prevention measures: HPV vaccination for young women, cervical cancer screening among eligible women, and timely treatment of cervical cancer and precancerous lesions. However, traditional cervical screening has low acceptance rates in countries like Indonesia, severely impacting HPV screening.

This study recruited women aged 20 to 50 from three cities in Indonesia, collecting urine and cervical swab samples. Zybio's virus nucleic acid extraction reagent kits were used to extract nucleic acids for HPV testing. The study found that self-collected urine samples had an accuracy rate of 98.48% for HPV-DNA diagnosis, suggesting that they could serve as an alternative sample for HPV-DNA detection.

As a member of the biopharmaceutical field, Zybio adheres to innovation-driven principles, committed to serving clinical patients with high-quality products. Continuously advancing product innovation and fostering academic exchange and cooperation platforms, Zybio promotes the development of global medical and health care with an open and inclusive attitude, serving customers worldwide.

References:

[1] Li S, Han D, Chen X, Zheng D, Cai Y, Lin D, Zhang X, Ke P, Qu P, Chen C. Evaluation of the Zybio EXS3000 mass spectrometry in routine identification of Clinical isolates. Heliyon. 2023 Aug 7;9(8):e18990. doi: 10.1016/j.heliyon.2023.e18990. PMID: 37600400; PMCID: PMC10432711.

[2] ?Xiong L, Long X, Ni L, Wang L, Zhang Y, Cui L, Guo J, Yang C. Comparison of Autof Ms1000 and EXS3000 MALDI-TOF MS Platforms for Routine Identification of Microorganisms. Infect Drug Resist. 2023 Feb 15;16:913-921. doi: 10.2147/IDR.S352307. PMID: 36814830; PMCID: PMC9939805.

[3] Dichtl K, Klugherz I, Greimel H, Luxner J, K?berl J, Friedl S, Steinmetz I, Leitner E. A head-to-head comparison of three MALDI-TOF mass spectrometry systems with 16S rRNA gene sequencing. J Clin Microbiol. 2023 Oct 24;61(10):e0191322. doi: 10.1128/jcm.01913-22. Epub 2023 Sep 21. PMID: 37732759;

[4] Ou G, Tang Y, Niu S, et al. Wastewater surveillance and an automated robot: effectively tracking SARS-CoV-2 transmission in the post-epidemic era [J]. Natl Sci Rev, 2023, 10(6): nwad089. DOI: 10.1093/nsr/nwad089

[5] Mai W, Ren Y, Tian X, et al. Comparison of common human respiratory pathogens among hospitalized children aged

[6] Intan N S, Utama R, Wulandari D, et al. Utilization of non-invasive urine sampling with multiplex PCR to enhance cervical cancer screening in developing countries: a cross-sectional diagnostic accuracy study [J]. medRxiv, 2023: 2023.10.26.23297586. DOI: 10.1101/2023.10.26.23297586