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Confronting Emerging Viral Challenges—Comprehensively Providing Validation Services for Ebola Virus Antigen and Nucleic Acid Testing

Confronting Emerging Viral Challenges—Comprehensively Supporting Ebola Virus Antigen and Nucleic Acid Testing Testing Verification Service

In a biosafety laboratory that meets national requirements
Supports Sudan, Zaire, and Bundibugyo ebolaviruses. Verification Service

Ebola Virus Disease (EVD) is an acute infectious disease caused by infection with the Ebola virus. It is characterized by rapid transmission and a high case-fatality rate. According to the “Diagnosis and Treatment Protocol for Ebola Virus Disease (2026 Edition)” and relevant authoritative literature [1–3], rapid and accurate etiological testing is a critical component for achieving “early detection, early reporting, early isolation, and early treatment,” among which… The coverage of different subtypes and the reliability of diagnostic reagents It is directly related to the effectiveness of epidemic prevention and control.

Therefore, the development and registration of Ebola virus test kits cannot be separated from… The authentic viral strain is maintained under compliant biosafety conditions. Systematic verification.

Jiangsu Ningpu, leveraging a biosafety laboratory that meets national standards, has officially begun offering services for handling the Ebola virus. and Hantaan virus, among others Antigen/Nucleic Acid Test Kit Validation Services, covering major circulating subtypes:

  • Sudan Ebola virus (SUDV)
  • Zaire ebolavirus (EBOV)
  • Bundibugyo ebolavirus (BDBV)

The verification services we offer include:

  • Precision Verification: In‑batch and Inter‑batch Repeatability Testing
  • Inclusive Validation: Verification of Coverage Across Different Viral Subtypes, Strains, and Sequences
  • Sensitivity Validation: Gradient Dilution Assay for the Limit of Detection (LoD), Combined with Evaluation Using Clinical Positive Samples at Different Ct Values
  • Specificity Verification: Cross-Reactivity and Interference Substance Testing

 

Service format:

Customize validation protocols based on kit type (antigen testing, Nucleic acid Testing, etc.)

Applicable to:

IVD reagent R&D companies are required to submit additional performance data when applying for registration.

Evaluation of Public Health Emergency Reserve Products

Why choose Jiangsu Ningpu?

Qualification Compliance: Partner Organizations Complies with national requirements for the management of pathogenic microorganism laboratories.

Complete subtyping: covering all subtypes, including Sudan, Zaire, and Bundibugyo.

Project Focus: Performance evaluation of test kits, with data applicable to regulatory registration and quality control.

Controllable cycles: Generate reports on demand, with expedited options available.

 

References:
[1] Li Lanjuan. Ebola Virus Disease [M]. Hangzhou: Zhejiang University Press, 2015.
[2] Yuan Min, Lu Hongzhou. Scientific Prevention and Control of Ebola Virus Disease [J]. Chinese Journal of Infectious Diseases, 2014, 32(9): 515–516.
[3] Chen Ye, Wang Ping, Liu Fangwei, et al. Advances in research on Ebola hemorrhagic fever [J]. Chinese Journal of Public Health, 2017.

 

Validation data represent the minimum standard for kit quality and provide the foundation of confidence for regulatory submissions.
Jiangsu Ningpu provides a “trustworthy, traceable, and compliant” verification closed-loop for Ebola diagnostic products.

 

 

Run, young dreamer!

Run, young dreamer!

There is a person who has paid more hardships than ordinary people. At work, the young man loves to specialize in research to meet difficulties, with full work enthusiasm, solid work style, as long as the product debugging needs, no matter how late, he will work overtime, never delay, the top of the night There is always his figure. He is a new employee in our sales department. Although he has a short entry time, he is proactive in his job and studies hard in experiments. In the experiment, we also have new thinking about the work; how to build the process of sales support work more perfect and transparent? It can make everyone better deal with it when the partner in charge of this work is away/when there is an emergency, and solve it calmly, so as to solve the problem for the customer as soon as possible. Life is a trek, only forward, not retreat. Perhaps walking, you will find that many things are not as simple as imagined, but what supports the non-stop pace is the dream of the guiding light! In the process of pursuing his dream, he has become more brave, and always firmly believes that as long as the dream is shining, the pace of progress will be solid and light!

2022-07-26

Welcome new colleagues to report!

Welcome new colleagues to report!

This is a new colleague from our purchasing department. He studies business knowledge seriously in his work. He is quick in response, enterprising and lively and cheerful in personality. In the latest production scheduling, due to the shortage of a certain material on the production line, urgent scheduling was needed. She took the initiative to coordinate the matter. After various communications, she finally successfully scheduled the materials in place, making this production proceed smoothly!

2022-07-21

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