China Veterinary Drug Association Releases Social Organization Standards for Nucleic Acid, Fluorescence, and Coagulation Testing

Three Social Organization Standards for 'Automated Animal Nucleic Acid Testing Systems' Released

The three Social Organization Standards for the "Automated Animal Nucleic Acid Testing System", "Animal Fluorescence Immunochromatographic Analyzer", and "Animal Coagulation Analyzer", were officially released on September 1, 2024. GlinX led the development of these standards in collaboration with Shanghai Veterinary Research Institute of the Chinese Academy of Agricultural Sciences, Shanghai Animal Disease Prevention and Control Center, Beijing Institute of Animal Science and Veterinary Medicine of the Chinese Academy of Agricultural Sciences, and IDEXX Laboratories (Shanghai) Co., Ltd.

For more details, refer to the China Veterinary Drug Association website: http://www.cvda.org.cn/a/tuantibiaozhun/2024/0827/24042.html

Significance of Social Organization Standards

With the rapid development of the pet industry, an increasing number of diagnostic products are entering the market. However, there is currently a lack of standardized criteria to evaluate their quality. Standards serve as mandatory agreements and entry thresholds, giving us confidence in the products we use. If all products adhere to these standards and focus on enhancing their performance, it will improve the accuracy of diagnostics and treatments, thereby enhancing animal health and welfare.

GlinX has led the development of Social Organization Standards for nucleic acid, fluorescence, and coagulation testing instruments. The company relies on its technological strengths, extensive research data, and clinical results to promote industry standards and advance animal welfare.

Highlights of the Newly Released Social Organization Standards

While the market is flooded with various automated nucleic acid testing products, the recently released Social Organization Standards have clarified what constitutes a true fully automated nucleic acid testing system: A testing system that integrates complete nucleic acid extraction and purification processes with real-time fluorescent PCR technology.

The most critical aspect of nucleic acid testing is accuracy. Due to the complexity of pet samples, failure to perform standardized nucleic acid extraction and purification can significantly impact the accuracy of test results.

In clinical practice, accuracy, stability, and repeatability are the most common issues encountered with animal fluorescence immunochromatographic analyzers and animal coagulation analyzers. The Social Organization Standards have established relevant criteria to address these concerns.

For the Animal Fluorescence Immunochromatographic Analyzer:

Negative Agreement: The negative control samples provided by the manufacturer must all test negative.

Positive Agreement: The positive control samples provided by the manufacturer must all test positive.

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Quality Control for Testing: Repeatability should be ≤ 5%.

For the Animal Coagulation Analyzer:

PT Repeatability: ≤ 3%

aPTT Repeatability: ≤ 4%

FIB Repeatability: ≤ 8%

TT Repeatability: ≤ 10%.

GlinX is committed to providing veterinarians with reliable products for accurate animal diagnostics. The company will continue to collaborate with peers to establish standards and advance the industry, ensuring the welfare of all animals.