Sansure’s Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit has received approval
2022-05-17 yang, rongchang

Sansure’s Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit has received approval

Sansure Biotech May 17, 2022

On May 12, the Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing) developed by Sansure Biotech was approved for marketing (GXZZ 20223400597). It is the first domestic test reagent based on multiplex fluorescence PCR technology to detect six common bacteria in a single tube, and is also a revolutionary product for molecular diagnosis, adding to Sansure Biotech’ overall solution for molecular testing for the confirmation of respiratory tract infections.

The National Health Commission posted calls for: improve the pathogenic detection rate

Lower respiratory tract infections are the fourth leading contributor to patient deaths worldwide. Bacteria are critical pathogens leading to infections, but the pathogens are diverse with complex clinical presentations. Pathogenic detection of bacteria plays a key role in guiding the precise use of drugs and the rational application of antibiotics. The document 2022 National Healthcare Quality and Safety Goalsreleased by the National Health Care Commission requires medical institutions at all levels to improve the pathogenic detection rate of inpatients prior to giving antibiotic therapy.

Current situation and challenges – higher clinical demand for bacterial detection

The shortcomings of long period, low sensitivity, and the influence of antibiotic therapy lead to the poor timeliness and low detection rate by traditional testing methods, bringing challenges to rapid and accurate clinical diagnosis. Patients usually have to wait 3-7 days to get the test report, and there is also the possibility of treatment failure if the pathogen is not identified empirically, leading to exacerbation or even death. Therefore, a rapid, accurate, antibiotic-independent bacterial detection method has become an urgent clinical need.

Molecular testing has played a vital role in the prevention and control of COVID-19 because of its advantages of high sensitivity and specificity, quick production of results and simple operation. The Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit based on multiplex fluorescence PCR technology, relying on melting curve technology, enables rapid detection of six common pathogens of respiratory infections, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa and Legionella pneumophila, in a single tube within 100 min, independent of the application of antibacterial drugs, with an anti-contamination system and full internal standard monitoring to ensure the accuracy of the test results and high consistency with sequencing methods, similar molecular testing reagents and culture methods. And the advantages of easy operation, high adaptability and high detection flux make it more accessible for use in detection. It aids in the rapid identification of pathogens and guides the targeted clinical use of drugs.

With nearly 10 years of history in the field of molecular diagnosis of respiratory tract infections, Sansure Biotech has accumulated a series of technologies and products and in particular, it has developed a full-scene overall solution in “accuracy” and “accessibility”. The company has launched a series of respiratory products such as Six Respiratory Pathogens Nucleic Acid Diagnostic Kit, SARS-CoV-2 and Influenza A/B Virus Nucleic Acid Diagnostic Kit, and Respiratory Adenovirus DNA Diagnostic Kit since April last year. All of them have been widely recognized by the community. The Six Respiratory Pathogens Nucleic Acid Diagnostic Kit has enjoyed a rapid increase of monthly testing volume in some hospitals, providing accurate, rapid and accessible full-scene solutions for departments such as respiratory, pediatrics, emergency medicine, ICU, geriatrics and hospital infection prevention and control, greatly promoting the precise diagnosis and treatment of respiratory-related diseases.

Sansure Biotech will give full play to its technical and product advantages and launch more products to provide a more complete and holistic solution to help realize the dream of health for all in the future.

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