PCR Freeze-dried Reagents Efficiently Screen And Detect 29 Common Respiratory Pathogens

In recent years, the incidence and transmission frequency of Respiratory Tract infections (RTI) have increased significantly. Especially in the context of the epidemic of influenza and Sars-CoV-2, the prevention and control of respiratory infections has become the focus of public health and clinical diagnosis. 

Data show that there are approximately 5 billion cases of respiratory infections worldwide every year, resulting in more than 4 million deaths from respiratory infection-related diseases. 

This data highlights the need for rapid and accurate multi-pathogen testing. The respiratory multiple pathogen nucleic acid detection kit launched by Bioteke uses Fluorescence PCR technology combined with freeze-drying technology to effectively support clinical and laboratory respiratory disease diagnosis. This article will provide an in-depth discussion of the key characteristics of the kit, its clinical significance in IVD diagnosis, and its application potential in the current prevention and control of respiratory infections.

• Diagnostic needs and background of respiratory tract infections

Respiratory tract infections are often caused by a variety of viruses or bacteria or fungus, and the clinical symptoms are often difficult to distinguish. 

According to the World Health Organization (WHO), about 20% to 30% of adults and children worldwide suffer from different types of respiratory infections. Multiplex pathogen nucleic acid testing can identify multiple pathogens in one test and is especially suitable for rapid diagnosis during high epidemic seasons.

• Technical advantages and clinical significance of multiple pathogen PCR diagnostic kits

Multiplex pathogen PCR diagnostic kits have become a key tool for the diagnosis of respiratory tract infections due to their high efficiency and sensitivity. 

Bioteke's respiratory multiple pathogen nucleic acid detection kit uses freeze-drying technology to stably preserve multiple PCR reagents, combined with sensitive fluorescent PCR methods, so that the product has the following advantages in sample operation, detection performance and application scenarios:

1. Fast and efficient diagnostic capabilities

Traditional pathogen isolation and culture methods are time-consuming, usually 24 hours to several days, while multiplex pathogen PCR detection technology can complete the detection within 1-2 hours. 

This Respiratory Multiplex Pathogens PCR kit can detect 29 common respiratory pathogens, including 17 viruses such as Covid-19, Flu A, Flu B, enterovirus, rhinovirus, syncytial virus, etc.; 9 bacteria such as Mycoplasma pneumoniae, Chlamydia pneumoniae, Group A Streptococcus, etc.; 3 types of fungi such as Aspergillus, Cryptococcus, etc. This provides the possibility of rapid screening and diagnosis of respiratory tract infections, and is especially suitable for emergency testing during influenza epidemics.

2. Detection sensitivity, specificity and accuracy

The kit demonstrated high sensitivity in multiple experiments, detecting pathogens less than 1,000 copies/mL. Silicon analysis was performed on the detected pathogens. There was no cross-reaction among the pathogens with more than 90% homology, and the specificity was excellent, providing a reliable diagnostic basis for clinical use. The precision Ct value (Cv, %) in the test sample is ≦5%. And the compliance rate of the tested negative/positive reference products is 100%.

3. Stability and convenience of freeze-drying process

Lyophilization technology facilitates the storage and transportation of reagents and significantly improves their stability. 

In multiple long-term stability tests, the lyophilized kit remained stable at -20±5°C for up to 12 months. It can be stored temporarily for 6 months at 4℃. And it can support normal temperature transportation within 1 month. 

This provides a more flexible solution for remote areas or scenarios with limited resources, and can meet the needs of various medical settings.

• Clinical Application and Significance 

Bioteke's respiratory multiple pathogen nucleic acid detection kits play an important clinical role in the current context of frequent cross-transmission of respiratory pathogens. Its multiple detection capabilities enable the identification and differentiation of common pathogenic factors in a single test, effectively supporting the diagnostic needs of complex infection cases. The following are its main application scenarios:

1. Epidemic surveillance and epidemiological research

Multiple pathogen detection is used in multiple epidemic surveillance programs around the world, which can provide real-time data for infectious disease trends and epidemiological research, and improve the rapid response capabilities of public health departments to respond to epidemics.

2.Clinical diagnosis and medication guidance

When detecting complex infections, Bioteke kits can provide accurate pathogen information and guide rational medication use. Studies have shown that the diagnostic accuracy of multiple pathogen detection in respiratory tract infections reaches more than 99%, significantly reducing the possibility of misuse of antibiotics and improving the treatment effect.

3. Primary medical screening and remote diagnosis

The convenience of Bioteke kits gives it great advantages in screening in community medical care, mobile clinics and remote areas. It is easy to operate and has strong stability. Data shows that the consistency rate of on-site testing and laboratory testing exceeds 98%, providing technical support for telemedicine and hierarchical diagnosis and treatment.

• Summary and Outlook

Today, with the growing demand for rapid diagnosis of respiratory infections, Bioteke's respiratory multiple pathogen nucleic acid detection kit provides medical institutions with a convenient, stable and efficient multiple pathogen detection solution by combining freeze-drying technology and fluorescent PCR technology. Data shows that multiplex PCR testing has become mainstream in the diagnosis of respiratory infections. In the future, Bioteke will continue to leverage its advantages in IVD diagnosis to help the precise diagnosis and control of respiratory diseases worldwide.