The sars-cov-2 outbreak began at the end of December 2019. On March 11, 2020, the World Health Organization (WHO) upgraded the SARS-CoV-2 from an epidemic to a global pandemic, calling on all countries to activate emergency mechanisms to inspect, isolate, detect and treat each case and track every close contact. Since the outbreak, the National Health Commission, the WHO and the CDC of United State have successively issued diagnosis and treatment plans, using viral nucleic acid testing as the standard for diagnosis.
In the face of the epidemic situation, Bioer Technology, adhering to the enterprise purpose of "caring for life with science and technology ", quickly responded and developed a set of solutions from sample sampling, preservation to nucleic acid extraction and detection, so that virus detection is more accurate, faster and safer.
Process of Bioer’s SARS-CoV-2 Detection solution:
1. Sample Pre-processing
Because nucleic acid is easy to degrade, the existing conventional sampling and preservation solution can’t guarantee the quality of nucleic acid in the sample, at the same time, it can’t inactivate the infectiousness which might lead to the secondary transmission of the sample during preservation, transportation and detection phases, and causes a very high risk of infection to the medical workers. In response to these problems, Bioer Technology timely launched efficient and stable sample preservation solution.
Bioer’s Sample Preservation Liquid (with swab)
Features of Sample Preservative Fluid
（1）Inactivation: Rapidly inactivate virus sample and cut off the source of infection to ensure the safety of frontline medical workers.
（2）Convenience: Different packaging specifications available, suitable for different application scenarios. The swab is convenient to operate, after the medical staff has collected the sample, put the swab directly into the sample preservation tube.
（3）Stability: Inhibit DNase / RNase activity, stable for transportation and storage at room temperature, effective detection rate.
Bioer’s sample preservative fluid has registered at NMPA with medical device product record number Z.H.X.B. 20200052, and also registered with CE certificate. The product quality has been highly recognized, crucial ingredient of it has been verified by human influenza A virus, cat coronavirus, African swine fever virus and other experimental detection, with stable and efficient performance.
Sample Preservative Fluid Application Case
The EU CE Certification for Sample Preservative Fluid
2. Virus nucleic acid extraction
Nucleic acid extraction is the basis of molecular detection, and high quality nucleic acid is also the premise to ensure downstream detection results. Bioer’s nucleic acid extraction products are deeply trusted and loved by the customers of disease control, clinical and scientific research colleges and universities. Both virus and pathogen kits can guarantee high quality nucleic acid extraction.
Magnetic bead method Nucleic acid extraction
Features of magnetic bead products：
（1） Efficient and rapid: High-throughput automated nucleic acid extraction of 32-96 samples within 35 min;
（2）Sensitivity: DNA virus concentration can reach 10 IU/mL, RNA virus concentration can reach 50 IU/mL;.
（3）Widely used: viral nucleic acids can be easily extracted from sputum, saliva, alveolar lavage fluid , nasopharynx swabs, cultured cells and other humeral samples (e.g. whole blood, plasma, serum, ascites, cerebrospinal fluid, oral fluid, etc.) , which can be used for downstream detection such as NGS, qPCR;
（4）Stable and reliable: fully automatic nucleic acid purification system equipped with a more comprehensive deep-well heating module, greatly reduce the setting temperature and the actual temperature difference in the tube, smaller well-to-well temperature difference, thus greatly improve the efficiency of lysis and elution.
（5） Easy operation: The use of pre-loaded kit can be operated by adding samples and PK only, and the extraction of non-nucleic acid precipitant ensures the good repeatability of many experiments
The EU CE Certificate of Magnetic Bead Nucleic Acid Extraction Kit
Centrifugal column Nucleic acid extraction
Features of Centrifugal Column Products:
（1）Simple and fast: The whole extraction process can be completed within 30 min;
（2）Sensitivity: DNA viral nucleic acid concentration can reach 10 IU/mL, RNA viral nucleic acid concentration can reach 100 IU/mL;
（3）Widely used: viral nucleic acids can be easily extracted from sputum, saliva, alveolar lavage fluid , nasopharynx swabs, cultured cells and other humeral samples (e.g. whole blood, plasma, serum, ascites, cerebrospinal fluid, oral fluid, etc.) , which can be used for downstream detection such as NGS, qPCR;
（4）Stable and reliable: no phenol chloroform and other toxic reagents, samples can be stored at room temperature;
（5） High purity: Purified viral nucleic acids do not contain contaminants such as PCR/RT-PCR inhibitors.
The EU CE certificate of Spin Column Nucleic Acid Extraction Kit
Nucleic Acid Extraction Reagents and Instruments of Bioer Technology
3. PCR testing
（1）Accuracy: Two-target genes were designed for specific conserved sequences of novel coronavirus (SARS-CoV-2) ORF1ab, encoding nucleocapsid protein N genes, and efficient one-step fluorescence RT-PCR reaction system was used to ensure the sensitivity and accuracy of the detection results.
（2） Specificity: The internal standard genes that monitor the sampling process, sample extraction process and PCR process are added to ensure the specificity of the test results to a great extent. There were no cross-reactions in samples of viruses, influenza A3 virus, influenza B virus, coronavirus OC43, coronavirus HKU1, coronavirus 229E, coronavirus NL63, and Middle East respiratory syndrome coronavirus.
（3） Anti-contamination: RT-PCR can be completed in one step without reverse transcription and PCR processing, fully closed-tube amplification and detection, which also can avoid false positive results.
（4） Short time consumption: Results interpretation can be completed in 1.5 hours.
Bioer’s SARS-CoV-2 Nucleic Acid Detection Kit (fluorescence RT-PCR) has passed the performance inspection of NMPA (China) and gets the EU CE certificate; product performance has been widely recognized by professional institutions at home and abroad.
Inspection Report from NMPA (China)
Bioer’s Detection Reagents and Instruments of SARS-CoV-2
The EU CE certificate of SARS-CoV-2 Nucleic Acid Detection Kit (fluorescence RT-PCR)
Bioer’s sample preservative fluid, nucleic acid extraction reagent and SARS-CoV-2 PCR detection reagent have all been certified by the European Union (EU) CE. With the nucleic acid purification instrument and real time PCR detection instrument of Bioer Technology, a complete set of new corona virus detection solutions has been formed, which can accurately and quickly screen and diagnose the novel corona virus. Bioer spares no effort to guarantee the production capacity and cater to the virus control and detection needs with our high standard quality products.