How does the “universal” PCR laboratory carry out inspection projects?

PCR laboratory is also called a gene amplification laboratory. Real-time fluorescent quantitative PCR technology is a leap forward in DNA quantitative technology. It is used to amplify specific DNA fragments, which can be regarded as special DNA replication in vitro. Through the DNA gene tracking system, the virus content in the patient’s body can be quickly grasped with an accuracy of the nanometer level. The real-time fluorescent quantitative PCR is the carrier to realize this technology. PCR experiments are often used to detect viral infectious diseases such as AIDS, hepatitis B, and poultry disease. By amplifying the genes contained in the virus, it is possible to detect whether some infected persons with low virus content contain specific viruses. The PCR Lab test method has the advantages of high sensitivity, high specificity, speed, and low sample requirements. Therefore, it is widely recognized by clinicians and has been widely used in clinical diagnosis in hospitals and diagnosis of poultry disease in various epidemic prevention and detection departments 

Driven by national policies and the development of the epidemic, hospitals at all levels in various regions have begun or are preparing to establish independent and compliant PCR laboratories factory, and they have become medical institutions with nucleic acid testing capabilities. However, due to the differences in the epidemic situation in various regions, some nucleic acid laboratories in long-term low-risk regions have almost stagnated except for emergency functions. This type of situation is also the most worrying issue for hospital leaders at all levels in setting up laboratories. They have invested money and energy but cannot bring income to the hospital.

The PCR laboratory is actually extremely powerful. Qualitative analysis and quantitative detection are its two biggest application directions. In addition to the new crown nucleic acid detection, what else can our “universal” PCR laboratory do?

Pathogen determination

The advent of PCR technology enables rapid and convenient pathogen detection. Because the false positive rate of PCR technology is too high, a positive result can be obtained as long as there is a small amount of pathogens, which cannot be used as a diagnostic basis, and it has clinical significance only when a certain number of pathogens exist. Therefore, it is particularly important to accurately quantify the template, and the results can be obtained quickly and accurately by using fluorescent technology PCR. PCR can be used to solve the “window period” problem of immunological testing, determine whether the disease is in a recessive or subclinical state, and when antibody testing cannot determine whether it is a current infection or a past infection.

Example: Novel coronavirus nucleic acid detection.

Methodology: fluorescence PCR method.

Uses: Used for in vitro qualitative detection of suspected cases of pneumonia, suspected clusters of patients with new coronavirus infection, and other patients who need to diagnose or identify new coronavirus infection.

Detection gene: new coronavirus (2019-nCoV) ORFlab and N gene, E gene.

Specimen types: upper respiratory tract specimens: throat swabs, nasal swabs; lower respiratory tract specimens: respiratory tract aspirates, alveolar lavage fluid samples, lung tissue biopsy specimens.

Detection process:

(1) Biosafety protection before nucleic acid testing (personal three-level protective wear by staff) → (2) Inactivation of samples (inactivation at 56°C for 30 minutes) → (3) Nucleic acid extraction of samples (manual, nucleic acid extractor) )→(4) PCR system preparation and template loading→(5) On-board testing and result analysis→(6) Disinfection after testing.

Other pathogen detection: HIV, hepatitis A, B and C, HPV, lung branches, lung coat, Epstein-Barr virus, adenovirus, cryptovirus, A and B stream, Ebola virus, group B streptococcus.

Hospitals and departments suitable for development: children’s hospitals, maternity and children’s clinics, pediatric clinics, third parties, and hospitals of various levels in need.

Zhejiang KD Health Technology Co., Ltd was established in the year 2015 and locates in the most beautiful city-Hangzhou, which is very near to Alibaba. This is a high-tech enterprise and they focus on innovative health technology products. Since the outbreak of Coronavirus, their factory has newly added seven production lines which were dedicated to the production of protective products, such as face mask, COVID-19 test kit, Infrared thermometer, safety glass, coverall and etc.

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