Service Background

According to the 'Guidelines for Review' document of the latest viral nucleic acid detection kit:

Positive Reference and Positive Controls

The positive reference product should contain all genotypes that can be detected by the kit, each genotype should be set at different concentration levels, and should be able to meet the needs of product performance verification, at least two concentration levels (weak positive, medium or strong positive); It is recommended to use inactivated virus serum/plasma for the setting of common genotype positive reference products. Other genotype-positive reference settings can use simulated clinical samples, such as pseudoviruses. For the method of obtaining positive reference products, it is recommended to use the gold standard method or similar methods or other proven methods for confirmation.

The positive quality control should contain the target gene, which is used to monitor the whole detection process, including: RNA extraction, gene amplification and detection. The positive quality control is used as a separate detection process to simulate patient samples for simultaneous detection with patient samples.

Introduction to fake virus

Pseudovirus is to wrap specific nucleic acid fragments in the viral coat protein to form a pseudovirus. Pseudovirus does not have the ability to replicate autonomously, has high biological safety, stable nucleic acid, and is not easy to degrade.

Pseudovirus standard requirements

·The pseudovirus standard has the same or similar physical and chemical properties as the target virus to be detected, such as protein particles coated with nucleic acid substances.

·The pseudovirus standard carries the same probe nucleic acid fragment as the target virus to be detected.

·The purity of the pseudovirus standard is high enough, and the exogenous contaminating nucleic acid substances need to be removed during production.

Service Advantage

·Reqbio provides two types of pseudoviral vectors, lentivirus and adenovirus, whose physical and chemical properties are very similar to clinical pathogenic RNA and DNA viruses, as internal control standards and positive controls, which can greatly improve the accuracy of virus detection and reduce false positives and false negatives result.

·Reqbio has a self-developed pseudovirus purification system, which can effectively remove DNA or RNA contamination during the production of pseudoviruses, and minimize the impact of nucleic acid substances carried by non-pseudoviruses on test results.

·Reqbio has a self-developed pseudovirus titer determination system, which can quickly, efficiently and accurately measure pseudovirus titers

·Reqbio has rich experience in reference materials related to the declaration of three types of medical devices, and provides various reference products and corresponding traceability documents to meet various needs of R&D and declaration.

Ordering method

  Service Hotline：4008-750-250                                  Phone：180-6607-1954

  QQ：4008-750-250                                                     Mail：sales@reqbio.com