IVD

IVD Technology

IVD

IVD
In vitro diagnostic products

Technology of auxiliary clinical diagnosis

In vitro diagnosis (IVD) refers to the process of taking blood, body fluid, tissue and other samples out of the human body, using in vitro detection reagents, kits, calibrators, quality control materials to detect and verify the samples, so as to prevent, diagnose, treat and detect diseases, observe later, evaluate health, and predict genetic diseases.

IVD advantage

The performance of the reagent is excellent

The sensitivity of gastric cancer detection is 89%, which is much higher than that of other methods (the sensitivity of gastric cancer detection by tumor markers is less than 35%);

Test result interpretation system

The reagent is equipped with a test result interpretation system based on the large sample size database to realize the quantitative analysis of test results;

National key new product certificate

Reagent won the national key new product certificate, Beijing innovative product certificate, etc; Fruit.

Leading market share

It has been well received by many medical examination centers of Grade 3A hospitals and third-party medical institutions.

Cooperation Hospitals

Cooperative hospital

Hebei Cancer Institute

Hebei Cancer Institute was established on March 12, 1976, under the leadership of Hebei Provincial Department of health and Hebei Academy of Medical Sciences
Peking Union Medical College Hospital

Peking Union Medical College Hospital is a large-scale general hospital located in Dongcheng District of Beijing, integrating medical treatment, scientific research and teaching. It belongs to China Union Medical College
Houston Medical Center

Texas Medical Center, located in Houston, USA, is the largest medical center in the world, with the concentration of the world's top hospitals. It is not only the first choice for the world, including China, to go to the United States for medical treatment

In vitro diagnostics

IVD regulations

Importance: timely acquisition and tracking of regulatory information issued by SFDA is crucial to all IVD products producing and operating enterprises that have attempted to enter or enter the Chinese mainland market.
Uniqueness: since June 1, 2007, the management of IVD reagents by SFDA has been separated from the supervision system of MD, and the whole system is in the adjustment stage of rapid development.
Complexity: regulatory information released by SFDA is relatively complex and scattered
Language barrier: SFDA only provides Chinese information, and does not provide any foreign information support.

In vitro diagnostic classification

Classification according to detection principle or method:
Biochemical diagnosis
Immunodiagnosis
Molecular diagnosis
Microbiological diagnosis
Urine diagnosis
Diagnosis of coagulation
Blood and flow cytometry diagnosis

Characteristics of in vitro diagnosis

Immunodiagnostic reagents will gradually replace clinical biochemical reagents and become the mainstream of the development of diagnostic reagents.
Diagnostic technology is developing towards two poles. On the one hand, it is highly integrated and automatic instrument diagnosis, on the other hand, it is simple, fast and easy to popularize.
The variety of inspection products will expand rapidly.

Service Flow

Appointment of gene Consultant

In the first consultation, the genetic counselor will determine the detection method through the other party's family history, personal living habits, physical condition, working environment and other factors.