The battle against COVID-19 is involving more and more extensive range from virus detection, differential diagnosis to medication guidance, virus research, etc., constantly testing the R&D speed and level of medical industry.

Since the outbreak of this pandemic, the health industry ecological chain built by DIAN Diagnostics for many years has continuously contributed efforts: the R&D Center, mass spectrometry platform, NGS platform, CRO, forensics, and industrial chain-related companies have carried out a variety of R&D and detection projects based on their own professional strengths and focusing on the key and difficult points of COVID-19 prevention and control, and have obtained short-term results.

So far, DIAN Diagnostics has formed a set of unique integrated solutions covering from detection methods of nucleic acid and antibody in clinical diagnosis, and multiple medication evaluations that guide the treatment, to immune function monitoring in the field of prognosis judgment and mechanism research platforms such as virtual anatomy and BioBank.

临床诊断 Clinical diagnostics

1.Nucleic acid detection

Important criteria for early screening, diagnosis confirmation and cure and discharge of patients

Nucleic acid detection is to detect whether there is viral nucleic acid in nasopharyngeal mucosa cells, which is the earliest and most effective screening and diagnostic way for all infectious diseases (including COVID-19). RT-PCR technology is used in nucleic acid detection that is currently an important detection method for infectious diseases. The COVID-19 Guideline issued by the state clearly points out that: nucleic acid detection should be taken as the major criteria for diagnosis confirmation and cure and discharge of patients.

On January 30, 2020, DIAN Diagnostics developed and launched a nucleic acid detection kit (fluorescent PCR) for 2019-nCoV which may detect the presence of the novel coronavirus in throat swabs, sputum, lower respiratory tract secretions, blood and feces. Upon a large number of clinical trials, the performance index of this kit reached and even exceeded the advanced level of similar reagents.

2.IgM/IgG antibody detection

To detect whether a body is in acute infection or whether it has a history of infection

Once there is any virus entering a human body, the body immunity will begin to respond. By exploring the antibody immune response, we can observe the type of virus, the intensity of attack and the ability of our body to guard. The IgM/IgG antibody detection may help us determine whether a body is in acute infection or whether it has a history of infection.

DIAN Diagnostics, together with Academician Li Xiaokun’s team from Wenzhou Medical University, co-developed a IgM/IgG antibody detection kit for 2019-nCoV which upon a large number of clinical trials, reached and even exceeded the advanced level of similar reagents with regard to performance index, and recently entered the green channel of National Medical Products Administration for review and registration.

The screening solution for 2019-nCoV combining nucleic acid detection (RT-PCR technology) and IgM antibody +IgG antibody detection (fluorescence immunochromatography)” may identify patients with latent period, early infection and asymptomatic infection on all aspects.  

3.One-time diagnosis of multiple infection sources

Nucleic acid detection of 18 common respiratory tract infection sources in 24 types

Therapy may vary from one to another as pathogens that can cause respiratory tract infection are large in number. Therefore, clinicians need to know the pathogens of infection at the first time for the purpose of effective treatment.

As a subsidiary of DIAN Diagnostics, Digena Diagnostics possesses the nucleic acid mass spectrometry technology leading in the world and has developed a kit for differential diagnosis of 18 clinically common pathogens in 24 types including 2019-nCoV which is of high sensitivity, high sample flux and low detection cost, and is able to help identify infection clinically in a more effective way and to provide basis for symptomatic treatment, so as to contribute to the prevention and control of COVID-19.

4.Metagenomic solutions for infection sources

To detect a variety of microbial pathogens at one time

Typically doctors check pathogenic bacteria of patients one by one using “the process of elimination” based on clinical manifestations and experience to determine the cause of a disease. However, the metagenomic detection may detect a variety of microorganisms and pathogens in patients at one time to help doctors find out the cause of a disease quickly.

DIAN Diagnostics can provide clinical metagenomic analysis technology to detect DNA and RNA of all microorganisms in patients simultaneously, and can find out the pathogenic virus, bacteria or fungi by analyzing the sequence of microbial genetic materials, so as to help doctor make diagnosis and treatment quickly and precisely.

Treatment guidance

5.Clinical effect evaluation of new drugs

To contribute to the efficacy evaluation of new drugs for COVID-19

As one of the largest clinical CRO central labs in China co-established by DIAN Diagnostics and Tigermed, Teddy lab is devoted to providing one-stop central lab services and bioanalysis services for clinical trials, and has conducted more than 260 clinical trials in China and Asia-Pacific region.

After the outbreak of COVID-19, Teddy lab, together with Wuhan DIAN, jointly undertook the clinical trials of Remdesivir.

6.Blood concentration monitoring

To contribute to safe medication in clinic and efficacy evaluation of drugs

Currently, the treatment of patients with COVID-19 mainly involves the large-scale screening of potentially effective drugs and the combined use of antibiotics and antiviral drugs in high dose. But the toxic and side effects of these drugs will bring great risks to patients. As a result, it is of great clinical significance to monitor the genomics and concentration of these drugs.

As a subsidiary of DIAN Diagnostics, Calibra Precision Medical cannot only monitor the concentration of multiple drugs in the blood of patients with COVID-19, but also screen nearly 60 kinds of drugs in 5 categories that must be banned due to interaction with antiviral drugs including cardiovascular drugs, antibiotics, drugs for central nervous system, etc., providing significant references for safe medication in clinic and efficacy evaluation of drugs.

7. Pharmacogenomics detection

To guide patients with COVID-19 for precise application of chloroquine phosphate

Although chloroquine phosphate has been officially included for antiviral treatment in the “Diagnosis and therapy for COVID-19 (Trial Version 6)” issued by National Health Commission of PRC, it is of high risks for chloroquine phosphate to cause hemolytic anemia of patients with G6PD deficiency (commonly known as “favism”).

In order to effectively identify patients with G6PD deficiency to reduce adverse drug reactions, Digena Diagnostics has completed the development of a G6PD (glucose-6-phosphate dehydrogenase) gene mutation detection kit (time-of-flight mass spectrometry, TOFMS) as fast as it can, to help guide patients with COVID-19 for precision application of chloroquine phosphate.

Prognosis judgment

8.Full-spectrum flow immunoassay

To evaluate the potential risks of patients in severe conditions and detect cytokine storm at an early stage

It is found in the clinical treatment of patients with COVID-19 that: the immune system of patients has been seriously damaged, especially those who suddenly turn to severe cases. They have a high mortality rate.  

Invested by  Zhejiang Healthcare Fund, an industrial fund established with the participation of DIAN Diagnostics, Righton has developed an immune status detection scheme based on the “technical platform of full spectrum flow cytometry” and a 15-color diagnostic kit for 27 lymphoid subsets, aiming to dynamically track the immune function status of human body, find out patients with atypical early symptoms, and determine whether they are infected by virus on respiratory tract, so as to control the spread of the epidemic at an early stage; moreover, the purpose is also to identify at an early date the risk factors for patients to become severe so that a forewarning model may be established to reduce mortality, and to help distinguish viral and bacterial infections of patients with COVID-19.

IgG antibody detection

To determine the recovery and immunity of patients based on the change of antibody titer

As in the process of rehabilitation of patients with COVID-19, the concentration of lgM will gradually decrease while that of lgG will gradually increase, continuous detection of lgG antibody titer may reflect the course of disease in a timely manner.

As stated in the “Guideline for Diagnosis and Treatment of COVID-19 (Trial Version 7)”, the increase by more than 4 times of the lgG antibody addresses an acute infection state, which is of certain significance for the diagnosis and cure criteria of COVID-19, and the detection of lgG titer after rehabilitation may also be taken as the basis of epidemiological investigation.

Study on mechanism

9.Virtual anatomy

To study on the pathogenesis and improve clinical diagnosis and therapy and effect

Autopsy is to study the changes of the tissues and organs of bodies with diseases, and clarify the etiology and pathogenesis, with the help of pathological techniques, which is a critical technology for the progress of clinical medicine. Due to traditional customs and concepts, it is quite difficult to conduct autopsy in China.

DIAN forensic team has developed a complete solution for virtual anatomy, which may replace in part the traditional autopsy with low risk of biosafety to help study on the mechanism of death of patients with COVID-19, contributing to the clinical awareness of the pathogenic and lethal mechanism of COVID-19 and to improving clinical diagnosis and therapy and effect.

10.BioBank

To study on the pathogenesis of diseases and provide a strong support for health industry

Sample bank of human genetic resources is a kind of national strategic resource, and standardized high-quality BioBank is the most valuable resource for basic and clinical research on major diseases, research on clinical diagnosis and treatment technologies, R&D of drugs, and health research and industrialization, especially for such infectious disease as sudden and highly pathogenic as COVID-19.

Avntech Biotechnology, a subsidiary of Hangzhou DIAN Holding, has been engaged in the research and service of biological sample industry for more than 20 years. It is distinguished among the industry and designed to provide the value services of the whole industrial chain of biological samples exclusively for scientific research institutions, hospitals and biomedical enterprises. So far, it has undertaken the construction and management of BioBank for a number of national, provincial, municipal and large-scale 3A hospitals.

As a pioneer in the third-party medical diagnostics industry, DIAN Diagnostics, guided by the strategy of leading tomorrow with technology”, will continue to give full play to the advantages of the upstream and downstream industrial chain of healthcare, carry forward the potential energy of infectious science, and contribute to the prevention, control and monitoring of COVID-19 and other infectious diseases.