WuXi Diagnostics' integrated testing solution for COVID-19 epidemiological investigation and diagnosis

SHANGHAI, Feb. 27, 2020 /PRNewswire/ -- WuXi Diagnostics has successfully developed a series of COVID-19 detection products, including 2019-nCoV IgM Detection kit (Enzyme-linked Immunoassay, ELISA), 2019-nCoV IgM/IgG Detection Kit (Enzyme-linked Immunoassay, ELISA) and 2019-nCoV Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method). All these products, as a set of "integrated detection" solution, assist medical institutions to diagnose COVID-19 infection quickly and accurately, and improve epidemic prevention and control capabilities for disease control centers at all levels.

IgM/IgG and IgM antibody detection, an effective measure for community preparedness

Immunoglobulin antibodies appear after the 2019-nCoV infection and initiate an immune response. IgM antibody is an indicator of current infection and IgG antibody is an important indicator of recent and past infection.

WuXi Diagnostics 2019-nCoV IgM/IgG and IgM Detection Kits can specifically detect IgM and IgG antibodies of COVID-19, covering the entire course of infection and recovery period of patients. This integrated approach improves the overall diagnosis of COVID-19 in both acute and recovery phases of illness.

Our two serological kits utilize enzyme-linked immunoassays, and provide an easy workflow, short turnaround time, and rapid diagnosis of COVID-19 suspected patients. Our kits can detect COVID-19 specific IgM and IgG antibodies in serum samples within 60 minutes with high reproducibility. Both methods do not require expensive medical instruments and consumables, and offer a favorable solution in primary medical institutions compared to other detection methods.

Nucleic acid detection, a "gold standard" for the diagnosis of COVID-19

Nucleic acid testing is considered to be the "gold standard" for the diagnosis of COVID-19. WuXi Diagnostics 2019-nCoV Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) is based on the latest COVID-19 sequence variation studies. Our Kit utilizes fluorescence quantitative PCR combined with a TaqMan probe with high specificity to ensure accurate identification of ORF1ab and N genes of 2019-nCoV. The kit offers a highly sensitive test with a limit of detection as low as 1000 copies/ml. Our assay is optimized with an internal control to exclude false-negative results from sample inhibitors and amplification failures. The kit can be used for the detection of 2019-nCoV infection in different types of samples, such as nasopharyngeal swabs, alveolar lavage fluid, sputum, etc. Our assay can provide the result as soon as two hours from processing a sample.

Coupling serological testing with nucleic acid detection provides a high-quality, multi-dimensional and cost-effective diagnostic solution

Performing just one type of test to diagnose COVID-19 could lead to a false-negative result or misdiagnosis due to complex medical conditions of the patients. Therefore, implementation of a combined diagnostic workflow by integrating serological and molecular tests using the three 2019-nCoV viral detection kits developed by WuXi Diagnostics, will provide a comprehensive diagnosis for clinicians.

We are at a critical moment for prevention and control of the COVID-19 epidemic. WuXi Diagnostics' integrated solution, which combines both serology and molecular tests, can meet the detection needs for early disease prevention and control, differential diagnosis, and epidemiological investigations. Our kits provide a high-quality, multi-dimensional and cost-effective solution for disease control departments and medical institutions.

"WuXi Diagnostics is devoting every effort with all healthcare providers to building a reliable line of defense against COVID-19", says Jason Liu, Ph.D., Chief Executive Officer of WuXi Diagnostics. "We will leverage advanced technology, continuously launch high-quality diagnostic solutions, and contribute in winning this battle against of COVID-19."

About WuXi Diagnostics

WuXi Diagnostics (WXDX) is establishing a next-generation integrated diagnostic enabling platform with headquarters and a CAP-accredited Independent Clinical Laboratory in Shanghai, a production facility in Suzhou, and an R&D center in Rochester, US. It is providing multidisciplinary technology solutions to improve health care practice and advance patient care.

Its core product, Enabling Solution Package (ESP), is a disease-focused total solution with advanced testing panels, medical paradigm and algorithms for disease diagnosis, and insightful medical content based on real-world clinical evidence. ESPs cover four phases of disease management: screening & early diagnosis, precision diagnosis, clinical decision support, and prognosis management.

WXDX dual enabling platforms for specialized testing service & medical innovation are advancing China's precision diagnosis and building a new ecosystem for next generation diagnostics. For more information, please visit: www.wuxidiagnostics.com/en.

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SOURCE WuXi Diagnostics