The testing results of novel coronavirus nucleic acid are of great reference value to make a definite diagnosis. After the outbreak of the epidemic, Sichuan strengthened the laboratory testing efficiency and applied the emergency upgrading of standby laboratories. As of February 19, 32 tertiary hospitals and 22 county-level disease control institutions were approved to carry out nucleic acid testing, achieving the full coverage in 21 cities (prefectures). In our park, there is also one authorized enterprise!

On February 15, Chengdu PerkinElmer Medical Laboratory located in Phase II of Tianfu Life Science Park passed the inspection and acceptance of the Chengdu Municipal Health Commission and the expert group of Chengdu CDC. It is qualified to test novel coronavirus nucleic acid and is ready to carry out preparations for the large detection of novel coronavirus samples. At present, it tests 1,000 people per day, and the results will be produced in 24 hours.

In May last year, Chengdu PerkinElmer Medical Laboratory was officially opened as the first settled enterprise of Phase II of Tianfu Life Science Park. It is the second independent medical laboratory of PerkinElmer (NYSE: PKI) in China. Targeting at pre-pregnancy, pre-delivery, newborn, pediatrics, and other fields of maternal and health care, the laboratory offers a series of special examination services based on self-developed products and other cutting-edge technical products.

Chengdu PerkinElmer Medical Laboratory Opens

"After the outbreak of COVID-19, we got the approval and recommendation from the health department of Chengdu High-tech Zone. Meanwhile, for the sake of corporate social responsibility and conditions, we decided to engage in the testing." According to Xiong Yehua, director of Chengdu PerkinElmer Medical Laboratory, PerkinElmer has rich experience in medical testing services. However, institutions carrying out new coronavirus testing must meet the level 2 biosafety (P2) standard, and the operator must be equipped with three-level protection equipment.

According to the requirements of novel coronavirus detection, Chengdu PerkinElmer Medical Laboratory has made corresponding preparations in terms of hardware, personnel, environment, materials, process, etc. Xiong Yehua introduced that this time they opened a standby standardized PCR laboratory, which was designed and built according to the super-secondary biosafety laboratory standard. It covers an area of 200 square meters and is equipped with a differential pressure control system. The differential pressure control ensures the accuracy of the experiment and the safety of the operator together with interlocking doors and standardized disinfection devices.

Chengdu PerkinElmer Medical Laboratory

In addition, the laboratory has invested in the full-automatic nucleic acid extraction instrument produced by PerkinElmer, prepared a variety of nucleic acid detection kits, and formulated strict biological safety protection procedures and all quality documents. With regard to personnel, strict training has been carried out many times and sufficient protective materials have been prepared.

"After full preparation, we submit applications to the Health Department of the High-tech Zone and Chengdu CDC. We are verified for on-site audit and acceptance by experts, and participate in the external quality assessment of Sichuan provincial clinical inspection center," Xiong Yehua said.

To meet the needs of novel coronavirus nucleic acid testing, a fully automatic sealed nucleic acid extractor is added here. The device is controlled by mechanical arms, which not only improves efficiency but also reduces the direct interactions between operators and test samples, which plays a protective role for the personnel.

Xiong Yehua said that Chengdu PerkinElmer Medical Laboratory currently tested 1,000 people per day. Thanks to this automatic testing device, only four operators are needed for the daily test.

The operator is working on the related works of new coronavirus nucleic acid testing.

Referring to the potential "false negativity" in the detection of novel coronavirus nucleic acid at present, Xiong Yehua said that four requirements should be met simultaneously to detect the novel coronavirus in the infected person: a certain amount of virus in cells, cells with viruses must be collected when collecting samples, effective in vitro diagnostic reagents, and standardized clinical nucleic acid detection laboratory.

He stressed that to avoid the "false negativity" test of novel coronavirus, it was necessary to collect qualified samples first. Otherwise, "false negativity" results would be shown. Meanwhile, the transportation of samples was also very important. Moreover, it was caused by the limitations of the kit itself, for example, the different sensitivity between different kits. If there were few viruses in the collected cells, lower than the kit's detection limit, there might be a "false negativity" result.

Therefore, a variety of high-sensitivity nucleic acid detection kits are adopted by Chengdu PerkinElmer Medical Laboratory to verify each other, which can effectively avoid the "false negativity" and ensure results' accuracy.

At present, the test samples received by Chengdu PerkinElmer Medical Laboratory mainly come from hospitals and the physical examination of employees in enterprises getting back to work. "As enterprises get to work in succession, we have prepared well for novel coronavirus nucleic acid testing to guarantee enterprises and institutions by offering the accurate physical examination of COVID-19." Xiong Yehua said.

About PerkinElmer

With a history of more than 80 years, PerkinElmer (NYSE: PKI), a global technology company, is committed to continuous innovation to create a healthier world. It is the world's leading provider of medical diagnosis, life science, testing, imaging, informatics, and scientific research services. At present, it employs over 10,000 staff around the world, serving more than 150 countries and regions. PerkinElmer is an NYSE listed company (NYSE: PKI) as well as a member of the S&P 500 Index.

As a leading enterprise of in vitro diagnosis industry, the diagnosis business of PerkinElmer, including reproductive health and independent medical laboratory business, clinical infection diagnosis and blood transfusion safety business, application gene analysis business, autoimmune and allergic disease diagnosis business, and so on, is mainly used in screening and diagnosis of inherited diseases, conventional tumors, infectious diseases (including blood bank system) and other immune projects, one-stop special examination service in other fields of maternal and health care including pre-pregnancy, pre-delivery, newborn, pediatrics, and others, genomics and sequencing related sample preparation and database solutions.

In 2018, PerkinElmer (China) invested more than RMB 30 million in Phase II of Tianfu Life Science Park, Chengdu High-tech Zone, to build the Chengdu PerkinElmer Medical Laboratory. Covering 2,200 square meters, it is a specialized third-party medical laboratory based on modern molecular diagnosis technology to carry out individualized diagnosis and drug guidance focusing on birth defects and genetic diseases. Targeting at pre-pregnancy, pre-delivery, newborn, pediatrics, and other fields of maternal and health care, the laboratory offers a series of special examination services based on self-developed products and other cutting-edge technical products.