About the only people busier than enumerators in China may be the doctors and midwives who are responsible for delivering an estimated 17 million newborns across this vast country in 2015.1 To put that into proper perspective, that number totals over 5% of the entire U.S. population and more than 3% of all of Europe…and that is just this year. With over 1.35 billion people and an estimated birth defect rate of between 4% – 6%, Chinese officials are working hard to improve and expand the efficiency of the country’s newborn screening programs.2
An Expanding Collaboration
In 2014, China's National Health and Family Planning Commission announced an exclusive, three-year collaboration with global life and environmental sciences company PerkinElmer to develop and implement an extensive newborn screening training initiative. Leveraging the company’s diagnostic technologies and expertise, more than 3,000 Chinese doctors, clinicians, and laboratory technicians across 600 rural counties are currently being trained in sample collection, clinical diagnostics and treatment, as well as site inspection and overall program management of China’s rapidly expanding newborn screening initiative. In addition, the company is working with the National Maternal and Children Health Surveillance Office to implement early detection of life-threatening disorders in newborns, including phenylketonuria, which can damage the central nervous system and the brain, and congenital hypothyroidism. In the past few years, PerkinElmer has also screened more than nine million babies in the country for hypothyroidism and many other disorders.3
Most health officials would cheer such a high volume of newborn screenings as a remarkable achievement. While indeed it is, the Chinese see it as a promising start to an immense initiative that values efficiency, quality, and healthy outcomes.
In April, 2015, the Chinese Food and Drug Administration (CFDA) approved PerkinElmer’s request to market its Genetic Screening Processor® (GSP) instrument and GSP Neonatal hTSH reagent kit to test for hyperthyroidism in newborns throughout the country. The GSP instrument is a fully automated analyzer that allows up to 26 96-well-plates that can be tested simultaneously for a variety of disorders using the company’s dried bloodspot testing technology.4
Planning Ahead With a Global Leader
China began its newborn screening program in 1981. This year, Chinese officials estimate that nearly 80% of newborns will be tested and that number will increase in the years ahead.5 Currently, the more advanced areas of the country test for more than 30 genetic disorders, but screening programs vary across China’s 30 provinces.6
“We are committed to developing innovative solutions to help newborn screening labs in China respond to rising birth rates and expand access to testing for serious health risks in newborn babies,” Johnson Zhang, PerkinElmer’s vice president and general manager for Asia-Pacific diagnostics, says. “As China seeks to improve the efficiency of newborn screening and reduce false-positive and false-negative rates, our advanced detection technologies are designed to deliver highly reliable results for better outcomes.”7
PerkinElmer is the world's largest producer of newborn screening tests, as well as sample collection devices, sample preparation and measuring instruments, and informatics to support the entire screening process from collection of the sample to follow-up of the screened baby. To date, the company has screened some 486 million babies worldwide and is involved in approximately 80% of China’s 218 neonatal screening centers.8
Big national birthrate rise signals new peak, China Daily.
Birth defects surveillance in China, World Journal of Pediatrics.
PerkinElmer Launches Newborn Screening Program in China, Genetic Engineering & Biotechnology News.
PerkinElmer Genetic Screening Processor.
Newborn screening and related policy against Phenylketonuria in China, Intractable Rare Dis Res. 2013 Aug; 2(3): 72–76.
The profile of newborn screening coverage in China, J Med Screen. December 2009 vol. 16no. 4 163–166.
PerkinElmer Launches First Fully Automated Genetic Disorder Screening System in China, PerkinElmer.