Reliable prenatal testing and newborn screening based on xMAP^® Technology

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xMAP Technology Enables Reliable Prenatal Testing and Newborn Screening

Prenatal testing and newborn screening programs are among the most effective tools to ensure that babies have the best chance to grow into healthy children. In Brazil, one company has lead the charge in this area for three decades: Intercientifica.

Founded in 1992 by Claudio Sampaio, Intercientifica runs all its tests on dried blood spot (DBS) samples. To produce a wealth of information from such low-volume samples, the company relies on xMAP^® Technology for multiplexing. In 1999, it became one of the first Luminex Licensed Technologies Partners in Latin America. Now, the company has fully automated its xMAP workflow to ensure high-throughput testing with a fast turnaround time.

Intercientifica’s Start in Neonatal Screening

Sampaio never expected his career to lead to newborn screening. In the early 1990s, he was working as a salesman for the laboratory department of a Brazilian company when he had the chance to travel to the U.S. and take a tour of Sigma Aldrich: one of the company’s vendors. During that visit, he met with the leader of Sigma’s newborn screening business. “She told me that it would soon be mandatory to have newborn screening in Brazil, and that I should look into it,” Sampaio recalls.

That conversation altered the trajectory of his career—and the health of babies across Brazil.

He launched Intercientifica as a startup enterprise from his own home, receiving business and technical advice from newborn screening and laboratory testing experts around the world. Today, the company maintains a large, GMP-compliant manufacturing and testing facility in Brazil, while its subsidiary in the U.S., Intercientifica, creates its own kits for newborn screening and prenatal testing.

Serendipity struck Sampaio again in 1999 when he met with the laboratory director for the New York State Department of Health. There, he was introduced to the multiplexing capabilities of xMAP Technology. “I was really excited about this, not only because of the ability to work with multiple markers, but also because of the sustainability,” he says. “With multiplexing, you can reduce the packaging, the water, and the space of your stock.” Additionally, xMAP-based assays require smaller volumes of reagents and antibodies, and the xMAP platform allows the use of just one DBS sample to perform the test. These two factors are beneficial to the economy of blood samples, a very important factor in the case of newborns.

While Sampaio was struck by the practical benefits of xMAP-based testing, he was also impressed by its utility, finding it easy to work with xMAP Technology. Today, the Intercientifica team has now developed several newborn screening and prenatal tests based on xMAP, which they run on a MAGPIX^® system. While their first tests multiplexed two analytes, the number of analytes run simultaneously on their tests has steadily expanded over time.

Today, Intercientifica serves the newborn screening and prenatal testing markets in both Brazil and Mexico. Its multiplex product kits can detect common newborn screening targets such as congenital hypothyroidism (TSH and T4), congenital adrenal hyperplasia (17OH), cystic fibrosis (IRT), and infectious diseases.

Automating xMAP-Based Workflows for High-Throughput Neonatal Screening

With so much demand for Intercientifica’s services, Sampaio and his team decided to automate their xMAP workflow for a popular NeoMAP 4Plex newborn screening test. The outcome is the integration of the MAGPIX system with the Hamilton Microlab Nimbus — including the production of data-analysis software for details of each batch as percentile, controls, samples median, and floating cut-off — with capacity to deliver 3,000 results in less than four hours. There are now more than 20 systems installed across Central and South America.

The Intercientifica team worked with Hamilton to design and build the automated workflow it leverages. “Our engineers worked to make the connection between Hamilton automation and the Luminex MAGPIX system,” Sampaio says. The project took a year to complete, and now the company has a fully automated, easy-to-use process for newborn screening. Automation allowed the team to increase their testing capacity by about 50 percent and to reduce the materials used in the workflow.

If you’re based in Latin America, please reach out to dmendoza@luminexcorp.com.

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