Early Check Study Disclaimer

Early Check Study Disclaimer

Early Check is state-wide, voluntary research program designed to identify children with rare health conditions before symptoms appear, and study the benefits of early treatments. The program offers parents the choice to screen their newborn for a carefully selected set of health conditions that go beyond standard newborn screening. Early Check partners include RTI International, the North Carolina State Laboratory of Public Health, the University of North Carolina at Chapel Hill, Duke University, and Wake Forest Baptist Medical Center.

Screening tests provide an early opportunity to detect many disorders before symptoms appear. Not all affected infants demonstrate characteristic manifestations of these disorders. Not all newborns will be identified through screening. The sensitivity of screening tests depends on various factors, including the way the specimen is collected, the infant’s age at testing, birth weight, gestational age, feeding type, transfusion status, and the presence of co-existing illness, medical conditions and medications. Screening tests do not represent a diagnosis or treatment and are not a replacement for professional medical evaluation, advice, diagnosis or treatment by a healthcare professional. RTI International does not engage in rendering medical advice or services. If an infant with normal screening test results has symptoms of a disorder, or medical problems associated with metabolic disorders, the healthcare provider should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient in determining the propriety of further diagnostic tests that may be necessary, regardless of the baby’s newborn screening results.

The performance characteristics of the real-time polymerase chain reaction (PCR) assay to detect deletions in SMN1 that can lead to SMA was determined by RTI International. The assay has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.

The performance characteristics of the capillary electrophoresis assay to detect FX (CGG repeats) was determined by RTI International. The assay has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.