(B) Detailed documentation of the device software including, but not limited to, standalone software applications and hardware-based devices that incorporate software (A) A detailed description of the test components, all required reagents, instrumentation and equipment, including illustrations or photographs of nonstandard equipment or methods (ii) A detailed description of all components in the test that includes: (B) The test is not intended to screen for less acute SCID syndromes, such as leaky SCID or variant SCID. (A) The test is not intended for diagnostic use, or for screening of SCID-like syndromes, such as DiGeorge syndrome or Omenn syndrome and (1) Premarket notification submissions must include the following information: The special controls for this device are: It is also not intended to screen for less acute SCID syndromes, such as leaky SCID or variant SCID. This test is not intended for use as a diagnostic test, or for screening of SCID-like syndromes, such as DiGeorge syndrome or Omenn syndrome. Presumptive positive results must be followed up by diagnostic confirmatory testing. A newborn screening test for SCID is a prescription device intended to measure T-cell receptor excision circle (TREC) DNA obtained from dried blood spot specimens on filter paper using a polymerase chain reaction based test as an aid in screening newborns for SCID. 866.5930 Newborn screening test for severe combined immunodeficiency disorder (SCID). PART 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES Keywords: Newborn screening (NBS) SCID TREC athymia hematopoietic cell transplant (HCT) prematurity.The information on this page is current as of Mar 28, 2023.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). We also found that low naïve T cell percentage is associated with a higher risk of SCID/CID, demonstrating the utility of memory/naïve T cell phenotyping as part of follow-up flow cytometry. Despite lower median TREC values in premature infants, the majority for all ages are well above the TREC cutoff and the algorithm, which selects urgent (undetectable TREC) and repeatedly abnormal TREC, minimizes referral. Compared to outcomes from the 10 years prior to SCID NBS, survival was higher (9/9 vs 4/7), likely due to a lower rate of infection before treatment.Ĭonclusions: Our data support a single NBS testing-and-referral algorithm for all gestational ages. One patient with athymia underwent successful thymus transplant. All patients with SCID/leaky SCID underwent hematopoietic cell transplant or gene therapy with 100% survival. SCID/leaky SCID incidence was ∼1 in 80,000, while ∼1 in 51,000 had severe T cell lymphopenia for which definitive treatment was indicated. Another 7 were diagnosed with other combined immunodeficiencies, and 3 with athymia. 9/237 were diagnosed with SCID/leaky SCID (4% of referrals vs 0.001% general population). Results: NBS of 720,038 infants prompted immunologic evaluation of 237 (0.03%). Methods: TREC values, diagnostic, and outcome data from all patients screened for SCID were evaluated. Objective: We describe developments and outcomes from the first 10 years of this program (Feb 1 2009-Jan 31 2019). Background: Massachusetts began newborn screening (NBS) for severe combined immunodeficiency (SCID) using measurement of T cell receptor excision circles (TRECs) from dried blood spots.
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