Or. Admin. Code § 333-024-0230

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-024-0230 - Testing for Metabolic Diseases: Methods of Testing

(1) Infants shall be tested for congenital disorders on the newborn screening test panel by methods approved by rule of the Oregon Health Authority. The following laboratory procedures are approved. No other method shall be approved unless it meets or exceeds these methods in respect to specificity, sensitivity, and precision of the assay. Persons wanting amendment of this rule to include another method must provide technical data to the state public health laboratory showing to the satisfaction of the state public health laboratory that the proposed method meets or exceeds the approved methods in these respects.

(2) Laboratory methods for detecting congenital disorders shall be performed upon dried blood specimens and be as follows:

(a) Amino acid and urea cycle disorders: Quantitative measurement of amino acids by tandem mass spectrometry.

(b) Biotinidase deficiency: Colorimetric assay for biotinidase activity.

(c) Congenital adrenal hyperplasia: Fluorescent immunoassay of 17-alpha hydroxyprogesterone (17-OHP).

(d) Congenital hypothyroidism: Fluorescent immunoassay of thyroxine (T4) with secondary assay of thyroid stimulating hormone (thyrotropin or TSH).

(e) Cystic fibrosis: Fluorescent immunoassay for the presence or absence of immunoreactive trypsinogen (IRT).

(f) Fatty acid oxidation disorders: Quantitative measurement of acylcarnitines by tandem mass spectrometry.

(g) Galactosemia: Fluorescent immunoassay for the presence or absence of detectable galactose uridyl transferase in erythrocytes and galactose.

(h) Hemoglobinopathies: Primary screening by isoelectric focusing and confirmation by high performance liquid chromatography to detect hemoglobin variants.

(i) Severe combined immunodeficiencies: DNA polymerase chain reaction (PCR) to detect the absence or presence of T-cell receptor excision circles (TREC assay).

Or. Admin. Code § 333-024-0230

HD 18-1981(Temp), f. & ef. 9-11-81; HD 3-1982, f. & ef. 2-25-82; HD 17-1983, f. & ef. 10-12-83; HD 10-1986, f. & ef. 6-11-86; HD 28-1994, f. 10-28-1994, cert. ef. 11-1-94; OHD 15-2002, f. & cert. ef. 10-4-02; PH 30-2004(Temp), f. & cert. ef. 9-17-04 thru 3-13-05; PH 37-2004, f. & cert. ef. 12-7-04; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14; PH 92-2018, amend filed 02/12/2018, effective 4/1/2018

Statutory/Other Authority: ORS 433.285

Statutes/Other Implemented: ORS 433.285