Current through Register Vol. 61, No. 4, April 1, 2022
(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.
Laboratory methods for detecting
congenital disorders shall be performed upon dried blood specimens and be as
(a) Amino acid and urea cycle
disorders: Quantitative measurement of amino acids by tandem mass
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).
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
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.
Severe combined immunodeficiencies: DNA polymerase chain reaction (PCR) to
detect the absence or presence of T-cell receptor excision circles (TREC
Or. Admin. R.
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;
92-2018, amend filed 02/12/2018, effective
Statutory/Other Authority: ORS
Statutes/Other Implemented: ORS