NEONATAL 17-OHP Screening
Quantitative fluorometric determination of 17-hydroxyprogesterone from neonatal dried blood spots.
The NEONATAL 17-OHP Screening FLISA is a fluorescent enzyme immunoassay for the quantitative determination of 17-hydroxyprogesterone in dried blood spots from newborns, for congenital adrenal hyperplasia (CAH) screening.
Designed for professional use in screening laboratories. For in vitro diagnostic use only - not intended for self or confirmatory testing.
Regulatory Status: CE-IVDR
Format: 192/576 tests
Method: fluorescent enzyme immunoassay (competitive ELISA)
Sample: DBS (903®/226 paper) - 3.2 mm punch
Storage: 2-8°C
Automation: Manual or automated
Turn around time: ~ 3h
General information
Advantages
Compatible instruments & related kits
The NEONATAL17-OHP Screening FLISA is a competitive ELISA in which both 17-OHP contained in the blood specimen and a labelled-17-OHP competitively bind to the anti-17-OHP antibodies covering the microplate. The labelled-17OHP is measured through the oxidation of 3-(4-Hydroxyphenyl)propionic acid (HPPA) by Horseradish Peroxidase (HRP)-labelled detection antibody, producing a fluorescent product. The measured fluorescent signal is therefore inversely proportional to the concentration of 17-OHP present in the newborn dried blood spot.
Test principle
Congenital adrenal hyperplasia is a group of autosomal-recessive disorders of adrenal steroid synthesis, most often 21-hydroxylase deficiency, that raise 17-hydroxyprogesterone. Severe salt-wasting forms can cause a life-threatening adrenal crisis in the first weeks of life; early detection allows prompt, life-saving hormone replacement. Elevated screening results are not diagnostic on their own and require confirmatory testing.
Disease
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