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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

icon fast
Less than 3 hours
icon flexibility
Different packagings to accommodate to laboratory needs
icon adaptability
Protocol available for manual and automated procedures
icon accurate
Quantitative test with controls and calibration curves supplied on blotting paper
icon comprehensive
All reagents and plates are included in the kit.

Compatible instruments & related kits

Automated fluorometric workstation for newborn screening assays (5 plates capacity).
Automated fluorometric workstation for newborn screening assays (12 plates capacity).

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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