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17-OH Progesterone ELISA Kit

INTENDED USE

Human 17-OH progesterone ELISA kit is a reliable quantitative procedure for measuring 17-hydroxyprogesterone (17-OH progesterone, 17OHP, 17 OH progesterone) in human serum and plasma. This assay has a minimum sensitivity detection limit of 0.037 ng/ml.

BACKGROUND

17 OH progesterone (17-hydroxyprogesterone, 17-OH progesterone or 17OHP) can be derived either from progesterone via 17-hydroxylase using the enzyme P450c17 or from 17-hydroxypregnenolone using the enzymes 3β-hydroxy-steroid dehydrogenase/delta 5-4 isomerase. It is a C-21 steroid hormone that can be produced during the synthesis of sex steroids (in the gonads) and glucocorticoids (in the adrenal gland). 17-OH progesterone has been routinely used as a suitable biochemical marker for diagnosing congenital adrenal hyperplasia (CAH). Deficiencies in 21-hydroxylase are found frequently in patients that have congenital adrenal hyperplasia and this result in excessive secretion of 17-OHP causing the blood levels to be elevated. Therefore, by measuring the activity of 21-hydroxylase in the adrenal cortex can be used to monitor the levels of 17-OH progesterone that are present in the blood and this in turn plays a significant role when diagnosing patients with CAH, since the typical defective enzymes (21-hydroxylase and 11b-hydroxilase) lead to the build-up of 17-hydroxyprogesterone (17OHP). CAH is one of the most frequently inborn endocrine disorders, where a prevalence of 1-20 in 10,000 children can be experienced.

The following  assay is designed for detecting various types of diagnostic applications. 17-OHP is a natural progestin and is found to increase during pregnancy in the third trimester which is predominately caused by the increase in production of fetal adrenal. Generally, normal levels in children range between 3-90 ng/dl and in women between 15-70 ng/dl prior to ovulation and these increase to 35-290 ng/dl during the luteal phase of the menstrual cycle.

17-OH PROGESTRONE ELISA KIT CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • Microtiter Plate 12×8 (break apart) strips: Wells coated with 17-OH progesterone antigen (polyclonal).
  • Calibrator 0-5: Concentrations 0.1-25 ng/ml, made up from anti 17 OHP.
  • Control 1 (Low) and Control 2 (High): Containing human 17-OH progesterone in serum.
  • Enzyme Conjugate: Consisting of human 17OHP antibody conjugated to horseradish peroxidase.
  • Substrate Solution: Tetramethylbenzidine (TMB)
  • Stop Solution: Contains 2 N acidic solution. Avoid contact with the stop solution. It may cause skin irritations and burns.
  • Wash Solution (10x Concentrated).

SENSITIVITY

The minimum sensitivity detection limit of human 17-hydroxyprogesterone (17 OH progesterone, 17OHP, 17-OH progesterone) using current 17OH progesterone ELISA kit was approximately 0.037 ng/ml. The dynamic assay range for this assay is 0.1 – 25.0 ng/ml.

ASSAY CHARACTERISTICS

– 17-Hydroxyprogesterone (17-OH Progesterone): ELISA
– Analytical Sensitivity: 0.014 ng/ml
– Specificity (Cross Reactivity): Progesterone (2.9%), 11-Desoxycortisol (2.71%), 11-Deoxycorticosterone (0.26%), Cortisone (0.19%), Pregnenolone (0.17%), Prednisone (0.11%), Cortisol (0.05%), Androstendione, Testosterone, Corticosterone, Estradiol, Estriol, Estrone, Prednisolone, DHEA, DHEA-S, Danazol, Dexamethasone (< 0.1%).
– Assay Dynamic Range: 0.1 – 25.0 ng/ml
– Intra-Assay Variation: 6.6 – 8.9%
– Inter-Assay Variation: 6.4 – 14.9%
– Recovery: 75 – 122%
– Linearity: 85 – 124%
– Drug Interferences: None

REFERENCES

  1. 17-Hydroxyprogesterone in children, adolescents and adults. Ann Clin Biochem. (2014) 51 (Pt 4): 424-40. Honour J.W.
  2. Quantitation of 17 OH progesterone (OHPG) for diagnosis of congenital adrenal-hyperplasia (CAH). Methods Mol Biol. (2010) 603: 271-7. Singh R.J.
  3. Circulating progesterone and obesity in men. Horm Metab Res. (2006) 38 (5): 330-5. Blanchette S., et al.
  4. Neonatal screening for congenital-adrenal hyperplasia. Nat Rev Endocrinol. (2009) 5 (9): 490-8. Review. White P.C.

ADDITIONAL INFORMATION

  • Full Name: 17-OH Progesterone ELISA Kit
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 0.037 ng/ml

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