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Free 17-OH Progesterone Saliva ELISA Kit (17OHP)

INTENDED USE

Human free 17-OH progesterone saliva ELISA kit is an accurate in vitro quantitative method for detecting free 17-hydroxyprogesterone (17-OH progesterone, 17OHP, 17 OH progesterone) in human saliva. This assay has a minimum sensitivity detection limit of 2.5 pg/ml.

BACKGROUND

17-hydroxyprogesterone (17 OH progesterone, 17OHP or 17-OH progesterone) is a produced by the adrenals, testes, ovaries and placenta. Deficiency are known to block the synthesis of cortisol which is often found to result in an increase in the serum levels, this also causes an increase in ACTH secretion. In addition to the classical CAH, there is also the possibility of late-onset and milder heterozygous forms of CAH to occur. These are known to clinically manifest themselves during the peripubertal period in the form of hirsutism and menstrual disturbances. CAH is one of the most frequently inborn endocrine disorders and a prevalence rate of 1-20 in 10,000 children can be experienced.

The determination of 17-OH progesterone using either serum or plasma samples from babies or even young children is quite difficult due to the high concentrations of conjugates present in blood. This means that samples need to be extracted prior to performing the assay, the importance of this stage increases with decreasing age of the patient. Since there are no conjugates present in the saliva, this allows the measurement to be carried out in new born’s using saliva samples without the need of an extraction step. This would not be possible if serum or plasma samples were used.

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.

  • Microtiterwells (96 Wells): Contain break apart strips that are coated with anti-17OHP polyclonal antibody.
  • Standards 0 – 5: Concentrations 0, 10, 50, 250, 500, 1000 pg/ml.
  • Control Low And Control High.
  • Enzyme Conjugate.
  • TMB Substrate Solution.
  • Stop Solution.
  • Wash Solution (40x Concentrated).

SENSITIVITY

The minimum detection level of  17-hydroxyprogesterone (17OHP) using this 17-OH progesterone salivary ELISA kit was approximately 3.0 pg/ml. The dynamic assay range of this kit is 5.0 – 5,000.0 pg/ml.

ASSAY CHARACTERISTICS

–  Assay Dynamic Range: 3.6 – 1000 pg/ml
– Specificity (Cross Reactivity): The percentage indicates cross reactivity at 50% displacement compared to 17-alpha-OHP; 17- α-OH Progesterone (100%), 11-Desoxycortisol (1.40%), Progesterone (1.20%), DOC (0.05%), Estriol, Estradiol 17beta, Testosterone, Dihydrotestosterone, DHEA, Cortisol, Aldosterone, Androstenedione, Dehydroepiandrosten sulfate, Prednisone (< 0.01%), DHEA-S (< 0.001%).
– Analytical Sensitivity: 2.5 pg/ml.
– Intra-Assay Variation: 3.5 – 8.0%
– Inter-Assay Variation: 2.0 – 10.4%
– Inter-Lot Variation: 1.3 – 10.4%
– Recovery: 93.1 – 107.5%
– Linearity: 83.6 – 113.2%
– Interfering Substances: Blood contamination of more than 0.04 % in saliva samples is found to affect results.

REFERENCES

  1. Neonatal screening for congenital adrenal hyperplasia. Nat Rev Endocrinol. (2009) 5 (9): 490-8. Review. White P.C.
  2. Enzyme immunoassay of 17-hydroxyprogesterone in plasma, microfilter paper blood and saliva of newborns, children and patients with congenital adrenal hyperplasia. Endokrinologie. (1982) 79 (2): 165-72. Hubl W., et al.
  3. Monitoring medical treatment in adolescents and young adults with congenital adrenal hyperplasia: utility of salivary 17α-hydroxyprogesterone day profiles. Exp Clin Endocrinol Diabetes. (2011) 119 (3): 131-8. Deutschbein T., et al.

ADDITIONAL INFORMATION

  • Full Name: Free 17-OH Progesterone Saliva ELISA Kit (17OHP)
  • Reactivity: Human
  • Sample Type: Saliva
  • Sensitivity: 3.0 pg/ml

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