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Free 17-OH Progesterone Saliva ELISA Kit

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. It is a metabolite of progesterone and 17-hydroxyprognenolone, it is also a precursor to cortisol. Deficiency of 21-hydroxylase are known to block the synthesis of cortisol which is often found to result in an increase in the serum levels of 17-OH progesterone, this also causes an increase in ACTH secretion.

Serum levels of 17 OHP have been primarily used to diagnose congenital adrenal hyperplasia (CAH). 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 17OHP 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 of 17-hydroxyprogesterone to be carried out in newborns using saliva samples without the need of an extraction step. This would not be possible if serum or plasma samples were used.

17-OH PROGESTERONE SALIVA 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.

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

SENSITIVITY

The minimum detection level of free saliva 17-hydroxyprogesterone (17OHP) using this human salivary 17-OH progesterone 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

– Free 17-Hydroxyprogesterone (Free 17-OH Progesterone) Saliva: ELISA
–  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.
  4. 17-Hydroxyprogesterone in children, adolescents and adults. Ann Clin Biochem. (2014) 51 (Pt 4): 424-40. Honour J.W.

ADDITIONAL INFORMATION

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

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