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Human Placental Lactogen ELISA Kit (hPL)

INTENDED USE

Human placental lactogen ELISA kit is a reliable quantitative procedure for measuring hPL (human placental lactogen) in human serum samples only. This assay has a minimum sensitivity detection limit of 0.43 mg/l.

BACKGROUND

Human placental lactogen (hPL) is also referred to as human chrionic somatommotropin (HCS), it has a total molecular mass of 22,125 and is made up of 191 amino acids that contains 8 helices which are linked by two disulphide bonds. In general elevated levels during pregnany are indicative of an optimal pregnancy, however, sometimes high levels may be indicate a substantial feta pathology in specific diseases for example fetal macrosomia, hydrops fetalis, diabetes mellitus and rhesus isoimmunization.

Even though the following assay is a useful indicator of fetal growth and well-being, there are also many other fetal testing procedures which have been more reliable. Currently, the physiological role of hPL is not well understand but due to its similarity to human growth hormone, there are many hypothesis regarding a possible role as a regulator of fetoplacental growth as well as  other physiological alterations that are required during pregnancy.

There is some suggestion that the “index of placental function” may reflect the maternal serum-level. There are also cases of depressed levels which have been linked to birth asphyxia, fetal distress in labour and intrauterine death. During a pregnancy that has proceed to full term uneventfully, it is highly unlikely that depressed levels are present.

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 12 x 8 (break apart) strips: Wells coated with anti hPL antibody (monoclonal).
  • Standard 1-4: Concentrations: 1.25, 5.0, 10.0, 20 mg/L. The standards are calibrated against the NIBSC International Standard IRP (73/545).
  • Zero Standard (also use as Sample Diluent).
  • Control Low And Control High.
  • Enzyme Conjugate: Consists of antibody conjugated to horseradish peroxidase.
  • Substrate Solution: Tetramethylbenzidine (TMB).
  • Stop Solution.

SENSITIVITY

The minimum sensitivity detection limit of human placental lactogen (hPL) using current hPL ELISA kit was approximately 0.43 mg/l. The dynamic range for this assay is 1.25 – 20.0 mg/L.

ASSAY CHARACTERISTICS

– Assay Dynamic Range: 0.04 – 20 mg/L.
– Specificity (Cross Reactivity): Highly specific for hPL, no cross reaction with hCG, AFP, hGH, prolactin was detected.
Sensitivity: 0.043 mg/L
– Intra-Assay Variability: 5.55 – 6.73%
– Inter-Assay Variability: 5.67 – 8.82%
– Recovery: 85.80 – 104.20%
– Linearity: 86.7 – 109.2%
– Drug Interferences: None
– High-Dose-Hook Effect: None detected up to 700 mg/L levels of hPL.
– Interfering Substances: None

REFERENCES

  1. The roles of placental growth hormone and placental lactogen in the regulation of human fetal growth and development. J Pediatr Endocrinol Metab. (2000) 13 (4): 343-56. Review. Handwerger S. and Freemark M.
  2. Use of biochemical tests of placental function for improving pregnancy outcome. Cochrane Database Syst Rev. (2015) (11): CD011202. Review. Heazell A.E., et al.
  3. Maternal prenatal depression is associated with decreased placental expression of the imprinted gene PEG3. Psychol Med. (2016) 46 (14): 2999-3011. Janssen A.B., et al.
  4. Forensic pregnancy diagnostics with placental mRNA markers. Int J Legal Med. (2010) 124 (1): 13-7. Gauvin J., et al.

ADDITIONAL INFORMATION

  • Full Name: Human Placental Lactogen ELISA Kit (hPL)
  • Reactivity: Human
  • Sample Type: Serum
  • Sensitivity: 0.43 mg/l

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