Keywords
Amniotic Fluid
Obstetric Labor
Premature
Validation Study
alternative matrix
Alternative analytical validation
How to Cite
Abstract
Introduction: Intra-amniotic inflammation is evidenced by the increase in proinflammatory cytokines and chemokines, including interleukin 6, even in the absence of infection of the placenta. Both situations generate a decrease in the time between the onset of contractions and delivery, with high rates of perinatal morbidity and mortality. Due to the inherent deleterious consequences of preterm delivery, biochemical markers, such as the determination of interleukin 6 in amniotic fluid, have been proposed to assess its risk. Aims: To validate the quantification of interleukin 6 in amniotic fluid of healthy pregnant women who underwent a Cesarean section in a Community University Hospital between May and October 2021. Materials and methods: The study was a prospective study based on the analysis of precision and trueness (EP15-A3), linearity (EP6-A) and reference intervals (EP28-A3C). The samples used were obtained from the reconstitution of commercial controls with amniotic fluid. Results: Interleukin 6 in amniotic fluid had an intra- and inter-assay performance ≤ 2.5 %. Trueness was validated from the clinical point of view and a maximum bias of 5 % was obtained. The method was statistically linear in the range from 1.5 to 4052 pg/ mL. Finally, a reference interval of 81 to 1714 pg/mL was obtained. Conclusions: It was possible to carry out a validation in a matrix other than the one tested by the manufacturer, in this case, interleukin 6 in amniotic fluid, to be used in a multivariable prediction model.
References
1. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016;128(4):e155-64, https://doi.org/10.1097/aog.0000000000001711
2. Resnik R, Lockwood CJ, Moore T, Greene MF, Copel J, Silver RM. Creasy & Resnik. Medicina maternofetal: Principios y práctica. Elsevier Health Sciences; 2019. 1408 p.
3. Rodríguez M, González Ramírez VE. Relación de las citoquinas proinflamatorias con la corioamnionitis subclínica y el parto pretérmino. Rev Cubana Adm Salud. 2011; 37(4):562-76.
4. Pasquier JC, Doret M. Les complications et la surveillance pendant la période de latence après une rupture prématurée des membranas avantterme: mise au point. J Gynecol Obstet Biol Reprod. 2008;37(6):568-78, https://doi.org/10.1016/j.jgyn.2007.11.031
5. Mor G, Aldo P, Alvero AB. The unique immunological and microbial aspects of pregnancy. Nat Rev Immunol. 2017;17(8):469-82, https://doi.org/10.1038/nri.2017.64
6. Gomez-Lopez N, StLouis D, Lehr MA, Sanchez-Rodriguez EN, Arenas- Hernandez M. Immune cells in term and preterm labor. Cell Mol Immunol. 2014;11(6):571-81, https://doi.org/10.1038/cmi.2014.46
7. Combs CA, Gravett M, Garite TJ, Hickok DE, Lapidus J, Porreco R, et al. Amniotic fluid infection, inflammation, and colonization in preterm labor with intact membranes. Am J Obstet Gynecol. 2014;210(2):125. e1-125.e15, https://doi.org/10.1016/j.ajog.2013.11.032
8. Cobo T, Aldecoa V, Figueras F, Herranz A, Ferrero S, Izquierdo M, et al. Development and validation of a multivariable prediction model of spontaneous preterm delivery and microbial invasion of the amniotic cavity
in women with preterm labor. Am J Obstet Gynecol. 2020;223(3):421. e1-21.e14, https://doi.org/10.1016/j.ajog.2020.02.049
9. Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008;371(9606):75-84, https://doi.org/10.1016/s0140-6736(08)60074-4
10. Wei SQ, Fraser W, Luo ZC. Inflammatory cytokines and spontaneous preterm birth in asymptomatic women: a systematic review. Obstet Gynecol. 2010;116(2 Pt 1):393-401, https://doi.org/10.1097/aog.0b013e3181e6dbc0
11. Son M, Miller ES. Predicting preterm birth: Cervical length and fetal fibronectin. Semin Perinatol. 2017;41(8):445-51, https://doi.org/10.1053/j.semperi.2017.08.002
12. Tsiartas P, Holst RM, Wennerholm UB, Hagberg H, Hougaard DM, Skogstrand K, et al. Prediction of spontaneous preterm delivery in women with threatened preterm labour: a prospective cohort study of multiple proteins in maternal serum. BJOG. 2012;119(7):866-73, https://doi.org/10.1111/j.1471-0528.2012.03328.x
13. Holst RM, Hagberg H, Wennerholm UB, Skogstrand K, Thorsen P, Jacobsson B. Prediction of spontaneous preterm delivery in women with preterm labor: analysis of multiple proteins in amniotic and cervical fluids. Obstet Gynecol. 2009;114(2Pt 1):268-77, https://doi.org/10.1097/aog.0b013e3181ae6a08
14. Glover AV, Manuck TA. Screening for spontaneous preterm birth and resultant therapies to reduce neonatal morbidity and mortality: A review. Semin Fetal Neonatal Med. 2018;23(2):126-32, https://doi.org/10.1016/j.siny.2017.11.007
15. Melekoglu R, Yilmaz E, Ciftci O, Kafadar YT, Celik E. Associations between second-trimester amniotic fluid levels of ADAMTS4, ADAMTS5, IL-6, and TNF-α and spontaneous preterm delivery in singleton pregnancies. J Perinat Med. 2019;47(3):304-10, https://doi.org/10.1515/jpm-2018-0297
16. Tarim E, Bağiş T, Kiliçdağ EB, Sezgin N, Yanik F. Are amniotic fluid Creactive
protein and glucose levels, and white blood cell counts at the time of genetic amniocentesis related with preterm delivery? J Perinat Med. 2005;33(6):524-9, https://doi.org/10.1515/jpm.2005.093
17. Prairie E, Côté F, Tsakpinoglou M, Mina M, Quiniou C, Leimert K, et al. The determinant role of IL-6 in the establishment of inflammation leading to spontaneous preterm birth. Cytokine Growth Factor Rev. 2021;59:118-30, https://doi.org/10.1016/j.cytogfr.2020.12.004
18. Westgard JO, Barry PL. Prácticas Básicas de Control de Calidad: Capacitación en Control de Calidad Estadístico para Laboratorios Clínicos. Westgard Quality Corporation; 2010.
19. Loyola L, Colimodio M J, Furci A, Giménez MI, Nardi MA. Validación de un método analítico para cuantificación de ferritina en líquido cefalorraquídeo. Acta bioquím clín latinoam. 2022;56(2):139-48.
20. Del Barco E, Franco-Jarava C, Vargas M, Maíz N, Arevalo S, Sánchez MÁ, et al. Reference values for interleukin-6 in the amniotic fluid of asymptomatic pregnant women. Acta Obstet Gynecol Scand. 2023;102(4):480-5, https://doi.org/10.1111/aogs.14524
21. Gervasi MT, Romero R, Bracalente G, Erez O, Dong Z, Hassan SS, et al. Midtrimester amniotic fluid concentrations of interleukin-6 and
interferon-gamma-inducible protein-10: evidence for heterogeneity of intra-amniotic inflammation and associations with spontaneous early (32 weeks) preterm delivery. J Perinat Med. 2012;40(4):329-43, https://doi.org/10.1515/jpm-2012-0034
22. McDaniel L. Total Allowable Error Table [Internet]. Data Innovations. Disponible en: https://www.datainnovations.com/allowable-totalerror-table/