Commercially Bottled Purified Water as an Alternative Instrument Feed Water in Automated Time-Resolved Fluorescent Immunoassay for TSH, 17-OHP and IRT in Neonatal Screening
Keywords:
fluorescent antibody technique, immunoassay, neonatal screening, clinical laboratory reagent waterAbstract
Objective. The study was undertaken to determine if commercially bottled purified water can be used as substitute instrument feed water for three (3) newborn screening immunoassays.
Methdology. A total of 294 control samples and 300 patient samples were included in this study. Accuracy and precision studies using control samples, and parallel testing using patient samples, were done to compare the use of clinical laboratory reagent water (CLRW) and commercially bottled purified water (CBPW) in the performance of automated time-resolved fluorescent immunoassay of thyroid stimulating hormone (TSH), 17α-OH-progesterone (17-OHP) and immunoreactive trypsinogen (IRT).
Results. The use of CBPW as instrument feed water for measurements of TSH, 17-OHP and IRT levels by automated time-resolved fluorescent immunoassay using AutoDELFIA (Perkin-Elmer) in NBS has an acceptable accuracy and precision compared to using CLRW. The parallel testing using patient samples showed that, overall, the performance of using CBPW in automated time-resolved fluorescent immunoassay for TSH, 17-OHP, and IRT is acceptable, compared with using CLRW as instrument feed water.
Conclusion. Commercially bottled purified water can be used as substitute when setting up a laboratory water purification system is too expensive for a laboratory, or as back up to clinical laboratory reagent water when there is breakdown of the installed water purification system to be used as instrument feed water in automated time-resolved fluorescent immunoassay of TSH, 17-OHP and IRT in NBS using AutoDELFIA (Perkin-Elmer).
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2. Padilla CD, Therrell BL. Newborn screening in the Asia Pacific region. J Inherit Metab Dis. 2007;30(4):490-506. PMID: 17643195. https://doi.org/10.1007/s10545-007-0687-7.
3. Desai MP, Sharma R, Riaz I, Sudhanshu S, Parikh R, Bhatia V. Newborn Screening Guidelines for Congenital Hypothyroidism in India: Recommendations of the Indian Society for Pediatric and Adolescent Endocrinology (ISPAE) - Part I: Screening and Confirmation of Diagnosis. Indian J Pediatr. 2018;85(6):440-7. PMID: 29380252. https://doi.org/10.1007/s12098-017-2575-y.
4. NSRC. Fact Sheet: Information for DOCTORS about the disorders included in the Expanded Newborn Screening Panel. Manila: NSRC; 2016. https://www.newbornscreening.ph/images/stories/ResourcesTechnicalDocuments/Expanded%20Screening%20Fact%20Sheets_Doctors_2015.pdf.
5. White PC. Update on diagnosis and management of congenital adrenal hyperplasia due to 21-hydroxylase deficiency. Curr Opin Endocrinol Diabetes Obes. 2018;25:178-84. PMID: 29718004. https://doi.org/10.1097/MED.0000000000000402.
6. Ross LF. Newborn screening for cystic fibrosis: a lesson in public health disparities. J Pediatr. 2008;153(3):308-13. PMID: 18718257. NIHMSID: NIHMS67805. PMCID: PMC256914.
7. Wilcken B, Wiley V. Newborn screening. Pathology 2008;40(2):104-15. PMID: 18203033. https://doi.org/10.1080/00313020701813743.
8. Witchel SF. Newborn screening for congenital adrenal hyperplasia: beyond 17-hydroxyprogesterone concentrations. J Pediatr (Rio J) 2018;pii: S0021-7557(18)30712-5. PMID: 29958845. https://doi.org/10.1016/j.jped.2018.06.003.
9. Kopacek C, Prado MJ, da Silva CMD, et al. Clinical and molecular profile of newborns with confirmed or suspicious congenital adrenal hyperplasia detected after a public screening program implementation. J Pediatr (Rio J) 2018;pii:S0021-7557(17)30413-8. PMID: 29715434. https://doi.org/10.1016/j.jped.2018.03.003.
10. Slagle KM, Ghosn SJ. Immunoassays: tools for sensitive, specific, and accurate test results. Laboratory Medicine. 1996;27:177-83. https://doi.org/10.1093/labmed/27.3.177.
11. Self CH, Dessi JL, Winger LA. Ultra-specific immunoassays for small molecules: roles of wash steps and multiple binding formats. Clin Chem. 1996;42(9):1527-31. PMID: 8787724.
12. Kocova M, Anastasovska V, Sukarova-Angelovska E, Tanaskoska M, Taseva E. Clinical practice: experience with newborn screening for congenital hypothyroidism in the Republic of Macedonia - a multiethnic country. Eur J Pediatr. 2015;174(4):443-8. PMID: 25192932. https://doi.org/10.1007/s00431-014-2413-4.
13. al Saedi S, Dean H, Dent W, Stockl E, Cronin C. Screening for congenital adrenal hyperplasia: the Delfia Screening Test overestimates serum 17-hydroxyprogesterone in preterm infants. Pediatrics. 1996;97(1):100-2. PMID: 8545200.
14. CLSI. Preparation and Testing of Reagent Water in the Clinical Laboratory: Approved Guideline. CLSI document C3-A4. Fourth ed. Wayne, Pennsylvania: CLSI; 2006.
15. DOH. Philippine National Standards for Drinking Water of 2017. AO 10 s 2017. https://www.doh.gov.ph/node/12121.
16. Ito K, Goto T, Tsuji A, Maeda M. Time-resolved fluoroimmunoassay for pituitary adenylate cyclase activating polypeptide 27 (PACAP27) using europium (III) ion chelate labeled streptavidin-biotin complex. Journal of Pharmaceutical and Biomedical Analysis. 1997;15(9-10):1489-95. PMID: 9226580.
17. Cox KL, Devanarayan V, Kriauciunas A, Manetta J, Montrose C, Sittampalam S. Immunoassay methods. In: Sittampalam G, Coussens N, Brimacombe K, eds. Assay guidance manual. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2012.
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