DOI QR코드

DOI QR Code

Development of a Smartphone-based Total Bilirubin Measuring System for Screening of Jaundice

황달 선별검사를 위한 스마트폰 기반의 총빌리루빈 측정시스템의 개발

  • 김원정 (연구개발부, (주)원드롭) ;
  • 송은지 (연구개발부, (주)원드롭) ;
  • 이주원 (연구개발부, (주)원드롭)
  • Received : 2021.10.19
  • Accepted : 2021.11.03
  • Published : 2021.11.20

Abstract

Hyperbilirubinemia is the most common neonatal disease and is observed in about 80% of newborns worldwide in neonatal period within a week after birth. Untreated infant hyperbilirubinemia may lead to brain damage and even death, so it is very important to diagnose it quickly and accurately. In this study, a total bilirubin measurement system was developed that is portable and easy to use without pre-processing using a commercial smartphone. This system measures using the LED and camera of the smartphone without the need for additional devices, and because a small amount of blood is injected without pre-treatment, anyone can easily measure it in the field. In a comparative study with Cobas c111 results, accuracy meets CLIA guidelines with 94% (17/18) within ±0.4 mg/dL below 3 mg/dL and 98% within ±20% above 3 mg/dL (276/282). This system offers a simple, fast and accurate diagnosis for jaundice in infants and young children in low-resource settings.

고빌리루빈혈증은 신생아기에 가장 흔히 볼 수 있는 질환으로 전세계적으로 생후 일주일내 신생아 중 약 80%에서 관찰된다. 고빌리루빈혈증을 치료하지 않을 경우 핵황달 및 사망에 이르게 되므로 신속하고 정확하게 진단하는 것이 매우 중요하다. 본 연구에서는 상용 스마트폰을 사용하여 휴대가 편리하고 전처리 과정없이 사용이 간편한 총빌리루빈 측정시스템을 개발하였다. 본 시스템은 추가의 장치가 필요없이 스마트폰의 LED와 카메라를 이용하여 측정하며 전처리 없이 소량의 혈액을 주입하면 되므로 현장에서 누구나 쉽게 측정이 가능하다. Cobas c111의 측정값과 비교한 결과 3 mg/dL 이하 ±0.4 mg/dL 이내 94%(17/18), 3 mg/dL 이상 ±20% 이내 98%(276/282)로 CLIA 가이드라인의 정확도 기준을 만족함을 확인하였다. 이는 의료 시설 및 훈련된 인력 부족한 현장에서 신속하게 영유아의 황달 상태를 확인하는 방법으로 사용할 수 있을 것으로 보여진다.

Keywords

Acknowledgement

이 성과는 KOICA 의 혁신적 기술 프로그램(CTS)의 지원을 받아 수행된 연구임.

References

  1. Arman, D., Topcuoglu, S., Gursoy, T., Ovali, F., & Karatekin, G. (2020). The accuracy of transcutaneous bilirubinometry in preterm infants. J. Perinatol. 40, 212-218. https://doi.org/10.1038/s41372-019-0445-3
  2. Barko, H. A., Jackson, G. L., and D, W. (2006). Evaluation of a point-of-care direct spectrophotometric method for measurement of total serum bilirubin in term and near-term neonates Engle Journal of Perinatology 26, 100-105. https://doi.org/10.1038/sj.jp.7211436
  3. Bhutani, V. K., et al. (2013). Neonatal hyperbilirubinemia and Rhesus disease of the newborn: Incidence and impairment estimates for 2010 at regional and global levels. Pediatr Res 74, 86-100. https://doi.org/10.1038/pr.2013.208
  4. Bolajoko, O. Olusanya, Stephanie Teeple and Nicholas J. Kassebaum (2018). The Contribution of Neonatal Jaundice to Global Child Mortality: Findings from the GBD 2016 Study Pediatrics p. 141.
  5. Chokemungmeepisarn, P., Tantiprabha, W., Kosarat, S., and Manopunya, S. (2020). Accuracy of the BilicareTM transcutaneous bilirubinometer as the predischarge screening tool for significant hyperbilirubinemia in healthy term and late preterm neonates. J. Matern Fetal Neonatal Med 33, 57-61. https://doi.org/10.1080/14767058.2018.1484098
  6. Cucuy, M., Juster-Reicher, A., Flidel, O., and Shinwell, E. (2018). Correlation between transcutaneous and serum bilirubin in preterm infants before, during, and after phototherapy. J. Matern. Fetal Neonatal. Med. 31, 1323-1326. https://doi.org/10.1080/14767058.2017.1315662
  7. Damjanow, I. (2009). Pathology Ssecrets. 3rd ed. Philadelphisa: Mosby Elsevier, 263-289.
  8. Doumas, B. and Wu, T. (1991). The measurement of bilirubin fractions in serum. Crit Rev Clin Lab Sci. 28, 415-445. https://doi.org/10.3109/10408369109106872
  9. Kazmierczak, S. C., Robertson, A. F., Catrou, P. G., Briley, K. P., Kreamer, B. L., and Gourley, G. R. (2002). Direct spectrophotometric method for measurement of bilirubin in newborns: comparison with HPLC and an automated diazo method. Clin Chem. 48, 1096-1097. https://doi.org/10.1093/clinchem/48.7.1096
  10. Lo, D. H., and Wu, T. W. (1983). Assessment of the fundamental accuracy of the Jendrassik-Grof total and direct bilirubin assays. Clin Chem 29, 31-36. https://doi.org/10.1093/clinchem/29.1.31
  11. Stoll, B. J. and Kliegman, R. M. (2004). Jaundice and hyperbilirubinemia in the newborn. In Behrman RE, Kliegman RM, Jenson HB, editors. Nelson Textbook of Pediatrics. 17th ed. Philadelphia: WB Saunders Co, p. 592-529.
  12. Sykes, E. and Epstein, E. (1990). Laboratory measurement of bilirubin. Clin Perinatol 17, 397-416. https://doi.org/10.1016/s0095-5108(18)30575-x
  13. Willems, W. A., van den Berg, L. M., de Wit, H., and Molendijk, A. (2004). Transcutaneous bilirubinometry with the Bilicheck® in very premature newborns J Matern Fetal Neonatal Med. 16, 4.
  14. 노의정.임재우.천은정.고경옥 (2006). 경피적 황달 측정을 통한 심각한 황달의 예측 가능성 대한신생아학회지 : 제 13 권 제 1 호.