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Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors.
Sci Rep. 2020 Jul 07; 10(1):11149.SR

Abstract

The study was aimed to evaluate the performance of a newly developed non-invasive and non-contact bilirubin measurement device (AJO-Neo) as an alternative to the conventional invasive biochemical method of total serum bilirubin (TSB) estimation in preterm and term neonates suffering from hyperbilirubinemia associated with risk factors, and/or undergoing phototherapy. The safety and efficacy of the device were assessed in 1968 neonates with gestational ages ranging from 28 to 41 weeks and suffering from incidences of hyperbilirubinemia. Linear regression analysis showed a good correlation between AJO-Neo and the conventional method of TSB (Pearson's coefficient, r = 0.79). The small bias (0.27 mg/dL) and limits of agreements (- 3.44 to 3.99 mg/dL) were within the range of clinical acceptance. The device was also precise in the measurement of bilirubin levels in all subgroups of the study. The receiver operator curve (ROC), that takes account of both sensitivity and specificity of a device showed high efficacy of the device (area under the curve, AUC = 0.83) in the detection of bilirubin. While monitoring the bilirubin level during phototherapy, the device indicated promising results showing good agreement with TSB. Specificities and sensitivities of the device indicated a much higher accuracy in neonates with associated risk factors for hyperbilirubinemia. Hence, the newly developed device (AJO-Neo) is reliable in measuring bilirubin level in preterm, and term neonates irrespective of gestational or postnatal age, sex, risk factors, feeding behavior or skin color.

Authors+Show Affiliations

Technical Research Centre, S. N. Bose National Centre for Basic Sciences, Block JD, Sector-III, Salt Lake, Kolkata, 700106, India. Department of Applied Optics & Photonics, University of Calcutta, Block JD-2, Sector-III, Salt Lake, Kolkata, 700106, India.Department of Chemical, Biological & Macromolecular Sciences, S. N. Bose National Centre for Basic Sciences, Block JD, Sector-III, Salt Lake, Kolkata, 700106, India.Technical Research Centre, S. N. Bose National Centre for Basic Sciences, Block JD, Sector-III, Salt Lake, Kolkata, 700106, India.Technical Research Centre, S. N. Bose National Centre for Basic Sciences, Block JD, Sector-III, Salt Lake, Kolkata, 700106, India. Center for Astroparticle Physics and Space Science, Bose Institute, Block EN, Sector-V, Kolkata, 700091, India.Technical Research Centre, S. N. Bose National Centre for Basic Sciences, Block JD, Sector-III, Salt Lake, Kolkata, 700106, India.Department of Paediatric Medicine, Nil Ratan Sircar Medical College & Hospital, 138, AJC Bose Road, Sealdah, Raja Bazar, Kolkata, 700014, India.Department of Paediatric Medicine, Nil Ratan Sircar Medical College & Hospital, 138, AJC Bose Road, Sealdah, Raja Bazar, Kolkata, 700014, India.Department of Paediatric Medicine, Nil Ratan Sircar Medical College & Hospital, 138, AJC Bose Road, Sealdah, Raja Bazar, Kolkata, 700014, India.Department of Haematology, Nil Ratan Sircar Medical College & Hospital, 138, AJC Bose Road, Sealdah, Raja Bazar, Kolkata, 700014, India.Department of Gynecology & Obstetrics, Nil Ratan Sircar Medical College & Hospital, 138, AJC Bose Road, Sealdah, Raja Bazar, Kolkata, 700014, India.Department of Chemistry, Faculty of Applied Science, Umm Al-Qura University, Makkah, 21955, Saudi Arabia.Department of Chemistry, Faculty of Applied Science, Umm Al-Qura University, Makkah, 21955, Saudi Arabia.Department of Chemistry, Faculty of Applied Science, Umm Al-Qura University, Makkah, 21955, Saudi Arabia. Department of Chemistry, Faculty of Science, Assiut University, Assiut, 71516, Egypt.Department of Paediatric Medicine, Nil Ratan Sircar Medical College & Hospital, 138, AJC Bose Road, Sealdah, Raja Bazar, Kolkata, 700014, India. drasimmallick@gmail.com.Technical Research Centre, S. N. Bose National Centre for Basic Sciences, Block JD, Sector-III, Salt Lake, Kolkata, 700106, India. skpal@bose.res.in. Department of Chemical, Biological & Macromolecular Sciences, S. N. Bose National Centre for Basic Sciences, Block JD, Sector-III, Salt Lake, Kolkata, 700106, India. skpal@bose.res.in.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32636410

Citation

Halder, Animesh, et al. "Large Scale Validation of a New Non-invasive and Non-contact Bilirubinometer in Neonates With Risk Factors." Scientific Reports, vol. 10, no. 1, 2020, p. 11149.
Halder A, Adhikari A, Ghosh R, et al. Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors. Sci Rep. 2020;10(1):11149.
Halder, A., Adhikari, A., Ghosh, R., Singh, S., Banerjee, A., Ghosh, N., Bhattacharya, A. M., Mandal, S., Chakrabarti, P., Bhattacharyya, D., Altass, H. M., Morad, M., Ahmed, S. A., Mallick, A. K., & Pal, S. K. (2020). Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors. Scientific Reports, 10(1), 11149. https://doi.org/10.1038/s41598-020-67981-9
Halder A, et al. Large Scale Validation of a New Non-invasive and Non-contact Bilirubinometer in Neonates With Risk Factors. Sci Rep. 2020 Jul 7;10(1):11149. PubMed PMID: 32636410.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors. AU - Halder,Animesh, AU - Adhikari,Aniruddha, AU - Ghosh,Ria, AU - Singh,Soumendra, AU - Banerjee,Amrita, AU - Ghosh,Nilanjana, AU - Bhattacharya,Arnab Madhab, AU - Mandal,Shrabani, AU - Chakrabarti,Prantar, AU - Bhattacharyya,Debasis, AU - Altass,Hatem M, AU - Morad,Moataz, AU - Ahmed,Saleh A, AU - Mallick,Asim Kumar, AU - Pal,Samir Kumar, Y1 - 2020/07/07/ PY - 2019/12/11/received PY - 2020/06/11/accepted PY - 2020/7/9/entrez PY - 2020/7/9/pubmed PY - 2020/7/9/medline SP - 11149 EP - 11149 JF - Scientific reports JO - Sci Rep VL - 10 IS - 1 N2 - The study was aimed to evaluate the performance of a newly developed non-invasive and non-contact bilirubin measurement device (AJO-Neo) as an alternative to the conventional invasive biochemical method of total serum bilirubin (TSB) estimation in preterm and term neonates suffering from hyperbilirubinemia associated with risk factors, and/or undergoing phototherapy. The safety and efficacy of the device were assessed in 1968 neonates with gestational ages ranging from 28 to 41 weeks and suffering from incidences of hyperbilirubinemia. Linear regression analysis showed a good correlation between AJO-Neo and the conventional method of TSB (Pearson's coefficient, r = 0.79). The small bias (0.27 mg/dL) and limits of agreements (- 3.44 to 3.99 mg/dL) were within the range of clinical acceptance. The device was also precise in the measurement of bilirubin levels in all subgroups of the study. The receiver operator curve (ROC), that takes account of both sensitivity and specificity of a device showed high efficacy of the device (area under the curve, AUC = 0.83) in the detection of bilirubin. While monitoring the bilirubin level during phototherapy, the device indicated promising results showing good agreement with TSB. Specificities and sensitivities of the device indicated a much higher accuracy in neonates with associated risk factors for hyperbilirubinemia. Hence, the newly developed device (AJO-Neo) is reliable in measuring bilirubin level in preterm, and term neonates irrespective of gestational or postnatal age, sex, risk factors, feeding behavior or skin color. SN - 2045-2322 UR - https://www.unboundmedicine.com/medline/citation/32636410/Large_scale_validation_of_a_new_non-invasive_and_non-contact_bilirubinometer_in_neonates_with_risk_factors L2 - http://dx.doi.org/10.1038/s41598-020-67981-9 DB - PRIME DP - Unbound Medicine ER -
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