TY - JOUR
T1 - Diagnostic Performance Analysis of the Point-of-Care Bilistick System in Identifying Severe Neonatal Hyperbilirubinemia by a Multi-Country Approach
AU - Greco, Chiara
AU - Iskander, Iman F.
AU - El Houchi, Salma Z.
AU - Rohsiswatmo, Rinawati
AU - Rundjan, Lily
AU - Ogala, Williams N.
AU - Ofakunrin, Akinyemi O.D.
AU - Moccia, Luciano
AU - Hoi, Nguyen Thi Xuan
AU - Bedogni, Giorgio
AU - Tiribelli, Claudio
AU - Coda Zabetta, Carlos D.
N1 - Funding Information:
The studies performed in Nigeria and Indonesia were possible through the generous support of the Saving Lives at Birth partners: the United States Agency for International Development (USAID), the Government of Norway, the Bill & Melinda Gates Foundation, Grand Challenges Canada, and the UK Government (FOG award N° AID-OAA-F-13-00072). The study in Viet Nam was realized with the contribution of Eric Hemel and Barbara Morgen (Scarsdale, USA), private donors of the East meets West Foundation (Oakland, CA, USA). C.G. conceptualized and designed the study, carried out the initial analyses, drafted the initial manuscript and reviewed and revised the manuscript. I.F.I. and S.Z.E.H. supervised data collection in Egypt and reviewed and revised the manuscript. R.R. and L.R. supervised data collection in Indonesia and reviewed and revised the manuscript. W.N.O. and A.O.D.O. supervised data collection in Nigeria and reviewed and revised the manuscript. L.M. and N.T.X.H. supervised data collection in Viet Nam and reviewed and revised the manuscript. G.B. designed and carried out the statistical analyses and reviewed and revised the manuscript. C.T. conceptualized and designed the study and critically reviewed the manuscript. C.D.C.Z. conceptualized and designed the study, coordinated and supervised data collection and critically reviewed the manuscript. All the other authors of the study team participated in the collection of the data. All authors approved the final manuscript as submitted and agree to be accountable for all aspect of the work. EGYPT: •Dina M. Akmal, Department of Pediatrics, Cairo University Children Hospital, Cairo, Egypt •Dalia A. Khairy, Department of Pediatrics, Cairo University Children Hospital, Cairo, Egypt, INDONESIA: •Radhian Amandito, Neonatal Intensive Care Unit, Pondok Indah General Hospital, South Jakarta, DKI Jakarta, Indonesia •Marcelina Heidy Limanto, Neonatal Unit Dr. Cipto Mangunkusumo, Jakarta, Indonesia •Rosida Sihombing, Neonatal Unit Budhi Asih District Hospital, Indonesia •Meiharty Bahar Zulkifli, Neonatal Unit Budhi Asih District Hospital, Indonesia •Dewi Iriani, Neonatal Unit Koja General Hospital, Jakarta, Indonesia •Opy Dyah Paramita, Neonatal Unit Tarakan General Hospital, Jakarta, Indonesia •Ellen Sianipar, Neonatal Unit Pasar Rebo General District Hospital, Jakarta, Indonesia •Rocky Wilar, Neonatal Unit Prof. Dr. RD Kandou Hospital, Manado, Indonesia •Johnny Rompis, Neonatal Unit Prof. Dr. RD Kandou Hospital, Manado, Indonesia •Magdalena Kristi Daradjati Saudale, Neonatal Unit WZ Johannes General Hospital, Kupang, Indonesia •Woro Indri Padmosiwi Purba, Neonatal Unit WZ Johannes General Hospital, Kupang, Indonesia, NIGERIA: •Stephen Oguche, Department of Pediatrics, University of Jos, Jos University Teaching Hospital, Jos, Nigeria •Christian Isichei, Department of Chemical Pathology, University of Jos, Jos University Teaching Hospital, Jos, Nigeria. •Bose O. Toma, Department of Paediatrics, University of Jos, Jos University Teaching Hospital, Jos, Nigeria •David D. Shwe, Department of Paediatrics, University of Jos, Jos University Teaching Hospital, Jos, Nigeria •Fidelia Bode-Thomas, Department of Paediatrics, University of Jos, Jos University Teaching Hospital, Jos, Nigeria •Udochukwu Michael Diala, Department of Paediatrics, University of Jos, Jos University Teaching Hospital, Jos •Christopher Sabo Yilgwan, Department of Paediatrics, University of Jos, Jos University Teaching Hospital, Jos •Isa Abdulkadir, Neonatal Unit, Department of Paediatrics, Ahmadu Bello University/Teaching Hospital, Zaria, Nigeria •Laila Hassan, Neonatal Unit, Department of Paediatrics, Ahmadu Bello University/Teaching Hospital, Zaria, Nigeria •Fatima Abdullahi, Neonatal Unit, Department of Paediatrics, Ahmadu Bello University/Teaching Hospital, Zaria, Nigeria •Zubaida L Farouk, Department of Paediatrics Bayero University, Kano/Aminu Kano Teaching Hospital, Kano, Nigeria •Idris Yahaya Muhammed, Department of Chemical Pathology, Bayero University, Kano/Aminu Kano Teaching Hospital, Kano, Nigeria •Shehu Umar, Department of Paediatrics, Bayero University, Kano/Aminu Kano Teaching Hospital, Kano, Nigeria •Abdussalam Muhammed, Department of Paediatrics Bayero University, Kano/Aminu Kano Teaching Hospital, Kano, Nigeria •Fatima Tsiga-Ahmed, Department of Community Medicine, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria. •Laila Umar, Department of Paediatrics, Murtala Muhammed Specialist Hospital, Kano, Nigeria, VIET NAM: •Nguyen Thuy Duong, Newborn Department, Saint Paul Hospital, Hanoi, Viet Nam •Vu Thi La, Vinh Phuc Obgyn & Pediatrics Hospital, Vinh Phuc province, Viet Nam •Khuat Thanh Binh, Pediatrics Department, Moc Chau Referral General Hospital, Son La, Viet Nam •Nguyen Thi Kim Ngoc, Pediatrics Department, Ninh Binh Obgyn & Pediatrics Hospital, Ninh Binh, Viet Nam •Nguyen Thi Luyen, Newborn Department, Quang Tri Provincial General Hospital, Quang Tri, Viet Nam •Vu Thi Hao, Newborn Department, Vietnam Sweden Hospital, Quang Ninh province, Viet Nam., The full study protocol can be available as supplementary material. Dr. Coda Zabetta had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr. Tiribelli is the President and CEO of Bilimetrix s.r.l. and Drs. Greco and Coda Zabetta are employees of Bilimetrix s.r.l. In addition, Dr. Tiribelli and Dr. Coda Zabetta have a patent IT 2016000094056 pending, a patent IT 2016000094078 pending, and a patent PCT/IB2017/055657 pending. The other authors declare no conflicts of interest.
Funding Information:
The studies performed in Nigeria and Indonesia were possible through the generous support of the Saving Lives at Birth partners: the United States Agency for International Development (USAID), the Government of Norway , the Bill & Melinda Gates Foundation , Grand Challenges Canada , and the UK Government (FOG award N° AID-OAA-F-13-00072 ). The study in Viet Nam was realized with the contribution of Eric Hemel and Barbara Morgen (Scarsdale, USA), private donors of the East meets West Foundation (Oakland, CA, USA).
Publisher Copyright:
© 2018 The Author(s)
PY - 2018/7/1
Y1 - 2018/7/1
N2 - Importance: The real prevalence and clinical burden of severe neonatal jaundice are undefined due to difficulties in measuring total serum bilirubin (TSB) outside secondary and tertiary clinical centers. Objective: To assess the diagnostic performance of the point-of care Bilistick System (BS) in identifying neonatal jaundice patients requiring treatment. Design: Between April 2015 and November 2016, 1911 neonates, were recruited to participate in the study. Blood samples were simultaneously collected for the TSB determination by BS and by hospital laboratory (Lab). Data were collected and sent to the Bilimetrix headquarter in Trieste where statistical analysis was performed. Newborns with neonatal jaundice were treated with phototherapy according to each center's guidelines. Setting: 17 hospitals from Nigeria, Egypt, Indonesia, and Viet Nam. Participants: 1911 newborns were included, of which 1458 (76·3%) fulfilled the inclusion criteria. Results: TSB level measured by BS agreed (p < .0001) with the lab result in all four countries. The diagnostic performance of BS showed a positive predictive value (PPV) of 92·5% and a negative predictive value (NPV) of 92·8%. Conclusions and Relevance: BS is a reliable system to detect neonatal jaundice over a wide range of bilirubin levels. Since Bilistick is a point-of-care test, its use may provide appropriate and timely identification of jaundiced newborns requiring treatment.
AB - Importance: The real prevalence and clinical burden of severe neonatal jaundice are undefined due to difficulties in measuring total serum bilirubin (TSB) outside secondary and tertiary clinical centers. Objective: To assess the diagnostic performance of the point-of care Bilistick System (BS) in identifying neonatal jaundice patients requiring treatment. Design: Between April 2015 and November 2016, 1911 neonates, were recruited to participate in the study. Blood samples were simultaneously collected for the TSB determination by BS and by hospital laboratory (Lab). Data were collected and sent to the Bilimetrix headquarter in Trieste where statistical analysis was performed. Newborns with neonatal jaundice were treated with phototherapy according to each center's guidelines. Setting: 17 hospitals from Nigeria, Egypt, Indonesia, and Viet Nam. Participants: 1911 newborns were included, of which 1458 (76·3%) fulfilled the inclusion criteria. Results: TSB level measured by BS agreed (p < .0001) with the lab result in all four countries. The diagnostic performance of BS showed a positive predictive value (PPV) of 92·5% and a negative predictive value (NPV) of 92·8%. Conclusions and Relevance: BS is a reliable system to detect neonatal jaundice over a wide range of bilirubin levels. Since Bilistick is a point-of-care test, its use may provide appropriate and timely identification of jaundiced newborns requiring treatment.
KW - Bilirubin
KW - Bilistick System
KW - Diagnostic accuracy study
KW - Low-medium income countries
KW - Neonatal jaundice
KW - Neonatal screening
KW - Point-of-care system
KW - Severe hyperbilirubinemia
KW - STARD
UR - http://www.scopus.com/inward/record.url?scp=85060945835&partnerID=8YFLogxK
U2 - 10.1016/j.eclinm.2018.06.003
DO - 10.1016/j.eclinm.2018.06.003
M3 - Article
AN - SCOPUS:85060945835
SN - 2589-5370
VL - 1
SP - 14
EP - 20
JO - EClinicalMedicine
JF - EClinicalMedicine
ER -