TY - JOUR
AU - Murki,, Srinivas
AB - Abstract Introduction Early diagnosis and appropriate management of neonatal jaundice is crucial in avoiding severe hyperbilirubinemia and brain injury. A low-cost, minimally invasive, point-of-care (PoC) tool for total bilirubin (TB) estimation which can be useful across all ranges of bilirubin values and all settings is the need of the hour. Objective To assess the accuracy of Bilistick system, a PoC device, for measurement of TB in comparison with estimation by spectrophotometry. Design/methods In this cross-sectional clinical study, in infants who required TB estimation, blood samples in 25-µl sample transfer pipettes were collected at the same time from venous blood obtained for laboratory bilirubin estimation. The accuracy of Bilistick in estimating TB within ±2 mg/dl of bilirubin estimation by spectrophotometry was the primary outcome. Results Among the enrolled infants, 198 infants were eligible for study analysis with the mean gestation of 36 ± 2.3 weeks and the mean birth weight of 2368 ± 623 g. The median age at enrollment was 68.5 h (interquartile range: 48–92). Bilistick was accurate only in 54.5% infants in measuring TB within ±2 mg/dl difference of TB measured by spectrophotometry. There was a moderate degree of correlation between the two methods (r = 0.457; 95% CI: 0.339–0.561, p value < 0.001). Bland–Altman analysis showed a mean difference of 0.5 mg/dl (SD ± 4.4) with limits of agreement between −8.2 and +9.1 mg/dl. Conclusion Bilistick as a PoC device is not accurate to estimate TB within the clinically acceptable difference (±2 mg/dl) of TB estimation by spectrophotometry and needs further improvement to make it more accurate. neonatal jaundice, bilirubin, Bilistick, hyperbilirubinemia, point-of-care device INTRODUCTION Neonatal jaundice is a common clinical condition during early neonatal period which is seen in nearly 80% of term newborns [1]. Approximately 5–10% of term neonates have clinically significant hyperbilirubinemia mandating the use of phototherapy [2, 3]. In some neonates, particularly those with hemolytic diseases, hyperbilirubinemia may be severe, resulting in irreversible brain injury (kernicterus) [4]. In some developing countries, the incidence of severe neonatal hyperbilirubinemia is ∼100 times as high as it is in the developed world due to delays in diagnosis and treatment [5]. Approximately 3% of neonates admitted to hospitals in such locations have signs of acute bilirubin encephalopathy [6]. Early diagnosis and appropriate management of hyperbilirubinemia is crucial in avoiding the development of severe hyperbilirubinemia and brain injury [1, 7]. Total serum/plasma bilirubin measurements and transcutaneous bilirubinometry (TcB) are common methods of screening, evaluating and managing neonatal hyperbilirubinemia. Total bilirubin (TB) estimation in clinical laboratories using the diazo method or spectrophotometry is the only reliable options available for management of neonatal hyperbilirubinemia [8]. However, this may not be available at all places in developing countries, needs skilled personnel, centrifugation and reports may be delayed for hours. TcB as a screening tool is inaccurate when the total bilirubin is >13 mg/dl, if the infant is under phototherapy or post-exchange transfusion and also overestimates the total bilirubin in black neonates [9–14]. In developing countries with limited access to diagnostic facilities, many clinicians or health care workers still depend on the physical assessment for neonatal jaundice which is not a reliable method [15] and thus leads to delay in identifying those with severe hyperbilirubinemia. These limitations necessitate the need for a low-cost and minimally invasive point-of-care (PoC) tool for TB measurement. The device should be useful in the community setting and also during home care visits [8]. In this context, Bilistick system (BS), a new portable PoC tool, to measure TB could provide significant advantages, accurate readings, with rapid results and faster treatment. Bilistick can be used for measuring TB up to 40 mg/dl. The main advantages of this device are its ease of use, quick results, low cost, portability, need for micro sample of whole blood (only 25 μl) and absent need for sample preparation or reagents [16]. These characteristics make it suitable for screening the TB across all settings [17, 18]. Two previous studies [16, 19] evaluating this device support the use of this device to measure TB but their methodology limit the use of this device on a larger scale and in the real-life scenario. With this background, we planned this study with an objective to assess the accuracy of BS for measurement of TB in comparison with the spectrophotometry. MATERIALS AND METHODS This prospective cross-sectional comparative study was conducted at a tertiary hospital for women and newborn, India, from 1 October 2018 to 30 June 2019. The study was approved by Institutional ethics committee. Admitted term and preterm neonates and those presenting to the outpatient clinic and requiring TB measurement, as decided by a pediatrician based on the clinical examination or risk factors or high TcB level were eligible for the study. Infants who received prior exchange or blood transfusion were excluded. Each infant was included in the study only once. After obtaining written informed consent from one of the parents, blood samples in 25-µl sample transfer pipettes were collected from venous blood at the same time when samples aliquoted for laboratory TB estimation by spectrophotometry. Blood sample for the Bilistick collected in sample transfer pipette was loaded on the Bilistick test strip cell separation filter. The result was obtained within 2 min from loading and this was recorded along with simultaneous laboratory spectrophotometric TB value. The TB result from the Bilistick was not used for clinical management. The person evaluating the bilirubin by spectrophotometry was blinded to the result recorded from the Bilistick. Preliminary data including demographic, antenatal and birth were documented from the case files. Primary outcome of the study was the accuracy of Bilistick in measuring the TB within ±2 mg/dl of TB measured by the spectrophotometry. The BS [16] consists of a hand-held rechargeable battery reflectance reader and test strips composed of a blood-plasma separator (filter) coupled with a nitrocellulose (NC) membrane, both encased in a plastic origami cassette. The size of the filter and volume of blood applied (25 µl) is dictated by the need to extract sufficient plasma from blood having a hematocrit up to 70%. After loading whole blood on the strip, the system requires only 100 s for plasma separation and NC membrane saturation. The reader measures reflectance of light emission (blue LED) from the plasma-saturated NC membrane (Fig. 1). The LED has an emission peak between 470 and 530 nm with a spectrum similar to the absorbance spectrum of bilirubin. A second LED (green) detects whether hemoglobin contamination is present. The instrument is internally calibrated to optimize sensitivity at zero bilirubin concentration, and a standard curve (reflectance vs. TB concentration) generated, using plasma spiked with purified bilirubin (B4126; Sigma-Aldrich, Milan, Italy), with TB ranging from 20.5 to 562.6 µmol/l (1.2–32.9 mg/dl). In case of technical problems, such as lack of appropriate saturation of the test strip or the presence of hemolysis in the sample, the reader identifies the problem and reports an error message that appears on its display. Fig. 1. Open in new tabDownload slide Schematic diagram of the BS and its functionality. After 25 µl blood loading onto the filter, the plasma passes the capillary tube to the NC membrane. When the strip is inserted in the reader, the intensity of reflected light Ir is measured by the device to calculate the bilirubin concentration [reproduced from Zabetta et al. [16]]. Fig. 1. Open in new tabDownload slide Schematic diagram of the BS and its functionality. After 25 µl blood loading onto the filter, the plasma passes the capillary tube to the NC membrane. When the strip is inserted in the reader, the intensity of reflected light Ir is measured by the device to calculate the bilirubin concentration [reproduced from Zabetta et al. [16]]. The direct spectrophotometric assay needs a centrifuged serum sample. It is the most commonly used method in newborns for the estimation of total (serum) bilirubin based on the absorbance of bilirubin at 454 nm; by contrast, hemoglobin absorbs light equally at both 454 and 528 nm. Subtraction of the absorbance at 528 nm from that at 454 nm eliminates the effect of hemolysis and yields a value that can be attributed primarily to bilirubin. In our study, we used One Beam bilirubinometer by Ginevri for estimation of serum bilirubin by spectrophotometry. As per college of American pathologists study, the differences between standard reference methods and direct spectrophotometry (by various instruments) varied between 2.06 and 2.74 mg/dl [20]. The Clinical Laboratory Improvement Amendments of 1988, USA, updated in 2019, allows ± 20% of error in the measurements of TB. Bhutani et al. [9] quote ‘American Academy of Paediatrics accepts a 10–20% range of inaccuracy in total serum bilirubin measurements to make the guidelines more practical from a clinician’s perspective’. Based on the above recommendations and the study methods by Taylor et al. [21], we chose the clinically acceptable difference between TSB estimation by Spectrophotometry and Bilistick as 2 mg/dl. In an earlier study, Greco et al. [19], comparing the Bilistick device with laboratory TB measurement, a mean difference of 1.3 mg/dl in TB estimation was observed between the two techniques. Using Bland–Altman analysis, allowing a maximum difference of 2.0 mg/dl, a sample size of 172 paired samples was required with a power of 80% (β = 0.20) and Type I error of 5% (α = 0.05). Assuming 10% attrition, we needed to enroll 190 patients in this study with paired samples. TB measured by BS was correlated with the corresponding value determined by direct spectrophotometry. Pearson’s correlation coefficient (r) was calculated to evaluate the accuracy of the BS. A Bland–Altman analysis was carried out to evaluate the performance of the Bilistick system. Differences between the TB values by both methods were analyzed, using the clinically acceptable difference of <±2 mg/dl across the range of bilirubin results. RESULTS During the study period, 211 infants were enrolled in the study. A total of 13 infants were excluded as there were errors on Bilistick due to hemolysis of the blood samples. Thus in 198 infants, paired blood samples were available for study analysis. The mean gestation of enrolled infants was 36 ± 2.3 weeks and the mean birth weight of 2368 ± 623 g (Table 1). In total 2% (n = 4) of the infants were small for gestation, 55% (n = 109) of infants were male and in 67.6% infants (n = 131) delivery was by cesarean section. Median APGAR scores at 1 and 5 min were 7 [interquartile range (IQR): 7–8] and 8 (IQR: 8–8), respectively. Rh incompatibility setting was seen in 10 (5%) infants but Rh isoimmunization as the cause of jaundice was seen in only 3 (1.5%) infants. ABO blood group incompatibility setting was the cause of jaundice in 21 (10.6%) infants. No infant had cephalohematoma or subgaleal hemorrhage. Average weight loss at enrollment was 6.8% and 49.4% of infants had significant weight loss of ≥7% at enrollment. The median age at enrollment was 68.5 h (IQR: 48–92). The age of enrollment within 24 h, 24–48 h, 48–72 h, 72 h to 7 days, 7–14 days, >14 days was in 8 (4%), 46 (23%), 70 (35%), 60 (30%), 12 (6%) and 2 (1%) infants, respectively. TB by direct spectrophotometry was <10 , 10–13, 13.1–18 and >18 mg/dl in 67 (33.5%), 84 (42%), 42 (21%) and 5 (2.5%) infants, respectively. Table 1 Baseline characteristics  of the study population Parameter . Value . Male, n (%) 109 (55) Mean gestation in weeks (±SD) 36 (±2.3) Mean birth weight in g (±SD) 2368 (± 623) Small for gestational age, n (%) 4 (2%) Delivered by cesarean section, n (%) 131 (67.6) Mean Apgar score at 1 min (±SD) 7.16 (±0.88) Mean Apgar score at 5 min (±SD) 8.16 (±0.43) Rh incompatibility setting, n (%) 10 (5) Rh isoimmunization, n (%) 3 (1.5%) ABO incompatibility, n (%) 21 (10.6) Mean age at enrollment (h) (±SD) 84.2 (±67.6) Number infants with weight loss ≥7% at enrollment, n (%) 98 (49.4) Parameter . Value . Male, n (%) 109 (55) Mean gestation in weeks (±SD) 36 (±2.3) Mean birth weight in g (±SD) 2368 (± 623) Small for gestational age, n (%) 4 (2%) Delivered by cesarean section, n (%) 131 (67.6) Mean Apgar score at 1 min (±SD) 7.16 (±0.88) Mean Apgar score at 5 min (±SD) 8.16 (±0.43) Rh incompatibility setting, n (%) 10 (5) Rh isoimmunization, n (%) 3 (1.5%) ABO incompatibility, n (%) 21 (10.6) Mean age at enrollment (h) (±SD) 84.2 (±67.6) Number infants with weight loss ≥7% at enrollment, n (%) 98 (49.4) Open in new tab Table 1 Baseline characteristics  of the study population Parameter . Value . Male, n (%) 109 (55) Mean gestation in weeks (±SD) 36 (±2.3) Mean birth weight in g (±SD) 2368 (± 623) Small for gestational age, n (%) 4 (2%) Delivered by cesarean section, n (%) 131 (67.6) Mean Apgar score at 1 min (±SD) 7.16 (±0.88) Mean Apgar score at 5 min (±SD) 8.16 (±0.43) Rh incompatibility setting, n (%) 10 (5) Rh isoimmunization, n (%) 3 (1.5%) ABO incompatibility, n (%) 21 (10.6) Mean age at enrollment (h) (±SD) 84.2 (±67.6) Number infants with weight loss ≥7% at enrollment, n (%) 98 (49.4) Parameter . Value . Male, n (%) 109 (55) Mean gestation in weeks (±SD) 36 (±2.3) Mean birth weight in g (±SD) 2368 (± 623) Small for gestational age, n (%) 4 (2%) Delivered by cesarean section, n (%) 131 (67.6) Mean Apgar score at 1 min (±SD) 7.16 (±0.88) Mean Apgar score at 5 min (±SD) 8.16 (±0.43) Rh incompatibility setting, n (%) 10 (5) Rh isoimmunization, n (%) 3 (1.5%) ABO incompatibility, n (%) 21 (10.6) Mean age at enrollment (h) (±SD) 84.2 (±67.6) Number infants with weight loss ≥7% at enrollment, n (%) 98 (49.4) Open in new tab Comparison of TB measurements by two methods (spectrophotometry and Bilistick) is shown Table 2. The median laboratory TB measurement by spectrophotometry and Bilistick at enrollment were 11 mg/dl (IQR: 9.37–12.6) and 10.85 mg/dl (IQR: 6.87–13.9), respectively. The mean difference between TB by spectrophotometry and Bilistick was 0.473 (SD ± 4.4; Fig. 2). Differences between TB measured by spectrophotometry and Bilistick varied from −20.4 to +13.4 mg/dl. The number of infants with TB on Bilistick within ± 2 mg/dl difference of TB by spectrophotometry were only 54% (n = 107) and within ±1 mg/dl of difference were 22.7% (n = 45; Table 3). On sub-group analysis, 47 infants had TB >13 mg/dl and in these infants, bilirubin on Bilistick within ±2 mg/dl difference of TB by spectrophotometry was seen in 27 (57.4%) infants. Fig. 2. Open in new tabDownload slide Correlation of TB measurements by the Bilistick and spectrophotometry [Pearson correlation coefficient (r) of 0.457 (95% CI: 0.339–0.561)]. Fig. 2. Open in new tabDownload slide Correlation of TB measurements by the Bilistick and spectrophotometry [Pearson correlation coefficient (r) of 0.457 (95% CI: 0.339–0.561)]. Table 2 Comparison of TB  measurements by the two methods Parameter . Spectrophotometry . Bilistick . Median (IQR) bilirubin (mg/dl) 11 (9.37–12.6) 10.85 (6.87–13.9) Minimum bilirubin (mg/dl) 4 1.9 Maximum bilirubin (mg/dl) 19.6 30.7 Parameter . Spectrophotometry . Bilistick . Median (IQR) bilirubin (mg/dl) 11 (9.37–12.6) 10.85 (6.87–13.9) Minimum bilirubin (mg/dl) 4 1.9 Maximum bilirubin (mg/dl) 19.6 30.7 Open in new tab Table 2 Comparison of TB  measurements by the two methods Parameter . Spectrophotometry . Bilistick . Median (IQR) bilirubin (mg/dl) 11 (9.37–12.6) 10.85 (6.87–13.9) Minimum bilirubin (mg/dl) 4 1.9 Maximum bilirubin (mg/dl) 19.6 30.7 Parameter . Spectrophotometry . Bilistick . Median (IQR) bilirubin (mg/dl) 11 (9.37–12.6) 10.85 (6.87–13.9) Minimum bilirubin (mg/dl) 4 1.9 Maximum bilirubin (mg/dl) 19.6 30.7 Open in new tab Table 3 Analysis of differences in TB measurements between spectrophotometry and the Bilistick TB by spectrophotometry (mg/dl) . Number of infants . Number of infants with TB within ±1 mg/dl of TB by spectrophotometry, n (%) . Number of infants with TB within ± 2 mg/dl of TB by spectrophotometry, n (%) . Overall 198 45 (22.7) 107 (54) <10 67 14 (20.8) 34 (50.7) 10–13 84 19 (22.6) 46 (54.7) 13.1–18 42 11 (26.1) 24 (57.1) >18 5 1 (20) 3 (60) TB by spectrophotometry (mg/dl) . Number of infants . Number of infants with TB within ±1 mg/dl of TB by spectrophotometry, n (%) . Number of infants with TB within ± 2 mg/dl of TB by spectrophotometry, n (%) . Overall 198 45 (22.7) 107 (54) <10 67 14 (20.8) 34 (50.7) 10–13 84 19 (22.6) 46 (54.7) 13.1–18 42 11 (26.1) 24 (57.1) >18 5 1 (20) 3 (60) Open in new tab Table 3 Analysis of differences in TB measurements between spectrophotometry and the Bilistick TB by spectrophotometry (mg/dl) . Number of infants . Number of infants with TB within ±1 mg/dl of TB by spectrophotometry, n (%) . Number of infants with TB within ± 2 mg/dl of TB by spectrophotometry, n (%) . Overall 198 45 (22.7) 107 (54) <10 67 14 (20.8) 34 (50.7) 10–13 84 19 (22.6) 46 (54.7) 13.1–18 42 11 (26.1) 24 (57.1) >18 5 1 (20) 3 (60) TB by spectrophotometry (mg/dl) . Number of infants . Number of infants with TB within ±1 mg/dl of TB by spectrophotometry, n (%) . Number of infants with TB within ± 2 mg/dl of TB by spectrophotometry, n (%) . Overall 198 45 (22.7) 107 (54) <10 67 14 (20.8) 34 (50.7) 10–13 84 19 (22.6) 46 (54.7) 13.1–18 42 11 (26.1) 24 (57.1) >18 5 1 (20) 3 (60) Open in new tab There was a moderate degree of correlation between TB by spectrophotometry and Bilistick with Pearson correlation coefficient (r) of 0.457 (95% CI: 0.339–0.561; p < 0.001). The comparison of TB between Bilistick and spectrophotometry by Bland–Altman analysis is shown in Fig. 3. Mean difference was 0.5 mg/dl and the limits of agreement (LOA) were between −8.2 to +9.1 mg/dl. When plotted against clinically acceptable difference of ±2 mg/dl between TB by spectrophotometry methods and Bilistick, most TB values by Bilistick were above and below these cutoff lines. Fig. 3. Open in new tabDownload slide Bland–Altman analysis between TB measurements by spectrophotometry and the Bilistick. Mean difference was 0.5 mg/dl and LOA were between −8.2 and +9.1 mg/dl (black lines). The red lines represent the difference of ±2 mg/dl (clinically acceptable) between TB measurements by spectrophotometry and the BS show that many TB values by the Bilistick are not in this clinically acceptable range. Fig. 3. Open in new tabDownload slide Bland–Altman analysis between TB measurements by spectrophotometry and the Bilistick. Mean difference was 0.5 mg/dl and LOA were between −8.2 and +9.1 mg/dl (black lines). The red lines represent the difference of ±2 mg/dl (clinically acceptable) between TB measurements by spectrophotometry and the BS show that many TB values by the Bilistick are not in this clinically acceptable range. DISCUSSION In this study, TB estimation by the Bilistick was inaccurate in predicting TB estimation by spectrophotometry within an acceptable clinical range of ± 2 mg/dl. This inaccuracy was seen across all the bilirubin levels seen in newborns with mild, moderate or severe hyperbilirubinemia. Although the correlation was statistically significant, the LOA of TB estimation by Bilistick on the Bland–Altman analysis make the utility of this device questionable in clinical settings, where TB evaluation is either needed as a screening or as a diagnostic test. The differences in estimation of TB by spectrophotometry and Bilistick varies from −20.4 to +13.4 mg/dl, likely miss many infants with severe hyperbilirubinemia and also result in inappropriate treatment of infants with mild hyperbilirubinemia. In the first study on Bilistick by Zabetta et al. [16], among the 118 infants enrolled from two different centers, the mean laboratory bilirubin concentration was 12.61 ± 5 mg/dl (215.6 ± 85.5 µmol/l) for Bilistick and 13.22 ± 5.05 mg/dl (226.1 ± 86.4 µmol/l) by diazo method. The mean age at enrollment was 6.2 (±3.6) days. The study showed good correlation between the two methods with a correlation coefficient of 0.961. On the Bland–Altman analysis, the mean difference was 0.6 mg/dl (10.3 µmol/l) and the 95% interval of agreement was 2.22–3.43 mg/dl (–38.0 to 58.7 µmol/l). The next study by Greco et al. [19], compared the accuracy of the JM-103 TcB device and the Bilistick with TB by standard laboratory as the reference method. In this study among the enrolled 126 infants, Bilistick underestimated the TB by reference method and the LOA with the reference method were −5.8 to 3.3 and −5.4 to 6.0 mg/dl for Bilistick and TcB, respectively. Even though the LOA for Bilistick were similar to TcB but the range of LOA is very wide and may not be acceptable for clinical utility. The maximum and minimum differences between the bilirubin estimation by Bilistick and reference method were unreasonably high (−6.7 and 7.9 mg/dl). From the paired plot of the differences between Bilistick and reference method in this study, it could be interpreted that in many cases the difference was >2 mg/dl between Bilistick and reference standard. Correlation between bilirubin estimation by Bilistick and TcB and with reference method was not reported. Nearly 40% of infants enrolled were after the first week of birth. In another recent study [22] by the device manufacturers in low resource settings, the device had a sensitivity of only 70.6% in identifying the infants in need of phototherapy. Although the authors report good agreement of TB estimation by Bilistick with that by lab measurement, the Bland–Altman analysis shows wide range of LOA varying from −7.5 to +6 mg/dl in the Nigerian sub-group. Our study did not evaluate other important clinical outcomes such as need for phototherapy or exchange, as many of study infants were not admitted or followed up at our center. The device is a promising PoC device and it is feasible to use it in the routine clinical setting. Simplification of the calibration process and improving clinical accuracy are further needed. By the end of this study, the device was malfunctioning and this highlights the need for good service and durability. CONCLUSION The BS, as a point-of-device, is not accurate to estimate the TB within the clinically acceptable difference (±2 mg/dl) of TB estimation by spectrophotometry. Further improvements in the performance of the device are needed to make it more precise and accurate. ACKNOWLEDGEMENTS The authors are grateful for the support of Dr Pramod G., CEO Fernandez Hospital and Foundation for the support to conduct the study. STATEMENT OF ETHICS Institutional Ethics Committee approval was taken before the study. AUTHOR CONTRIBUTIONS B.K., A.T., V.V., D.S., D.P., D.K., P.M.: Data collection and article writing. S.K., S.M.: Protocol design and review of article. REFERENCES 1 Bhutani VK , Stark AR, Lazzeroni LC, et al. Predischarge screening for severe neonatal hyperbilirubinemia identifies infants who need phototherapy . J Pediatrics 2013 ; 162 : 477 – 82 . Google Scholar Crossref Search ADS WorldCat 2 Maisels MJ , Gifford K, Antle CE, et al. Jaundice in the healthy newborn infant: a new approach to an old problem . Pediatrics 1988 ; 81 : 505 – 11 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 3 Kivlahan C , James EJ. The natural history of neonatal jaundice . Pediatrics 1984 ; 74 : 364 – 70 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 4 Watchko JF , Tiribelli C. Bilirubin-induced neurologic damage—mechanisms and management approaches . N Engl J Med 2013 ; 369 : 2021 – 30 . Google Scholar Crossref Search ADS PubMed WorldCat 5 Slusher TM , Olusaniya BO. Neonatal jaundice in low- and middle-income countries. In: Stevenson DK, Maisels MJ, Watchko JF (eds). Care of the Jaundiced Neonate. New York : McGraw-Hill , 2012 , 263 – 73 . Google Scholar Google Preview OpenURL Placeholder Text WorldCat COPAC 6 Ogunlesi TA , Dedeke IOF, Adekanmbi AF, et al. The incidence and outcome of bilirubin encephalopathy in Nigeria: a bi-centre study . Niger J Med 2007 ; 16 : 354 – 9 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 7 American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation . Pediatrics 2004 ; 114 : 297 . Crossref Search ADS PubMed WorldCat 8 Olusanya BO , Ogunlesi TA, Kumar P, et al. Management of late-preterm and term infants with hyperbilirubinaemia in resource-constrained settings . BMC Pediatr 2015 ; 15 : 39 . Google Scholar Crossref Search ADS PubMed WorldCat 9 Bhutani VK , Gourley GR, Adler S, et al. Noninvasive measurement of total serum bilirubin in a multiracial predischarge newborn population to assess the risk of severe hyperbilirubinemia . Pediatrics 2000 ; 106 : e17 . Google Scholar Crossref Search ADS PubMed WorldCat 10 Engle WD , Jackson GL, Stehel EK, et al. Evaluation of a transcutaneous jaundice meter following hospital discharge in term and near-term neonates . J Perinatol 2005 ; 25 : 486 – 90 . Google Scholar Crossref Search ADS PubMed WorldCat 11 Maisels MJ , Engle WD, Wainer S, et al. Transcutaneous bilirubin levels in an outpatient and office population . J Perinatol 2011 ; 31 : 621 – 4 . Google Scholar Crossref Search ADS PubMed WorldCat 12 Murli L , Thukral A, Sankar MJ, et al. Reliability of transcutaneous bilirubinometry from shielded skin in neonates receiving phototherapy: a prospective cohort study . J Perinatol 2017 ; 37 : 182 . Google Scholar Crossref Search ADS PubMed WorldCat 13 O’Connor MC , Lease MA, Whalen BL. How to use: transcutaneous bilirubinometry . Arch Dis Child Educ Pract Ed 2013 ; 98 : 154 – 9 . Google Scholar Crossref Search ADS PubMed WorldCat 14 Olusanya BO , Imosemi DO, Emokpae AA. Differences between transcutaneous and serum bilirubin measurements in black African neonates . Pediatrics 2016 ; 138 : e20160907 . Google Scholar Crossref Search ADS PubMed WorldCat 15 Keren R , Tremont K, Luan X, et al. Visual assessment of jaundice in term and late preterm infants . Arch Dis Child Fetal Neonatal Ed 2009 ; 94 : F317 – 22 . Google Scholar Crossref Search ADS PubMed WorldCat 16 Zabetta CC , Iskander IF, Greco C, et al. Bilistick: a low-cost point-of-care system to measure total plasma bilirubin . Neonatology 2013 ; 103 : 177 – 81 . Google Scholar Crossref Search ADS PubMed WorldCat 17 Gotink MJ , Benders MJ, Lavrijsen SW, et al. Severe neonatal hyperbilirubinemia in the Netherlands . Neonatology 2013 ; 104 : 137 – 42 . Google Scholar Crossref Search ADS PubMed WorldCat 18 Brown S , Small R, Argus B, et al. Early postnatal discharge from hospital for healthy mothers and term infants . Cochrane Database Syst Rev 2002 ; CD002958 . Google Scholar OpenURL Placeholder Text WorldCat 19 Greco C , Iskander IF, Akmal DM, et al. Comparison between Bilistick System and transcutaneous bilirubin in assessing total bilirubin serum concentration in jaundiced newborns . J Perinatol 2017 ; 37 : 1028 – 31 . Google Scholar Crossref Search ADS PubMed WorldCat 20 Lo SF , Miller WG, Doumas BT. Laboratory performance in neonatal bilirubin testing using commutable specimens: a progress report on a College of American Pathologists study . Arch Pathol Lab Med 2013 ; 137 : 912 – 5 . Google Scholar Crossref Search ADS PubMed WorldCat 21 Taylor JA , Burgos AE, Flaherman V; for the Better Outcomes through Research for Newborns Network. Discrepancies between transcutaneous and serum bilirubin measurements . Pediatrics 2015 ; 135 : 224 – 31 . Google Scholar Crossref Search ADS PubMed WorldCat 22 Greco C , Iskander IF, El Houchi SZ, et al. Diagnostic performance analysis of the point-of-care Bilistick System in identifying severe neonatal hyperbilirubinemia by a multi-country approach . EClinicalMedicine 2018 ; 1 : 14 – 20 . Google Scholar Crossref Search ADS PubMed WorldCat © The Author(s) [2020]. Published by Oxford University Press. All rights reserved. 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TI - Accuracy of Bilistick (a Point-of-Care Device) to Detect Neonatal Hyperbilirubinemia
JF - Journal of Tropical Pediatrics
DO - 10.1093/tropej/fmaa026
DA - 2020-12-01
UR - https://www.deepdyve.com/lp/oxford-university-press/accuracy-of-bilistick-a-point-of-care-device-to-detect-neonatal-30GsQ41CPc
SP - 630
EP - 636
VL - 66
IS - 6
DP - DeepDyve
ER -