Page 313 - 16Neonatal Jaundice_compressed
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Appendix H: Evidence tables
Bibliographic details Study type & Patient characteristics Test, Reference Standard, Results Reviewers Comments
Evidence level Threshold for a positive test
Rhodesia GA: Not reported not specified)
Postnatal age: Range 2 to 24 days Blinding – yes
63 Gender: Not reported Data not extractable for
calculating values of TP, FP,
Ethnicity: TN & FN
Black = 100%
Exclusion: not defined
Briscoe L; Study Type: Babies > 34 weeks who were having TcB reading using Minolta JM-102 Correlation of JM-102 with lab TSB levels Unselected population
Diagnostic study blood taken for any reason, mostly done at the forehead (Pearson correlation coefficient, n = 303) Test & Reference test described
Year: 2002 for clinical jaundice. (mean of 3 readings used for in detail
Evidence Level: analysis) r = 0.76, P < 0.0001 Test and reference test carried
Country: II n = 303 out within one hour
UK median BW 3267 g - range 1800–5008 Reference standard: Laboratory Diagnostic accuracy of JM-102 for detecting Blinding – not specified
median GA 39 weeks - range 34–42 TSB levels measured concurrently TSB > 249 micromol/litre (n = 303) Data not extractable for
46 median age at presentation: 3 – range 0 to calculating values of TP, FP,
13 days For diagnostic accuracy: Area under ROC = 0.89 TN & FN
Gender: Not reported Area under ROC curve calculated
for detecting TSB Predictive accuracy of JM-102 value 19.9
Ethnicity > 249 micromol/litre (highest accuracy from ROC curve)
White: 94.7% Sensitivity: 86% (81–89%)
Specificity: 78% (73–83%)
Prevalence of TSB > PPV: Not reported
300 micromol/litre = 3.3% (10/303) NPV: Not reported
Exclusion: babies who had previously
received phototherapy
Carbonell X; Study Type: Healthy term babies Test: Correlation of TcB levels with lab TSB Unselected population but no
Diagnostic study 1. Umbilical cord blood bilirubin levels for Sternal vs Forehead site (Pearson exclusion criterion
Year: 2001 n = 2004 – 610 in phase one ± 1394 in (UCB) measured at birth (threshold correlation coefficient) Test & Reference test described
Evidence Level: phase 2 value: ≥ 37 micromol/litre) in detail
Country: II ROC curve used to find the best At < 24 hours (n = 120) Reference test a standard one
Spain mean BW 3230 ± 491 g cut-off value of UCB. Sternum Forehead Test and reference test carried
mean GA 39 weeks 0.81 0.77 out within one hour
26 Gender: Males = 50.7% 2. TSB (in phase 1 & 2) and TcB Blinding – not specified
(phase 1 only) measured at At 24–48 hours (n = 126)
Ethnicity 24 hours (threshold value for Sternum Forehead
Not reported TSB = 102 micromol/litre and for 0.89 0.83
TcB > 11)
In first phase (n = 610), cord blood At > 48 hours (n = 412)
bilirubin (UCB) at birth and TcB with 3. TSB and TcB (in phase 1 & 2) Sternum Forehead
Minolta JM-102 measured at 24 hours, measured at 48 hours (threshold 0.94 0.83
48 hours & 60–96 hours of life. value for TSB = 154 micromol/litre
Additionally TSB was done for all at 60– and for TcB > 13) Diagnostic accuracy of TcB for detecting
96 hours. On 169 babies TSB also TSB > 222 micromol/litre
measured at 24 & 48hours TcB reading using Minolta JM-102
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