Page 244 - 16Neonatal Jaundice_compressed

Appendix H: Evidence tables

Bibliographic details Study type & Patient characteristics Test, Reference Standard, Results Reviewers Comments
Evidence level Threshold for a positive test
Diagnostic study newborn nursery. Umbilical cord blood bilirubin value > 35 micromol/litre) for predicting Test & Reference test described
Year: 1992 (UCB) measured at birth TSB > 200 micromol/litre in detail
Evidence Level: II n = 138 Reference test is a standard one
Country: median GA 40 weeks - range 38 to 43 Threshold values: Prevalence: 28/138 (20.3%) Blinding – Not reported.
Denmark median BW 3495 g - range 2571 to ≥ 20 micromol/litre Sensitivity: 20/28 (71.4%)
4456 ≥ 25 micromol/litre Specificity: 75/110 (68.2%) Reported using Minolta JM to
29 Gender: Males = 52.2% ≥ 30 micromol/litre PPV: 20/55 (36.4%) estimate TcB but no details
Ethnicity: Not reported ≥ 35 micromol/litre NPV: 75/83 (90.4%) given
40 micromol/litre
Exclusion:
preterm babies, Reference standard: Laboratory
sick babies TSB measured on Day 3
Rhesus sensitisation.
TSB ≥ 200 micromol/litre taken as
value for hyperbilirubinaemia

ROC curve used to find the best
cut-off value of UCB.

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: II phase 2, value: ≥ 37 micromol/litre) in detail
Country: mean BW 3230 ± 491 g ROC curve used to find the best At < 24 hours (n = 120) Reference test a standard one
Spain mean GA 39 weeks cut-off value of UCB. Sternum Forehead Test and reference test carried
0.81 0.77 out within one hour
26 Gender: Males = 50.7% 2. TSB (in phase 1 & 2) and TcB Blinding – Not reported
Ethnicity Not reported (phase 1 only) measured at At 24–48 hours (n = 126)
24 hours (threshold value for Sternum Forehead
In first phase (n = 610), cord blood
bilirubin (UCB) at birth and TcB with TSB = 102 micromol/litre and for 0.89 0.83
Minolta JM-102 measured at 24hrs, TcB > 11)
48 hours & 60–96 hours of life. 3. TSB and TcB (in phase 1 & 2) At > 48 hours (n = 412)
Sternum Forehead
Additionally TSB done for all at 60– measured at 48 hours (threshold 0.94 0.83
96 hours. On 169 babies TSB also value for TSB = 154 micromol/litre
measured at 24 & 48hrs
and for TcB > 13) Diagnostic accuracy of TcB for detecting
In second phase (n = 1394), TcB and TcB reading using Minolta JM-102 TSB > 222 micromol/litre

lab TSB values obtained to find at the forehead and the sternum Sensitivity: 98%
accuracy of TSB and TcB at 24hrs (mean of 3 measurements recorded Specificity: 72%
and 48 hours to predict at each site used for analysis)
hyperbilirubinaemia.
Diagnostic accuracy for predicting
Prevalence of TSB > Reference standard: Laboratory TSB = 290 micromol/litre
290 micromol/litre = 2.9% in phase 1 TSB measured on Day 3–4
(18/610) and 3.25% in phase 2 Prevalence of TSB = 290 micromol/litre
(46/1324) TSB = 290 micromol/litre taken as
indicative of 2.9% in phase 1 (18/610) and 3.25% in

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