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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
black = 4% Reference standard: Laboratory By nurses
Asian = 7% TSB levels within 30 min. Mean of Area = 0.73
Other = 2% two samples used for analysis. By primary investigator
Area = 0.70
Exclusion: jaundice above zone 3 of For diagnostic accuracy: κ = 0.48
Kramer scale within 48 hours, positive Area under ROC curve calculated
DCT, for detecting TSB > 190
th
BW < 10 centile for GA, Comparison 2:
any sign or symptom of illness,
phototherapy already started Correlation of JM-102 with lab TSB levels
(Pearson correlation coefficient, n = 107
observations)
2
R = 0.76, P < 0.01
Difference to TSB: 56 ± 28 micromol/litre
Diagnostic accuracy for detecting TSB
> 190 micromol/litre (Area underROC
curve, N = Not reported)
Area = 0.96
Comparison 3:
At forehead
Correlation of BiliChek with lab TSB levels
(Pearson correlation coefficient, n = 107
observations)
2
R = 0.45, P < 0.01
Difference to TSB: -8 ± 33 micromol/litre
Diagnostic accuracy for detecting TSB
> 190 micromol/litre (Area underROC
curve, N = Not reported)
Area = 0.88
At sternum
Correlation of BiliChek with lab TSB levels
(Pearson correlation coefficient, n = 107
observations)
2
R = 0.59, P < 0.01
Difference to TSB: 10 ± 31 micromol/litre
Diagnostic accuracy for detecting TSB
> 190 micromol/litre (Area underROC
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