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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
                                                                                                    PPV: 11/67 (16.4%)
                                                                                                    NPV: 101/102 (100%)

                                                                                                    For TSB in phase 2
                                                                                                    (threshold = 154 micromol/litre)
                                                                                                    Sensitivity: 45/46 (97.8%)
                                                                                                    Specificity: 348/774 (45%)
                                                                                                    PPV: 45/471 (9.5%)
                                                                                                    NPV: 348/349 (99.7%)

              Agarwal R;        Study Type:     All infants with GA > 35 weeks with   Test:         Diagnostic accuracy of TSB (threshold   Unselected population
                                Diagnostic study   no significant illness requiring NICU   TSB at 24 ± 6 hours after birth –   value > 102 micromol/litre) for predicting   Test & Reference test described
              Year: 2002                        admission for > 12 hours, absence of                TSB = 290 micromol/litre (n = 213)   in detail
                                Evidence Level: 1b   any major congenital malformations   three samples taken and mean of          Reference test a standard one
              Country:                          and residing near hospital whose   two closest values taken for   Prevalence: 22/213 (10.3%)   Blinding – yes
                                                                           analysis
              India                             parents agreed to come for follow-up.               Sensitivity: 21/22 (95.4%)
                                                                                                    Specificity: 135/191 (70.7%)
              27                                n = 220                    Threshold value:         PPV: 21/77 (27,3%)
                                                mean GA 38 ± 1.4 weeks     > 102 micromol/litre     NPV: 135/136 (99.3%)

                                                mean BW 2827 ± 459 g       Reference standard: Laboratory
                                                                           TSB measured on Day 5 when
                                                Gender: Males = 53.3%      clinical jaundice
                                                Ethnicity: Not reported
                                                                           > 171 micromol/litre
                                                Exclusion:
                                                babies requiring NICU admission,   TSB ≥ 290 micromol/litre taken as
                                                                           indicative of hyperbilirubinaemia
                                                Rh hemolysis.


              Alpay F;          Study Type:     All healthy full term newborn babies   Test:        Diagnostic accuracy of TSB for predicting   Unselected population
                                Diagnostic study   with GA = 38 weeks.     TSB within first 24 hours (mean   TSB = 290 micromol/litre (n = 498)   Test & Reference test described
              Year: 2000                                                   17.1 hours)                                             in detail
                                Evidence Level: II   n = 498                                        Threshold value = 102 micromol/litre   Reference test a standard one
              Country:                          mean GA Not reported       ROC curve used for threshold   Prevalence: 60/498 (12.0%)   Blinding – Not reported
              Turkey                            mean BW Not reported       value with highest sensitivity for   Sensitivity: 54/60 (90%)
                                                Gender: Not reported       predicting hyperbilirubinaemia   Specificity: 286/438 (65.3%)
              28                                Ethnicity: Not reported    (threshold               PPV: 54/206 (26.2%)
                                                                           value: = 102 micromol/litre)   NPV: 286/292 (97.9%)
                                                Exclusion:
                                                babies with blood groups A, AB, B   Results also given for threshold   Threshold value = 120 micromol/litre
                                                and O/Rhesus blood factor   values = 120 micromol/litre   Sensitivity: 36/60 (60%)
                                                incompatibility and a positive direct   and = 137 micromol/litre
                                                antiglobulin test result                            Specificity: 363/438 (82.9%)
                                                G6PD deficiency            Reference standard: Laboratory   PPV: 36/111 (32.4%)
                                                                                                    NPV: 363/387 (97.8%)
                                                                           TSB measured at 24 hours interval
                                                                           for next 4 days          Threshold value = 137 micromol/litre

                                                                                                    Sensitivity: 21/60 (35%)


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