Diagnostic tests for bacterial infection from birth to 90 days---a systematic review

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Abstract
AIM To determine the clinical value of common diagnostic tests for bacterial infection in early life. METHODS A Medline search (1966–95) was undertaken to identify studies that reported the assessment of a diagnostic “test,” predicting the presence or absence of bacterial infection in infants up to 90 days of age. The quality of each selected study was assessed using defined criteria. Data were extracted twice to minimise errors. RESULTS Six hundred and seventy articles were identified. Two independent investigators agreed that 194 studies met the inclusion criteria (κ = 0.85), 52 of which met primary quality criteria; 23 studies reported data on (a) haematological indices, (b) C reactive protein evaluation, and (c) surface swab assessment. For haematological indices, the likelihood ratios for individual tests ranged from 20.4 (95% confidence interval 7.3 to 56.8) for a white cell count < 7000/mm3 to 0.12 (0.04 to 0.37) for an immature:total (I:T) white cell ratio < 0.2. For C reactive protein evaluation, the likelihood ratios ranged from 12.56 (0.79 to 199.10) for a value of > 6 mg/l to 0.22 (0.08 to 0.65) for a negative value. For surface swab assessment, the likelihood ratios ranged from 33.6 (2.1 to 519.8) for a positive gastric aspirate culture to 0.08 (0.006 to 1.12) for microscopy of ear swab material that did not show any neutrophils. Likelihood ratios for combinations of these individual tests ranged from 10.17 (3.64 to 28.41) to 0.47 (0.22 to 1.00). CONCLUSIONS The methodological quality of studies assessing the accuracy of diagnostic tests is generally poor. Even in rigorous studies, the reported accuracy of the tests varies enormously and they are of limited value in the diagnosis of infection in this population.