Pormohammad, A; Nasiri, MJ; McHugh, TD; Riahi, SM; Bahr, NC; (2019) A systematic review and meta-analysis of the diagnostic accuracy of nucleic acid amplification tests in cerebrospinal fluid for tuberculous meningitis. Journal of Clinical Microbioloy 10.1128/JCM.01113-18. (In press).

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Abstract

Introduction: Diagnosis of tuberculous meningitis (TBM) is difficult and poses a significant challenge to physicians worldwide. Recently, nucleic acid amplification (NAA) tests have shown promise for diagnosis of TBM, although performance has been variable. We undertook a systematic review and meta-analysis to evaluate the diagnostic accuracy of NAA tests in cerebrospinal fluid (CSF) samples against culture as the reference standard or a combined reference standard (CRS) for TBM.Methods: We searched Embase, PubMed, Web of Science and the Cochrane library for the relevant records. QUADS-2 tool was used to assess the quality assessment of the studies. Diagnostic accuracy measures (i.e. sensitivity and specificity) were pooled with a random effects model. All Statistical analyses were performed with STATA version 14 (Stata Corporation, College Station, TX, USA), Meta-DiSc version 1.4 (Cochrane Colloquium, Barcelona, Spain) and RveMan version 5.3 (Copenhagen: The Nordic Cochrane Centre, the Cochrane Collaboration).Results: Sixty-three studies were included in final analysis, comprising 1381cases of confirmed TBM and 5712 non-TBM controls. These 63 studies were divided into two groups comprising 71 datasets (43 in-house tests and 28 commercial tests) that used culture as the reference standard and 24 datasets (21 in-house tests and 3 commercial tests) that used a CRS. Studies which used a culture reference standard had better pooled summary estimates compared to studies which used CRS. The overall pooled estimates of sensitivity, specificity, positive likelihood ratio (PLR) and negative likelihood ratio (NLR) of NAA tests against culture were 82% (95% CI: 75-87), 99% (95% CI: 98-99), 58.6 (35.3-97.3) and 0.19 (0.14-0.25), respectively. The pooled sensitivity, specificity, PLR and NLR of NAA tests against CRS were 68% (95% CI: 41-87), 98% (95% CI: 95-99), 36.5 (15.6-85.3) and 0.32 (0.15-0.70), respectively.Conclusion: The analysis has demonstrated that the diagnostic accuracy of NAA tests is currently insufficient to replace culture as a lone diagnostic test. NAA tests may be used in combination with culture due to the advantage of time to result and in scenarios where culture tests are not feasible. Further work to improve NAA tests would benefit from standardized reference standards and the methodology.

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