Bedside colorimetric reagent dipstick in the diagnosis of meningitis in low- and middle-income countries: A prospective, international blinded comparison with laboratory analysis.

Background: Colorimetric reagent dipstick (CRD) for leukocyte esterase (LE) has shown potential for diagnosing and ruling out bacterial meningitis. Potential advantages over traditional cerebrospinal fluid (CSF) analysis include the small quantity of CSF required, rapid results, and easy interpretation. Our study aimed to determine whether clinicians in LMICs could accurately diagnose bacterial meningitis using CRD at the bedside. Methods: A convenience sample of 143 patients requiring lumbar puncture for possible meningitis were enrolled from 1 October 2018 to 31 December 2019 at three hospitals, one each in rural Burundi, the Democratic Republic of Congo, and Kenya. CSF was analyzed using CRD followed by traditional laboratory-based analysis by technicians blinded to bedside results. Results were analyzed for concordance rates, sensitivity/specificity, positive and negative predictive values and impact on clinical decision-making. Results: One hundred and one patients were included in the analysis. The prevalence of bacterial meningitis in the convenience sample was 35% (35/101) as defined by microscopy or positive Gram stain. Using a threshold of "any positivity" for LE on the CRD, bedside testing correctly identified 33/35 cases (sensitivity 94.3%) and had a NPV of 92%. When only a clearly positive (≥ "+" for LE) CRD criterion was used, sensitivity and NPV were 77.1% and 86.2%, respectively. Conclusion: Despite considerable promise, in our study, color reagent dipstick analysis of CSF did not perform well enough to rule out meningitis or screen samples for the need for microscopy. The development of a CSF-specific dipstick should be considered.