Field evaluation of commercial immunoglobulin M antibody capture ELISA diagnostic tests for the detection of Japanese encephalitis virus infection among encephalitis patients in Nepal.

ABSTRACT

OBJECTIVES: Japanese encephalitis (JE) is a devastating disease with high rates of death and disability that occurs particularly in resource-limited, rural regions of Asia. Simple, accurate and inexpensive diagnostics tests are vital for quantifying the burden of illness. This field study evaluated two commercial JE immunoglobulin M antibody capture (MAC) ELISA kits using samples from routine JE surveillance. METHODS: Positive (n=132) and negative (n=218) sera were randomly selected from patient samples collected as part of JE surveillance in Nepal in 2005. Samples were tested in a national public health laboratory with commercial kits produced by XCyton and Inverness (Panbio). Results were compared with those of the research lab-based reference standard, the Armed Forces Research Institute of Medical Sciences JE MAC ELISA. RESULTS: Positive and negative predictive values and 95% confidence intervals were 90% (82-95%) and 85% (79-89%) for Panbio1, 94% (88-98%) and 89% (87-93%) for Panbio2, and 84% (77-90%) and 96% (92-98%) for XCyton kits, respectively. Sensitivities of Panbio1, Panbio2, and XCyton kits were 71% (63-79%), 80% (72-87%), and 93% (88-97%); specificities were 95% (91-98%), 97% (94-99%), and 89% (85-93%), respectively. Overall percent agreement was 86% for Panbio1 and 91% for both Panbio2 and XCyton. CONCLUSIONS: Both commercial kits had good predictive values when single serum samples from encephalitis cases were tested in a national laboratory. Either kit can be used in similar JE-endemic settings where co-transmission of dengue virus, a flavivirus which has strong cross-reactivity with JE, is limited. These results can inform decisions by countries and the World Health Organization laboratory networks on national-level use of these kits for JE surveillance.