Abstract
Diagnosis of the aetiological agent in case of acute encephalitic syndrome (AES) continues to pose a challenge in clinical practice as a variety of pathogens are known to cause AES. Here, we report the validation of a Syndrome Evaluation System (SES) developed for simultaneous detection of multiple AES pathogens using a well characterized set of Cerebrospinal fluid (CSF) samples. The validation of the SES was carried out in two phases. In the first phase, the SES was validated using 51 CSF samples obtained from autopsy proven cases and 50 samples obtained from apparently healthy individuals undergoing spinal anesthesia for minor surgeries served as “controls.” The SES detected etilogical agent in 48/51 (94.11 %) samples obtained from autopsy proven AES cases while all the 50 CSF samples obtained from “controls” were negative. In the second phase, the SES was validated using well characterized CSF samples obtained from AES patients fulfilling the WHO case definition of AES (Group I; n = 207) and samples that were collected from patients with non-infectious neurological disorder (Group II; n = 90). All the samples were tested using multiple conventional/serological assays and categorized into various groups. Amongst the AES cases fulfilling WHO case definition, the SES detected AES pathogens in 160/207 (77.29%) cases while conventional serological/molecular assays were able to detect AES pathogens only in 77/207 (37.1%) of cases. Further, in 12/83 CSF samples that were positive by SES and negative by conventional serological/molecular tests, the results were additionally confirmed by sequencing the PCR products to rule out non-specific amplification in the SES. In patients with non-infectious neurological disorders the SES detected latent viruses 12/90 CSF samples. These results indicate that the SES, apart being a rapid, sensitive, specific, and cost-effective method provides the major advantage of simultaneous detection of multiple pathogens using as single specimen of CSF.
Highlights
Acute encephalitis syndrome (AES) is a major public health problem in India and a variety of pathogens are known to cause acute encephalitic syndrome (AES) [1]
The Syndrome Evaluation System (SES) described in the study was developed to address the unmet clinical and epidemiological needs of AES cases that occur in India
Multiple panels of these commercial multiplex PCR assays need to be used to cover the AES pathogens relevant to the Indian context (e.g., JEV, DEN, CHIKV)
Summary
Acute encephalitis syndrome (AES) is a major public health problem in India and a variety of pathogens are known to cause AES [1]. In a retrospective study carried out in San Diego, California [2], it was noted that patients with a positive CSF PCR result for enteroviruses had significantly fewer ancillary tests performed, received I.V antibiotics for less time and had markedly shorter hospital stay They noted that a positive enterovirus PCR result was associated with more rapid hospital discharge. There are a few methods available at present for the simultaneous and rapid detection of multiple pathogens (FILMARRAY R Meningitis/Encephalitis (ME) Panel, by Biomerieux, FTlyo Viral meningitis/FTlyo Bacterial meningitis, by FastTrack Diagnostics) and many of the pathogens are not relevant to the Indian context. Sensitivity of these tests is not adequate. We report the validation of the SES using well characterized set of CSF samples obtained from proven and suspected cases of AES as well as those obtained from patients with non-infectious neurological disorders and controls
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