• M Rajamani, Anwesh Maile, A P Sugunan, and P Vijayachari.
• ICMR-Regional Medical Research Centre, WHO Collaborating Centre for Diagnosis, Research, Reference & Training in Leptospirosis, Port Blair, Andaman & Nicobar Islands, India.
• Indian J Med Res. 2021 Jul 1; 154 (1): 115-120.

Background & ObjectivesThe biological spectrum of leptospirosis ranges from acute undifferentiated febrile illness to severe fatal syndrome or a combination of syndromes. Diagnosis on clinical grounds alone is difficult and depends on laboratory support. However, no confirmatory tests are available, which is rapid and can be performed with minimum facilities available. The objectives of this study were to evaluate the diagnostic utility, accuracy and reproducibility of a rapid real time-PCR based method (TruenatTM) for early diagnosis of leptospirosis, and its usage in low resource settings.MethodsThe Truenat™ test was performed using plasma sample collected from confirmed patients and controls. DNA was extracted from plasma samples and the reaction was performed as per the manufacturer's instructions. Leptospiral isolates were also used to assess the performance using different serovars.ResultsEvaluation of the Truenat™ test with RT-PCR as the gold standard showed that Truenat™ had a sensitivity of 97.4 per cent and a specificity of 98.6 per cent. The overall agreement with RT-PCR was 98.2 per cent.Interpretation & ConclusionsOur results showed that the test would be a useful tool for early diagnosis of leptospirosis in settings with minimal facilities and the test results could be obtained within an hour. This indicates that a specific therapy can be instituted during the early phase of the disease even at peripheral healthcare facilities as well during the outbreaks.

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