Freuling, Conrad Martin

Hoffmann, Bernd

Kliemt, Jeannette

Mettenleiter, Thomas C.

Müller, Thomas

Schlottau, Kore

English

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 54  Lateral flow devices as diagnostic tools for rabies – a comparative study with six different tests with surprising results.   Conrad Freuling, Jeannette Kliemt, Bernd Hoffmann, Kore Schlottau, Thomas Mettenleiter, Thomas Müller.  Rabies is a neglected zoonotic disease that causes estimated 60,000 human rabies deaths annually. The main burden suffer developing countries of Asia and Africa, where surveillance and disease detection is hampered by lacking laboratory facilities and/or the difficulties of submitting samples from remote areas to laboratories.   Under these settings, alternative easy-to-use tests such as immunochromatographic assays, i.e. lateral flow devices (LFD) may increase surveillance and improve control efforts. Previously, while specific LFDs had shown their applicability, others showed a poor performance. These contradictory results prompted us to investigate the test performance of available LFDs for the detection of rabies antigen in brain. We purchased LFDs in Germany (N=2), in the US (N=1), in India (N=1), and in China (N=2). All LFDs were used according to the manufacturers‟ instruction for experimentally infected animals, as well as for field samples. Additionally, a dilution series of positive in negative brain was also tested with various modifications of the procedures and realtime RT-PCR was also used to quantify the viral load in each sample tested.   Although LFDs have been shown to be highly sensitive and specific diagnostic tools for other diseases, surprisingly, we observed a low sensitivity in all tests and none of the tests was fit for purpose. Our results indicate that this may be due to several reasons including differences in batch quality, dilution effects or the general design of the test.   The high number of false negative results reiterates the necessity to perform a proper test validation before being marketed and used in the field. In this respect, marketing authorization and batch release control would grant a sufficient quality for these alternative tests, which could then fulfil their potential.                            

Lateral flow devices as diagnostic tools for rabies – a comparative study with six different tests with surprising results

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Lateral flow devices as diagnostic tools for rabies – a comparative study with six different tests with surprising results

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