Evaluation of a rapid immunochromatographic test kit to the gold standard fluorescent antibody test for diagnosis of rabies in animals in Bhutan

Abstract

Background: Rabies kills approximately 59,000 people each year worldwide. Rapid and accurate diagnosis of rabies is important for instituting rapid containment measures and for advising the exposed people for postexposure treatment. The application of a rapid diagnostic tests in the field can greatly enhance disease surveillance and diagnostic activities, especially in resource poor settings. In this study, a total of 179 brain tissue samples collected from different rabies suspect animal species (113 dogs, 50 cattle, 10 cats, 3 goats, 2 horses, and 1 bear) were selected and tested using both rapid immunochromatographic kit and the reference standard fluorescent antibody test (FAT). We evaluated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of a rapid antigen detection test kit produced by BioNote, Inc. (Hwaseong-si, Korea) relative to a FAT for its fit-for-purpose for confirmation of clinical cases of rabies for early response and enhancing rabies surveillance. Results: Among 179 samples examined in this study, there was a concordance in results by the rapid test and FAT in 115 positive samples and 54 negative samples. Test results were discordant in 10 samples which were positive by FAT, but negative (false negative) by rapid kit. The rapid test kit showed a sensitivity of 92% (95% CI: 85.9-95.6) and specificity of 100% (95% CI: 93.4-100) using FAT as the reference standard. The positive and negative predictive values were found to be 100% (95% CI:96.7-100) and 84.4% (95% CI: 73.6-91.3), respectively. Overall, there was 94.4% (95% CI: 90-96.9) test agreement between rapid test and FAT (Kappa value = 0.874) with a positive percent agreement and negative percent agreement of 92 and 100%, respectively. Conclusions: Our finding demonstrated that the rapid test kit (BioNote) can be used for rabies surveillance and confirming clinical case of rabies in animals for making rapid decisions particularly controlling rabies outbreaks in resource poor settings.

From Field Tests to Molecular Tools—Evaluating Diagnostic Tests to Improve Rabies Surveillance in Namibia

“…Besides molecular confirmation, we also anticipated an increase in the level of surveillance by decentralized testing using LFDs. Generally, Anigen/Bionote rabies LFD performance demonstrated an almost perfect agreement compared to the FAT ( Table 3 ) which partly corresponds to previous assessments, e.g., [ 28 , 29 , 30 ], whereas other studies found a poorer sensitivity [ 21 , 31 ]. The results indicate that testing of fresh brain samples in the field results in higher sensitivity compared with testing at a later time point at a central veterinary laboratory ( Figure 2 ).…”

Surveillance of Animal Rabies in Burkina Faso: A Retrospective Laboratory Data from 2008 to 2012

“…For cats, respectively 374, 472, 626, 744 and 806 have been vaccinated while 84, 84, 203, 71 and 62 nonhuman primates have been vaccinated (Ministère des ressources animales, 2015).Surveillance has been implemented for animal rabies in the country by the National Livestock Laboratory (LNE) since 2000. In this surveillance program, samples from each rabies suspect animal, from different regions in the country, are sent to the LNE for rabies diagnostic confirmation using Fluorescent Antibody Test (FAT) as previously described (Tenzin et al 2020). Since surveillance program has been implemented data collected have never been analyzed to study distribution of rabies in animals and also factors associated with dogs' rabies, the main vector of human rabies in the country.…”

The potential of diagnostic point‐of‐care tests (POCTs) for infectious and zoonotic animal diseases in developing countries: Technical, regulatory and sociocultural considerations

“…There have been increasing numbers of studies reviewing POCTs for diagnosis of infectious animal diseases published in recent years, and reports of their application in LMICs have also been on the rise. POCTs for rapid detection of infectious animal diseases with important zoonotic and/or economic impacts are the most commonly reported and often a range of different POCT formats have been developed, including for FMD (Abd El Wahed et al., 2013 ; Bath et al., 2020 ; Dukes et al., 2006 ; Madi et al., 2012 ; Reid et al., 2001 ; Yamazaki et al., 2013 ), highly pathogenic avian influenza (HPAI) (Boland et al., 2006 ; Imai et al., 2007 ; Postel et al., 2010 ; Slomka et al., 2012 ; Takekawa et al., 2010 ), canine rabies (Léchenne et al., 2016 ; Rupprecht et al., 2018 ; Tenzin et al., 2020 ) and ASF (Cappai et al., 2017 ; Sastre, Gallardo, et al., 2016 ; Sastre, Pérez, et al., 2016 ). Other target diseases for diagnostic veterinary POCTs include anthrax (Kurosaki et al., 2009 ; Muller et al., 2015 ; Pillai et al., 2019 ), PPR (Brüning‐Richardson et al., 2011 ; Rajko‐Nenow et al., 2019 ; Yang et al., 2017 ), bovine tuberculosis in cattle and in various wildlife species (Fresco‐Taboada et al., 2019 ; Lyashchenko et al., 2008 ; Tschopp et al., 2010 ), animal African trypanosomiasis (Boulangé et al., 2017 ) and a variety of parasites including Anaplasma marginale (Giglioti et al., 2019 ), Trichenella (Li et al., 2019 ) and Haemonchus contortus (Melville et al., 2014 ).…”