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Further Evidence of Inadequate Quality in Lateral Flow Devices Commercially Offered for the Diagnosis of Rabies.
Trop Med Infect Dis 2020; 5(1)TM

Abstract

As a neglected zoonotic disease, rabies causes approximately 5.9 × 104 human deaths annually, primarily affecting low- and middle-income countries in Asia and Africa. In those regions, insufficient surveillance is hampering adequate medical intervention and is driving the vicious cycle of neglect. Where resources to provide laboratory disease confirmation are limited, there is a need for user-friendly and low-cost reliable diagnostic tools that do not rely on specialized laboratory facilities. Lateral flow devices (LFD) offer an alternative to conventional diagnostic methods and may strengthen control efforts in low-resource settings. Five different commercially available LFDs were compared in a multi-centered study with respect to their diagnostic sensitivity and their agreement with standard rabies diagnostic techniques. Our evaluation was conducted by several international reference laboratories using a broad panel of samples. The overall sensitivities ranged from 0% up to 62%, depending on the LFD manufacturer, with substantial variation between the different laboratories. Samples with high antigen content and high relative viral load tended to test positive more often in the Anigen/Bionote test, the latter being the one with the best performance. Still, the overall unsatisfactory findings corroborate a previous study and indicate a persistent lack of appropriate test validation and quality control. At present, the tested kits are not suitable for in-field use for rabies diagnosis, especially not for suspect animals where human contact has been identified, as an incorrect negative diagnosis may result in human casualties. This study points out the discrepancy between the enormous need for such a diagnostic tool on the one hand, and on the other hand, a number of already existing tests that are not yet ready for use.

Authors+Show Affiliations

Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Institute of Molecular Virology and Cell Biology, 17493 Greifswald-Insel Riems, Germany.Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Institute of Molecular Virology and Cell Biology, 17493 Greifswald-Insel Riems, Germany.Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Institute of Molecular Virology and Cell Biology, 17493 Greifswald-Insel Riems, Germany.Kimron Veterinary Institute (KVI), Veterinary Services and Animal Health, P.O. Box 12, Beit Dagan 50250, Israel.Kimron Veterinary Institute (KVI), Veterinary Services and Animal Health, P.O. Box 12, Beit Dagan 50250, Israel.Kimron Veterinary Institute (KVI), Veterinary Services and Animal Health, P.O. Box 12, Beit Dagan 50250, Israel.Onderstepoort Veterinary Institute (OVI), Rabies Unit, Private Bag X05, Onderstepoort 0110, South Africa.Onderstepoort Veterinary Institute (OVI), Rabies Unit, Private Bag X05, Onderstepoort 0110, South Africa.Onderstepoort Veterinary Institute (OVI), Rabies Unit, Private Bag X05, Onderstepoort 0110, South Africa.Istituto Zooprofilattico Sperimentale delle Venezie, FAO Reference Centre for Rabies, Viale dell'Università, 10, 35020 - Legnaro (PD), Italy.Istituto Zooprofilattico Sperimentale delle Venezie, FAO Reference Centre for Rabies, Viale dell'Università, 10, 35020 - Legnaro (PD), Italy.Centers for Disease Control and Prevention (CDC), Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, GA, 30329 USA.Centers for Disease Control and Prevention (CDC), Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, GA, 30329 USA.Centers for Disease Control and Prevention (CDC), Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, GA, 30329 USA.Canadian Food Inspection Agency, Centre of Expertise for Rabies, Ottawa Laboratory Fallowfield, 3851 Fallowfield Road, Nepean, Ontario K2H 8P9, Canada.Canadian Food Inspection Agency, Centre of Expertise for Rabies, Ottawa Laboratory Fallowfield, 3851 Fallowfield Road, Nepean, Ontario K2H 8P9, Canada.French Agency for Food, Environmental and Occupational Health and Safety (Anses), Laboratory for Rabies and Wildlife, Domaine de Pixérécourt, 54220 Malzéville Cedex, France.French Agency for Food, Environmental and Occupational Health and Safety (Anses), Laboratory for Rabies and Wildlife, Domaine de Pixérécourt, 54220 Malzéville Cedex, France.Animal and Plant Health Agency (APHA), Weybridge, New Haw, Addlestone, Surrey KT15 3NB, UK.Animal and Plant Health Agency (APHA), Weybridge, New Haw, Addlestone, Surrey KT15 3NB, UK.Animal and Plant Health Agency (APHA), Weybridge, New Haw, Addlestone, Surrey KT15 3NB, UK.Animal and Plant Health Agency (APHA), Weybridge, New Haw, Addlestone, Surrey KT15 3NB, UK.Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Institute of Molecular Virology and Cell Biology, 17493 Greifswald-Insel Riems, Germany.Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Institute of Molecular Virology and Cell Biology, 17493 Greifswald-Insel Riems, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31963635

Citation

Klein, Antonia, et al. "Further Evidence of Inadequate Quality in Lateral Flow Devices Commercially Offered for the Diagnosis of Rabies." Tropical Medicine and Infectious Disease, vol. 5, no. 1, 2020.
Klein A, Fahrion A, Finke S, et al. Further Evidence of Inadequate Quality in Lateral Flow Devices Commercially Offered for the Diagnosis of Rabies. Trop Med Infect Dis. 2020;5(1).
Klein, A., Fahrion, A., Finke, S., Eyngor, M., Novak, S., Yakobson, B., ... Freuling, C. M. (2020). Further Evidence of Inadequate Quality in Lateral Flow Devices Commercially Offered for the Diagnosis of Rabies. Tropical Medicine and Infectious Disease, 5(1), doi:10.3390/tropicalmed5010013.
Klein A, et al. Further Evidence of Inadequate Quality in Lateral Flow Devices Commercially Offered for the Diagnosis of Rabies. Trop Med Infect Dis. 2020 Jan 18;5(1) PubMed PMID: 31963635.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Further Evidence of Inadequate Quality in Lateral Flow Devices Commercially Offered for the Diagnosis of Rabies. AU - Klein,Antonia, AU - Fahrion,Anna, AU - Finke,Stefan, AU - Eyngor,Marina, AU - Novak,Shiri, AU - Yakobson,Boris, AU - Ngoepe,Ernest, AU - Phahladira,Baby, AU - Sabeta,Claude, AU - De Benedictis,Paola, AU - Gourlaouen,Morgane, AU - Orciari,Lillian A, AU - Yager,Pamela A, AU - Gigante,Crystal M, AU - Knowles,M Kimberly, AU - Fehlner-Gardiner,Christine, AU - Servat,Alexandre, AU - Cliquet,Florence, AU - Marston,Denise, AU - McElhinney,Lorraine M, AU - Johnson,Trudy, AU - Fooks,Anthony R, AU - Müller,Thomas, AU - Freuling,Conrad M, Y1 - 2020/01/18/ PY - 2019/12/17/received PY - 2020/01/13/revised PY - 2020/01/15/accepted PY - 2020/1/23/entrez KW - diagnostics KW - lateral flow devices KW - rabies KW - validation JF - Tropical medicine and infectious disease JO - Trop Med Infect Dis VL - 5 IS - 1 N2 - As a neglected zoonotic disease, rabies causes approximately 5.9 × 104 human deaths annually, primarily affecting low- and middle-income countries in Asia and Africa. In those regions, insufficient surveillance is hampering adequate medical intervention and is driving the vicious cycle of neglect. Where resources to provide laboratory disease confirmation are limited, there is a need for user-friendly and low-cost reliable diagnostic tools that do not rely on specialized laboratory facilities. Lateral flow devices (LFD) offer an alternative to conventional diagnostic methods and may strengthen control efforts in low-resource settings. Five different commercially available LFDs were compared in a multi-centered study with respect to their diagnostic sensitivity and their agreement with standard rabies diagnostic techniques. Our evaluation was conducted by several international reference laboratories using a broad panel of samples. The overall sensitivities ranged from 0% up to 62%, depending on the LFD manufacturer, with substantial variation between the different laboratories. Samples with high antigen content and high relative viral load tended to test positive more often in the Anigen/Bionote test, the latter being the one with the best performance. Still, the overall unsatisfactory findings corroborate a previous study and indicate a persistent lack of appropriate test validation and quality control. At present, the tested kits are not suitable for in-field use for rabies diagnosis, especially not for suspect animals where human contact has been identified, as an incorrect negative diagnosis may result in human casualties. This study points out the discrepancy between the enormous need for such a diagnostic tool on the one hand, and on the other hand, a number of already existing tests that are not yet ready for use. SN - 2414-6366 UR - https://www.unboundmedicine.com/medline/citation/31963635/Further_Evidence_of_Inadequate_Quality_in_Lateral_Flow_Devices_Commercially_Offered_for_the_Diagnosis_of_Rabies L2 - http://www.mdpi.com/resolver?pii=tropicalmed5010013 DB - PRIME DP - Unbound Medicine ER -