Clinical Evaluation of a Rapid Diagnostic Test Kit for Canine Parvovirus and Coronavirus
Keywords:
Canine parvovirus, Canine coronavirus, Rapid diagnostic tests, Sensitivity and specificityAbstract
Canine parvovirus type 2 (CPV-2) and canine coronavirus (CCoV) are major pathogens that can induce gastroenteritis in dogs. They are highly contagious and have a high morbidity rate. There are no specific treatments available for them to date. Therefore, rapid and accurate diagnosis becomes essential. The rapid diagnostic test (RDT) for animals can be used widely in the field because it is fast and easy to use for diagnosis. Thus, this study aimed to clinically evaluate and confirm the clinical utility of CPV-2/CCoV RDT. The parameters evaluated included the limit of detection (LoD), cross-reactivity, interference, sensitivity, specificity, negative likelihood ratio (NLR), and kappa value. The results revealed that the LoD values for CPV-2 and CCoV were 9.7×10 TCID50/mL and 2.5×102 TCID50/mL, respectively. There was no cross-reactivity with nine pathogens or interference by interfering materials. The RDT showed a sensitivity of 90.0%, a specificity of 100.0%, an NLR of 0.1, and a kappa value of 0.90 for diagnosing both viruses. In conclusion, the CPV-2/CCoV RDT is useful as a screening test because of its high sensitivity, specificity, kappa value, and low NLR.
References
Duijvestijn M, Mughini-Gras L, Schuurman N, et al., 2016, Enteropathogen Infections in Canine Puppies: (Co-)Occurrence, Clinical Relevance and Risk Factors. Vet Microbiol, 195: 115–122. https://doi.org/10.1016/j.vetmic.2016.09.006
Cavalli A, Desario C, Kusi I, et al., 2014, Detection and Genetic Characterization of Canine Parvovirus and Canine Coronavirus Strains Circulating in District of Tirana in Albania. J Vet Diagn Invest, 26(4): 74–95. https://doi.org/10.1177/1040638714538965
Ogbu KI, Anene BM, Nweze NE, et al., 2017, Canine Parvovirus: A Review. Int J Sci Appl Res, 2(2): 74–95.
Mylonakis M, Kalli I, Rallis T, 2016, Canine Parvoviral Enteritis: An Update on the Clinical Diagnosis, Treatment, and Prevention. Vet Med, 7: 91–100. https://doi.org/10.2147/VMRR.S80971
Ntafis V, Mari V, Decaro N, et al., 2013, Canine Coronavirus, Greece. Molecular Analysis and Genetic Diversity Characterization. Infect Genet Evol, 16: 129–136. https://doi.org/10.1016/j.meegid.2013.01.014
Pratelli A, 2011, The Evolutionary Processes of Canine Coronaviruses. Adv Virol, 2011: 562831. https://doi.org/10.1155/2011/562831
Licitra BN, Duhamel GE, Whittaker GR, 2014, Canine Enteric Coronaviruses: Emerging Viral Pathogens with Distinct Recombinant Spike Proteins. Viruses, 6(8): 3363–3376. https://doi.org/10.3390/v6083363
Shima FK, Gberindyer FA, Tion MT, et al., 2021, Diagnostic Performance of a Rapid Immunochromatographic Test Kit for Detecting Canine Parvovirus Infection. Top Companion Anim Med, 45: 100551. https://doi.org/10.1016/j.tcam.2021.100551
Kantere MC, Athanasiou LV, Spyrou V, et al., 2015, Diagnostic Performance of a Rapid In-Clinic Test for the Detection of Canine Parvovirus Under Different Storage Conditions and Vaccination Status. J Virol Methods, 215–216: 52–55. https://doi.org/10.1016/j.jviromet.2015.02.012
Tinky SS, Ambily R, Nair SR, et al., 2015, Utility of a Rapid Immunochromatographic Strip Test in Detecting Canine Parvovirus Infection Compared with Polymerase Chain Reaction. Vet World, 8(4): 523–526. https://doi.org/10.14202/vetworld.2015.523-526
Howson ELA, Soldan A, Webster K, et al., 2017, Technological Advances in Veterinary Diagnostics: Opportunities to Deploy Rapid Decentralised Tests to Detect Pathogens Affecting Livestock. Rev Sci Tech Off Int Epiz, 36(2): 479–498. https://doi.org/10.20506/rst.36.2.2668
Kang K-M, Suh T-Y, Kang H-G, et al., 2019, Trends and Prospect of the Market for Veterinary Medical Devices in Korea. J Vet Clin, 36(1): 1–6. https://doi.org/10.17555/jvc.2019.02.36.1.1
Park HM, Lee CM, et al. Safety Information and Cases of Adverse Effects of Veterinary Medical Devices, 2017, Animal and Plant Quarantine Agency, Gimcheon.
Kim HS, 2021, Rapid Tests for the Diagnosis of Viral Infections. Korean J Med, 96(5): 415–420. https://doi.org/10.3904/kjm.2021.96.5.415
NCCLS. Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. NCCLS Document EP17-A. 2004, National Committee for Clinical Laboratory Standards, Wayne.
CLSI. Interference Testing in Clinical Chemistry; Approved Guidelines – Second Edition. CLSI Document EP07-A2. 2005, Clinical and Laboratory Standards Institute, Wayne.
Ji I, 2019, Industry Status of Companion Animal in the United States. World Agric, 224: 45–78.
Kim E, Choe C, Yoo JG, et al., 2018, Major Medical Causes by Breed and Life Stage for Dogs Presented at Veterinary Clinics in the Republic of Korea: A Survey of Electronic Medical Records. PeerJ, 6: e5161. https://doi.org/10.7717/peerj.5161
Martini M, Fenati M, Agosti M, et al., 2017, A Surveillance System for Diseases of Companion Animals in the Veneto Region (Italy). Rev Sci Tech Off Int Epiz, 36(3): 1007–1014. https://doi.org/10.20506/rst.36.3.2732
Zhao Y, Lin Y, Zeng X, et al., 2013, Genotyping and Pathobiologic Characterization of Canine Parvovirus Circulating in Nanjing, China. Virol J, 10: 272. https://doi.org/10.1186/1743-422X-10-272
Gan J, Tang Y, Lv H, et al., 2021, Identification and Phylogenetic Analysis of Two Canine Coronavirus Strains. Anim Dis, 1: 10. https://doi.org/10.1186/s44149-021-00013-9
Decaro N, Desario C, Billi M, et al., 2013, Evaluation of an In-Clinic Assay for the Diagnosis of Canine Parvovirus. Vet J, 198(2): 504–507. https://doi.org/10.1016/j.tvjl.2013.08.032
Song C-S, Sung H-H, Kim J-H, et al., 2018, Fusion Analytical Sensitivity of Rapid Influenza Antigen Limit of Detection Tests for Human Influenza Virus. J Korea Converg Soc, 9(3): 165–171. https://doi.org/10.15207/JKCS.2018.9.3.165
Anfossi L, Di Nardo F, Cavalera S, et al., 2019, Multiplex Lateral Flow Immunoassay: An Overview of Strategies Towards High-Throughput Point-of-Need Testing. Biosensors, 9(1): 2. https://doi.org/10.3390/bios9010002
Li J, Macdonald J, 2016, Multiplexed Lateral Flow Biosensors: Technological Advances for Radically Improving Point-of-Care Diagnoses. Biosens Bioelectron, 83: 177–192. https://doi.org/10.1016/j.bios.2016.04.021
Yoon S-J, Seo K-W, Song K-H, 2018, Clinical Evaluation of a Rapid Diagnostic Test Kit for Detection of Canine Coronavirus. Korean J Vet Res, 58(1): 27–31. https://doi.org/10.14405/kjvr.2018.58.1.27
Kim W-S, Chong C-K, Kim H-Y, et al., 2014, Development and Clinical Evaluation of a Rapid Diagnostic Kit for Feline Leukemia Virus Infection. J Vet Sci, 15(1): 91–97. https://doi.org/10.4142/jvs.2014.15.1.91
Attia J, 2003, Moving Beyond Sensitivity and Specificity: Using Likelihood Ratios to Help Interpret Diagnostic Tests. Aust Prescr, 26(5): 111–113. https://doi.org/10.18773/austprescr.2003.082
Kong KA, 2017, Statistical Methods: Reliability Assessment and Method Comparison. Ewha Med J, 40(1): 9–16. https://doi.org/10.12771/emj.2017.40.1.9
Moon JS, Kang KM, et al. Guideline for Performance Evaluation and Stability Test of in vitro Diagnostic Veterinary Medical Reagent, 2019, Animal and Plant Quarantine Agency, Gimcheon.