title: Development and clinical evaluation of a rapid diagnostic kit for feline leukemia virus infection.
abstract: Feline leukemia virus (FeLV) causes a range of neoplastic and degenerative diseases in cats. To obtain a more sensitive and convenient diagnosis of the disease, we prepared monoclonal antibodies specific for the FeLV p27 to develop a rapid diagnostic test with enhanced sensitivity and specificity. Among these antibodies, we identified two clones (hybridomas 8F8B5 and 8G7D1) that specifically bound to FeLV and were very suitable for a diagnostic kit. The affinity constants for 8F8B5 and 8G7D1 were 0.35 × 10⁸ and 0.86 × 10⁸, respectively. To investigate the diagnostic abilities of the rapid kit using these antibodies, we performed several clinical studies. Assessment of analytical sensitivity revealed that the detection threshold of the rapid diagnostic test was 2 ng/mL for recombinant p27 and 12.5 × 10⁴ IU/mL for FeLV. When evaluating 252 cat sera samples, the kit was found to have a kappa value of 0.88 compared to polymerase chain reaction (PCR), indicating a significant correlation between data from the rapid diagnostic test and PCR. Sensitivity and specificity of the kit were 95.2% (20/21) and 98.5% (257/261), respectively. Our results demonstrated that the rapid diagnostic test would be a suitable diagnostic tool for the rapid detection of FeLV infection in cats.
authors.affiliation: Department of Clinical Pathology Laboratory Science, Daejeon Health Science College, Daejeon 300-711, Korea.
authors.forename: Won-Shik
authors.initials: WS
authors.lastname: Kim
authors.forename: Chom-Kyu
authors.initials: CK
authors.lastname: Chong
authors.forename: Hak-Yong
authors.initials: HY
authors.lastname: Kim
authors.forename: Gyu-Cheol
authors.initials: GC
authors.lastname: Lee
authors.forename: Wooseog
authors.initials: W
authors.lastname: Jeong
authors.forename: Dong-Jun
authors.initials: DJ
authors.lastname: An
authors.forename: Hye-Young
authors.initials: HY
authors.lastname: Jeoung
authors.forename: Jae-In
authors.initials: JI
authors.lastname: Lee
authors.forename: Young-Ki
authors.initials: YK
authors.lastname: Lee
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000097:blood; D002415:Cats; D003955:Diagnostic Tests, Routine / Q000662:veterinary*; D005260:Female; D015683:Gene Products, gag / Q000097:blood*; D005256:Leukemia Virus, Feline / Q000276:immunology / Q000302:isolation & purification*; D016582:Leukemia, Feline / Q000175:diagnosis*; D008807:Mice, Inbred BALB C; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D015683:Gene Products, gag; C117471:feline leukemia virus protein p27
keywords: anti-FeLV p27 monoclonal antibody; feline leukemia virus; polymerase chain reaction; rapid diagnostic test; recombinant FeLV p27