Evaluation of SD BIOLINE Tetanus Kit / 대한진단검사의학회지
The Korean Journal of Laboratory Medicine
; : 192-196, 2007.
Article
en Ko
| WPRIM
| ID: wpr-24303
Biblioteca responsable:
WPRO
ABSTRACT
BACKGROUND: Point-of-care-testing (POCT) kits for tetanus toxoid antibody are used in emergency departments to evaluate the immunization status of patients with tetanus. The objective of this study was to evaluate the analytical performance and the utility of SD BIOLINE tetanus kit (Standard Diagnostic Inc., Yongin, Korea), as a POCT. METHODS: A total of 326 peripheral blood specimens (whole blood, 319; serum, 326) from healthy subjects and patients were used. SD BIOLINE tetanus kit was evaluated for precision, accuracy, effect of specimens, operator variance, and the total processing time. The results from SD BIOLINE tetanus kit were compared with those from 2 quantitative ELISA kits. RESULTS: Compared with ELISA kits, SD BIOLINE tetanus kit revealed a sensitivity of 88-97%, specificity of 87-92%, positive predictive value of 81-89%, negative predictive value of 90-98%, and kappa agreement of 0.78-0.82. SD BIOLINE tetanus kit also showed an excellent precision and a high accuracy. It showed a high concordance rate between whole blood and serum specimens. The total processing time of SD BIOLINE tetanus kit was 30-40 min. CONCLUSIONS: SD BIOLINE tetanus kit showed an excellent analytical performance. With its rapid turnaround time and the ease of handling and interpretation, SD BIOLINE tetanus kit seems appropriate for the evaluation of tetanus immunization status as a POCT device. However, education for operators and standardized guidelines for result interpretation should be emphasized.
Palabras clave
Texto completo:
1
Índice:
WPRIM
Asunto principal:
Juego de Reactivos para Diagnóstico
/
Tétanos
/
Ensayo de Inmunoadsorción Enzimática
/
Toxoide Tetánico
/
Reproducibilidad de los Resultados
/
Sensibilidad y Especificidad
/
Sistemas de Atención de Punto
/
Anticuerpos Antibacterianos
Tipo de estudio:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
Límite:
Humans
Idioma:
Ko
Revista:
The Korean Journal of Laboratory Medicine
Año:
2007
Tipo del documento:
Article