Article

[Evaluation of SD BIOLINE tetanus kit].

Department of Laboratory Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
The Korean Journal of Laboratory Medicine (Impact Factor: 0.72). 07/2007; 27(3):192-6. DOI: 10.3343/kjlm.2007.27.3.192
Source: PubMed

ABSTRACT 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.
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.
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.
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.

0 Bookmarks
 · 
236 Views
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: In order to determine a practically useful quantitative assay method for tetanus antibody in a large-scale seroepidemiological study, a method combining an in-house ELISA with a particle agglutination test (KPA) was evaluated in comparison with the in vivo mouse neutralization test. Serum samples with mouse neutralization antibody titers 0.01 IU/ml (the minimum protective level) or below showed considerable overestimation of antitoxin titers up to 1.0 IU/ml when studied by in-house ELISA alone. On the other hand, the KPA values were highly correlated with the mouse test, even in cases of titers equal to 0.01 IU/ml or below. The combination of these two procedures, in which in-house ELISA values of 1.0 IU/ml or below were replaced by KPA values, provided a high correlation in antibody titers with the mouse test (r = 0.968). We applied this combined method to a tetanus seroepidemiological survey in a province in Turkey. The survey included 347 subjects from the healthy population, and the quantitative analyses showed high antibody levels in children and young adults and significantly low levels among adults aged 40 or over. A characteristic distribution of antibody titers in each age group was also demonstrated.
    Japanese journal of infectious diseases 07/2004; 57(3):97-102. · 1.51 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Determination of seroconversion and measurement of protective antibody levels in children against vaccine components are essential for gauging and monitoring the efficacy of paediatric vaccination programmes. For this purpose, we assessed the combined toxin-binding inhibition (ToBI) test for determining neutralizing antibodies to tetanus and diphtheria in a diphtheria-pertussis-tetanus (DPT) vaccine field trial in Viet Nam. A simple procedure involving collection of blood samples on filter-paper was found to be a suitable alternative to collection by venepuncture, despite a reduction in the sensitivity of the ToBI test as a result of the step necessary to elute the antibodies from the filter-paper. The results obtained demonstrate that the ToBI test can feasibly be carried out under field conditions. Preliminary results obtained with the ToBI test in DPT field trials indicate that a fourth dose of DPT vaccine one year after the third dose should be considered by developing countries.
    Bulletin of the World Health Organisation 02/1996; 74(3):275-82. · 5.25 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: A rapid quantitative microenzyme-linked immunosorbent assay for the detection of immunoglobulin G antibodies to tetanus toxoid is described. The assay is performed in 2.5 h and detects antibody levels of between 0.1 and 6 U/ml. Quantitation of the antibody concentration is unique in that multiple serum dilutions are tested on a single patient, the results are plotted as an antibody dilution curve, and the area under the curve is integrated for a final concentration. Tests for immune status on sera from 77 individuals demonstrated tetanus antibody concentrations of greater than or equal to 0.1 U/ml in 92% of a pediatric group and 62% of an adult group. The microenzyme-linked immunosorbent assay procedure is reproducible and is useful for the determination of immune status and immunization response.
    Journal of Clinical Microbiology 08/1983; 18(1):104-9. · 4.07 Impact Factor

Full-text (2 Sources)

View
2 Downloads
Available from