[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: 1.31). 07/2007; 27(3):192-6. DOI: 10.3343/kjlm.2007.27.3.192
Source: PubMed


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.

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    ABSTRACT: Tetanus remains a problem of immense concern worldwide. Management of tetanus with its attendant complications are challenges to the physician and its prevention is the chief priority. The choice of tetanus prophylaxis for patients with wounds depends on obtaining their vaccination history, which has been demonstrated to be unreliable. The tetanus antibody test may avoid inadequate prophylactic measures and reduce costs. This study is conducted to determine the feasibility of rapid tetanus antibody test (SD Bioline) in the accident and emergency department. A randomized prospective study was conducted on 50 patients, divided into two groups-A and B with 25 patients each respectively. Group A had patients with a history of tetanus immunization <5 years elapsed from the last booster dose. Group B had patients who did not know the immunization status or more than 5 years elapsed from the last booster dose of tetanus immunization. Groups A and B were further classified into Group 1 and Group 2 based on whether the wound is tetanus prone or a clean wound respectively. Tetanus antibody test was done using whole-blood from the patients by finger prick. Among the 50 patients, 25 (50 %) were classified as 'unprotected' according to the history. Thirteen of the 25 patients showed tetanus antibody positive. In Group A, only 9 of the 25 patients showed tetanus antibody positive. The rapid tetanus antibody test in the emergency room could make tetanus prevention more accurate with improved technical feasibility. The test may eliminate unnecessary injecting of vaccine, reduce the cost and can be performed at the hospital setting.
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