Korean J Lab Med.  2007 Jun;27(3):192-196. 10.3343/kjlm.2007.27.3.192.

Evaluation of SD BIOLINE Tetanus Kit

• Lee JE
• Lee SY

• KMID: 1781483
• DOI: http://doi.org/10.3343/kjlm.2007.27.3.192

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.

Keyword

Tetanus; Antibody; Point-of-care-testing (POCT); Evaluation

MeSH Terms

Antibodies, Bacterial/blood
Enzyme-Linked Immunosorbent Assay
Humans
Point-of-Care Systems
*Reagent Kits, Diagnostic
Reproducibility of Results
Sensitivity and Specificity
Tetanus/*diagnosis/prevention & control
Tetanus Toxoid/*immunology

Reference

References

1. Humeau Y, Doussau F, Grant NJ, Poulain B. How botulinum and tetanus neurotoxins block neurotransmitter release. Biochimie. 2000; 82:427–46.

2. Kim HJ, Kang GH, Kim GW, Kim SC, Kim YS, Kim CH, et al. Korean multicenter study of tetanus antibody titer (KoMUST). J Korean Soc Emerg Med. 2005; 16:667–76.

3. Hsu SS, Groleau G. Tetanus in the emergency department: a current review. J Emerg Med. 2001; 20:357–65.

4. Coplu N, Esen B, Gozalan A, Miyamura K, Yoshida I, Kurtoglu D, et al. Tetanus antibody assay combining in-house ELISA and particle agglutination test and its serosurvey application in a province in Turkey. Jpn J Infect Dis. 2004; 57:97–102.

5. Caglar K, Karakus R, Aybay C. Determination of tetanus antibodies by a double-antigen enzyme-linked immunosorbent assay in individuals of various age groups. Eur J Clin Microbiol Infect Dis. 2005; 24:523–8.

6. Hong HA, Ke NT, Nhon TN, Thinh ND, van der Gun JW, Hendriks JT, et al. Validation of the combined toxin-binding inhibition test for determination of neutralizing antibodies against tetanus and diphtheria toxins in a vaccine field study in Viet Nam. Bull World Health Organ. 1996; 74:275–82.

7. Hendriksen CF, vd Gun JW, Nagel J, Kreeftenberg JG. The toxin binding inhibition test as a reliable in vitro alternative to the toxin neutralization test in mice for the estimation of tetanus antitoxin in human sera. J Biol Stand. 1988; 16:287–97.

8. Wahren E, Bengtsson C, Bjorksten B, Mark A, Granstrom M. Capture EIA for determination of IgE to diphtheria and tetanus toxins in comparison to RIA. Vaccine. 1998; 16:873–6.

9. Booth JR, Nuttall PA. A rapid automated latex screen for tetanus toxoid antibodies. Vox Sang. 1978; 34:239–40.

10. Sedgwick AK, Ballow M, Sparks K, Tilton RC. Rapid quantitative microenzyme-linked immunosorbent assay for tetanus antibodies. J Clin Microbiol. 1983; 18:104–9.

11. Nichols JH. Quality in point-of-care testing. Expert Rev Mol Diagn. 2003; 3:563–72.

12. Colombet I, Saguez C, Sanson-Le Pors MJ, Coudert B, Chatellier G, Espinoza P. Diagnosis of tetanus immunization status: multicenter assessment of a rapid biological test. Clin Diagn Lab Immunol. 2005; 12:1057–62.

13. Yoon YS, Kim EC, Lee WH, Chung SW, Yi JH, Park IC, et al. Utility of Tetanus Quick Stick test for selective tetanus prophylaxis. J Korean Soc Emerg Med. 2004; 15:95–101.