Lab Med Online.  2015 Apr;5(2):77-83. 10.3343/lmo.2015.5.2.77.

Evaluation of Centaur Syphilis, Immulite Syphilis, and Mediace TPLA for Detecting Treponemal Antibodies

• Seo DH
• Whang DH
• Joo SY
• Choi HH

• KMID: 2312279
• DOI: http://doi.org/10.3343/lmo.2015.5.2.77

Abstract

BACKGROUND
We evaluated the efficacy of two chemiluminescence immunoassays that detect treponemal antibodies, Centaur Syphilis and Immulite Syphilis, in comparison with Mediace Treponema pallidum latex agglutination (TPLA).
METHODS
The study was conducted in two phases. In the first phase, we tested 1,147 serum samples that were sequentially submitted for routine syphilis serology. In the second phase, we tested a panel of 119 frozen serum samples that had previously tested positive by Mediace RPR. The kappa value, total agreement percentage, and sensitivity and specificity were analyzed.
RESULTS
Of the 1,147 random samples, 24 (2.09%) tested positive with Centaur Syphilis, 16 (1.39%) with Immulite Syphilis, and 19 (1.66%) with Mediace TPLA. Of the 119 Mediace RPR-positive samples, 103 (86.6%) tested positive with Centaur Syphilis, 101 (84.9%%) with Immulite Syphilis, and 105 (88.2%) with Mediace TPLA. The percent agreements (kappa values) were 98.8% (0.934) between Centaur Syphilis and Mediace TPLA, 99.0% (0.94) between Immulite Syphilis and Mediace TPLA, and 99.2% (0.955) between Centaur Syphilis and Immulite Syphilis. To measure the sensitivity and specificity of each treponemal test, samples showing agreement in three or four of the tests (three treponemal tests and Mediace-RPR) were regarded as true positive (n=117) or true negative (n=1,142). The respective values for sensitivity and specificity were 100% and 99.6% for Centaur Syphilis, 98.3% and 100% for Immulite Syphilis, and 99.2% and 99.7% for Mediace TPLA.
CONCLUSIONS
Results from the three treponemal assays were in good agreement. Greater sensitivity of Centaur Syphilis and greater specificity of Immulite Syphilis were suggested.

Keyword

Syphilis; Treponema pallidum; Chemiluminescence immunoassay; Treponemal test; Non-treponemal test

MeSH Terms

Agglutination
Antibodies*
Immunoassay
Latex
Luminescence
Sensitivity and Specificity
Syphilis*
Treponema pallidum
Antibodies
Latex

Reference

1. Larsen SA, Steiner BM, Rudolph AH. Laboratory diagnosis and interpretation of tests for syphilis. Clin Microbiol Rev. 1995; 8:1–21.

2. Choi KC. Recent trends in clinical observation of syphilis and consideration for laboratory tests. J Korean Med Assoc. 2009; 52:1100–1106.

3. Workowski KA, Berman S. Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010; 59:1–110.

4. French P, Gomberg M, Janier M, Schmidt B, van Voorst Vader P, Young H. IUSTI. 2008 European Guidelines on the Management of Syphilis. Int J STD AIDS. 2009; 20:300–309.

5. Korean Centers for Disease Control and Prevention, The Korean Association of Urogenital Tract Infection and Inflammation. Sexually Transmitted Infection Korean Treatment Guideline.

6. Centers for Disease Control and Prevention (CDC). Syphilis testing algorithms using treponemal tests for initial screening--four laboratories, New York City, 2005-2006. MMWR Morb Mortal Wkly Rep. 2008; 57:872–875.

7. Centers for Disease Control and Prevention (CDC). Discordant results from reverse sequence syphilis screening-five laboratories, United States, 2006-2010. MMWR Morb Mortal Wkly Rep. 2011; 60:133–137.

8. Marangoni A, Moroni A, Accardo S, Cevenini R. Laboratory diagnosis of syphilis with automated immunoassays. J Clin Lab Anal. 2009; 23:1–6.

9. Song EY, Yang JS, Chae SL, Kim S, Choi YS, Cha YJ. Current status of external quality assessment of syphilis test in Korea. Korean J Lab Med. 2008; 28:207–213.

10. Loeffelholz MJ. It is time to use treponema-specific antibody screening tests for diagnosis of syphilis. J Clin Microbiol. 2012; 50:2–6.