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

Dong Hee Seo; Dong Hee Whang; Shin Young Joo; Hyen Hee Choi

doi:10.3343/lmo.2015.5.2.77

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Seo, Whang, Joo, and Choi: Evaluation of Centaur Syphilis, Immulite Syphilis, and Mediace TPLA for Detecting Treponemal Antibodies

Original Article

Diagnostic Immunology

Laboratory Medicine Online 2015; 5(2): 77-83.

Published online: 1 April 2015

DOI: https://doi.org/10.3343/lmo.2015.5.2.77

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

Dong Hee Seo, M.D.¹, Dong Hee Whang, M.D.², Shin Young Joo, M.D.², Hyen Hee Choi, M.D.¹

¹Labgenomics Clinical Laboratories, Seoul, Korea.

²Department of Laboratory Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea.

Corresponding author: Dong Hee Whang. Department of Laboratory Medicine, Inje University Seoul Paik Hospital, 9 Mareunnae-ro, Jung-gu, Seoul 100-032, Korea. Tel: +82-2-2270-0152, Fax: +82-2-2270-0148, dhwhang@lycos.co.kr

Received 21 July 2014 Revised 1 October 2014 Accepted 4 November 2014

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: Syphilis, Treponema pallidum, Chemiluminescence immunoassay, Treponemal test, Non-treponemal test

Figures and Tables

Table 1

Classification of sequentially RPR-requested serum samples (n=1,147) by reactivity to three treponemal assays, ADVIA Centaur Syphilis, Mediace TPLA, and IMMULITE 2000 Syphilis Screen

Specimen group	Number of specimens (%)	Treponemal assay			Mediace RPR
Specimen group	Number of specimens (%)	ADVIA Centaur Syphilis	Mediace TPLA	IMMULITE 2000 Syphilis Screen	Mediace RPR
1	1,121 (97.7)	Nonreactive	Nonreactive	Nonreactive	Nonreactive
2	13 (1.1)	Reactive	Reactive	Reactive	Nonreactive
3	1 (0.1)	Reactive	Reactive	Reactive	Reactive
4	5 (0.4)	Reactive	Nonreactive	Nonreactive	Nonreactive
5	2 (0.2)	Nonreactive	Reactive	Nonreactive	Nonreactive
6	2 (0.2)	Reactive	Nonreactive	Reactive	Nonreactive
7	2 (0.2)	Reactive	Reactive	Nonreactive	Nonreactive
8	1 (0.1)	Reactive	Reactive	Nonreactive	Reactive
Total	1,147 (100.0)

Table 2

Classification of Mediace RPR positive samples (n=119) based on reactivity to three treponemal assays, ADVIA Centaur Syphilis, Mediace TPLA, and IMMULITE 2000 Syphilis Screen

Specimen group	Number of specimens (%)	Treponemal assay
Specimen group	Number of specimens (%)	ADVIA Centaur Syphilis	Mediace TPLA	IMMULITE 2000 Syphilis Screen
1	12 (10.1)	Nonreactive	Nonreactive	Nonreactive
2	100 (84.0)	Reactive	Reactive	Reactive
3	1 (0.8)	Reactive	Nonreactive	Nonreactive
4	4 (3.4)	Nonreactive	Reactive	Nonreactive
5	1 (0.8)	Reactive	Nonreactive	Reactive
6	1 (0.8)	Reactive	Reactive	Nonreactive
Total	119 (100.0)

Table 3

Consensus classification of all samples (n=1,266) on the basis of the majority results for reactivity to three treponemal assays, ADVIA Centaur Syphilis, Mediace TPLA, and IMMULITE 2000 Syphilis Screen, and Mediace RPR

Specimen group	Number of specimens (%)	Treponemal assay			Mediace RPR	Final decision^*
Specimen group	Number of specimens (%)	Centaur Syphilis	Mediace TPLA	IMMULITE Syphilis	Mediace RPR	Final decision^*
1	1,121 (88.5)	Nonreactive	Nonreactive	Nonreactive	Nonreactive	Nonreactive
2	12 (0.9)	Nonreactive	Nonreactive	Nonreactive	Reactive	Nonreactive
3	13 (1.0)	Reactive	Reactive	Reactive	Nonreactive	Reactive
4	101 (8.0)	Reactive	Reactive	Reactive	Reactive	Reactive
5	5 (0.5)	Reactive	Nonreactive	Nonreactive	Nonreactive	Nonreactive
6	1 (0.1)	Reactive	Nonreactive	Nonreactive	Reactive	Indeterminate
7	2 (0.2)	Reactive	Nonreactive	Reactive	Nonreactive	Indeterminate
8	1 (0.1)	Reactive	Nonreactive	Reactive	Reactive	Reactive
9	2 (0.2)	Reactive	Reactive	Nonreactive	Nonreactive	Indeterminate
10	2 (0.2)	Reactive	Reactive	Nonreactive	Reactive	Reactive
11	4 (0.3)	Nonreactive	Reactive	Nonreactive	Nonreactive	Nonreactive
12	2 (0.2)	Nonreactive	Reactive	Nonreactive	Reactive	Indeterminate
Total	1,266 (100.0)

^*The final classification of a specimen was positive when three treponemal assays showed reactivity, or two of three treponemal assays and Mediace RPR showed reactivity; the specimens were classified as negative when three treponemal assays showed non-reactivity, or two of three treponemal assays and Mediace RPR showed non-reactivity.

Table 4

Concordance among three treponemal assays

		TPLA^*		Agreement (%)	kappa		Immulite^†		Agreement (%)	kappa
		N	P	Agreement (%)	kappa		N	P	Agreement (%)	kappa
Centaur^‡	N	1,133	6	98.8	0.934	N	1,139	0	99.2	0.955
	P	9	118			P	10	117
Immulite^†	N	1,139	10	99.0	0.940
	P	3	114

^*TPLA, Mediace TPLA; ^†Immulite, IMMULITE 2000 Syphilis Screen; ^‡Centaur, ADVIA Centaur Syphilis.

Abbreviations: N, negative; P, positive; TPLA, Treponema pallidum latex agglutination.

Notes

This article is available from http://www.labmedonline.org

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