Establishment and Multicenter Evaluation of a National Reference Panel for Syphilis Antibodies in Korea

Hee Jin Huh; Seok Lae Chae; Deok-Ja Oh; Quehn Park; Chae Seung Lim; Tae Hyun Um; Yun Mi Park; Young Joo Cha

doi:10.3343/lmo.2014.4.1.36

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Huh, Chae, Oh, Park, Lim, Um, Park, and Cha: Establishment and Multicenter Evaluation of a National Reference Panel for Syphilis Antibodies in Korea

Original Article

Diagnostic Immunology

Laboratory Medicine Online 2014; 4(1): 36-42.

Published online: 1 January 2014

DOI: https://doi.org/10.3343/lmo.2014.4.1.36

Establishment and Multicenter Evaluation of a National Reference Panel for Syphilis Antibodies in Korea

Hee Jin Huh, M.D.¹, Seok Lae Chae, M.D.¹, Deok-Ja Oh, M.D.², Quehn Park, M.D.³, Chae Seung Lim, M.D.⁴, Tae Hyun Um, M.D.⁵, Yun Mi Park, M.D.⁶, Young Joo Cha, M.D.⁷

¹Department of Laboratory Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.

²KRC Jung-Bu Blood Laboratory Center, Daejeon, Korea.

³Department of Laboratory Medicine, Chung-Ang University Hospital, Seoul, Korea.

⁴Department of Laboratory Medicine, Korea University Guro Hospital, Seoul, Korea.

⁵Department of Laboratory Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea.

⁶Siemens Healthcare, Seoul, Korea.

⁷Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.

Corresponding author: Young Joo Cha. Department of Laboratory Medicine, Chung-Ang University College of Medicine, 102 Heukseok-ro, Dongjak-gu, Seoul 156-755, Korea. Tel: +82-2-6299-2720, Fax: +82-2-6298-8630, chayoung@cau.ac.kr

Received 22 November 2012 Revised 27 April 2013 Accepted 27 April 2013

(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

Establishment of a national reference panel for syphilis antibodies is necessary to evaluate the performance of in-vitro diagnostic tests for syphilis and to verify test quality. This study aimed to establish a national reference panel for syphilis antibodies, to assess the suitability of a panel for non-treponemal and treponemal testing, and to assess the reactivity of the various tests currently in use.

Methods

Treponemal pallidum particle agglutination (TPPA)-positive and -negative fresh frozen plasma samples were obtained. After the fresh frozen plasma was converted to serum by defibrination, the samples were pooled. Two candidate reference standards containing no syphilis antibodies and 10 candidate reference standards containing syphilis antibodies were prepared on the basis of reactivity in the TPPA assay. Candidate reference standards were tested by three laboratories using five non-treponemal tests and four treponemal tests.

Results

All three laboratories reported positive non-treponemal test results for the mixed-titer performance panel (MP)/6-MP/12. MP/1, MP/2, and MP/3 were negative for non-treponemal tests. MP/4 and MP/5 were reported either as positive or negative according to the laboratories. All laboratories reported positive TPPA results for MP/3-MP/12 and negative results for MP/1 and MP/2. No significant difference was detected among the treponemal testing results in three laboratories.

Conclusions

We established 12 candidate national reference standards containing various concentrations of syphilis antibodies. A collaborative study using nine tests demonstrated that 12 candidate national reference standards presented consistent results, except a few assays with low sensitivity, and thus could be used as a national reference panel for syphilis antibody testing.

Keywords: Syphilis, National reference standard, Reference panel, Treponemal test, Non-treponemal test

Figures and Tables

Table 1

Results of TPPA and Mediace RPR for selected fresh frozen plasma

^*Spiking with fresh frozen plasma containing high titers of non-treponemal antibodies.

Abbreviations: MP, mixed titer performance panel; TPPA, Treponemal pallidum particle agglutination; RPR, rapid plasma reagin; N, negative.

Table 2

Assays used in the multicenter study

Abbreviations: RPR, rapid plasma reagin; VDRL, Venereal Disease Research Laboratory; TIA, turbidoimmunoassay; ICA, immunochromatography assay; TPPA, Treponemal pallidum particle agglutination; CMIA, chemiluminescent microparticle immunoassay; TPLA, T. pallidum latex agglutination.

Table 3

Results of RPR card and VDRL

Abbreviations: RPR, rapid plasma reagin; MP, mixed titer performance panel; N, negative; VDRL, Venereal Disease Research Laboratory; WP, weak positive.

Table 4

Results of Mediace RPR (Sekisui)

Abbreviations: RPR, rapid plasma reagin card; MP, mixed titer performance panel; N, negative.

Table 5

Results of TPPA (Fujirebio)

Abbreviations: TPPA, Treponemal pallidum particle agglutination; MP, mixed titer performance panel; N, negative.

Table 6

Results of Mediace TPLA (Sekisui)

Abbreviations: TPLA, T. pallidum latex agglutination; MP, mixed titer performance panel; N, negative.

Table 7

Results of CMIA (Abbott)

Abbreviations: CMIA, chemiluminescent microparticle immunoassay; MP, mixed titer performance panel; N, negative.

Notes

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

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