Evaluation of Three Automated Nontreponemal Rapid Plasma Reagin (RPR) Tests for the Laboratory Diagnosis of Syphilis

Author:

Shukla Mayur R.1ORCID,Pereira Lara1,Gaynor Anne M.2,Sun Yongcheng1,Edwards Daniel3,Simmons Tamara4,Andrews Curtis W.5,Park Ina U.1,Hong Jaeyoung1,Cao Weiping1,Kersh Ellen N.1ORCID,Fakile Yetunde1

Affiliation:

1. Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

2. Association of Public Health Laboratories, Silver Spring, Maryland, USA

3. Oklahoma State Department of Health, Oklahoma City, Oklahoma, USA

4. Georgia Public Health Laboratory, Decatur, Georgia, USA

5. Alabama Department of Public Health, Mobile, Alabama, USA

Abstract

Automated nontreponemal rapid plasma reagin (RPR) tests were recently introduced in the United States for syphilis testing and limited performance data are available. In collaboration with the Association of Public Health Laboratories, three public health laboratories (PHL) were chosen through a competitive selection process to evaluate the performance of three FDA-cleared automated RPR test systems: BioPlex 2200 Syphilis Total & RPR assay (Bio-Rad Laboratories), AIX 1000 (Gold Standard Diagnostics), and ASI Evolution (Arlington Scientific).

Funder

HHS | Centers for Disease Control and Prevention

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference24 articles.

1. CDC. 2023. National overview of STDs 2021. https://www.cdc.gov/std/statistics/2021/overview.htm. Accessed 17 April 2023.

2. The Laboratory Diagnosis of Syphilis

3. Larsen SA, Johnson RE. 1998. Diagnostic tests, p 2–52. In Larsen SAPV, Johnson RE, Kennedy EJ (ed), A manual of tests for syphilis, 9th ed American Public Health Association, Washington, DC.

4. CDC. 2022. Sexually transmitted infections treatment guidelines 2021. https://www.cdc.gov/std/treatment-guidelines/syphilis.htm. Accessed 7 November 2022.

5. Development of a novel magnetic particle-based agglutination immunoassay for anticardiolipin antibody detection in syphilis

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