Evaluation of AutoLab Rapid Plasma Reagin and AutoLab Treponema pallidum Latex Agglutination for Syphilis Infection Testing.
10.15263/jlmqa.2015.37.1.29
- Author:
Mi Jung PARK
1
;
Pil Whan PARK
;
Yiel Hea SEO
;
Jeong Yeal AHN
;
Kyung Hee KIM
;
Ja Young SEO
;
Ji Hun JEONG
;
Moon Jin KIM
;
Hwan Tae LEE
Author Information
1. Department of Laboratory Medicine, Gachon University Gil Medical Center, Gachon University, Incheon, Korea. pwpark@gilhospital.com
- Publication Type:Original Article
- Keywords:
Rapid plasma reagin;
Treponema pallidum latex agglutination;
Syphilis
- MeSH:
Agglutination*;
Diagnosis;
Humans;
Latex*;
Limit of Detection;
Plasma*;
Serologic Tests;
Syphilis*;
Treponema pallidum*
- From:Journal of Laboratory Medicine and Quality Assurance
2015;37(1):29-36
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND: Automated assays have recently been developed for efficient serological testing of syphilis infection. Here, we evaluate the performance of new automated serological assays for syphilis infection. METHODS: The precision, linearity, and detection limit of the automated kits AutoLab rapid plasma reagin (RPR) (IVD-RPR) and AutoLab (Treponema pallidum Latex Agglutination) TPLA (IVD-TPLA) (IVDLab Co., Korea) were evaluated using an immunoturbidimetric method. In addition, the results of these tests were compared with those obtained using the HiSens Auto RPR LTIA (HBi-RPR) and HiSens Auto TP LTIA (HBi-TPLA) tests (HBi Co., Korea) with 122 serum samples. RESULTS: Both the IVD-RPR and IVD-TPLA kits showed acceptable precision for the positive controls (IVDLab Co., Korea). The within-run and total precision of IVD-RPR were better than those of HBi-RPR at cut-off levels (CV, 7.0% to 7.4% for IVD-RPR; CV, 33.3% to 40.0% for HBi-RPR). The IVD-RPR and IVD-TPLA kits demonstrated acceptable linearity and limits of detection. The agreement rate between IVD-RPR and HBi-RPR was 83.60% (102/122). Nineteen samples were IVD-RPR negative but HBi-RPR positive; 12 of these were from patients with a history of syphilis. The agreement rate between IVD-TPLA and HBi-TPLA was 96.72% (118/122). All discrepant results were IVD-TPLA positive and HBi-TPLA negative. CONCLUSIONS: IVD-RPR and IVD-TPLA exhibited acceptable precision, linearity, and limits of detection for the diagnosis of syphilis infection. IVD-RPR was suitable for monitoring syphilis infections with good precision that was near cut-off levels. IVD-TPLA was useful for detecting primary syphilis infection.
