Evaluation of an automated chemiluminescence assay for detection of syphilis infection from blood donors at 108 Military Central Hospital

  • Le Huy Khoi 108 Military Central Hospital
  • Do Giang Binh 108 Military Central Hospital
  • Nguyen Xuan Thanh 108 Military Central Hospital
  • Vu Hoang Trung Thai Nguyen University of Medicine and Pharmacy
  • Pham Thi Thu Huong 108 Military Central Hospital
  • Vu Xuan Nghia 108 Military Central Hospital

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Keywords

Blood donor, syphilis, VITROS(®) syphilis TPA

Abstract

Objective: The aim of this study was to evaluate VITROS(®) syphilis Treponema pallidum agglutination (VITROS(®) syphilis TPA) assay based on enhanced chemiluminescence principle for detection of syphilis infection in blood donors. Subject and method: A total of 110 random blood samples collected from the blood donors and 30 syphilis known sero-reactive samples stored at -20°C, were used to evaluate the performance of VITROS(®) syphilis TPA assay based on enhanced chemiluminescence assay on VITROS(®) immunodiagnostics system to analyze the terms of its sensitivity, precision, cross-reactivity and interference studies. Result: The results showed that VITROS(®) syphilis TPA got 100% sensitivity and specificity with precision (20 days study) of < 10% co-efficient of variation. There was no cross-reactivity with other viral and auto-immune antibodies. No interference was observed from endogenous interfering substances like free hemoglobin or fats. Conclusion: The results suggested that VITROS(®) syphilis TPA should be done to further reduce the risk of transfusion-transmitted TP infection, decrease unnecessary blood waste and loss of blood donors.

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References

1. David HD and Joy HG (1990) Congenital syphilis presenting in infants after the newborn period. Engl J Med 323: 1299-1302.
2. Egglestone SI et al (2000) Serological diagnosis of syphilis communicable disease and public health. Commun Dis Public Health 3(3): 158-162.
3. Lesinski J, Krach J, Kadziewicz E (1974) Specificity, sensitivity, and diagnostic value of the TPHA test. Br J Vener Dis 50: 334-340.
4. Castro R, Prieto ES, Santo I, Azevedo J, Exposto Fda L (2003) Evaluation of an enzyme immunoassay technique for detection of antibodies against Treponema pallidum. J Clin Microbiol 41: 250-253.
5. Lefevre JC, Bertrand MA, Bauriaud R (1990) Evaluation of the Captia enzyme immunoassays for detection of immunoglobulins G and M to Treponema pallidum in syphilis. J Clin Microbiol 28: 1704-1707.
6. Young H, Pryde J, Duncan L, Dave J (2009) The architect syphilis assay for antibodies to Treponema pallidum: An automated screening assay with high sensitivity in primary syphilis. Sex Transm Infect 85: 19-23.
7. Pope V (2004) Use of treponemal tests to screen for syphilis. Infect Med 21: 399-404.
8. Reisner BS, Mann LM, Tholcken CA, Waite RT, Woods GL (1997) Use of the Treponema pallidum-specific captia syphilis IgG assay in conjunction with the rapid plasma reagin to test for syphilis. J Clin Microbiol 35: 1141-1143.
9. Knight CS, Crum MA, Hardy RW (2007) Evaluation of the LIAISON chemiluminescence immunoassay for diagnosis of syphilis. Clin Vaccine Immunol 14: 710-713.
10. VITROS® Immunodiagnostic Products Syphilis TPA Assay [Package Insert]. New Brunswick, NJ: Ortho-Clinical Diagnostics, Inc.; 2011.