Display options
Cite
Tiwari AK, Pandey PK, Dara RC, et al. Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital. Asian J Transfus Sci. 2015;9(1):65-9doi: 10.4103/0973-6247.150955.
Tiwari, A. K., Pandey, P. K., Dara, R. C., Rawat, G. S., Raina, V., & Bhargava, R. (2015). Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital. Asian journal of transfusion science, 9(1), 65-9. https://doi.org/10.4103/0973-6247.150955
Tiwari, Aseem K, et al. "Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital." Asian journal of transfusion science vol. 9,1 (2015): 65-9. doi: https://doi.org/10.4103/0973-6247.150955
Tiwari AK, Pandey PK, Dara RC, Rawat GS, Raina V, Bhargava R. Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital. Asian J Transfus Sci. 2015 Jan-Jun;9(1):65-9. doi: 10.4103/0973-6247.150955. PMID: 25722576; PMCID: PMC4339936.
Copy Download .nbib Format: NLM
Share it on

Asian J Transfus Sci. 2015 Jan-Jun;9(1):65-9. doi: 10.4103/0973-6247.150955.

Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital.

Asian journal of transfusion science

Aseem K Tiwari, Prashant K Pandey, Ravi C Dara, Ganesh S Rawat, Vimarsh Raina, Richa Bhargava

Affiliations

  1. Department of Transfusion Medicine, Medanta, The Medicity, Gurgaon, Haryana, India.
  2. Department of Laboratory and Transfusion Services, Medanta, The Medicity, Gurgaon, Haryana, India.
  3. Department of Gastroenterology, Medanta, The Medicity, Gurgaon, Haryana, India.

PMID: 25722576 PMCID: PMC4339936 DOI: 10.4103/0973-6247.150955

Abstract

CONTEXT: Syphilis is a transfusion transmissible infections and it is mandatory to do serological test for syphilis (STS) on all donor blood samples. STS is usually based on detection of antibodies against the cardiolipin-lecithin antigen or against the Treponema-specific antigen. STS with good sensitivity and specificity helps enhance blood safety and consolidation of STS along with other transfusion transmittable infections such as human immunodeficiency virus, hepatitis-C virus, and hepatitis-B virus helps in reducing the errors and enhances efficiency.

AIMS: This study was designed to evaluate the performance of newly introduced VITROS(®) syphilis Treponema pallidum agglutination (TPA) assay based on enhanced chemiluminescence principle for its analytical performance for use as a STS on donor blood samples at a tertiary care health center in National Capital Region, India.

MATERIALS AND METHODS: A total of 108 random blood units collected from the donors (both voluntary and replacement donors) and 28 known syphilis 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(®) ECiQ immunodiagnostics system along with its analytical performance in terms of its sensitivity, precision, cross-reactivity and interference studies.

RESULTS: VITROS(®) syphilis TPA showed 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.

CONCLUSIONS: Performance of the VITROS(®) syphilis TPA assay meets the requirements for its use as STS in blood bank, thus allowing consolidation with other transfusion transmittable infections screening assay on chemiluminescence platform, which is highly valuable for optimizing workflow and efficiency.

Keywords: Non-treponemal test; serological test for syphilis; treponemal test

References

  1. J Clin Microbiol. 1997 May;35(5):1141-3 - PubMed
  2. J Clin Microbiol. 2003 Jan;41(1):250-3 - PubMed
  3. World J Gastroenterol. 2007 Jul 21;13(27):3730-3 - PubMed
  4. J Clin Microbiol. 1990 Aug;28(8):1704-7 - PubMed
  5. Sex Transm Infect. 2009 Feb;85(1):19-23 - PubMed
  6. Clin Microbiol Rev. 1999 Apr;12(2):187-209 - PubMed
  7. Br J Vener Dis. 1974 Oct;50(5):334-40 - PubMed
  8. J Vener Dis Inf. 1946 Jul;27(7):169-74 - PubMed
  9. Clin Vaccine Immunol. 2007 Jun;14(6):710-3 - PubMed
  10. Trop Doct. 2009 Jul;39(3):152-4 - PubMed
  11. Indian J Pathol Microbiol. 1999 Oct;42(4):411-6 - PubMed
  12. Indian J Med Sci. 2004 Jun;58(6):255-7 - PubMed
  13. Public Health Rep. 1964 May;79:410-2 - PubMed
  14. Indian J Pathol Microbiol. 2010 Apr-Jun;53(2):308-9 - PubMed

Publication Types