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Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay

Year 2018, Volume: 2 Issue: 1, 1 - 6, 01.03.2018
https://doi.org/10.30621/jbachs.2018.277

Abstract

Purpose: The use of Architect Syphilis TP CMIA in the blood bank raised the number of syphilis positive samples requiring confirmation. The aim of this study is to determine a sample-to-cutoff s/co ratio for CMIA predicting ≥95% of true-positive samples to reduce these samples.Methods: CMIA reactive samples n=177 were evaluated by Western blot WB as the reference standard, as well as by Treponema pallidum hemagglutination TPHA and Rapid Plasma Reagin RPR tests. The s/co ratio predicting ≥95% of true-positive samples was defined as the threshold leaving ≥95% of WB confirmed samples greater than the particular value. The performances of TPHA and RPR tests were also evaluated with respect to s/co ratios of CMIA positive samples.Results: The s/co ratio 15.17 predicted a true-positive result for ≥95% of samples tested 95% confidence interval: 85.9–99.3 and reduced the number of samples requiring confirmation by 29.9%. Higher s/co ratios were correlated with the increasing number of bands on WB strips p95% of positive samples with s/co ratios ≥15, its sensitivity was 47.7%.Conclusion: Higher s/co ratios can be used to define true-positivity and may indicate an active infection. TPHA may replace WB to confirm samples with s/co ratios between 3 and 15. RPR should not be used as a screening test in blood banks as it could miss almost half of the truepositive samples

References

  • World Health Organization. Department of HIV/AIDS. Global prevalence and incidence of selected curable sexually transmitted infections: overview and estimates. Geneva, Switzerland: WHO; 2001. Available from: http://www.who.int/reproductivehealth/ publications/rtis/HIV_AIDS_2001_2/en/ Accessed: November 29, 2017.
  • World Health Organization. Screening donated blood for transfusion- transmissible infections: recommendations. Geneva, Switzerland: WHO; 2009. Available from: http://www.who.int/bloodsafety/ ScreeningTTI.pdf Accessed: November 29, 2017.
  • Centers for Disease Control and Prevention. Syphilis testing algorithms using treponemal tests for initial screening –four laboratories, New York City, 2005–2006. MMWR Morb Mortal Wkly Rep 2008;57:872–875.
  • French P, Gomberg M, Janier M, et al. IUSTI: 2008 European Guidelines on the Management of Syphilis. Int J STD AIDS 2009;20:300–309. [CrossRef]
  • de Lemos EA, Belém ZR, Santos A, Ferreira AW. Characterization of the Western blotting IgG reactivity patterns in the clinical phases of acquired syphilis. Diagn Microbiol Infect Dis 2007;58:177–183. [CrossRef]
  • Wang LN, Li JM. Evaluation of immunoglobulin M and G Western blot and ELISA for screening antibodies to Treponema pallidum in blood donors. Sex Transm Dis 2009;36:413–416. [CrossRef]
  • Welch RJ, Litwin CM. Evaluation of two immunoblot assays and a Western blot assay for the detection of antisyphilis immunoglobulin g antibodies. Clin Vaccine Immunol 2010;17:183–184. [CrossRef]
  • Backhouse JL, Nesteroff SI. Treponema pallidum western blot: comparison with the FTA-ABS test as a confirmatory test for syphilis. Diagn Microbiol Infect Dis 2001;39:9–14.
  • Young H, Pryde J, Duncan L, Dave J. The Architect Syphilis assay for antibodies to Treponema pallidum: an automated screening assay with high sensitivity in primary syphilis. Sex Transm Infect 2009;85:19–23. [CrossRef]
  • Marangoni A, Moroni A, Accardo S, Cevenini R. Laboratory diagnosis of syphilis with automated immunoassays. J Clin Lab Anal 2009;23:1– 6. [CrossRef]
  • Alter MJ, Kuhnert WL, Finelli L; Centers for Disease Control and Prevention. Guidelines for laboratory testing and results reporting of antibody to hepatitis C virus. Centers for Disease Control and Prevention. MMWR Recomm Rep 2003;52:1–15.
  • Kiely P, Walker K, Parker S, Cheng A. Analysis of sample-to-cutoff ratios on chemiluminescent immunoassays used for blood donor screening highlights the need for serologic confirmatory testing. Transfusion 2010;50:1344–1351. [CrossRef]
  • Oncul O, Emekdas G, Cavuslu S, Artuk C, Aksoy A. The sixteen- year trend of syphilis in Turkey: data from blood donors. Trop Doct 2008;38:181–182. [CrossRef]
  • Kocak N, Hepgul S, Ozbayburtlu S, et al. Trends in major transfusion- transmissible infections among blood donors over 17 years in Istanbul, Turkey. J Int Med Res 2004;32:671–675. [CrossRef]
  • Gok G, Yurdakul B, Dundar IH, et al. Evaluation of Turkish Red Crescent Aegean Regional Blood Bank donor screening results. Proceeding of the Second National Blood Centers and Transfusion Medicine Congress; 2007 Nov 15–19 Antalya, Turkey. p.206–261.
  • McGill MA, Edmondson DG, Carroll JA, Cook RG, Orkiszewski RS, Norris SJ. Characterization and serologic analysis of the Treponema pallidum proteome. Infect Immun 2010;78:2631–2643. [CrossRef]
  • Kingston M, French P, Goh B, et al.; Syphilis Guidelines Revision Group 2008, Clinical Effectiveness Group. UK National Guidelines on the Management of Syphilis 2008. Int J STD AIDS 2008;19:729–740. [CrossRef]
  • Maple PA, Ratcliffe D, Smit E. Characterization of Treponema pallidum particle agglutination assay-negative sera following screening by treponemal total antibody enzyme immunoassays. Clin Vaccine Immunol 2010;17:1718–1722. [CrossRef]
  • Sánchez PJ, Wendel GD Jr, Grimprel E, et al. Evaluation of molecular methodologies and rabbit infectivity testing for the diagnosis of congenital syphilis and neonatal central nervous system invasion by Treponema pallidum. J Infect Dis 1993;167:148–157.
  • McKevitt M, Brinkman MB, McLoughlin M, et al. Genome scale identification of Treponema pallidum antigens. Infect Immun 2005;73:4445–4450. [CrossRef]
  • Brinkman MB, McKevitt M, McLoughlin M, et al. Reactivity of antibodies from syphilis patients to a protein array representing the Treponema pallidum proteome. J Clin Microbiol 2006;44:888–891. [CrossRef]
Year 2018, Volume: 2 Issue: 1, 1 - 6, 01.03.2018
https://doi.org/10.30621/jbachs.2018.277

Abstract

References

  • World Health Organization. Department of HIV/AIDS. Global prevalence and incidence of selected curable sexually transmitted infections: overview and estimates. Geneva, Switzerland: WHO; 2001. Available from: http://www.who.int/reproductivehealth/ publications/rtis/HIV_AIDS_2001_2/en/ Accessed: November 29, 2017.
  • World Health Organization. Screening donated blood for transfusion- transmissible infections: recommendations. Geneva, Switzerland: WHO; 2009. Available from: http://www.who.int/bloodsafety/ ScreeningTTI.pdf Accessed: November 29, 2017.
  • Centers for Disease Control and Prevention. Syphilis testing algorithms using treponemal tests for initial screening –four laboratories, New York City, 2005–2006. MMWR Morb Mortal Wkly Rep 2008;57:872–875.
  • French P, Gomberg M, Janier M, et al. IUSTI: 2008 European Guidelines on the Management of Syphilis. Int J STD AIDS 2009;20:300–309. [CrossRef]
  • de Lemos EA, Belém ZR, Santos A, Ferreira AW. Characterization of the Western blotting IgG reactivity patterns in the clinical phases of acquired syphilis. Diagn Microbiol Infect Dis 2007;58:177–183. [CrossRef]
  • Wang LN, Li JM. Evaluation of immunoglobulin M and G Western blot and ELISA for screening antibodies to Treponema pallidum in blood donors. Sex Transm Dis 2009;36:413–416. [CrossRef]
  • Welch RJ, Litwin CM. Evaluation of two immunoblot assays and a Western blot assay for the detection of antisyphilis immunoglobulin g antibodies. Clin Vaccine Immunol 2010;17:183–184. [CrossRef]
  • Backhouse JL, Nesteroff SI. Treponema pallidum western blot: comparison with the FTA-ABS test as a confirmatory test for syphilis. Diagn Microbiol Infect Dis 2001;39:9–14.
  • Young H, Pryde J, Duncan L, Dave J. The Architect Syphilis assay for antibodies to Treponema pallidum: an automated screening assay with high sensitivity in primary syphilis. Sex Transm Infect 2009;85:19–23. [CrossRef]
  • Marangoni A, Moroni A, Accardo S, Cevenini R. Laboratory diagnosis of syphilis with automated immunoassays. J Clin Lab Anal 2009;23:1– 6. [CrossRef]
  • Alter MJ, Kuhnert WL, Finelli L; Centers for Disease Control and Prevention. Guidelines for laboratory testing and results reporting of antibody to hepatitis C virus. Centers for Disease Control and Prevention. MMWR Recomm Rep 2003;52:1–15.
  • Kiely P, Walker K, Parker S, Cheng A. Analysis of sample-to-cutoff ratios on chemiluminescent immunoassays used for blood donor screening highlights the need for serologic confirmatory testing. Transfusion 2010;50:1344–1351. [CrossRef]
  • Oncul O, Emekdas G, Cavuslu S, Artuk C, Aksoy A. The sixteen- year trend of syphilis in Turkey: data from blood donors. Trop Doct 2008;38:181–182. [CrossRef]
  • Kocak N, Hepgul S, Ozbayburtlu S, et al. Trends in major transfusion- transmissible infections among blood donors over 17 years in Istanbul, Turkey. J Int Med Res 2004;32:671–675. [CrossRef]
  • Gok G, Yurdakul B, Dundar IH, et al. Evaluation of Turkish Red Crescent Aegean Regional Blood Bank donor screening results. Proceeding of the Second National Blood Centers and Transfusion Medicine Congress; 2007 Nov 15–19 Antalya, Turkey. p.206–261.
  • McGill MA, Edmondson DG, Carroll JA, Cook RG, Orkiszewski RS, Norris SJ. Characterization and serologic analysis of the Treponema pallidum proteome. Infect Immun 2010;78:2631–2643. [CrossRef]
  • Kingston M, French P, Goh B, et al.; Syphilis Guidelines Revision Group 2008, Clinical Effectiveness Group. UK National Guidelines on the Management of Syphilis 2008. Int J STD AIDS 2008;19:729–740. [CrossRef]
  • Maple PA, Ratcliffe D, Smit E. Characterization of Treponema pallidum particle agglutination assay-negative sera following screening by treponemal total antibody enzyme immunoassays. Clin Vaccine Immunol 2010;17:1718–1722. [CrossRef]
  • Sánchez PJ, Wendel GD Jr, Grimprel E, et al. Evaluation of molecular methodologies and rabbit infectivity testing for the diagnosis of congenital syphilis and neonatal central nervous system invasion by Treponema pallidum. J Infect Dis 1993;167:148–157.
  • McKevitt M, Brinkman MB, McLoughlin M, et al. Genome scale identification of Treponema pallidum antigens. Infect Immun 2005;73:4445–4450. [CrossRef]
  • Brinkman MB, McKevitt M, McLoughlin M, et al. Reactivity of antibodies from syphilis patients to a protein array representing the Treponema pallidum proteome. J Clin Microbiol 2006;44:888–891. [CrossRef]
There are 21 citations in total.

Details

Primary Language English
Journal Section Research Article
Authors

İ. Ebru Akçakanat This is me

Özgen Alpay Ozbek This is me

Yavuz Doğan This is me

Yusuf Hakan Abacıoğlu This is me

Publication Date March 1, 2018
Published in Issue Year 2018 Volume: 2 Issue: 1

Cite

APA Akçakanat, İ. E., Ozbek, Ö. A., Doğan, Y., Abacıoğlu, Y. H. (2018). Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay. Journal of Basic and Clinical Health Sciences, 2(1), 1-6. https://doi.org/10.30621/jbachs.2018.277
AMA Akçakanat İE, Ozbek ÖA, Doğan Y, Abacıoğlu YH. Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay. JBACHS. March 2018;2(1):1-6. doi:10.30621/jbachs.2018.277
Chicago Akçakanat, İ. Ebru, Özgen Alpay Ozbek, Yavuz Doğan, and Yusuf Hakan Abacıoğlu. “Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay”. Journal of Basic and Clinical Health Sciences 2, no. 1 (March 2018): 1-6. https://doi.org/10.30621/jbachs.2018.277.
EndNote Akçakanat İE, Ozbek ÖA, Doğan Y, Abacıoğlu YH (March 1, 2018) Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay. Journal of Basic and Clinical Health Sciences 2 1 1–6.
IEEE İ. E. Akçakanat, Ö. A. Ozbek, Y. Doğan, and Y. H. Abacıoğlu, “Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay”, JBACHS, vol. 2, no. 1, pp. 1–6, 2018, doi: 10.30621/jbachs.2018.277.
ISNAD Akçakanat, İ. Ebru et al. “Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay”. Journal of Basic and Clinical Health Sciences 2/1 (March 2018), 1-6. https://doi.org/10.30621/jbachs.2018.277.
JAMA Akçakanat İE, Ozbek ÖA, Doğan Y, Abacıoğlu YH. Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay. JBACHS. 2018;2:1–6.
MLA Akçakanat, İ. Ebru et al. “Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay”. Journal of Basic and Clinical Health Sciences, vol. 2, no. 1, 2018, pp. 1-6, doi:10.30621/jbachs.2018.277.
Vancouver Akçakanat İE, Ozbek ÖA, Doğan Y, Abacıoğlu YH. Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay. JBACHS. 2018;2(1):1-6.