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Improvement of reverse sequence algorithm for syphilis diagnosis using optimal treponemal screening assay signal-to-cutoff ratio.
PLoS One. 2018; 13(9):e0204001.Plos

Abstract

BACKGROUND

Although reverse sequence algorithms (RSA) for syphilis screening are performing well, they still have to rely on treponemal confirmatory tests at least for sera reactive by enzyme immunoassay/chemiluminescence immunoassay (EIA/CIA) and unreactive by rapid plasma reagin (RPR). Quebec's laboratory network previously showed that 3.3% of EIA/CIA reactive and weakly-reactive RPR samples (RPR titer of 1 to 4) would have been misclassified as syphilis cases if a treponemal confirmatory test had not been performed.

OBJECTIVES

To correlate the magnitude of signal-to-cutoff (S/CO) ratios of the 4 most used commercial first-line EIA/CIA kits in Quebec with syphilis confirmation results and establish a S/CO value above which treponemal confirmation would not be required.

METHODS

Serum samples from previously undiagnosed individuals (n = 7 404) obtained between January 2014 and February 2017 that were reactive by EIA/CIA and either negative by RPR or reactive with a low titer (1 to 4) were included in the study. All samples were tested with Treponema pallidum particle agglutination (TP-PA) and, if negative or inconclusive, with a line immunoassay (LIA). Syphilis infection confirmation was defined by a reactive TP-PA or LIA. Logistic regression analysis was used to determine S/CO values (95% CI lower bound = 0.98) above which confirmation would not be required. The four kits studied were Architect TP, BioPlex IgG, Syphilis EIA II, and Trep-Sure.

RESULTS

Of 2609 reactive EIA/CIA specimens tested for the determination of S/CO values, 1730 (66%) were confirmed as true syphilis cases. Confirmation rate was significantly higher in samples with low-titer positive RPR (92%) than with negative RPR samples (54%); p<0.01. A linear probability model (95% CI lower bound = 0.98) predicted the S/CO value above which a confirmation would no longer be needed for the Architect TP (16.4), Bioplex IgG (7.4) and Trep-Sure (24.6). No linearity was observed between the S/CO value of Syphilis EIA II and the confirmation rate. The validity of the predicted S/CO values was investigated using 4 795 specimens. The use of an S/CO value of 16.4 with the Architect TP kit and of 24.6 for the Trep-Sure kit would obviate the need for confirmation of 18.5% and 13.2% of sera from the all RPR subgroup, respectively. For the BioPlex IgG kit, 81.1% of sera would not require confirmation when using the S/CO value of 7.4 in the low titer RPR subgroup.

CONCLUSION

Signal-to-cut-off values could be used to identify sera that do not require extra treponemal confirmation for 3 of the 4 most used first-line EIA/CIA kits in Quebec. Using these values in our current reverse screening algorithm (RSA) would avoid the need for confirmatory tests in 14 to 20% of sera, a proportion that could reach 75% among low-titer RPR.

Authors+Show Affiliations

Laboratoire de santé publique du Québec/Institut national de santé publique du Québec, Sainte-Anne-de-Bellevue, Québec, Canada.CIUSSS de l'Est-de-l'Île-de-Montréal, Hôpital Maisonneuve-Rosemont, Service de Maladies infectieuses et microbiologie médicale, Montréal, Canada.Laboratoire de santé publique du Québec/Institut national de santé publique du Québec, Sainte-Anne-de-Bellevue, Québec, Canada.Unité de surveillance des maladies chroniques et de leur déterminants/Institut national de santé publique du Québec, Québec, Québec, Canada.Unité des infections transmissibles sexuellement et par le sang/Institut national de santé publique du Québec, Montréal, Québec, Canada.Laboratoire de santé publique du Québec/Institut national de santé publique du Québec, Sainte-Anne-de-Bellevue, Québec, Canada.Laboratoire de santé publique du Québec/Institut national de santé publique du Québec, Sainte-Anne-de-Bellevue, Québec, Canada.Centre hospitalier de l'Université de Montréal, Département de microbiologie médicale et infectiologie, Montréal, Québec, Canada.Centre hospitalier de l'Université de Montréal, Département de microbiologie médicale et infectiologie, Montréal, Québec, Canada.

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

30212544

Citation

Serhir, Bouchra, et al. "Improvement of Reverse Sequence Algorithm for Syphilis Diagnosis Using Optimal Treponemal Screening Assay Signal-to-cutoff Ratio." PloS One, vol. 13, no. 9, 2018, pp. e0204001.
Serhir B, Labbé AC, Doualla-Bell F, et al. Improvement of reverse sequence algorithm for syphilis diagnosis using optimal treponemal screening assay signal-to-cutoff ratio. PLoS ONE. 2018;13(9):e0204001.
Serhir, B., Labbé, A. C., Doualla-Bell, F., Simard, M., Lambert, G., Trudelle, A., Longtin, J., Tremblay, C., & Fortin, C. (2018). Improvement of reverse sequence algorithm for syphilis diagnosis using optimal treponemal screening assay signal-to-cutoff ratio. PloS One, 13(9), e0204001. https://doi.org/10.1371/journal.pone.0204001
Serhir B, et al. Improvement of Reverse Sequence Algorithm for Syphilis Diagnosis Using Optimal Treponemal Screening Assay Signal-to-cutoff Ratio. PLoS ONE. 2018;13(9):e0204001. PubMed PMID: 30212544.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improvement of reverse sequence algorithm for syphilis diagnosis using optimal treponemal screening assay signal-to-cutoff ratio. AU - Serhir,Bouchra, AU - Labbé,Annie-Claude, AU - Doualla-Bell,Florence, AU - Simard,Marc, AU - Lambert,Gilles, AU - Trudelle,Annick, AU - Longtin,Jean, AU - Tremblay,Cécile, AU - Fortin,Claude, Y1 - 2018/09/13/ PY - 2017/11/01/received PY - 2018/08/31/accepted PY - 2018/9/14/entrez PY - 2018/9/14/pubmed PY - 2019/3/7/medline SP - e0204001 EP - e0204001 JF - PloS one JO - PLoS ONE VL - 13 IS - 9 N2 - BACKGROUND: Although reverse sequence algorithms (RSA) for syphilis screening are performing well, they still have to rely on treponemal confirmatory tests at least for sera reactive by enzyme immunoassay/chemiluminescence immunoassay (EIA/CIA) and unreactive by rapid plasma reagin (RPR). Quebec's laboratory network previously showed that 3.3% of EIA/CIA reactive and weakly-reactive RPR samples (RPR titer of 1 to 4) would have been misclassified as syphilis cases if a treponemal confirmatory test had not been performed. OBJECTIVES: To correlate the magnitude of signal-to-cutoff (S/CO) ratios of the 4 most used commercial first-line EIA/CIA kits in Quebec with syphilis confirmation results and establish a S/CO value above which treponemal confirmation would not be required. METHODS: Serum samples from previously undiagnosed individuals (n = 7 404) obtained between January 2014 and February 2017 that were reactive by EIA/CIA and either negative by RPR or reactive with a low titer (1 to 4) were included in the study. All samples were tested with Treponema pallidum particle agglutination (TP-PA) and, if negative or inconclusive, with a line immunoassay (LIA). Syphilis infection confirmation was defined by a reactive TP-PA or LIA. Logistic regression analysis was used to determine S/CO values (95% CI lower bound = 0.98) above which confirmation would not be required. The four kits studied were Architect TP, BioPlex IgG, Syphilis EIA II, and Trep-Sure. RESULTS: Of 2609 reactive EIA/CIA specimens tested for the determination of S/CO values, 1730 (66%) were confirmed as true syphilis cases. Confirmation rate was significantly higher in samples with low-titer positive RPR (92%) than with negative RPR samples (54%); p<0.01. A linear probability model (95% CI lower bound = 0.98) predicted the S/CO value above which a confirmation would no longer be needed for the Architect TP (16.4), Bioplex IgG (7.4) and Trep-Sure (24.6). No linearity was observed between the S/CO value of Syphilis EIA II and the confirmation rate. The validity of the predicted S/CO values was investigated using 4 795 specimens. The use of an S/CO value of 16.4 with the Architect TP kit and of 24.6 for the Trep-Sure kit would obviate the need for confirmation of 18.5% and 13.2% of sera from the all RPR subgroup, respectively. For the BioPlex IgG kit, 81.1% of sera would not require confirmation when using the S/CO value of 7.4 in the low titer RPR subgroup. CONCLUSION: Signal-to-cut-off values could be used to identify sera that do not require extra treponemal confirmation for 3 of the 4 most used first-line EIA/CIA kits in Quebec. Using these values in our current reverse screening algorithm (RSA) would avoid the need for confirmatory tests in 14 to 20% of sera, a proportion that could reach 75% among low-titer RPR. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/30212544/Improvement_of_reverse_sequence_algorithm_for_syphilis_diagnosis_using_optimal_treponemal_screening_assay_signal_to_cutoff_ratio_ L2 - http://dx.plos.org/10.1371/journal.pone.0204001 DB - PRIME DP - Unbound Medicine ER -