Economic Assessment of Reverse Algorithm Syphilis Screening in a High Prevalence Population

Buono, Sean; Basurto‐Dávila, Ricardo; Godwin, Hilary; Green, Nicole M.

doi:10.1097/olq.0000000000000875

Cited by 7 publications

(7 citation statements)

References 17 publications

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“…On the heels of groundbreaking advances in the cultivation and genomic analysis of T. pallidum, [16][17][18] the development of new, highly sensitive, and specific treponemal immunoassays promised accuracy, efficiency, and cost savings for highvolume laboratories. 19 The Abbott ARCHITECT syphilis TP chemiluminescent immunoassay is highly precise and accurate for laboratory diagnosis of past or current syphilis in pregnancy when compared with reference standard TPPA, and relative S/CO ratio may be useful in identifying cases of clinically infectious syphilis to aid in triage and management of exposed neonates. Importantly, a thorough clinical history and staging evaluation by the obstetrician remains essential for early identification and treatment of the pregnant patient with syphilis.…”

Section: Discussionmentioning

confidence: 99%

Abbott ARCHITECT Syphilis TP Chemiluminescent Immunoassay Accurately Diagnoses Past or Current Syphilis in Pregnancy

et al. 2020

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Objective We evaluate diagnostic accuracy of the ARCHITECT chemiluminescent immunoassay (CIA) screening test in pregnancy, and evaluate pregnancy outcomes among screen-positive women. Study Design Samples from routine prenatal rapid plasma reagin (RPR) tests were collected between June 22 and August 18, 2017 and frozen. Samples were batch-tested with the Abbott ARCHITECT syphilis TP immunoassay (CIA, index test). We calculated sensitivity, specificity, predictive value, and false positivity. We compared pregnancy and neonatal outcomes among screen-positive women. Results Of 1,602 specimens, 35 (2.2%) were RPR + ; of those, 24 (69%) were CIA +/Treponema pallidum particle agglutination assay (TPPA)+ and 11 (31%) were CIA-/TPPA-. Of 1,567 RPR- specimens, 14 (0.9%) were CIA + ; of those, 13 (93%) were TPPA + , and one (7%) had a false positive CIA test. Sensitivity of the CIA (95% CI) was 100% (90.5–100%), specificity 99.9% (99.6–100%), positive predictive value 97.4% (86.2–99.9%), and false positive rate 0.06% (0.002–0.4%) for current or past syphilis. Among 37 CIA +/TPPA+ women, seven (19%) had RPR-negative status (Group 1), 11 (30%) had previously treated syphilis (Group 2), and 19 (51%) had active infection (Group 3). One stillbirth occurred in a woman with early, active syphilis identified at delivery; no adverse perinatal outcomes occurred among women in Groups 1 or 2. Conclusion The ARCHITECT syphilis TP immunoassay accurately diagnoses current or past syphilis in pregnancy. Clinical history and staging remain essential using a reverse algorithm.

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Section: Discussionmentioning

confidence: 99%

Abbott ARCHITECT Syphilis TP Chemiluminescent Immunoassay Accurately Diagnoses Past or Current Syphilis in Pregnancy

et al. 2020

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“…These data are not consistent with a study that reported the reverse sequence algorithm as being cost-effective when applied to screening lower-prevalence prenatal and nonprenatal populations with a syphilis prevalence of 0.076% and 1.94%, respectively ( 90 ). In an economic impact model on a local sexually transmitted diseases (STD) program in Los Angeles County, California, the reverse algorithm was less expensive and identified more patients for treatment if the cost of the treponemal test was $1.67 less than the nontreponemal (lipoidal antigen) test cost of $5.80 ( 91 ). Testing, treatment, and follow-up costs were included in the analysis.…”

Section: Recommendations For Syphilis Testing In the United Statesmentioning

confidence: 99%

CDC Laboratory Recommendations for Syphilis Testing, United States, 2024

Papp,

Park,

Fakile

et al. 2024

MMWR Recomm. Rep.

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Summary This report provides new CDC recommendations for tests that can support a diagnosis of syphilis, including serologic testing and methods for the identification of the causative agent Treponema pallidum . These comprehensive recommendations are the first published by CDC on laboratory testing for syphilis, which has traditionally been based on serologic algorithms to detect a humoral immune response to T. pallidum . These tests can be divided into nontreponemal and treponemal tests depending on whether they detect antibodies that are broadly reactive to lipoidal antigens shared by both host and T. pallidum or antibodies specific to T. pallidum , respectively. Both types of tests must be used in conjunction to help distinguish between an untreated infection or a past infection that has been successfully treated. Newer serologic tests allow for laboratory automation but must be used in an algorithm, which also can involve older manual serologic tests. Direct detection of T. pallidum continues to evolve from microscopic examination of material from lesions for visualization of T. pallidum to molecular detection of the organism. Limited point-of-care tests for syphilis are available in the United States; increased availability of point-of-care tests that are sensitive and specific could facilitate expansion of screening programs and reduce the time from test result to treatment. These recommendations are intended for use by clinical laboratory directors, laboratory staff, clinicians, and disease control personnel who must choose among the multiple available testing methods, establish standard operating procedures for collecting and processing specimens, interpret test results for laboratory reporting, and counsel and treat patients. Future revisions to these recommendations will be based on new research or technologic advancements for syphilis clinical laboratory science.

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“…A study in Canada concluded that the reverse algorithm was more cost-effective than the traditional algorithm (Chuck et al, 2008). In contrast, a study in the U.S. reported that the reverse algorithm would be more expensive in terms of public health (Buono et al, 2018). Despite the slight increase in false-positive cases, the reverse algorithm can detect substantial cases missed by the traditional algorithm.…”

Section: Algorithmsmentioning

confidence: 99%

Evaluation of the Elecsys Syphilis electrochemiluminescence immunoassay as a first-line screening test in the reverse algorithms for syphilis serodiagnosis

Lee

Lim

et al. 2019

International Journal of Infectious Diseases

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With the development of the automated treponemal test, new syphilis serodiagnosis algorithms, reverse algorithm, and European Centre for Disease Prevention and Control (ECDC) algorithm have been recommended recently. We investigated the efficacy of an electrochemiluminescence immunoassay (ECLIA) as an initial screening test in the reverse and ECDC algorithms. Methods: Samples from 4,771 subjects were included in this study. We performed rapid plasma reagin (RPR), ECLIA, and Treponema pallidum particle agglutination (TPPA) according to these three algorithms. The fluorescent treponemal antibody absorbed (FTA-ABS) test was additionally applied for discordant cases between the RPR and ECLIA results. The FTA-ABS results and the consensus of three algorithms were considered a gold standard. Results: A total of 208 subjects were diagnosed with syphilis. The traditional algorithm had a sensitivity of 25.96%, specificity of 100%, and accuracy of 96.77%. Both the reverse and ECDC algorithms showed the same diagnostic performance, sensitivity of 95.19%, specificity of 99.96%, and accuracy of 99.75%. The agreements between the traditional algorithm and the other algorithms were 96.9% with a kappa value of 0.415. Conclusions: The diagnostic accuracy of the reverse and ECDC algorithms using the ECLIA as a first-line screening test was superior to that of the traditional algorithm.

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Economic Assessment of Reverse Algorithm Syphilis Screening in a High Prevalence Population

Abstract: Using the reverse algorithm would have been slightly more expensive for the Los Angeles County Department of Public Health, but would have identified more syphilis cases and would have resulted in lower laboratory costs.

Cited by 7 publications

References 17 publications

Abbott ARCHITECT Syphilis TP Chemiluminescent Immunoassay Accurately Diagnoses Past or Current Syphilis in Pregnancy

Abbott ARCHITECT Syphilis TP Chemiluminescent Immunoassay Accurately Diagnoses Past or Current Syphilis in Pregnancy

CDC Laboratory Recommendations for Syphilis Testing, United States, 2024

Evaluation of the Elecsys Syphilis electrochemiluminescence immunoassay as a first-line screening test in the reverse algorithms for syphilis serodiagnosis

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