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Procedures for In Vitro Cultivation of Treponema pallidum, the Syphilis Spirochete

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[Evaluation of a syphilis testing algorithm using a treponemal test for screening].

O Alpay Ozbek¹, Yavuz Doğan

¹Dokuz Eylül University Faculty of Medicine, Department of Medical Microbiology, İzmir, Turkey. alpay.ozbek@deu.edu.tr

Mikrobiyoloji Bulteni

|February 23, 2011

Summary

A new syphilis testing algorithm is proposed. Chemiluminescence microparticle enzyme immunoassay (CMIA) positive results with low signal-to-cutoff ratios require confirmation by a second treponemal test to avoid false positives.

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Area of Science:

Clinical diagnostics
Infectious disease testing
Serological assays

Background:

Traditional syphilis testing involves nontreponemal screening followed by treponemal confirmation.
Automated, sensitive treponemal screening tests are now available, but consensus on follow-up testing is lacking.
Conflicting guidelines exist regarding confirmatory testing after a positive treponemal screen.

Purpose of the Study:

To evaluate a syphilis testing algorithm using chemiluminescence microparticle enzyme immunoassay (CMIA) for primary screening.
To assess the correlation between CMIA results and confirmatory tests (RPR, TPHA).
To propose an optimized syphilis testing algorithm based on study findings.

Main Methods:

Retrospective review of laboratory data for 12,195 serum samples from 10,878 patients screened for syphilis.
Initial screening using CMIA; positive CMIA samples were retested with RPR.
CMIA positive results with discrepancies were confirmed by TPHA; quantitative CMIA values (s/co ratios) were analyzed.

Main Results:

Positive screening results were found in 1.1% of patients and 2% of samples.
CMIA confirmation rates by TPHA were 19.1% for s/co ratios < 12 and 100% for s/co ratios > 12.
High RPR titers (≥ 1/32) correlated with CMIA s/co ratios > 21.

Conclusions:

Low s/co ratios in CMIA screening may indicate false-positive results.
Confirmation of CMIA positive results with another treponemal test prior to RPR testing is recommended.
A revised syphilis testing algorithm incorporating these findings is proposed.