Abstract
ObjectiveTo synthesize lessons from comparison of results obtained from the immuno-chromatographic SD Bioline testing method and the chemiluminescent micro-particle immunoassay Architect in the diagnosis of syphilis at Livingstone Central hospital laboratory.ResultsThe specificity and sensitivity of SD Bioline syphilis 3.0 against the chemiluminescent immunoassay using the Architect syphilis Treponema pallidum (TP) was 85.3% and 91.3% respectively with substantial agreement between the two test methods (88%, ĸ = 0.76; p < 0.0005). We recommend further comprehensive study with a larger sample size and clinical details to ascertain the validity of our findings. We also recommend using a non-treponemal test with the current treponemal tests being used to aid diagnosis.
Highlights
The laboratory serologic diagnosis of syphilis can be complicated [1] especially with limited diagnostic tools owing to the natural course of the infection which is characterized by periods with and without clinical manifestations [1]
The traditional screening of syphilis recommended by the Center for Disease Control and Prevention (CDC) is the use of a nontreponemal test, such as rapid plasma reagin (RPR) [4]
We randomly selected 100 samples from the syphilis suspected specimens that tested reactive and nonreactive (1:1) on SD Bioline which were compared with the reference standard, Architect syphilis Treponemal pallidum (TP)
Summary
Total number of syphilis suspected samples collected and tested between March and May were 781 (Table 1) of which 116 (14.9%) tested positive with SD Bioline syphilis rapid kit. 50 samples that tested negative and positive respectively, on SD Bioline syphilis rapid kit were retested on Architect and the diagnostic tests evaluated (Table 2). The positive and negative predictive values were 84% and 93% at prevalence of 54% (expected). Using actual point prevalence of 15.3%, the positive and negative predictive values were 53.7% and 46.9%. Roc curve for SD Bioline against the Architect test We performed a receiver operator curve (ROC) analysis (graph not shown) yielding an area under the curve of 0.88, (standard error, 0.032; 95% confidence interval [0.81, 0.95] p < 0.001). We performed a concordance test (Table 3 below) to assess the degree of agreement between the two tests
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
