Evaluation of SD BIOLINE Syphilis 3.0 for Rapid Diagnosis of Syphilis: Report from a Regional Sexually Transmitted Infection Reference Laboratory in North India
BACKGROUND:
Serology
is considered the mainstay of syphilis diagnosis. The limitations of the
traditional serological methods and the advent and availability of novel
immunochromatographic assays have led to the widespread application of rapid
point-of-care procedures as screening tools for syphilis. However, these tests
have not been extensively evaluated. This study was designed to evaluate the
performance of a rapid syphilis diagnostic test known as SD BIOLINE Syphilis
3.0 (SD Biostandard Diagnostics Private Limited, Gurgaon, Haryana, India).
MATERIALS AND METHODS:
A
panel comprising of 50 venereal disease research laboratory reactive and 50
nonreactive sera was tested using SD BIOLINE Syphilis 3.0. The performance of
the test was evaluated using IMMUTREP Treponema pallidum hemagglutination assay
(TPHA) (OMEGA Diagnostics Limited, Scotland, United Kingdom) as the reference
standard and sensitivity, specificity, and negative and positive predictive
values were calculated.
RESULTS:
The
sensitivity, specificity, and positive and negative predictive values of SD
BIOLINE Syphilis 3.0 were 92.86% (confidence interval of 95%: 80.52-98.50%),
98.28% (90.76-99.96%), 97.50% (86.84-99.94%), and 95.00% (86.08-98.96%),
respectively, compared to TPHA as the gold standard.
CONCLUSION:
Keeping
in view the high sensitivity and specificity of SD BIOLINE Syphilis 3.0, we
conclude that the test can be used as a tool for rapid on-site diagnosis of
syphilis and as an alternative to TPHA for detection of antibodies to Treponema
pallidum.
- 1Department of Microbiology, Maulana Azad Medical College, New Delhi, India.
- J Lab Physicians. 2016 Jan-Jun;8(1):36-40. doi: 10.4103/0974-2727.176239.
No comments:
Post a Comment