LabMedica

Download Mobile App
Recent News Expo Clinical Chem. Molecular Diagnostics Hematology Immunology Microbiology Pathology Technology Industry Focus

Recombinant Antigen-Based ELISA Evaluated for Syphilis

By LabMedica International staff writers
Posted on 28 Aug 2013
Print article
Image: Photomicrograph of Treponema pallidum (Photo courtesy of Susan Lindsley).
Image: Photomicrograph of Treponema pallidum (Photo courtesy of Susan Lindsley).
The diagnostic performance of the latest screening enzyme-linked immunosorbent assay (ELISA) for syphilis has been compared with the currently used treponemal tests.

The etiological agent of syphilis, Treponema pallidum, cannot be cultured and there is no single optimal alternative test. Serological testing is the most frequently used approach in laboratory diagnosis of the disease.

Scientists at Sekisui Virotech (Rüsselsheim, Germany) compared their Treponema pallidum Screen ELISA with standard tests. These tests included the fluorescent treponemal antibody absorption (FTA-ABS, Zeus Scientific; Branchburg, NJ, USA) test, which is an indirect fluorescent antibody technique; the T. pallidum particle agglutination (TPPA, Fujirebio; Hoofddorp, the Netherlands) test, which is a qualitative assay for the detection of antibodies to T. pallidum in serum or plasma. The most relevant test used for comparison was the Trep-Sure ELISA (Phoenix Bio-Tech Corporation; Mississauga, ON, Canada).

To establish the sensitivity and specificity of the Virotech Screen, 421 serum samples from different panels of infected and non-infected patients, sera from seronegative pregnant women as well as international syphilis standard sera and panels were tested. In comparison to combined TPPA/FTA-abs tests, Phoenix Trep-Sure and Virotech Screen demonstrated a sensitivity of 100% and a specificity of 93.9% and 98.3%, respectively.

All samples of a well-defined syphilis serum panel were correctly identified by the Virotech test, whereas the Phoenix test identified two Treponema negative samples as equivocal. The Trep Sure test is approved by the US Food and Drug Administration (FDA; Silver Springs, MD, USA). Results of both ELISAs highly correlated with TPPA negative and positive samples. The analytical sensitivity of the Virotech Screen with international standards was determined at 0.02 IU/mL and 0.03 IU/mL, and was slightly superior to the Phoenix Trep-Sure.

The authors concluded that the Virotech Screen ELISA demonstrated good diagnostic sensitivity and specificity when evaluated as a screening test for syphilis among various patient populations, including samples with increased rates of false positive nontreponemal test results. The Virotech ELISA may be used in automatic analyzers as an alternative to the manual TPPA. However, the use of a confirmatory test remains a must in order to avoid false-positive results. The study was published in the May/June, 2013 issue of the journal Clinical Laboratory.

Related Links:

Sekisui Virotech
Zeus Scientific
Fujirebio


Gold Member
Pharmacogenetics Panel
VeriDose Core Panel v2.0
Verification Panels for Assay Development & QC
Seroconversion Panels
New
Piezoelectric Micropump
Disc Pump
New
Auto Clinical Chemistry Analyzer
cobas c 703

Print article

Channels

Molecular Diagnostics

view channel
Image: The experimental blood test accurately indicates severity and predicts potential recovery from spinal cord injury (Photo courtesy of 123RF)

Blood Test Identifies Multiple Biomarkers for Rapid Diagnosis of Spinal Cord Injury

The National Institutes of Health estimates that 18,000 individuals in the United States sustain spinal cord injuries (SCIs) annually, resulting in a staggering financial burden of over USD 9.... Read more

Microbiology

view channel
Image: Schematic representation illustrating the key findings of the study (Photo courtesy of UNIST)

Breakthrough Diagnostic Technology Identifies Bacterial Infections with Almost 100% Accuracy within Three Hours

Rapid and precise identification of pathogenic microbes in patient samples is essential for the effective treatment of acute infectious diseases, such as sepsis. The fluorescence in situ hybridization... Read more

Industry

view channel
Image: Tumor-associated macrophages visualized using the Multiomic LS Assay (Photo courtesy of ACD)

Leica Biosystems and Bio-Techne Expand Spatial Multiomic Collaboration

Bio-Techne Corporation (Minneapolis, MN, USA) has expanded the longstanding partnership between its spatial biology brand, Advanced Cell Diagnostics (ACD, Newark, CA, USA), and Leica Biosystems (Nussloch,... Read more
Sekisui Diagnostics UK Ltd.