Related Experiment Video
Updated: Jul 24, 2026
Procedure and Key Optimization Strategies for an Automated Capillary Electrophoretic-based Immunoassay Method
Published on: September 10, 2017
Evaluation of chemiluminescence immunoassay as a screening test for syphilis on blood donor samples
Cherry Gupta1, Kshitija Mittal1, Ravneet Kaur1
1Department of Transfusion Medicine, Government Medical College and Hospital, Chandigarh, India.
Insights
Chemiluminescence immunoassay (CLIA) demonstrates superior performance for syphilis screening in blood donors compared to the Rapid Plasma Reagin (RPR) test. CLIA offers higher sensitivity and specificity, making it a reliable alternative for blood donation centers.
Area of Science:
- Medical Diagnostics
- Infectious Disease Screening
- Blood Transfusion Safety
Background:
- Syphilis re-emergence poses a significant public health challenge, particularly among blood donors.
- Effective screening methods are crucial for timely intervention and preventing transfusion-transmitted infections.
Purpose of the Study:
- To evaluate the diagnostic efficiency of Chemiluminescence immunoassay (CLIA) as a syphilis screening test.
- To compare the performance of CLIA against established syphilis screening methods in blood donors.
Main Methods:
- A prospective cross-sectional observational study involving 360 blood donors.
- Syphilis screening using Rapid Plasma Reagin (RPR) test, Treponema pallidum haemagglutination assay (TPHA) as the gold standard, and CLIA.
- Comparative analysis of test results.
Main Results:
- CLIA exhibited 100% sensitivity and 99.7% specificity.
- CLIA demonstrated higher positive predictive value (PPV) and negative predictive values (NPV) compared to the RPR test.
- One sample reactive by CLIA alone was identified among RPR non-reactive samples.
Conclusions:
- CLIA is a highly sensitive and specific diagnostic tool for syphilis screening in blood donors.
- CLIA offers improved diagnostic accuracy over the RPR test.
- CLIA presents a viable and effective alternative for syphilis screening in blood donation settings.
Background And Objective:
Global re-emergence of syphilis among blood donors necessitates novel diagnostic and prevention approaches that encourage timely intervention. Thus, the present study was planned to evaluate the efficiency of Chemiluminescence immunoassay (CLIA) as a screening test for syphilis.
Material And Methods:
This prospective cross-sectional observational study was conducted from October 2021 to September 2022. A total of 344 donors were enrolled by purposive sampling method, including additional 16 donors who were reactive by the Rapid plasma reagin test (RPR) during the study period. Data from three screening tests - RPR test, Treponema pallidum haemagglutination assay (TPHA) and CLIA for 360 blood donors were analysed. TPHA was considered the gold standard test.
Results:
Of the total 360 samples tested, 21 (5.8 %) were reactive by the RPR test. Of these 21 RPR reactive samples, 19 (90.5 %) were reactive by both TPHA and CLIA, while 2 (9.5 %) RPR reactive samples were non-reactive by both TPHA and CLIA. Of the remaining 339 RPR non-reactive samples, 1 (0.3 %) sample was reactive by both TPHA and CLIA, and 1 (0.3 %) was reactive by CLIA alone. CLIA was found to have sensitivity and specificity of 100 % and 99.7 % and positive predictive value (PPV) and negative predictive values (NPV) of 95.2 % and 100 % respectively, while it was 95 %, 99.4 %, 90 %, and 99.7 %, respectively, with the RPR test.
Conclusion:
CLIA was found to have a higher sensitivity, specificity, PPV and NPV than the RPR test. Thus, CLIA can be an acceptable alternative for syphilis screening in blood donors.
More Related Videos
06:50A High-Throughput Electrochemiluminescence 7-Plex Assay Simultaneously Screening for Type 1 Diabetes and Multiple Autoimmune Diseases
Published on: May 29, 2020
10:10Development of a Lateral Flow Immunochromatographic Strip for Rapid and Quantitative Detection of Small Molecule Compounds
Published on: November 13, 2021
