Kulkarni Sangeeta, Kale Varsha, Vidhate Pallavi, Sane Suvarna, Muralidhar Sumathi, Chawla Rohit, Bandopadhyay Bhaswati, Sawant Sandhya, Deoraj Pramod, Jadhav Sachin, Bhosale Hemant, Shirsath Sandip, Jagtap Priyanka, Borate Mayuri, Kamal Shivali, Mishra Smita, Rao Bhawna, Khan Abdul Arif, Mane Arati, Thakar Madhuri
Department of Microbiology, ICMR-National Institute of Translational Virology and AIDS Research (NITVAR), Pune, India.
Department of Serology and Immunology, ICMR-National Institute of Translational Virology and AIDS Research (NITVAR), Pune, India.
Indian J Med Res. 2025 Feb;161(2):152-158. doi: 10.25259/IJMR_1195_2024.
Background & objectives This study was performed to assess the suitability of dried blood spot (DBS) samples for the serological screening of syphilis. Methods Two hundred paired DBS and plasma samples collected from six sexually transmitted infection (STI) clinics during the year 2023 were tested using three kits -Treponema pallidum haemagglutination assay (TPHA), Syphilis Total Ab and ErbaLisa Syphilis after standardization of the dilutions of the DBS elutes and considering the results of the paired plasma samples as a true status. Results The TPHA showed 89 per cent sensitivity and 100 per cent specificity, the EIA-Syphilis Total Ab. Kit showed 100 per cent sensitivity and 97 per cent specificity, whereas ErbaLisa syphilis showed 89 per cent sensitivity and 100 per cent specificity. However, one kit Syphilis ELISA (Oscar Medicare Pvt. Ltd., New Delhi) did not show agreement with the paired plasma samples at any dilution and was not considered suitable for the testing of DBS samples. The agreement between the plasma and DBS results was found to range from 94.5 to 98.5 per cent with a kappa agreement score of 0.89 for TPHA, ErbaLisa, and 0.97 for ELISA-Syphilis Total Ab. Interpretation & conclusions The findings of this study confirmed that the DBS samples can be used for the detection of anti-treponemal antibodies using the above-validated kits and thus may be a valuable tool in surveillance and epidemiological surveys conducted in India. The study also highlighted the need for validation of any plasma/serum syphilis antibody detection assay on DBS samples before using it on DBS samples.
背景与目的 本研究旨在评估干血斑（DBS）样本用于梅毒血清学筛查的适用性。方法 2023年从6家性传播感染（STI）诊所收集了200对DBS样本和血浆样本，在对DBS洗脱液进行标准化稀释后，使用三种试剂盒——梅毒螺旋体血凝试验（TPHA）、梅毒总抗体检测试剂盒以及艾伯乐梅毒酶联免疫吸附测定法（ErbaLisa Syphilis）进行检测，并将配对血浆样本的检测结果视为真实状态。结果 TPHA的灵敏度为89%，特异性为100%；梅毒总抗体酶联免疫吸附测定试剂盒（EIA-Syphilis Total Ab）的灵敏度为100%，特异性为97%；而艾伯乐梅毒酶联免疫吸附测定法的灵敏度为89%，特异性为100%。然而，有一种梅毒酶联免疫吸附测定试剂盒（新德里奥斯卡医疗保健私人有限公司）在任何稀释度下与配对血浆样本的检测结果均不一致，因此被认为不适用于检测DBS样本。血浆和DBS检测结果之间的一致性在94.5%至98.5%之间，TPHA、艾伯乐梅毒酶联免疫吸附测定法的kappa一致性评分分别为0.89，梅毒总抗体酶联免疫吸附测定法的kappa一致性评分为0.97。解读与结论 本研究结果证实，使用上述经过验证的试剂盒，DBS样本可用于检测抗梅毒螺旋体抗体，因此可能是印度开展监测和流行病学调查的一项有价值的工具。该研究还强调，在将任何血浆/血清梅毒抗体检测方法用于DBS样本检测之前，需要对其进行验证。
