Abstract

BackgroundDue to the inconsistent results of anti-treponema pallidum (TP) specific antibodies by enzyme-linked immunosorbent assay (ELISA) and Treponema pallidum granule agglutination assay (TPPA) in clinical work, there will be a certain proportion of false-positives and false-negatives depending on TPPA as confirmation results. This study aimed to evaluate the necessity of Western blotting (WB) in samples with inconsistent results in detecting anti-TP antibodies by ELISA and TPPA.MethodsSpecific anti-TP test results in our clinical laboratory were retrospectively analyzed. The specimens with a positive or a negative result, but with colored ELISA plates, were retested by TPPA. WB was used to confirm the suspicious results between ELISA and TPPA. The Chi-square test was used to analyze whether the difference was statistically significant.ResultsA total of 106,757 anti-TP specimens were screened by ELISA from August 2018 to December 2019; 3972 were retested by TPPA, and 3809 were positive by TPPA. ELISA and TPPA showed different results in 163 specimens. Among them, 29 specimens were negative and 134 were positive by ELISA; 76 were negative, 23 were positive, and 64 were “reserve” by TPPA; 93 were negative, 31 were positive, and 39 were suspicious by the WB confirmation test. Compared with WB, the difference in the results of ELISA and TPPA was statistically significant.ConclusionsTPPA is an effective retest method for anti-TP antibody detection. If the results of anti-TP antibodies by ELISA and TPPA are inconsistent, it is necessary to use WB for confirmation.Trial registration This retrospective analysis is in accordance with the ethical guidelines of China and approved by the second hospital of Jiaxing (jxey-2018048).

Highlights

  • Due to the inconsistent results of anti-treponema pallidum (TP) specific antibodies by enzyme-linked immunosorbent assay (ELISA) and Treponema pallidum granule agglutination assay (TPPA) in clinical work, there will be a certain proportion of false-positives and false-negatives depending on TPPA as confirmation results

  • Samples with inconsistent results of preliminary screening of anti-TP antibodies by ELISA and retest by TPPA were taken as experiment subjects for other Western blotting (WB) tests

  • Since TPPA is not a true diagnostic method, Chinese Center for Disease Control and Prevention (CDC) points out that when anti-TP antibody test results are inconsistent with TPPA test results, WB is recommended for the confirmation of anti-TP antibody results

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Summary

Introduction

Due to the inconsistent results of anti-treponema pallidum (TP) specific antibodies by enzyme-linked immunosorbent assay (ELISA) and Treponema pallidum granule agglutination assay (TPPA) in clinical work, there will be a certain proportion of false-positives and false-negatives depending on TPPA as confirmation results. This study aimed to evaluate the necessity of Western blotting (WB) in samples with inconsistent results in detecting anti-TP antibodies by ELISA and TPPA. Syphilis is a sexually transmitted disease caused by Treponema pallidum (TP). According to official data (http://www.nhfpc.gov.cn/), the cases of syphilis in China continue to increase every year, with syphilis being at the top of the list of sexually transmitted diseases. Samples with inconsistent results of preliminary screening of anti-TP antibodies by ELISA and retest by TPPA were taken as experiment subjects for other WB tests. WB was used to confirm the results of anti-TP antibodies

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