Retrospective comparison of false-positive result frequencies of 3 syphilis serology screening tests in pregnant and nonpregnant patients at an academic medical center in Appalachia.

Jianbo Yang, Danyel H Tacker, Sijin Wen, P Rocco LaSala
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Abstract

Objective: This study retrospectively compared false-positive result frequencies of 3 syphilis serology screening tests and assessed whether false positivity was associated with pregnancy and age.

Methods: Results for 3 screening tests were retrieved from the laboratory database, including rapid plasma reagin (RPR) assay between October 2016 and September 2019, BioPlex 2200 Syphilis Total immunoassay between May 2020 and January 2022, and Alinity i Syphilis TP assay between February 2022 and April 2023. The false-positive result frequencies were calculated based on testing algorithm criteria.

Results: False-positive result frequency for BioPlex was 0.61% (90/14,707), significantly higher than 0.29% (50/17,447) for RPR and 0.38% (55/14,631) for Alinity (both P < .01). Patients with false-positive results were significantly older than patients with nonreactive results for RPR (median age: 36 vs 28, P < .001), but not for BioPlex or Alinity. For all 3 tests, the positive predictive values in pregnant women were lower than those in nonpregnant women or men. However, pregnant women did not exhibit a higher false-positive result frequency.

Conclusion: Although false-positive result frequencies were low overall for all 3 syphilis serology tests, there is a significant difference between different tests. Pregnancy was not associated with more false-positive results for all 3 tests.

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回顾性比较阿巴拉契亚地区一家学术医疗中心对怀孕和未怀孕患者进行的 3 种梅毒血清学筛查试验的假阳性结果频率。
目的本研究回顾性比较了3种梅毒血清学筛查试验的假阳性结果频率,并评估了假阳性是否与妊娠和年龄有关:从实验室数据库中检索了3种筛查试验的结果,包括2016年10月至2019年9月期间的快速血浆试剂(RPR)测定、2020年5月至2022年1月期间的BioPlex 2200梅毒全免疫测定以及2022年2月至2023年4月期间的Alinity i梅毒TP测定。假阳性结果频率是根据检测算法标准计算得出的:BioPlex的假阳性结果频率为0.61%(90/14,707),明显高于RPR的0.29%(50/17,447)和Alinity的0.38%(55/14,631)(P均<0.01)。在 RPR 检测中,假阳性结果患者的年龄明显大于非反应性结果患者(中位年龄:36 岁 vs 28 岁,P < .001),但在 BioPlex 或 Alinity 检测中,假阳性结果患者的年龄明显小于非反应性结果患者(中位年龄:36 岁 vs 28 岁,P < .001)。在所有 3 项检测中,孕妇的阳性预测值均低于非孕妇或男性。然而,孕妇的假阳性结果频率并不高:结论:虽然三种梅毒血清学检测的假阳性结果频率总体较低,但不同检测之间存在显著差异。在所有3种检测中,怀孕与更多的假阳性结果无关。
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