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Mikrogen 沙眼衣原体 IgG ELISA 在预测不孕不育女性输卵管因素不孕(TFI)中的表现:与 Medac MOMP IgG ELISA 加测的比较

Performance of the multitarget Mikrogen Chlamydia trachomatis IgG ELISA in the prediction of tubal factor infertility (TFI) in subfertile women: comparison with the Medac MOMP IgG ELISA plus.

机构信息

Laboratory of Immunogenetics, Department of Medical Microbiology and Infection Control, VU University Medical Center, 1007 MB Amsterdam, The Netherlands.

Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen, 9700 RB Groningen, The Netherlands.

出版信息

Pathog Dis. 2017 Sep 29;75(7). doi: 10.1093/femspd/ftx067.

Abstract

There is a need for more accurate Chlamydia trachomatis (CT) IgG antibody tests for tubal factor infertility (TFI) diagnostics. We evaluated the predictive value for TFI of Medac ELISA plus (MOMP) and multitarget Mikrogen ELISA (MOMP-CPAF-TARP). Based on Medac ELISA plus results, 183 subfertile women underwent either hysterosalpingography or laparoscopy to diagnose TFI. TFI was defined as extensive adhesions and/or distal occlusion of at least one tube. Women not fulfilling the definition of TFI served as controls. Serum was subsequently tested with Mikrogen ELISA and results were compared. 48 patients had TFI, 135 were controls. Mikrogen ELISA tested 125 patients positive/borderline of which 32% had TFI. Medac ELISA plus tested 77 patients positive/borderline of which 29.9% had TFI. Mikrogen tested 40 out of 48 TFI patients positive/borderline, Medac 23 out of 48. Kappa value was 0.34. PPV of Mikrogen ELISA and Medac ELISA plus were respectively 32% (95% CI 26%-39%) and 30% (95% CI 24%-37%), and NPV 86% (95% CI 81%-91%) and 76% (95% CI 70%-82%). Both tests were comparable in the prediction of TFI. However, Mikrogen ELISA had a higher NPV and might be more reliable in identifying patients without TFI. Kappa-value showed limited concordance between both tests.

摘要

需要更准确的沙眼衣原体 (CT) IgG 抗体检测来诊断输卵管因素不孕 (TFI)。我们评估了 Medac ELISA plus (MOMP) 和多靶点 Mikrogen ELISA (MOMP-CPAF-TARP) 对 TFI 的预测价值。根据 Medac ELISA plus 的结果,183 名不孕女性接受了子宫输卵管造影术或腹腔镜检查以诊断 TFI。TFI 定义为至少一条输卵管广泛粘连和/或远端阻塞。未满足 TFI 定义的女性作为对照组。随后用 Mikrogen ELISA 检测血清,并比较结果。48 例患者有 TFI,135 例患者为对照组。Mikrogen ELISA 检测到 125 例阳性/边界病例,其中 32%有 TFI。Medac ELISA plus 检测到 77 例阳性/边界病例,其中 29.9%有 TFI。Mikrogen 检测到 48 例 TFI 患者中的 40 例阳性/边界病例,Medac 检测到 23 例阳性/边界病例。Kappa 值为 0.34。Mikrogen ELISA 和 Medac ELISA plus 的 PPV 分别为 32%(95%CI 26%-39%)和 30%(95%CI 24%-37%),NPV 分别为 86%(95%CI 81%-91%)和 76%(95%CI 70%-82%)。两种检测方法在预测 TFI 方面具有可比性。然而,Mikrogen ELISA 的 NPV 更高,在识别无 TFI 的患者时可能更可靠。Kappa 值表明两种检测方法的一致性有限。

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