Kumamoto Y, Sato T, Hiroi M, Hashizume S, Nakata H, Kojima H, Matsuda S, Yamazaki S, Sugao M, Noguchi M
Department of Urology, Sapporo Medical College.
Kansenshogaku Zasshi. 1993 Apr;67(4):315-30. doi: 10.11150/kansenshogakuzasshi1970.67.315.
We assessed the C. trachomatis antibody assay kit HITAZYME (Hitachi Chemical Co., Ltd.) using clinical specimens. This kit is based on an enzyme immunoassay (EIA) which utilized purified Chlamydia trachomatis outer membrane antigen as the solid phase antigen. Twenty-nine untreated male urethritis patients, 816 pregnant housewives, 188 cervicitis patients, and 76 pelvic inflammatory disease patients were tested. Agreement between the HITAZYME test and antigen detection in infected area was assessed, and a comparison was made with IPAzyme (a commercially available indirect immunoperoxidase assay kit). 1) Summary of HITAZYME and IPAzyme IgA: Agreement between the two assays was relatively good, i.e., 82.6% (916/1109). However, 5.5% (61/1109) were HITAZYME (-), IPAzyme (+), and 11.9% (132/1109) were HITAZYME (+), IPAzyme (-). Thus, in quite a few cases the results did not agree. IgG: Agreement between the two assays was 73.7% (817/1109). Agreement was relatively low, 24.4% (271/1109) were HITAZYME (-), IPAzyme (+). 2) In the cases of disagreement, more specific Western blot analysis was performed to check the reactivity of the anti-C. trachomatis antibody. When IgA was used, agreement between HITAZYME and Western blot analysis was 69.6% (16/23), and agreement between IPAzyme and Western blot analysis was 30.4% (7/23), whereas when IgG was used, agreement between HITAZYME and Western blot analysis was 80.0% (12/15), and agreement between IPAzyme and Western blot analysis was 20.0% (3/15). There was significantly greater agreement with HITAZYME than with IPAzyme. In other words, HITAZYME had greater specificity when reacted with C. trachomatis antigen than IPAzyme. 3) The IgA antibody-positive rate in antigen (+) cases (male urethritis: 72.7%, pregnant housewives: 65.7%, cervicitis: 70.3%, pelvic inflammatory disease: 70.0%) was significantly (p < 0.01) higher than in antigen (-) cases (male urethritis: 16.7%, pregnant housewives: 13.6%, cervicitis: 22.6%, pelvic inflammatory disease: 30.4%). Therefore, IgA antibody can serve as a suitable indicator for active infection. 4) The IgG antibody-positive rate in antigen (-) female cases was 15.5% using HITAZYME and significantly (p < 0.01) lower than with IPAzyme. HITAZYME had greater specificity than IPAzyme. In conclusion, HITAZYME has relatively good sensitivity and specificity. Moreover, since it is an EIA assay, it allows objective evaluation of results. It permits processing of a large number of specimens because it is easy to perform. Thus, HITAZYME is a superior antibody assay for C. trachomatis. It can be used when antigen tests are difficult to perform. It is strongly anticipated that HITAZYME will be able to be used clinically as a screening test.
我们使用临床标本对沙眼衣原体抗体检测试剂盒HITAZYME（日立化成株式会社）进行了评估。该试剂盒基于酶免疫测定（EIA），利用纯化的沙眼衣原体外膜抗原作为固相抗原。对29例未经治疗的男性尿道炎患者、816例孕妇、188例宫颈炎患者和76例盆腔炎患者进行了检测。评估了HITAZYME检测与感染部位抗原检测之间的一致性，并与IPAzyme（一种市售的间接免疫过氧化物酶检测试剂盒）进行了比较。1）HITAZYME和IPAzyme IgA总结：两种检测方法之间的一致性相对较好，即82.6%（916/1109）。然而，5.5%（61/1109）为HITAZYME（-）、IPAzyme（+），11.9%（132/1109）为HITAZYME（+）、IPAzyme（-）。因此，在相当多的情况下结果不一致。IgG：两种检测方法之间的一致性为73.7%（817/1109）。一致性相对较低，24.4%（271/1109）为HITAZYME（-）、IPAzyme（+）。2）在结果不一致的情况下，进行了更具特异性的蛋白质印迹分析以检查抗沙眼衣原体抗体的反应性。当使用IgA时，HITAZYME与蛋白质印迹分析之间的一致性为69.6%（16/23），IPAzyme与蛋白质印迹分析之间的一致性为30.4%（7/23），而当使用IgG时，HITAZYME与蛋白质印迹分析之间的一致性为80.0%（12/15），IPAzyme与蛋白质印迹分析之间的一致性为20.0%（3/15）。与IPAzyme相比，HITAZYME的一致性显著更高。换句话说，与IPAzyme相比，HITAZYME与沙眼衣原体抗原反应时具有更高的特异性。3）抗原（+）病例中的IgA抗体阳性率（男性尿道炎：72.7%，孕妇：65.7%，宫颈炎：70.3%，盆腔炎：70.0%）显著（p<0.01）高于抗原（-）病例（男性尿道炎：16.7%，孕妇：13.6%，宫颈炎：22.6%，盆腔炎：30.4%）。因此，IgA抗体可作为活动性感染的合适指标。4）使用HITAZYME时，抗原（-）女性病例中的IgG抗体阳性率为15.5%，显著（p<0.01）低于IPAzyme。HITAZYME比IPAzyme具有更高的特异性。总之，HITAZYME具有相对较好的敏感性和特异性。此外，由于它是一种EIA检测方法，它允许对结果进行客观评估。由于操作简便，它可以处理大量标本。因此，HITAZYME是一种用于沙眼衣原体的优良抗体检测方法。当抗原检测难以进行时可以使用。强烈预期HITAZYME将能够作为一种筛查试验用于临床。
