We assessed the
C. trachomatis antibody assay kit HITAZYME
® (Hitachi ChemicalCo., 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
® (acommercially 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) wereHITAZYME
® (+), 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.
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