Two Comparative Studies of the Abbott IMx Select~® Chlamydia Assay with Endocervical Specimens, one versus the SYVA Microtrak II Chlamydia EIA Assay and another versus the VIDAS Chlamydia Assay

摘要

Two studies were conducted, one comparing IMx to SWA and another comparing IMx to VIDAS. The gold standard used to compare assay performance in both studies was chlamydial cell culture with discordant samples resolved by a direct fluorescent antibody test. The IMx Chlamydia Blocking Reagent (CBR) was used to verify the presence of chlamydial antigen in IMx reactive specimens. In the first evaluation, IMx sensitivity (sens.) and specificity (spec.) were 90.2% (37/41) and 97.6% (246/252). Using the CBR, the spec. increased to 99.6% (251/252). SWA sens. and spec. were 87.8% (36/41) and 99.2% (250/252). In the second evaluation, IMx sens. and spec. were 88.9% (24/27) and 98.5% (262/266). Incorporating the CBR, the spec. improved to 100% (266/266). VIDAS sens. and spec. were 70.4% (19/27) and 100% (266/266). The IMx assay and the CBR prove to be highly sensitive and specific for the detection of chlamydial antigen.