The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS (Direct Transfer) System ("TIGRIS System"), can be tested on the PANTHER System. The intended use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER System. ACT Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.
This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis) Assay. Instead, testing was conducted and results were generated with the Gen-Probe APTIMA(R) Combo 2 Assay (for Chlamydia trachomatis and Neisseria gonorrhoeae). See Protocol Identification AC2PS-US11-001 (NCT01733069) for results. This action was recommended by the RRS team per their email to me on 8 February 2013.
Study Type
OBSERVATIONAL
APTIMA Assay for Chlamydia trachomatis
Wishard Health Services Department of Pathology Wishard Health Services
Indianapolis, Indiana, United States
Louisianna State University Health Center
New Orleans, Louisiana, United States
New England Center for Clinical Research
Fall River, Massachusetts, United States
Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference
Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference
Time frame: approximately one year
Positivity Rate
Positivity Rate
Time frame: approximately one year
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