Version 2.1.0.0

Abstract

Abstract: DESCRIPTION (provided by applicant): During phase I Xtrana/BioPool (formerly Molecular Innovations, Inc.) demonstrated the feasibility of a urine-based diagnostic test that potentially could be performed in the clinic to detect both genital chlamydia and gonorrhea. The strategy involves the release of Chlamydia trachomatis (CT) and Neisseria gonorrhoea (GC) ribosomal RNA, capture onto Xtrana/Biopool's XtraBind solid phase bead matrix, followed by direct isothennal amplification using Nucleic Acid Sequence Based Amplification (NASBA). After NASBA, haptenized primers are added so that the amplified product is directly visualized as a blue line immediately following wicking through a lateral flow membrane. The integration of solid phase capture, direct isothermal amplification, and visual lateral flow detection enables device platforms with simple protocols compatible with nucleic acid testing at the point-of-care at reduced cost using only a heat block for instrumentation. Finalized chemistry, device design, prototyping, and manufacturing, followed by clinical validation studies will be performed in phase II. At the conclusion of phase 11, extraction, amplification, and detection chemistry run within the prototype will be completed and its performance characterized utilizing urine specimens. PROPOSED COMMERCIAL APPLICATION: Not Available

Thesaurus Terms:
biomedical equipment development, chlamydial disease, communicable disease diagnosis, diagnosis design /evaluation, gonorrhea, noninvasive diagnosis, urinalysis
Chlamydia trachomatis, Neisseria gonorrhoeae, bacterial DNA, clinical chemistry
human subject

Institution:	XTRANA, INC.
	717 YOSEMITE CIR
	DENVER, CO 80220
Fiscal Year:	2002
Department:
Project Start:	30-SEP-1999
Project End:	29-SEP-2003
ICD:	CENTER FOR PREVENTION SERVICES, CDC
IRG:	ZRG1