The first commercial test kit using polymerase chain reaction(PCR) technology was cleared for marketing by the FDA onTuesday.
Roche Molecular Systems Inc., a subsidiary of Hoffmann-LaRoche Inc., is marketing the Amplicor Chlamydia Assay, whichis sensitive enough to detect the sexually transmittedbacterium even in difficult samples such as male urine.
"A number of patients who have chlamydia infections havebeen missed due to the relative lack of sensitivity withconventional testing methods," said Donald Jungkind, directorof the microbiology clinical laboratory at Thomas JeffersonUniversity Hospital.
Inaccurate chlamydia test results can interfere with timelytreatment of the infection, leaving patients vulnerable tocomplications that can lead to infertility in women and sterilityin men.
(c) 1997 American Health Consultants. All rights reserved.