ABBOTT LCX CT

Description of Event or Problem

RPTR HAD PROBLEMS LATE IN 2000 WITH THE LCX GONORRHEA ASSAY. RPTR THEN SEARCHED AND FOUND: "REPRODUCIBILITY PROBLEMS WITH THE ABBOTT LAB LCX ASSAY FOR CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE" BY ANN M GRONOWSKI, SUSAN COPPER, DAVID BAORTO, AND PATRICK R MURRAY (DEPT OF PATHOLOGY, DIV OF LABORATORY MEDICINE, WASHINGTON UNIV SCHOOL OF MEDICINE, AND BARNES-JEWISH HOSP, ST LOUIS, MISSOURI 63110). JOURNAL OF CLINICAL MICROBIOLOGY, JUNE 2000, P 2416-2418, VOL 38, NO 6. ABSTRACT: THIS STUDY DEMONSTRATES THAT SIGNIFICANT REPRODUCIBILITY PROBLEMS CAN OCCUR DURING ROUTINE USE OF THE ABBOTT LABORATORIES LCX ASSAY FOR CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE. THESE PROBLEMS CAN GO UNDETECTED BY THE QUALITY CONTROL PROCEDURE OUTLINED IN THE MFR'S PACKAGE INSERT. RPTR OUTLINES HERE PROCEDURES FOR DETECTING AND PREVENTING CONTAMINATION AND REPRODUCIBILITY PROBLEMS. RPTR IS ALREADY DOING MANY OF THEIR SUGGESTIONS BUT NOT USING THE EXTENDED GREY ZONE. RPTR STARTED USING THE EXTENDED GREY ZONE AND IMPLEMENTED THE REMAINDER OF THEIR SUGGESTIONS AND NO LONGER HAVE A PROBLEM WITH EITHER ASSAY. OF NOTE IS THAT WHEN RPTR TELEPHONED ABBOTT AND CITED THIS ARTICLE, NO ONE RPTR FOUND AT ABBOTT SEEMED TO KNOW ABOUT THE ARTICLE DESPITE THE STATEMENT IN THE ARTICLE THAT "AFTER REPEATED DISCUSSIONS WITH ABBOTT LAB AND OTHER LABS PERFORMING THE LCX ASSAY, IT BECAME CLEAR THAT THESE TYPES OF PROBLEMS ARE NOT UNCOMMON. RPTR CONCLUDED THAT REPRODUCIBILITY PROBLEMS ORIGINATED PRIMARILY IN THE SAMPLE PROCESSING AREA. BASED ON SUGGESTIONS FROM ABBOTT LABS AND OTHER LCX USERS, THE MICROBIOLOGY LAB UNDERWENT NUMEROUS CHANGES IN ITS SPECIMEN PROCESSING AND HAS INCORPORATED PROCEDURES THAT ARE NOT LISTED IN THE LCX PACKAGE INSERT." AS OF WHEN RPTR LAST CHECKED, THERE ARE STILL NO CHANGES IN THE PACKAGE INSERT AND RPTR IS UNAWARE THAT ABBOTT HAS CALLED THIS ARTICLE TO THE ATTENTION OF USERS.