ELECSYS FT3 III

Additional Manufacturer Narrative

ONE SAMPLE WAS PROVIDED FOR INVESTIGATION. THE CUSTOMER'S THYROID VALUES ABOVE THE REFERENCE RANGE COULD NOT BE REPRODUCED. FT3 RESULTS WERE FOUND COMPARABLE WITHIN REFERENCE RANGE WITH BOTH TEST GENERATIONS ON COBAS E801 AS WELL AS COBAS E411. NO HINTS AGAINST SA INTERFERENCE AND NO PREWASH EFFECT COULD BE OBSERVED. INTERFERENCE ANALYSIS - STREPTAVIDIN AGENT (SA) COMPONENT THE SAMPLE WAS MEASURED WITH A-TG (OLD TEST GENERATION) AND A-TG (BIOTIN UPDATE / NEW TEST GENERATION) ON COBAS E801 TO CHECK IF AN INTERFERING FACTOR AGAINST SA COULD BE PRESENT. RESULTS OF BOTH A-TG TEST GENERATIONS WERE COMPARABLE HIGH WITH 2000 IU/ML. NO DIFFERENCE BETWEEN THE CONCENTRATION VALUES COULD BE SEEN. INTERFERENCE ANALYSIS - FT3 IDIOTYPE. INTERFERENCE ANALYSIS WAS CARRIED OUT WITH FT3 ON COBAS E411 TO CHECK IF AN INTERFERING FACTOR AGAINST ASSAY ANTIBODY/ IDIOTYPE COULD BE PRESENT IN THIS SAMPLE. WITHIN THIS INTERFERENCE ANALYSIS AN INTERFERING FACTOR AGAINST ASSAY ANTIBODY / IDIOTYPE ON FT3 COULD BE IDENTIFIED SLIGHTLY AS DECREASED FT3 CONCENTRATION VALUE WITH R&D RESEARCH KIT USING POLYCLONAL ANTIBODY COULD BE SEEN. THE INVESTIGATION DETERMINED THAT A SLIGHT INTERFERING FACTOR AGAINST FT3 ASSAY ANTIBODY / IDIOTYPE COULD BE IDENTIFIED IN THIS INVESTIGATED SAMPLE BECAUSE DECREASED FT3- CONCENTRATION VALUE WITH R&D RESEARCH KIT COULD BE SEEN. THE INVESTIGATION ALSO DETERMINED THAT AN INTERFERING FACTOR AGAINST SA COULD BE EXCLUDED FROM THIS INVESTIGATED SAMPLE BECAUSE NO DIFFERENCE OF CONCENTRATION VALUES BETWEEN DIFFERENT TEST GENERATIONS WITH A-TG AND FT3 ASSAYS COULD BE SEEN. THE RARELY OCCURRING EVENT OF THE DETECTED INTERFERING FACTOR IS COVERED BY A DISCLAIMER IN THE SECTION LIMITATION - INTERFERENCE IN THE METHOD SHEETS OF ALL APPLICABLE PRODUCTS: IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. NO PRODUCT PROBLEM COULD BE FOUND. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS.

Description of Event or Problem

THE INITIAL REPORTER ALLEGED A NON-SPECIFIC INTERFERENCE FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS FT3 III V2 (FT3 G3 V2) ASSAY ON A COBAS 8000 E801 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4)WHEN COMPARED TO A NON-ROCHE ASSAY. INITIAL RESULT: 4.41 PG/ML REPEAT RESULT: 3.28 PG/ML (TESTED WITH WAKO ASSAY BY ACCURASEED). NO ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY.

Additional Manufacturer Narrative

THE CUSTOMER COMPARED THE SAMPLE TO ANOTHER SAMPLE AFTER ADDING 25% PEG TREATMENT AND THE FT3 G3 V2 VALUES WERE 3.26 PG/ML, 2.67 PG/ML, 163.8 PG/ML. THE CUSTOMER STATED THAT NO DECREASE IN RECOVERY RATE AFTER 25% PEG TREATMENT WAS OBSERVED. ADDITIONALLY, THE RETEST RESULT ON ELECSYS FT3 G3 V2 ASSAY WAS LOWER THAN THE FIRST RESULT. THE SAMPLE WAS REQUESTED FOR INVESTIGATION. INVESTIGATION IS ONGOING. H3 OTHER TEXT .