ATHENA MULTILYTE
Received Jan 10, 2006
Report MW1037711 · MDR key 663816
Product problems
- False Positive Result
- Product Quality Problem
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THIS IS TO REPORT A PROBLEM WITH A LABORATORY ASSAY - NON LIFE THREATENING-THE PERFORMANCE CHARACTERISTICS OF THE ATHENA WAMPOLE/ZUES MULTILYTE KIT FOR ANA SCREENING DOES NOT AT ALL CORRELATE WITH PATIENT HISTORY, SIGNS AND SYMPTOMS. THE KIT IS DESIGNED TO DETECT LUPUS OR OTHER CONNECTIVE TISSUE DISEASE ASSOCIATED ANTIBODIES. AS A "SCREENING" METHOD IT HAS VERY POOR CORRELATION WITH PT PRESENTATION. THIS METHOD HAS A SENSITIVITY LEVEL WELL BEYOND WHAT IS CONSIDERED NORMAL, THEREBY DETECTING THE PRESENCE OF ANTIBODIES, ESPECIALLY RNP, AND TO A LESSOR EXTENT, SS-B, SCL-70 AND JO-1. RPTR'S LABORATORY HAS FOR THE LAST 3 MONTHS ROUTINELY RUN THESE SPECIMENS BY SECONDARY METHOD ONLY TO HAVE VERY FEW "CONFIRM" WITH WHAT WOULD BE A HIGH FALSE POSITIVITY RATE. FOR DIAGNOSED LUPUS PTS THIS TEST WORKS WELL, HOWEVER DOES NOT SEEM TO BE DESIGNED FOR SCREENING "ALL COMERS." RPTR HAS UNSUCCESSFULLY CONVINCED THE MFR THAT THERE IS A PROBLEM. THEY REFUSE TO CONFIRM ISSUES.