The ZEUS AtheNA Multi-Lyte ANA-II Plus Test System is a diagnostic aid and by itself is not diagnostic. Test results should be interpreted in conjunction with the clinical evaluation and the results of other diagnostic procedures. Positive ANA may be found in apparently healthy people. It is therefore imperative that the results be interpreted in light of the patient’s clinical picture by a medical authority. SLE patients undergoing steroid therapy may have negative test results. Many commonly prescribed drugs may induce ANA. Hemolytic, icteric, or lipemic samples may interfere with the outcome of this assay. Additionally, specimens with abnormal IgG concentrations may interfere with the outcome of this assay. Use of these types of specimens should be avoided. REFERENCES U.S. Department of Labor, Occupational Safety and Health Administration: Occupational Exposure to Bloodborne Pathogens, Final Rule. Fed. Register 1991. Procedures for the Handling and Processing of Blood Specimens. NCCLS Document H18-A, Vol. 10, No. 12, Approved Guideline, 1990. Procedures for the collection of diagnostic blood specimens by venipuncture. 2nd edition. Approved Standard (1984). Published by National Committee for clinical Laboratory Standards. Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guidelines – 4th Edition (2010). CLSI Document (ISBN 1-56238-724-3). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087.
The ZEUS AtheNA Multi-Lyte ANA-II Plus Test System is a diagnostic aid and by itself is not diagnostic. Test results should be interpreted in conjunction with the clinical evaluation and the results of other diagnostic procedures. Positive ANA may be found in apparently healthy people. It is therefore imperative that the results be interpreted in light of the patient’s clinical picture by a medical authority. SLE patients undergoing steroid therapy may have negative test results. Many commonly prescribed drugs may induce ANA. Hemolytic, icteric, or lipemic samples may interfere with the outcome of this assay. Additionally, specimens with abnormal IgG concentrations may interfere with the outcome of this assay. Use of these types of specimens should be avoided. REFERENCES U.S. Department of Labor, Occupational Safety and Health Administration: Occupational Exposure to Bloodborne Pathogens, Final Rule. Fed. Register 1991. Procedures for the Handling and Processing of Blood Specimens. NCCLS Document H18-A, Vol. 10, No. 12, Approved Guideline, 1990. Procedures for the collection of diagnostic blood specimens by venipuncture. 2nd edition. Approved Standard (1984). Published by National Committee for clinical Laboratory Standards. Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guidelines – 4th Edition (2010). CLSI Document (ISBN 1-56238-724-3). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087.
A21101%2520AtheNA%2520ANA-II%2520Plus%2520CLSI.docx