Quality assurance of immunodiagnostic tests in Australasia.
A Royal College of Pathologists of Australasia (RCPA) sponsored Quality Assurance Program (QAP) in Clinical Immunology, involving 128 laboratories over a 1 yr period, revealed the following: successful participation in the program by 16 overseas laboratories (distant from Australia); only 30% of laboratories succeeded in returning their results by the scheduled date on every occasion; quantitation of urinary total protein and Bence Jones protein was poor and varied over a log scale; immunofixation was more successful in characterizing urinary paraprotein than immunoelectrophoresis; densitometry of protein electrophoresis appeared the method of choice in quantitating serum paraproteins accurately; nephelometric techniques gave better concordance between laboratories than turbidometric, radial immunodiffusion or agglutination techniques; poor concordance between laboratories in detecting weakly positive antinuclear antibodies (ANA); some laboratories had difficulties in identifying ANA patterns (only 60% of laboratories correctly identified the anticentromere pattern); few laboratories could correctly identify antibodies to extractable nuclear antigens (ENA); flow cytometry gave a smaller dispersion of lymphocyte subpopulation percentages than microscopy. A method was established to rank laboratory performance of selected tests over the 1 yr period. Such a comparative ranking scheme may alert laboratories in identifying specific or generalized deficiencies in performance.
Roberts-Thomson
P
P
Department of Clinical Immunology, Flinders Medical Centre, Bedford Park, South Australia.
McEvoy
R
R
Gale
R
R
Jovanovich
S
S
Bradley
J
J
D000974:Antibodies, Antinuclear / Q000032:analysis; D000941:Antigens / Q000032:analysis; D001208:Asia; D001315:Australia; D003176:Complement C3 / Q000378:metabolism; D004586:Electrophoresis; D006801:Humans; D007136:Immunoglobulins / Q000378:metabolism; D007159:Immunologic Tests / Q000592:standards*; D007753:Laboratories / Q000592:standards*; D010266:Paraproteins / Q000378:metabolism; D010865:Pilot Projects; D011507:Proteinuria / Q000652:urine; D011785:Quality Assurance, Health Care
D000974:Antibodies, Antinuclear; D000941:Antigens; D003176:Complement C3; D007136:Immunoglobulins; D010266:Paraproteins