Evaluation of the RheumaStrip ANA profile test: a rapid test strip procedure for simultaneously determining antibodies to autoantigens U1-ribonucleoprotein (U1-RNP), Sm, SS-A/Ro, SS-B/La, and to native DNA.
The "LipoGen RheumaStrip ANA Profile" test method (LipoGen, Inc.) is a new assay format for autoantibody detection in which recombinant autoantigens are used. This enzyme immunoassay, in test-strip format, detects antibodies to autoantigens U1-ribonucleoprotein (U1-RNP), Sm, SS-A/Ro, SS-B/La, and to native DNA (nDNA). We evaluated 200 antinuclear antibody (ANA)-positive and 100 ANA-negative sera for the presence of antibodies to U1-RNP, Sm, SS-A/Ro, SS-B/La, and nDNA by the new test-strip procedure. These data correlated well with those obtained with either Ouchterlony double immunodiffusion for U1-RNP, Sm, SS-A/Ro, and SS-B/La or with Crithidia luciliae indirect immunofluorescence for anti-nDNA. Assay sensitivity and assay specificity of the ANA Profile method as compared with those of established procedures were respectively as follows: 89.8% and 98.8% for U1-RNP, 86.4% and 95.3% for Sm, 97.9% and 89.3% for SS-A/Ro, 98.3% and 86.3% for SS-B/La, and 97.5% and 93.1% for nDNA. Agreement between the ANA Profile test and these other test methodologies ranged from 88.7% for the SS-B/La test to 97.3% for the U1-RNP test. This new test procedure substantially decreases the time and effort required to perform these assays. Total hands-on time and overall assay time were decreased by 72% and 97%, respectively.
Paxton
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Maryland Medical Laboratory, Inc., Baltimore 21227.
Bendele
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T
O'Connor
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L
Haynes
D C
DC
D000906:Antibodies / Q000032:analysis*; D001324:Autoantigens / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay; D005455:Fluorescent Antibody Technique; D006801:Humans; D005779:Immunodiffusion; D011233:Precipitin Tests; D011934:Reagent Strips; D012261:Ribonucleoproteins / Q000276:immunology*; D017411:Ribonucleoproteins, Small Nuclear
D000906:Antibodies; D001324:Autoantigens; D011934:Reagent Strips; D012261:Ribonucleoproteins; D017411:Ribonucleoproteins, Small Nuclear