PMID- 2140076 OWN - NLM STAT- MEDLINE DCOM- 19900618 LR - 20190722 IS - 0009-9147 (Print) IS - 0009-9147 (Linking) VI - 36 IP - 5 DP - 1990 May TI - 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. PG - 792-7 AB - 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. FAU - Paxton, H AU - Paxton H AD - Maryland Medical Laboratory, Inc., Baltimore 21227. FAU - Bendele, T AU - Bendele T FAU - O'Connor, L AU - O'Connor L FAU - Haynes, D C AU - Haynes DC LA - eng PT - Comparative Study PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - Clin Chem JT - Clinical chemistry JID - 9421549 RN - 0 (Antibodies) RN - 0 (Autoantigens) RN - 0 (Reagent Strips) RN - 0 (Ribonucleoproteins) RN - 0 (Ribonucleoproteins, Small Nuclear) SB - IM MH - Antibodies/*analysis MH - Autoantigens/*immunology MH - Enzyme-Linked Immunosorbent Assay MH - Fluorescent Antibody Technique MH - Humans MH - Immunodiffusion MH - Precipitin Tests MH - *Reagent Strips MH - Ribonucleoproteins/*immunology MH - Ribonucleoproteins, Small Nuclear EDAT- 1990/05/01 00:00 MHDA- 1990/05/01 00:01 CRDT- 1990/05/01 00:00 PHST- 1990/05/01 00:00 [pubmed] PHST- 1990/05/01 00:01 [medline] PHST- 1990/05/01 00:00 [entrez] PST - ppublish SO - Clin Chem. 1990 May;36(5):792-7.