ANA Screen

Key Features and Values

– Same sample type can be used across all assays to simplify inclusion into routine serology work-up
– Ready to use reagents reduces hands-on time for assay preparation
– Long shelf life cost-effective solution by reducing wastage due to expired kits
– Suitable for inclusion on automated plate systems simplifies scale-up of test volume
– Supported by a complete panel of assays for diagnosis of SLE and APS

Product Description

ANA Screen kit is an indirect solid phase enzyme immunometric assay (ELISA) designed for semiquantitative measurement of IgG antibodies directed against Sm (Smith), RNP/Sm, Scl-70, SS-A (Ro) (52kDa and 60kDa), SS-B (La), Jo1, U1-SmRNP, CENP-B, dsDNA and Histones in human serum or plasma.  ANA Screen kit is intended for laboratory use only.

Scientific Description
The anti-nuclear antigen autoantibodies represent a large family of non-organ- and non-species-specific autoantibodies, detection of which is of great importance and widely used in laboratory diagnosis of systemic rheumatic autoimmune diseases1-4. From the laboratory point of view, systemic autoimmune diseases are characterised by the presence of anti-nuclear antibodies (ANAs).  ANA is the first autoantibody test ordered for patients with suspected systemic autoimmune disorders. Despite its considerable use in diagnosis of these autoimmune disorders, ANA is often detected in healthy subjects without clinical presentation of any autoimmune disorder. It has recently been suggested that detection of ANA in such healthy subjects is a risk factor for development of connective tissue disease5.
ANAs can be assessed by a variety of methods with the immunofluorescence assay (IFA) being considered the gold standard method6. IFA positivity for ANA indicates the presence of autoantibodies directed against various nuclear antigens (DNA, histones, non-histonic proteins, nuclear antigens, etc.) or cytoplasmic antigens7,8. Significantly high-titre positivity for ANAs should be further investigated via testing for anti-ENA, anti-dsDNA and anti-CENP-B autoantibodies. Positivity for ANAs and for one or more specific tests for anti-ENA, anti-dsDNA, and/or anti-CENP is highly suggestive of systemic autoimmune disorders: systemic lupus erythematosus (SLE), Sjögren’s Syndrome (SS), progressive systemic sclerosis (PSS), dermatomyositis/polymyositis (DM/PM), and/or mixed connective tissue disease (MCTD).
The most useful and most commonly tested anti-ANA autoantibodies are anti- Sm (Smith), anti-RNP/Sm, anti-Scl70, anti SS-A/Ro, anti SS-B/La, anti-Jo1, anti-CENP-B, histones and anti-dsDNA.

1. CA von Mühlen, EM Tan. Autoantibodies in the diagnosis of systemic rheumatic diseases. Sem Arthr Rheum 1995; 24: 323-58
2. RL Humbel. Auto-immunité, auto-anticorps et maladie. In: Humbel RL, ed. Autoanticorps et maladies autoimmunes. Paris, France: Edition Scientifiques Elsevier; 1997: 17-20
3. PN Hollingsworth, SC Pummer, RL Dawkins. Antinuclear antibodies. In: Peter JB, Shoenfeld Y, eds. Autoantibodies. Amsterdam, The Netherlands: Elsevier Science BV; 1996: 74-90
4. CA Slater, RB Davis, RH Shmerling. Antinuclear antibodies testing. A study of clinical utility. Arch Int Med 1996; 156: 1421-5
5. Selmi C, Ceribelli A, Generali E, Scirè CA, Alborghetti F, Colloredo G, Porrati L, Achenza MI, De Santis M, Cavaciocchi F, Massarotti M, Isailovic N, Paleari V, Invernizzi P, Matthias T, Zucchi A, Meroni PL.  Serum antinuclear and extractable nuclear antigen antibody prevalence and associated morbidity and mortality in the general population over 15 years.  Autoimmun Rev. 2016 Feb;15(2):162-6
6. Pisetsky DS.  Antinuclear antibody testing – misunderstood or misbegotten?  Nat Rev Rheumatol. 2017 Aug;13(8):495-502
7. RL Humbel. Detection of antinuclear antibodies by immunofluorescence. In: van Venrooij, Maini RN eds. Manual of Biological Markers of Disease. Dordrecht, The Netherlands: Kluwer; 1993: A2:1-16
8. National Committee for clinical Laboratory Standardization. Quality assurance for the indirect immunofluorescence test for autoantibodies to nuclear antigen (IF-ANA). Approved Guideline. Wayne, PA: NCCLS I/LA2-A, vol. 16 (11); 1996


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Code: DKO099
Clinical Area: ,
Incubation: 30+30+15 min
Sensitivity: 87.1%
Specificity: 80%
Classification: IVD, CE
Number of Tests: 96
Sample Type: Serum, heparin plasma, EDTA plasma
Sample Volume: 10 µL (1:100 predilution)
Assay Range: N/A