5016 – DotDiver ANA
Intended Purpose
The DotDiver ANA is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (Sm, Sm/RNP, SS-A, SS-B, Jo-1, Scl-70, PM-Scl-100, CENP-A/B) in human serum. The DotDiver ANA is intended as an aid in the diagnosis of systemic autoimmune diseases in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.
Diagnostic Relevance
Progressive systemic sclerosis (PSS) or systemic scleroderma is an autoimmune disease of connective tissue characterized by slowly progressive fibrosis leading to sclerosis.
Scl-70 autoantibodies are pathognomonic for PSS patients. Polymyositis and dermatomyositis are idiopathic inflammatory muscle disorders with an unknown etiology, however, autoantibodies to t-RNA transferases like Jo-1, PL-7, and PL-12 are found in myositis patients. Antibodies to SRP are also specific markers for Polymyositis. Mi-2 autoantibodies are detected almost exclusively in patients with dermatomyositis. Patients tested positive for Mi-2 have a relatively mild clinical course.
Product Specifications
| Title | DotDiver ANA |
| Product code | 5016 |
| Indication | Systemic autoimmune diseases |
| Description | Dot immunoassay for the qualitative determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum |
| Format | Test strips coated with Sm, Sm/RNP, SS-A, SS-B, Jo-1, Scl-70, PM-Scl-100 and CENP-A/B |
| Total incubation time | 64 min. |
| Sample volume | 10 µL serum |
| No. of determinations | 24 x 8 |
Free downloads
SDS [REF 5016][eng] SDS [REF 5016][deu]Restricted downloads - Password required
Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.