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| Product Name | Antinuclear Antibodies (ANA) Test Kit |
| Catalog No. | FAI-QCY-0010 |
| Description | This kit is an indirect immunofluorescence assay designed for the qualitative detection and semi-quantitative measurement of anti-nuclear antibodies (ANA) of IgG subtypes in human serum using manual or automated fluorescence microscopy. The presence of ANA, in conjunction with other serological tests and clinical manifestations, aids in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases. |
| Certification | FDA |
| Sample Type | Serum |
| Applicable Instrument | Fluorescence immunoassay analyzer |
| Kit Components | HEp-2 (human epithelial cell) substrate slides. FITC IgG conjugate with 4',6-diamidino-2-phenylindole (DAPI), containing 0.09% sodium azide. Positive control: ANA titratable pattern, human serum with antibodies to HEp-2 nuclei in buffer, containing 0.09% sodium azide, pre-diluted, ready to use. Negative control: Diluted human serum with no ANA 3 present, containing 0.09% sodium azide, pre-diluted, ready to use. PBS II (40x) concentrate, sufficient for making 2000 mL of 1x PBS II. Mounting medium, containing 0.09% sodium azide. Coverslips. |
| Application | This kit is intended for qualitative or semi-quantitative detection of antinuclear antibodies (ANA) to aid in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases. |
| Storage | Store at 2-8°C. |
| Validity Period | 12 months |
For in vitro diagnostic use.
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