CLARK LABORATORIES, INC. 2327670 Trinity Biotech

Captia™ ds/DNA

Anti-dsDNA is an ELISA test system for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma. This product is intended for professional in vitro diagnostic use only.

1.Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. dsDNA SC Coated Wells: 12 breakapart 8 well strips coated with calf thymus dsDNA antigen. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.5. dsDNA SC Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-dsDNA autoantibody: 1000, 333, 111, 37, 12.3 IU/mL. Ready to use.6. dsDNA SC Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use.8. HRP Wash Concentrate (40X): 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.9.dsDNA SC Single Stranded Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.10. HRP dsDNA SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.11. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.12. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.