Human Sm RNP IgG ELISA Kit

Sample

Human sera

Species Reactivity

Human

Detection Method

sELISA

Intended Use

Our ENA ELISA test systems are semi-quantitative immunoassay for the detection of IgG antibodies to Jo-1, Sm, Sm/RNP, SSA(Ro), SSB(La), and Scl-70 in human sera. When performed according to these instructions, the results of these assays may aid in the diagnosis and treatment of autoimmune connective tissue disorders. This device is for research use only.

Contents of Kit

Each kit contains the following components in sufficient quantities to perform the number of tests indicated on packaging label.

Storage

1. Store the unopened kit at 2°C and 8°C.
2. Coated microwell strips: Store between 2°C and 8°C. Extra strips should be immediately resealed with desiccant and returned to proper storage. Strips are stable for 60 days after the envelope has been opened and properly resealed and the indicator strip on the desiccant pouch remains blue.
3. Conjugate: Store between 2°C and 8°C. DO NOT FREEZE.
4. Calibrator, Positive Control and Negative Control: Store between 2°C and 8°C.
5. TMB: Store between 2°C and 8°C.
6. Wash Buffer concentrate (10X): Store between 2°C and 25°C. Diluted wash buffer (1X) is stable at room temperature (20°C - 25°C) for up to 7 days or for 30 days between 2°C and 8°C.
7. Sample Diluent: Store between 2°C and 8°C.
8. Stop Solution: Store at 2°C and 25°C.

Performance Characteristics

Comparative Study:
A comparative study was performed to demonstrate the equivalence of the various our ENA ELISA test systems to other commercially available autoantibody ELISA test systems. The performance of the ELISAs was evaluated using 337* serum specimens; 152 normal donor samples from the northeastern and southeastern United States, and 185 disease-state repository samples previously characterized with respect to autoantibody activity. The results of the investigation have been summarized in Tables 1 and 2 below:
* The total population tested for anti-Jo-1 was 126; 64 normal donor samples, and 62 of the disease-state repository samples.

A. Number of specimens reactive on our Test System.
B. Number of specimens reactive on Commercial ELISA Test System.
C. Number of discrepant specimens.
D. Number of positive specimens in the population after resolution of the discrepant specimens using alternate methodology such as gel immunodiffusion (GID), IFA, and third-party ELISA tests.

A. Number of specimens non-reactive on our Test System.
B. Number of specimens non-reactive on Commercial ELISA Test System.
C. Number of discrepant specimens.
D. Number of non-reactive specimens in the population after resolution of the discrepant specimens using alternate methodology such as gel immunodiffusion (GID), IFA, and third-party ELISA tests.