Instructions for use of the ELECTRA Tp. Ab. CLIA chemiluminescence immunoassay kit for detecting Treponema pallidum antibodies in human serum or plasma.
ELECTRA Tp. Ab. CLIA is a microwell chemiluminescence immunoassay kit manufactured by Qualpro Diagnostics, a division of Tulip Diagnostics (P) Ltd., for the detection of total antibodies to Treponema pallidum in human serum or plasma. The kit uses recombinant 47Kd and 17Kd antigens coated on micro-wells and an HRP-conjugated antigen, and is intended for use on ELECTRA SA and ELECTRA FA analyzers.
This instructions-for-use document covers kit components, storage and stability, sample collection, reagent preparation, the test procedure, calculations, interpretation of results, and performance characteristics. It also includes remarks, precautions, and test validation criteria.
| Intended Use | Detection of antibodies to Treponema pallidum in human serum or plasma |
|---|---|
| Test Formats | 96 tests and 192 tests |
| Coating Antigens | Recombinant 47Kd and 17Kd antigens |
| Storage Condition | 2-8°C up to the expiry date printed on the label |
| Sample Volume | 50 µl per well |
| Incubation | 45 minutes at 37°C |
| Cutoff Factor | 400000 for ELECTRA SA and ELECTRA FA |
| Result Interpretation | ECI ≥ 1.00 reactive; ECI < 1.00 non-reactive |
It is a microwell chemiluminescence assay for detecting total antibodies (IgG, IgM, IgA) to Treponema pallidum in human serum or plasma.
The assay is for use on ELECTRA SA and ELECTRA FA analyzers.
Results are expressed as Electra cutoff Index (ECI); samples with ECI values greater than or equal to 1.00 are considered reactive and those below 1.00 non-reactive.
The kit is stable at 2-8°C up to the expiry date printed on the label.