(182 days)
The ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical findings to provide serological evidence of infection with T. pallidum. This test is for in vitro diagnostic use only.
This test is not intended for screening blood or plasma donors.
The ZEUS ELISA Treponema pallidum IgG Test System is designed to detect IgG class antibodies in human sera to Treponema pallidum. Wells of plastic microwell strips are sensitized by passive absorption with T. pallidum antigen. The test procedure involves three incubation steps:
- Test sera are diluted with SAVE Diluent. During sample incubation, any antigen specific lgG antibody in the sample will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components.
- Peroxidase conjugated goat anti-human IgG is added to the wells and the plate is incubated. The conjugate will react with IgG antibody immobilized on the solid phase in step 1. The wells are washed to remove unbound conjugate.
- The microwells containing immobilized peroxidase conjugate with peroxidase substrate solution. Hydrolysis of the substrate by peroxidase produces a color change. After ten minutes have elapsed, the reaction is stopped and the color intensity of the solution is measured photometrically. The color intensity of the solution depends on upon the antibody concentration in the original test sample.
The Zeus Scientific Inc. ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non-treponemal testing and clinical findings to provide serological evidence of infection with T. pallidum. It is for in vitro diagnostic use only and not intended for screening blood or plasma donors.
Acceptance Criteria and Device Performance
The acceptance criteria for the ZEUS ELISA Treponema pallidum IgG Test System are implicitly demonstrated by the performance against the predicate device and the specified reproducibility metrics. While explicit quantitative acceptance criteria for clinical performance (e.g., specific sensitivity, specificity thresholds) are not individually listed for each study, the submission aims to demonstrate substantial equivalence to the predicate device.
The internal and external reproducibility studies provide quantitative acceptance criteria for precision (Total CV 1.1 Positive) |
|---|---|---|---|
| Intended Use Populations | | | |
| 500 patients with syphilis test ordered | TPPA (treponemal reference assay) | Phoenix Bio-Tech Trep-Chek | PPA: 80.0% (95% CI: 28.4-99.5%), NPA: 99.2% (95% CI: 97.9-99.8%) |
| 500 pregnant women with syphilis test ordered | TPPA (treponemal reference assay) | Phoenix Bio-Tech Trep-Chek | PPA: 75.0% (95% CI: 19.4-99.4%), NPA: 100.0% (95% CI: 99.4-100%) |
| Other Clinical Performance Studies | | | |
| 1000 unselected hospitalized patients | TPPA (treponemal reference assay) | Phoenix Bio-Tech Trep-Chek | PPA: Not fully reported (21 Positive, 1 Equivocal by predicate resulted in 13 Positive by device), NPA: 97.1% (95% CI: 95.9-98.1%) |
| 223 Retrospective HIV-1 Positive Samples | TPPA (treponemal reference assay) | Phoenix Bio-Tech Trep-Chek | PPA: 85.4% (95% CI: 72.2-93.9%), NPA: 99.4% (95% CI: 96.9-100%) |
| 280 Retrospective TPPA/RPR Positive Samples | TPPA/RPR (reference assays) | Phoenix Bio-Tech Trep-Chek | PPA: 98.5% (95% CI: 96.2-99.6%), NPA: 70.6% (95% CI: 46.9-98.7%) |
| 277 Retrospective TPPA Negative/Positive Pregnant Women | TPPA/RPR (reference assays) | Phoenix Bio-Tech Trep-Chek | PPA: 92.9% (95% CI: 76.5-99.1%), NPA: 99.6% (95% CI: 97.8-100%) |
| 157 CDC Syphilis Panel | Clinical Diagnosis | N/A | % Agreement with Clinical Diagnosis: 93.0% (95% CI: 87.8-96.5%) |
| Precision (Repeatability) | | | |
| 15 samples (Negative, High Negative, Near Cut-off, Low Positive, High Positive) | Internal testing, 48 replicates each | N/A | Total CV for reactive samples: 3.5% to 7.0% (all
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).