Treponema Pallidum Treponemal Test Reagents

Treponema pallidum treponemal test reagent is a laboratory medical device designed to identify antibodies that specifically target the Treponema pallidum bacterium, which is responsible for syphilis, in a patient’s blood sample. This device comprises a collection of antigens sourced directly from Treponema pallidum, accompanied by control reagents. It is utilized in various serological assays, such as the Fluorescent Treponemal Antibody Absorption (FTA-ABS) test, to confirm the presence of syphilis by detecting these specific antibodies in the serum, thereby facilitating a conclusive diagnosis of the infection.

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), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Intended Use: It is intended to aid in the diagnosis of syphilis or in conjunction with a non-treponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. The Access Syphilis assay is not intended for blood and tissue donor screening.

Device Description: The assay is a two-step enzyme immunoassay using a sample, buffer, and paramagnetic particles coated with recombinant Treponema pallidum antigens Tp17 and Tp47, and biotinylated antigens. The sample is incubated in a reaction vessel, and materials are held in a magnetic field. Alkaline phosphatase conjugates bind to the immunoglobulin on the particles. A chemiluminescent substrate is added, and the light produced is measured with a luminometer. The light quantity is used to determine the presence of the analyte.

Intended Use: The Test Kit is used as a qualitative test for detecting IgG and IgM antibodies to Borrelia burgdorferi in human serum from symptomatic patients or those suspected of infection. Positive and equivocal results from the first-tier screening must be confirmed by:

1. a) Standard two-tier test methodology (STTT) using IgG/IgM blot testing, or
2. b) Modified two-tier test methodology (MTTT) using Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test. This test can also serve as a second-tier confirmation test when combined with the MTTT methodology for initial screening.

The Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit detects IgG and IgM antibodies to VlsE and OspC antigens in serum from symptomatic patients or those suspected of having Lyme disease. Positive and equivocal first-tier results require confirmation through STTT or MTTT using specific ELISA assays. Positive findings from STTT or MTTT indicate possible exposure to Borrelia burgdorferi and should be interpreted in conjunction with patient history and lab results for diagnosing Lyme disease.

Device Description: The kit includes 12 x 8 well Antigen Coated strips, Conjugate, Substrate, Stop Solution, Wash Buffer, Diluent, Negative Control, Positive Control, and a Cutoff Control. The controls are provided to determine if the assay is functioning properly and to determine the antibody level. The reagents are sufficient for 96 determinations.

Stability Studies
Precision/Reproducibility
Detection studies
Detection limit
Analytical specificity
Traceability (controls, calibrators, or method)
Retrospective Study
Analytical Sensitivity
Assay cut-off.
Analytical Specificity (Cross-Reactivity)
Interfering Substances
Precision – Intra and Inter-assay
Prozone effect study

The same is applicable for CE Marking under IVDR also.

Clinical Testing is mandatory for 510k submission and IVDR CE Marking