RIDASNAP™ TB-IGRA Assay
Catalog Number: SN24001
Package Specification: 56 Preps/Kit
Partnered with R-Biopharm AG
Intended use
For in vitro diagnostic use. The RIDASNAPTM TB-IGRA ASSAY is a enzyme immunoassay for the direct quantitative detection of interferon gamma-induced protein 10 (IP-10) from human plasma samples of individuals with suspected Mycobacterium tuberculosis infection (including disease). This IVD test is intended for use in conjunction with the RIDASNAP™ TB Tubes for in vitro stimulation with specific M. tuberculosis antigens. The assay is compatible with automated ELISA systems such as Dynex Agility, Dynex DS2, and Aikang ELISA platforms, enabling high-throughput screening in laboratory settings.
Principle
Whole blood must be pretreated using RIDASNAPTM TB Tubes to stimulate IP-10 production, before using the RIDASNAPTM TB-IGRA ASSAY. Blood can be collected directly into the tubes or indirectly via a lithium heparin tube, then transferred into the TB tubes. Samples are incubated at 37 °C for 16–24 hours, and plasma is collected per IFU guidelines.
Each person must provide three plasma samples (NEG, TEST, POS) for a valid result. The assay uses a sandwich ELISA method: wells coated with anti-IP-10 monoclonal antibodies bind IP-10 if present. Biotinylated antibodies (conjugate 1) and streptavidin-polyperoxidase (conjugate 2) enable color detection.
A blue color indicates IP-10 presence; after a stop reagent, the color turns yellow, and the optical density at 450/620 nm correlates with IP-10 concentration.
Storage
RIDASNAPTM TB-IGRA ASSAY should be stored at 2 °C to 8 °C.