It will be important for local labs to verify the reproducibility reported herein when implementing this decentralized assay to ensure the quality of the test's results, including ongoing process monitoring [ 38].
The results demonstrate the need to account for sequence polymorphisms when designing and implementing this highly specific assay.
To implement this experimentally, we assayed 435 mutants at each generation.
As a step toward demonstrating that the RPAC assay could be performed in a low-resource setting, we implemented the assay in a paper and plastic foldable device requiring only a micropipet, pipet tips, and a single temperature heater.
As real-time PCR has become widely implemented, these assays should be readily adaptable by technical staff in any laboratory using this technology.
Despite several publications on the analytical performance of high-sensitivity cardiac troponin (hs-cTn) assays, there has been little information on how laboratories should validate and implement these assays into clinical service.
Several research groups have already implemented these assays in fully automated staining stations [ 76,80,97,98], some of which are US FDA-approved for diagnostic IHC assays.
However, more effort should be devoted in optimizing and reevaluating this technique as a great advantage of SPA is that this assay utilizes hamster oocytes are more readily available than human and clinical application of SPA could possibly be more realistic than implementing an assay that requires resources which are currently limited.
By implementing an affinity assay based on the competitive bonding between concanavalin A and dextran, the selectivity of the membrane can be transferred to the glucose specific recognition of the affinity assay.
The likelihood of carryover contamination can be reduced in the future by implementing the RPAC assay on a compact, fully enclosed device that completely contains the reaction.
