Obviously for new drugs, appropriate, well-characterized strain sets must be possessed by pharmaceutical manufacturers or affiliates, as data from these strains are required to establish the susceptibility breakpoints for the drug.
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3 The rationale is that the disk diffusion method for common drugs was instituted before CLIA 1988 and therefore is exempt from its own verification requirements, 4 a somewhat problematic strategy, as the disks were originally cleared based on categorical performance around former, but not updated breakpoints, and accordingly important essential agreement metrics cannot be assessed. The often-recommended fall back for the latter is to compare with the disk diffusion method using correspondingly updated zone sizes. Availability of appropriate strains sets is also needed for “off-label” verification of existing methods when breakpoints are adjusted to reflect evolving best practice consensus (eg, annual Clinical and Laboratory Standards Institute updates). Practically, for new antibiotics, where to find such characterized strain sets is unclear. Most hospital laboratories consequently opt to verify new AST methods using a set of strains already characterized by a reference method such as BMD (or a nonreference, FDA-cleared method that has been previously verified in a CLIA-accredited laboratory) and that has an appropriate representation of susceptible and resistant isolates. Verification could entail comparing the new AST method with a reference standard such as broth microdilution (BMD), but this gold-standard method requires significant assay expertise, technologist effort, and ready availability of antimicrobial powder. In the absence of explicit guidance, use of accepted standards in the field are a reasonable and commonly used substitute, codified in documents such as Cumitech 31A. CLIA stipulations are nonspecific and for FDA-approved assays only indicate the need to verify accuracy and precision to an unstated degree.
Nevertheless, before implementation of any AST method for a new drug, clinical laboratories must still verify its performance per Clinical Laboratory Improvement Amendments (CLIA) of 1988 requirement. Fortunately, diffusion-based methods may offer an interim solution. 1 However, it can still take years before novel antimicrobials become incorporated into commercial panels. The FDA recognized this problematic discordance and hence made efforts to coordinate release of antimicrobials and commercial AST methods. Ceftaroline, for example, did not have an FDA-cleared AST method until 7 months after the initial approval in 2010 and automated systems took another 2.5 to 3.5 years to gain clearance. In the recent past, the time delay between Food and Drug Administration (FDA) approval of new antimicrobials and the availability of corresponding AST methods has been a significant hindrance to the utilization of new drugs for clinical care. However, for an AST result to be meaningful for patient management, it usually must be available in a few days at most. As a result, isolates must be sent to a reference laboratory delaying AST results for up to a week or more. Historically there has been a time lag in the availability of susceptibility testing methods for new antibiotics. However, they are only useful clinically if the microbiology laboratory can provide timely antimicrobial susceptibility testing (AST) results. Stop by and see what treasures, or horrors, you can find.National resources available at local levelīringing new drugs on board: new antibiotics offer potentially life-saving options for multidrug-resistant infections. Some stories will be connected Others will be random one-shots. since there seems to be a lot of misunderstandings caused by my random one-shotsĪ collection of inane nonsense (ranging from Error being reincarnated as Palette to Dust finding a new love for the color pink) circling around the many AUs and Multiverses of the Undertale world.I just want to reiterate that NOT all stories are connected.at this point I have given up on tagging everything.Alternate Universe - Outertale (Undertale).Alternate Universe - Aftertale (Undertale).Alternate Universe - Underswap (Undertale).Alternate Universe - Reapertale (Undertale).