8-Panel Drug Test (Any combination) + Alcohol (Strip) (DTS336)

Regulatory status: For research use only, not for use in diagnostic procedures.

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Intended Use
The CD DOA/Alcohol Rapid Test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of drug substances in human urine specimens. This assay may be used in the point of care setting. Below is a list of cut-off concentrations for each drug.
The DOA/Alcohol Rapid Test Device should be stored at 4 to 30°C and will be effective until the expiration date stated on the package. The product is humidity-sensitive and should be used immediately after being open. Any improperly sealed product should
The cut-off concentrations (sensitivity level) of the DOA/Alcohol Rapid Test Device are determined to be: AMP 1000 ng/ml, BAR, 300 ng/ml, BZO 300 ng/ml, BUP 10 ng/ml, COC 300 ng/ml, EDDP 100 ng/ml, KET 1000 ng/ml, MTD 300 ng/ml, MET 1000 ng/ml, MDMA 500 ng/ml, OPI 300 ng/ml, OPI II 2000 ng/ml, OXY 100 ng/ml, PCP 25 ng/ml , PPX 300 ng/ml, THC 50 ng/ml, 200ng/ml of TRA and TCA 1000 ng/ml.


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Zoliflodacin: An Oral Spiropyrimidinetrione Antibiotic for the Treatment of Neisseria gonorrheae, Including Multi-Drug-Resistant Isolates


Authors: Bradford, Patricia A.; Miller, Alita A.; O'Donnell, John; Mueller, John P.

The Centers for Disease Control and the World Health Organization have issued a list of priority pathogens for which there are dwindling therapeutic options, including antibiotic-resistant Neisseria gonorrheae, for which novel oral agents are urgently needed. Zoliflodacin, the first in a new class of antibacterial agents called the spiropyrimidinetriones, is being developed for the treatment of gonorrhea. It has a unique mode of inhibition against bacterial type II topoisomerases with binding sites in bacterial gyrase that are distinct from those of the fluoroquinolones. Zoliflodacin is bactericidal, with a low frequency of resistance and potent antibacterial activity against N. gonorrheae, including multi-drug-resistant strains (MICs ranging from <= 0.002 to 0.25 mu g/mL). Although being developed for the treatment of gonorrhea, zoliflodacin also has activity against Gram-positive, fastidious Gram-negative, and atypical pathogens. A hollow-fiber infection model using S. aureus showed that that pharmacokinetic/pharmacodynamic index of fAUC/MIC best correlated with efficacy in in vivo neutropenic thigh models in mice. This data and unbound exposure magnitudes derived from the thigh models were subsequently utilized in a surrogate pathogen approach to establish dose ranges for clinical development with N. gonorrheae. In preclinical studies, a wide safety margin supported progression to phase 1 studies in healthy volunteers, which showed linear pharmacokinetics, good oral bioavailability, and no significant safety findings. In a phase 2 study, zoliflodacin was effective in treating gonococcal urogenital and rectal infections. In partnership with the Global Antibiotic Research Development Program (GARDP), zoliflodacin is currently being studied in a global phase 3 clinical trial. Zoliflodacin represents a promising new oral therapy for drug-resistant infections caused by N. gonorrheae.

Analytical Performance Validation of Next-Generation Sequencing Based Clinical Microbiology Assays Using a K-mer Analysis Workflow


Authors: Lepuschitz, Sarah; Weinmaier, Thomas; Mrazek, Katharina; Beisken, Stephan; Weinberger, Johannes; Posch, Andreas E.

Next-generation sequencing (NGS) enables clinical microbiology assays such as molecular typing of bacterial isolates which is now routinely applied for infection control and epidemiology. Additionally, feasibility for NGS-based identification of antimicrobial resistance (AMR) markers as well as genetic prediction of antibiotic susceptibility testing results has been demonstrated. Various bioinformatics approaches enabling NGS-based clinical microbiology assays exist, but standardized, computationally efficient and scalable sample-to-results workflows including validated quality control parameters are still lacking. Bioinformatics analysis workflows based on k-mers have been shown to allow for fast and efficient analysis of large genomics data sets as obtained from microbial sequencing applications. We here demonstrate applicability of k-mer based clinical microbiology assays for whole-genome sequencing (WGS) including variant calling, taxonomic identification, bacterial typing as well as AMR marker detection. The wet-lab and dry-lab workflows were developed and validated in line with Clinical Laboratory Improvement Act (CLIA) guidelines for laboratory-developed tests (LDTs) on multi-drug resistant ESKAPE pathogens. The developed k-mer based workflow demonstrated >= 99.39% repeatability, >= 99.09% reproducibility and >= 99.76% accuracy for variant calling and applied assays as determined by intra-day and inter-day triplicate measurements. The limit of detection (LOD) across assays was found to be at 20x sequencing depth and 15x for AMR marker detection. Thorough benchmarking of the k-mer based workflow revealed analytical performance criteria are comparable to state-of-the-art alignment based workflows across clinical microbiology assays. Diagnostic sensitivity and specificity for multilocus sequence typing (MLST) and phylogenetic analysis were 100% for both approaches. For AMR marker detection, sensitivity and specificity were 95.29 and 99.78% for the k-mer based workflow as compared to 95.17 and 99.77% for the alignment-based approach. Summarizing, results illustrate that k-mer based analysis workflows enable a broad range of clinical microbiology assays, potentially not only for WGS-based typing and AMR gene detection but also genetic prediction of antibiotic susceptibility testing results.

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