ABOUT GUIDANCE UTI TESTING METHODOLOGY
Methodology and Clinical Significance:
Pathnostics’ GUIDANCE UTI Test utilizes PCR amplification for the targeted detection of agents. Pathogens are reported in ranges of organism(s) per milliliter of urine:
- No pathogenic DNA detected:
– <10,000 cells/mL
– 10,000-49,999 cells/mL
– 50,000-99,999 cells/mL
– >100,000 cells/mL
Detected resistance genes are shown as RGD (Resistance Gene(s) Detected). In addition, phenotypic antimicrobial susceptibility results are ascertained for the detected polymicrobial population by employing a high-throughput, broth microdilution, spectrophotometric assay in which the detected mono or polymicrobial population is applied to a panel of antimicrobial agent’s array on a microplate to determine the minimum inhibitory concentration (MIC).
Information About the Table:
Supportive Evidence indicates situations for which antibiotic use either FDA-approved or off label uses for antibiotics is illustrated in peer-reviewed literature.
Treatment options are not intended to be prescriptive for this patient. Appropriate medical judgment should be exercised by the attending physician before prescribing a course of treatment.
Moreover, changes in research studies may occur. Although we attempt to update the report with new data promptly, we cannot prevent delays. White boxes indicate situations where the pool of organisms was susceptible to an antibiotic and there is supportive evidence for all bacterial organisms listed.
In the case for which pooled antibiotic sensitivity could not be performed, highlighted boxes reflect situations for which the antibiotics are clinically recommended for all bacteria listed.
Pooled Phenotypic Sensitivity:
Antibiotic susceptibility testing performed when at least a single organism within a pool of organisms reaches at least 10,000 cells/ml and can grow in the presence of the antibiotic in the assay within the time of testing.
Antibiotic susceptibility testing is currently unavailable for Ureaplasma urealyticum, Actinobaculum schaalii, Aerococcus urinae, Alloscardovia omnicolens, Corynebacterium riegelii, Mycoplasma hominis, and Mycoplasma genitalium due to fastidious characteristics in vitro.
Susceptibility testing is not performed for Viridans Streptococci because suggested antibiotics have a high efficacy rate.
Clinically Recommended Antifungal Agents:
|– Amphotericin B (IV)||– Fluconazole (PO/IV)||– Micafungin (IV)|
|– Anidulafungin (IV)||– Isavuconazole (PO/IV)||– Posaconazole (PO/IV)|
|– Caspofungin (IV)||– Itraconazole (PO)||– Voriconazole (PO/IV)|
|– Cidofovir for BK virus|
|– Cidofovir or Vidarabine for Adenovirus|
|– Foscamet or Cidofovir for CMV|
|– Acyclovir or Valacyclovir for HSV|
|Please refer to DOI: 10.1007/s11918-007-006-7 for further specific treatment information.|
Treatment Options for Sexually Transmitted Infections:
– *Broad Spectrum Resistant genes identified confers resistance across multiple classes of antibiotics including penicillin derivatives, cephalosporins, monobactams and carbapenems
– ** Coagulase Negative Staphylococcus includes: Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus lugdunenesis, and Staphylococcus saprophyticus
– *** ESBL Positive for extended-spectrum beta-lactamases (ESBL) which are enzymes that confer resistance to most beta-lactam antibiotics, including penicillins, cephalosporins, and the monobactam aztreonam. Infections with ESBL producing organisms have been associated with poor outcomes
– **** Viridans Group Strep includes: Streptococcus anginosus, Streptococcus oralis, and Streptococcus pasteuranus
This test was developed and its performance characteristics determined by Pathnostics. It has not been cleared or approved by the US Food and Drug Administration. The FDA has determined that such clearance or approvals is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical testing. Urine specimens received greater than 5 days post collection may give unreliable cells/mL counts due to overgrowth of microorganism(s).
LICENSES AND ACCREDITATIONS
CLIA (Clinical Laboratory Improvement Amendments of 1988): 05D2024468
State of California Department of Public Health: CLF00340926
Florida Agency for Health Care Administration: