UTIDX™ Test Methodology

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UTIDX™ utilizes Multiplex PCR for the targeted molecular detection of bacterial DNA and antibiotic resistance genes. Additionally, antibiotic susceptibility is performed using an internally developed method for Antibiotic Susceptibility Testing (AST). Together, the results deliver personalized treatment options for urinary tract infections.

If detected, targets are reported semi-quantitatively as cells per milliliter in the following ranges:

– <10,000 cells/mL
– 10,000-49,999 cells/mL
– 50,000-99,999 cells/mL
– >100,000 cells/mL

UTIDX™ also includes the detection of resistance genes. When detected, Resistance Genes Detected (RGD) will be indicated on the table of the report.

– Broad Spectrum resistant genes confer resistance across multiple classes of antibiotics including penicillin derivatives, cephalosporins, monobactams, and carbapenems.

– Extended-spectrum beta-lactamases (ESBL) are enzymes that are responsible for resistance to most beta-lactam antibiotics, including penicillins, cephalosporins, and the monobactam aztreonam. Infections with ESBL producing organisms have been associated with poor outcomes.

Antibiotic Sensitivity Testing (AST) of the microbial community is determined when the population of detected pathogens is applied to a panel of antibiotic agents. 

AST is not performed for Virdians streptococci, or fastidious microorganisms such as Ureaplasma urealyticum, Actinobaculum schaalii, Aerococcus urinae, Alloscardovia omnicolens, Corynebacterium riegelii, Mycoplasma hominis, and Enterococcus faecium.

In addition to providing both the presence of resistance genes (R) and antibiotic susceptibility patterns (S), we also include a table of antibiotics that have shown strong supportive evidence for use in the treatment of UTI.

The checkmarks indicate antibiotics listed in the table are based on the most current recommendations by established guidelines and should act as a guide for suspected UTI management. Appropriate medical judgement should be exercised by the health care provider before prescribing a course of treatment. Further treatment or workup may be necessary if clinically indicated.

 We do not perform antifungal susceptibility testing 

This test was developed and its performance characteristics determined by EmeritusDX. 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).