Urinary Tract Infection Panel

WHAT IS THE REALTIME LABS URINARY TRACT INFECTION PANEL?

For years, the gold standard for UTI diagnosis has been urinalysis and standard urine culture. However, lengthy turnaround times, potential false positive results, and difficulty in reporting speciation and antibiotic susceptibility are among the shortcomings in culture methodology. Thus, newer technologies have now been developed to aid in the diagnosis and treatment of UTIs.
These newer technologies include Polymerase Chain Reaction (PCR) testing which involves the amplification and detection of targeted DNA. Not only are the urine pathogens (disease-causing organisms) detected by PCR, but the test also screens for antibiotic resistance. Realtime Laboratories, Inc. in Carrollton, Texas, has implemented a UTI PCR test for 17 bacteria, 1 yeast, and 7 genes marking resistance to antibiotics. The RealTime Labs Urinary Tract Infection Panel is 99% accurate and specific.

Patients are required to fill-out a SURVEY then submit “Medical Release Form” to order the UTI test
Price: $350

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If you reside in one of those states (AK, MN, OK, AZ, MS, SD, AR, MO, TX, DE, MT, UT, NB, VT, IN, NM, VA, IA, NC, WA, KS, ND, WV, LA, OH, WI, D.C.) you may purchase this test without a physician order, however, in accordance with state laws, if you reside in all other states, a practitioner must order the test for you.

ORGANISMS ON THE RTL UTI PANEL

Gram Positive Cocci	Gram Negative Bacilli	Yeast
Enterococcus faecalis	Acinetobacter baumannii	Candida albicans
Enterococcus faecium	Citrobacter freundii
Streptococcus agalactiae	Enterobacter cloacae complex
Staphylococcus xylosus/saprophyticus	Escherichia coli
	Klebsiella aerogenes (Enterobacter aerogenes)
	Klebsiella oxytoca
	Klebsiella pneumoniae
	Morganella morganii
	Proteus mirabilis
	Proteus vulgaris
	Providencia stuartii
	Pseudomonas aeruginosa

ANTIBIOTIC RESISTANCE GENES DETECTED ON RTL UTI PANEL

Gene(s)	Antibiotics and/or Bacteria Involved
mecA	MRSA (Methicillin resistant Staphylococcus aureus (MRSA)/ Beta-lactam resistance
blaSHV	Class A Beta-lactam resistant and MRSA/Beta-Lactamase
vanB	Vancomycin resistance
ermB	Erythromycin resistance
sul1	Trimethoprim/Sulfamethoxazole (Septra/Bactrim) resistance
blaKPC	Carbapenem hydrolyzing class A beta-lactamase KPC
qnrA	Quinolone resistance

DISCLOSURE: RTL does not treat or recommend treatments for uncomplicated or complicated UTIs. The information contained here is taken from noted source documents. For further guidance, the reader may contact the Medical Department at RTL concerning any issues regarding UTIs or treatments.

Urinary tract infections (UTI) occur in more than one-half of adult women in the United States. Many will develop at least two infections in a six-month period or may even have three infections within one year. Many national and international bodies have published peer-reviewed documents on uncomplicated and complicated UTIs. The two types of urinary tract infections are shown below.

1. Uncomplicated Lower UTIs or Cystitis

Female patients without catheters and without any co-morbid conditions.

2. Complicated Lower UTIs or Cystitis

Men
Pregnant women
Women with co-morbid conditions, including but not limited to:

Kidney stones or surgery
Urinary retention
Spinal cord injury or hemiplegia
Moderate or severe liver disease
Diabetes
Chronic anticoagulation
Sickle cell disease
Immunodeficiency or on suppressants of immune system

The reader is referred to the Michigan Hospital Medicine Safety Consortium document on Guidelines for Treatment of UTIs. For further information (https://mi-hms.org/sites/default/files/UTI%20Guideline-6.9.21.pdf).

FIVE HEALTHCARE PROVIDER BENEFITS

Antibiotic Stewardship
*RealTime Labs supports the Core Elements of Antibiotic Stewardship, which includes the effort to improve how antibiotics are prescribed by clinicians and used by patients
* The test targets the infection-causing microbe, either yeast or bacteria.
* The presence of a gene for resistance to antibiotics is determined, which optimizes the physician’s ability to treat infections. This will protect patients from harm caused by unnecessary antibiotic use and thus, improve patient outcomes.
* The reader is referred to the link of CDC showing extensive documents concerning antibiotic stewardship in different patient populations:
i. https://www.cdc.gov/antibiotic-use/core-elements/outpatient.html
ii. https://www.cdc.gov/antibiotic-use/core-elements/nursing-homes.html
Reduced False Negatives
* The test results from RTL will help eliminate false negative results.
* Positive and negative controls are conducted in tandem with each patient’s test.
Reduced Bacterial Resistance with Pathogen Identification
* The international consortium noted here lists treatment modalities to use and/or avoid. https://mi-hms.org/sites/default/files/UTI%20Guideline-6.9.21.pdf
* The treatment modalities recommended in the Michigan Consortium document is as follows:

Uncomplicated Lower Urinary Tract Infection or Cystitis

Antibiotic	Duration	Considerations
Nitrofurantoin	5 days	Avoid if CrCl < 30 ml/min
Trimethoprim-sulfamethoxazole	3 days	Increasing E. coli resistance
Alternative
Fosfomycin	1 dose	Cost ~$60/dose May not be available at some retail pharmacies May consider extending duration to 3-5 doses
Oral beta-lactam	3-7 days

Complicated Lower Urinary Tract Infection or Cystitis

Antibiotic	Duration	Considerations
Nitrofurantoin	7 days	Avoid if CrCl < 30 ml/min
Fosfomycin	48 hrs x 3-5 doses	Cost ~$60/dose May not be available at some retail pharmacies
Trimethoprim-sulfamethoxazole	3 days	Increasing E. coli resistance
Oral beta-lactam, aztreonam in setting of severe penicillin or cephalosporin allergy	7 days

Uncomplicated Pyelonephritis

Antibiotic	Duration
Trimethoprim-sulfamethoxazole	7-14 days
Fluoroquinolones	5-7 days
Beta-lactams	Oral beta-lactam or oral trimethoprim-sulfamethoxazole therapy: 7-14 days

When incorrect antibiotics are prescribed, pathogens gain strength and become resistant to treatment.
Antimicrobial resistance has the potential to affect people at any stage of life, as well as the healthcare, veterinary, and agricultural industries.
This makes it one of the world’s most urgent public health problems.
Bacteria and yeast do not have to be resistant to every antibiotic or antifungal to be dangerous.

Further Information on Antibiotic Dosage

Antibiotic	Dose
Trimethoprim-sulfamethoxazole (160 mg/800 mg)	1 DS tablet po BID
Nitrofurantoin	100 mg po BID
Fosfomycin	3 g dose (see tables for complicated and uncomplicated lower UTI)
Amoxicillin-clavulanate (Augmentin)	875 mg po BID Uncomplicated cystitis: 500 mg po BID
Cephalexin	500 mg po BID Uncomplicated cystitis: 500 mg po BID
Cefpodoxime	100-200 mg po BID Uncomplicated cystitis: 100 mg po BID
Cefdinir	300 mg po BID
Cefuroxime	500 mg po BID
Ciprofloxacin	250-750 mg po BID

THE 5 Ds of Antibiotic Choice
1. Diagnosis
2. Drug
3. Dose
4. Duration
5. De-escalation (reduction in the spectrum of administered antibiotics through the discontinuation of antibiotics)
* Diagnostic tests should be used wisely to avoid unnecessary antibiotic therapy or therapy that is unnecessarily broad-spectrum, with consideration of healthcare value.
* Rapid diagnostic tests, biomarkers, and decision rules that have acceptable performance characteristics to differentiate bacterial vs. non-bacterial infection should be used to avoid unnecessary antibiotic therapy.

5. Increased Patient Satisfaction with better outcome
* The results from RealTime Labs will help healthcare providers improve patient satisfaction by providing the correct diagnostic tool and results in a timely manner.
* We deliver an overnight kit to patients with simple instructions for specimen collection and return it to the lab by overnight carrier.
* In 8 to 24 hours the results are available for review and an informed decision can be made by the healthcare provider giving personalized treatment for the patient.
* This will improve both patient satisfaction and ultimately result in better outcomes.

FIVE PATIENT BENEFITS OF THE REALTIME LABS URINARY TRACT INFECTION PANEL

The test is available in all 50 states
Test kit is sent overnight to your door
Lab results reviewed upon completion and antibiotic genetic results available to discuss antibiotic selection with the patient’s healthcare provider
More personalized approach to treating a patient’s condition
99% accurate and specific