UTI Assay, PCR

CPT: 87086

  • Aid in the differential identification of Urinary Tract Infection Pathogens and Antibiotic Resistance Markers by nucleic acid amplification

    Pathogens

    • Acinetobacter baumannii

    • Bacteroides fragilis

    • Candida albicans*

    • Candida dubliniensis*

    • Candida glabrata*

    • Candida krusei*

    • Candida parapsilosis*

    • Candida tropicalis*

    • Citrobacter freundii

    • Citrobacter koseri

    • Enterobacter cloacae

    • Enterococcus spp.

    • Escherichia coli

    • Klebsiella aerogenes

    • Klebsiella oxytoca

    • Klebsiella pneumoniae

    • Morganella morganii

    • Mycoplasma genitalium*

    • Mycoplasma hominis*

    • Prevotella bivia*

    • Proteus mirabilis

    • Pseudomonas aeruginosa

    • Serratia marcescens

    • Staphylococcus aureus

    • Staphylococcus epidermidis

    • Staphylococcus saprophyticus

    • Streptococcus agalactiae (Group B)*

    • Streptococcus pyogenes (Group A)

    • Ureaplasma urealyticum*

    Antibiotic Resistance Markers

    • Class A beta-lactamase

    • Class A beta-lactamase

    • Class B metallo-beta-lactamase

    • Vancomycin A

    • Vancomycin B

    • Methicillin/Oxacillin

    • Sulfonamides

    • Fluoroquinolones

    • Trimethoprim

    Methodology

    Multiplex real-time PCR (RT-PCR)

    Reference Interval

    Not detected

    Limitations

    Not Detected (Negative) results do not preclude an infection and should not be used as the sole basis for treatment or other patient management decisions. Not Detected (Negative) results must be combined with clinical observations, patient history and other clinical information.

    Detected (POSITIVE) results are indicative of possible active infection but do not rule out fungal infection or co-infection with other bacteria.

    The pathogen(s) detected may not be the definite cause of disease. A positive (Detected) test result may be observed after successful antibiotic treatment due to target nucleic acid from residual not viable organism(s).

    DISCLAIMER:

    The assays in the molecular panel are not 510K cleared, but managed by CMS and FDA under the Clinical Laboratory Improvement Amendment (CLIA) as a laboratory developed test (LDT). The analytical performance characteristics of these assays have been determined by FutureGeneration Laboratories. The assays have been validated pursuant to the CLIA regulations and are used for Clinical Diagnostic Purposes.

    • Insurance

    • If insurance is not billed, patients are responsible for the cost for testing - $200.

  • 1-3 days

    Turnaround time is defined as the usual number of days from the date of receipt of a specimen to the laboratory. Testing schedules may vary.

  • Submit one specimen per specimen source on tests requested

    Collection

    All providers must follow the provided collection and processing instructions. These instructions are adopted in FutureGeneration Laboratories’ established policies and procedures – including patient and specimen identification, processing, storage and rejection.

    Note: Specimen collection is not conducted at FutureGeneration Laboratories. Clinical specimens are only processed and tested by the laboratory.

    Collection of Clean Catch Urine for Women (Test: UTI Plus)

    1. Wash hands thoroughly with soap and water.

    2. Open the towelette and remove the cap on the Sterile Container. Set the cap aside, with the inside facing up. Avoid touching the inside of the cap or container.

    3. Separate the skin folds around the urinary tract opening.

    4. Using the towelette, cleanse the urinary opening and surrounding areas from front to back.  Discard the towelette after cleansing.

    5. Urinate into the toilet for a few seconds and then bring the empty container into the path of the stream to collect a clean, mid-stream specimen.

    6. Finish voiding the remaining urine into the toilet.

    7. Tightly screw the cap back onto the container.

    8. Provide fresh, unpreserved specimens to the clinician immediately.

    9. Clinician will transfer Urine into Urine vacutainer containing preservative boric acid (grey top) tube.

    Collection of Clean Catch Urine for Men (Test: UTI Plus)

    1. Wash hands thoroughly with soap and water.

    2. Open the towelette and remove the cap on the Sterile Container. Set the cap aside, with the inside facing up. Avoid touching the inside of the cap or container.

    3. If present, retract the foreskin away from the urethral opening.  Using the towelette, cleanse the urethral opening and work away from the area to cleanse the entire head of the penis. Discard the towelette after cleansing.

    4. Urinate into the toilet for a few seconds and then bring the empty container into the path of the stream to collect a clean, mid-stream specimen.

    5. Finish voiding the remaining urine into the toilet.

    6. Tightly screw the cap back onto the container.

    7. Provide fresh, unpreserved specimens to the clinician immediately.

    8. Clinician will transfer Urine into Urine vacutainer containing preservative boric acid (grey top) tube.

    Transferring Urine into Preservative Tube (Test: UTI Plus)

    1. Unscrew the cap on the sterile container containing the urine specimen.

    2. Submerge tip of transfer straw into the specimen.

    3. Push the Urine vacutainer containing preservative boric acid (grey top) tube into the transfer straw completely. Hold in position until the flow stops.

    4. Remove Urine vacutainer containing preservative boric acid (grey top) tube, leaving transfer straw in the specimen container, and invert 8-10 times to completely mix the sample.

    5. Dispose of the transfer straw into the sharps container and screw the cap back onto original sterile container.

    Volume

    3 mL

    StorageRequirements

    Maintain specimen at 15°C to 30°C up to 3 days.

    Rejection Criteria

    The following samples will be unacceptable for testing and will be rejected: 

    1. Specimen is unlabeled or improperly labeled. Properly labeled includes two patient identifiers matching submitted requisition form.

    2. Requisition form is missing or incomplete.

    3. Specimen is improperly sealed, resulting in leakage and possible contamination during transport.

    4. Incorrect specimen type (i.e. non-clean catch sample).

    5. Insufficient sample volume for testing.

    6. Urine specimens submitted in Aptima buffer or other container with no bacteriostatic preservative.

    7. Specimens received after 3 days post-collection.

    8. Co-mingled samples.

    9. If the laboratory received a specimen and the reason for rejection cannot be resolved, the provider will receive a rejection report.

  • None