IndicatoRx*

This page contains information on IndicatoRx* for veterinary use.
The information provided typically includes the following:
  • IndicatoRx* Indications
  • Warnings and cautions for IndicatoRx*
  • Direction and dosage information for IndicatoRx*

IndicatoRx*

This treatment applies to the following species:
Manufacturer: Idexx Labs.

IN-CLINIC URINARY MICROBIOLOGY TEST

Test Kit for Canine/Feline Urinary Tract Infection

Introduction And Product Use

The IndicatoRx* Test Kit, developed by IDEXX Laboratories, Inc., screens for a variety of bacterial infections in canine and feline urine specimens and provides early indication of whether an effective antibiotic is being used to treat an infection. For in vitro veterinary diagnostic use only.

IndicatoRx* is a 24 hour test that:

1. Detects the presence of bacteria in canine or feline urine samples

2. Identifies bacteria as one of the primary gram-negative uropathogens (i.e., Escherichia coli, Klebsiella, Enterobacter spp., and Proteus spp.) that are responsible for feline and canine urinary tract infections (UTI).

3. Predicts the antibiotic resistance pattern for the UTI-related gram-negative bacteria found in canine and feline urine samples.

The IndicatoRx* test device is composed of 5 test wells, labeled “BAC”, ”GM(-)”, “FQ”, “AMO”, “CEP” and 2 control wells labeled "NC" and "PC". Each test well contains a specific medium coupled with a fluorogenic enzyme substrate for the detection of target bacteria and their respective antibiotic resistance patterns. Fluorescence in the BAC well is indicative of viable bacteria in the urine sample, but does not differentiate the type of bacteria present. Fluorescence in the GM(-) well identifies the viable bacteria as one of the common gram-negative uropathogens (i.e., E. coli, Klebsiella, Enterobacter spp., and Proteus spp.). The FQ, AMO, and CEP wells each contain reagent mixtures with a different indicator antibiotic that serves as a predictor for a specific class of antibiotics. FQ is the predictor for the fluoroquinolones (i.e., ciprofloxacin, enrofloxacin and marbofloxacin). AMO is the predictor for some beta-lactams (i.e., amoxicillin, ampicillin and Clavamox). CEP is the predictor for the cephalosporins (i.e., cephalothin, cephalexin and cephadroxil). Fluorescence in the antibiotic wells indicates that the bacterium is resistant to the corresponding antibiotic. Non-fluorescence in the antibiotic wells indicates that the bacterium is susceptible to the antibiotic in that well.

Note: The antibiotic wells do not predict the susceptibility for the BAC well, only the GM(-). Therefore, in cases where only the BAC well is flourescent, indicative of gram positive bacteria, the clinician should not assume that these bacteria are susceptible to all three antibiotics.

Storage

The IndicatoRx* devices and test reagents are stable until expiration date when stored at 2° - 7°C (36° - 45°F). Alternatively, the IndicatoRx* test kit may be stored at room temperature 15° - 30°C (59° - 86° F) for 90 days. Once IndicatoRx* reagents and devices are removed from 2° - 7°C (36° - 45°F) for more than 24 hours, the expiration date is 90 days or the printed expiration date, whichever occurs first. If the 90 day expiration date would occur prior to the printed expiration, record the new date in the space provided on the outer box.

Precautions

For in vitro Veterinary Diagnostic Use Only.

After use, the IndicatoRx* device and test reagents may contain viable microorganisms. Handle and discard all waste by following Good Laboratory Practice for decontamination prior to disposal.

The expiration date applies to the product in its intact container when stored as directed. Do not use test components past the expiration date.

A separate test device, sample pipette, device pipette and sample dilution bottle should be used for each sample. Do not reuse the test device, sample pipette, device pipette or sample dilution bottle once the urine sample has been introduced.

Kit Components

Each IndicatoRx* Test Kit contains the materials necessary to perform 10 tests.

10 IndicatoRx* tests (each foil bag contains 1 test device and 1 sample pipette); 10 sample diluent bottles (5 mls/ bottle); 10 sterile wrapped device pipettes for dispensing diluted sample into device; 10 sealable plastic bags for storing devices during the incubation step; 1 Read Solution bottle (5 ml/bottle)

Other Equipment Required For Testing

6 watt 365 nm UV Lamp; Laboratory Incubator set @ 35°C

Sample Information

For best results, fresh urine specimens should be tested as soon as possible. If it is not possible to test within 4 hours, urine specimens may be stored at 2° - 7°C (36° - 45°F) for no more than 48 hours prior to testing. Samples collected either by catheterization, by cystocentesis, or as clean-catch specimens must be tested according to the protocol outlined in the test instructions of this insert (4 drops of urine).

Test Procedure

1. For each specimen to be tested, remove one foil package, one sample diluent bottle, one sterile wrapped device pipette and one sealable plastic bag from kit box. Remove the IndicatoRx* test device from the foil package. Leave the sample pipette in the foil bag until ready to transfer urine specimen. Label the device and sample diluent bottle with the patient identification.

2. Loosen cap on the diluent bottle for easier handling during the sample transfer step.

3. Using the sample pipette provided in the foil bag, carefully transfer 4 drops of the urine specimen into the sample diluent bottle. Hold the sample pipette vertically while dispensing urine sample into bottle. Be careful not to contaminate the bottle cap by setting it down on a non-sterile surface.

4. Tightly cap the sample diluent bottle and mix thoroughly by inverting several times.

5. Place the test device on a flat surface. Verify that the device windows are in the open position (blue button of the device should be set at position “o”). Care must be taken not to touch or contaminate the open wells with fingers, etc., prior to running the test.

6. Uncap the sample diluent bottle. Open the sterile wrapped device pipette and draw sample/diluent mixture up into the pipette. Holding device pipette vertically over the center of the BAC well, add 2 drops of the sample/diluent mixture into the BAC well of the device. Repeat this procedure for each of the other 6 wells, refilling the device pipette if necessary.

7. Slide the blue button of the device (from position “o” to position “x”) to close the test well windows.

8. Insert each device into a separate sealable plastic bag (included with the kit). Seal bag tightly to prevent dehydration during the incubation step.

9. Incubate the sealed device at 35°C for 24 hours.

Note: Results are valid for up to 28 hours of total incubation.

10. After incubating, remove the device from the sealed plastic bag and slide the blue button from position "x" to position "o" to open the test wells.

11. Add 1 drop of the IndicatoRx* Read Solution to each of the seven test wells. Be sure that the tip of the bottle does not come in contact with the inside of any of the wells.

12. Read the test results by placing a 6 watt 365 nm UV lamp 6 to 8 inches above the test device. The INDICATORx device contains examples of positive (PC) and negative (NC) test results that can be visualized using a UV lamp. Fluorescent wells produce a bright blue color that can be distinguished from the dull blue color in negative wells. Wells that develop a fluorescent color more intense than the negative control are positive. Use the PC and NC wells as guides to determine the test distance of the lamp from the device while reading test results. A fluorescent BAC or GM(-) well signifies a positive result indicative of bacterial growth. A non-fluorescent BAC or GM(-) well signifies a negative result indicative of no bacterial growth. Fluorescent and non-fluorescent FQ, AMO and CEP wells signify the results indicated in the table below. Be careful not to look directly at the UV source while reading the test results.

13. Slide the blue button of the device from position "o" to position "x" to close the test wells. Place the device back into the plastic bag and seal it.

NOTE: If confirmation testing is required, follow the proper storage and shipping guidelines.

Interpretation of Test Result

BAC

GM-

FQ

AMO

CEP

Result Interpretation

Recommendations

-

-

-

-

-

No bacterial growth

Confirm by a reference laboratory.1 This is indicative of bacteria other than the common gram-negative uropathogens (e.g., Staphylococcus spp. or Enterococcus spp. or some strains of Pseudomonas).2

+

-

-

-

-

Positive bacterial growth; no common gram negative uropathogens detected. Antibiotic wells do not apply.

 

+

+

-

-

-

Common gram negative uropathogens detected. The detected uropathogens are susceptible to all three classes of antibiotics.3

 

+

+

+

-

-

Common gram negative uropathogens detected. The detected uropathogens are susceptible to the beta-lactams and cephalosporins, but are resistant to the fluoroquinolones.

 

+

+

-

+

-

Common gram negative uropathogens detected. The detected uropathogens are susceptible to the fluoroquinolones and cephalosporins, but are resistant to the beta-lactams.

 

+

+

-

-

+

Common gram negative uropathogens detected. The detected uropathogens are susceptible to the fluoroquinolones and beta-lactams, but are resistant to the cephalosporins.

 

+

+

+

+

-

Common gram negative uropathogens detected. The detected uropathogens are susceptible to the cephalosporins, but are resistant to the fluoroquinolones and beta-lactams.

 

+

+

+

-

+

Common gram negative uropathogens detected. The detected uropathogens are susceptible to the beta-lactams, but are resistant to fluoroquinolones and cephalosporins.

 

+

+

-

+

+

Common gram negative uropathogens detected. The detected uropathogens are susceptible to the fluoroquinolones, but are resistant to the beta-lactams and cephalosporins.

 

+

+

+

+

+

Common gram negative uropathogens detected. The detected uropathogens are resistant to all three antibiotic classes (fluoroquinolone, beta-lactam and cephalosporin).

Confirm by a reference laboratory.1
This may be indicative of a resistant strain or a mixed culture containing several different bacteria.

Test Result Patterns other than those reported in this table are invalid.
Repeat testing is recommended
.

1 If this result pattern is obtained, it is recommended that a fresh urine sample be collected and analyzed by a reference laboratory for confirmatory testing, e.g., standard microbial identification and antimicrobial susceptibility assays. Alternatively, you may call IDEXX Customer Support at the number listed at the end of the insert to inquire about confirmatory testing using the sealed IndicatoRx* device.

2 Aucoin, DVM, David, 1998. Target The Antimicrobial Reference Guide to Effective Treatment, 1998 Edition. North American Compendiums, Inc., pp. 1-2.

3 Correlation of IndicatoRx * to Kirby-Bauer Standard Method of Susceptibility/Resistance prediction for a population of 138 canine/feline urine samples:

FQ Well

CIP 5: 95%,
ENO 5: 95%

AMO Well

AM 10: 92%

CEP Well

CF 30: 84%

Limitations

IndicatoRx* is recommended for use as a screening method for detection of bacteria in feline or canine urine specimens. It is intended for use in detecting the most common gram negative uropathogens (E. coli, Klebsiella, Enterobacter spp., and Proteus spp.) and in determining their antibiotic resistance patterns. The antibiotic resistance patterns of other bacteria e.g., Staphylococcus aureus, Enterococcus spp., and some strains of Pseudomonas, should be determined by a reference laboratory. The IndicatoRx* test is not intended for use as a method of quantitative antimicrobial susceptibility testing. If the quantitative antimicrobial susceptibility information is desired, an approved antimicrobial susceptibility test should be used.

The IndicatoRx* test is intended to assist veterinary practitioners in confirming or selecting an antibiotic treatment regimen for feline and canine bacterial urinary tract infections. As with any diagnosis or treatment decision, however, the practitioner should use clinical discretion with each patient based on a complete evaluation of the patient, including physical presentation and other relevant data.

*IndicatoRx is either a trademark or a registered trademark of Idexx Laboratories, Inc. in the United States and/or other countries.

Any questions or comments, Call IDEXX Customer Support

USA/Canada 800-248-2483

Europe 00800 1234 3399

Australia 612-310-4799

Please help us to maintain high quality of our products.

Report any unusual results to IDEXX Customer Support.

If possible, please have your kit lot number available.

Manufacturer: IDEXX Laboratories, Inc. One IDEXX Drive, Westbrook, Maine 04092, USA

06-04283-02

NAC No.: 11160611

IDEXX LABORATORIES, INC.
ONE IDEXX DRIVE, WESTBROOK, ME, 04092
Telephone:   207-556-0300
Fax:   207-556-4346
Pet Diagnostics/Order Desk:   800-248-2483
Poultry/Livestock Diagnostics:   800-548-9997
Poultry/Livestock Order Desk:   800-943-3999
Website:   www.idexx.com
Email:   lpdweb@idexx.com
Every effort has been made to ensure the accuracy of the IndicatoRx* information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-04-11

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