HESKA E.R.D.-HealthScreen Canine Urine Test (Canada)

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HESKA E.R.D.-HealthScreen Canine Urine Test

This treatment applies to the following species:
Manufacturer: Heska

IN-CLINIC TEST

EARLY RENAL DAMAGE

In vitro test for the detection of microalbuminuria in dogs.

Product Description

The E.R.D.-HealthScreen™ Canine Urine Test is a rapid immunoassay that detects low levels of albumin in canine urine. The test is specific, sensitive and simple to use. It is intended to be used as a test to determine whether more comprehensive evaluation for early renal damage is indicated.

Early Renal Damage In Dogs

The kidneys filter a dog’s entire blood volume every 30 minutes. As a result, they are continually exposed to a myriad of potentially damaging substances, infectious agents, or conditions (e.g., antigen-antibody complexes, toxins, bacteria, hypertension). Various disease processes may damage nephrons, resulting in leakage of albumin into the urine. Examples of these disease processes include the following:

Inflammatory diseases (e.g., dental disease, pyoderma, immune-mediated diseases, inflammatory bowel disease); Infectious diseases (e.g., heartworm, ehrlichiosis, Lyme); Metabolic diseases (e.g., diabetes mellitus, hyperadrenocorticism, hypertension); Neoplasia

Low levels of albumin in the urine are referred to as “microalbuminuria” (“micro-” refers to small amounts of albumin, not the size of albumin). Persistent microalbuminuria suggests the presence of either an underlying disease process causing early renal damage or lower urinary tract disease (LUTD). Detection of microalbuminuria during a routine health examination provides veterinarians with a new tool to discover many common canine diseases that are subclinical.

Progressive Renal Disease In Dogs

Chronic progressive renal disease is a leading cause of death in dogs. Conventional renal disease diagnostic tests (e.g., serum urea nitrogen, serum creatinine, urine specific gravity) are only capable of detecting “late-stage” renal disease when the kidneys have lost >70% of their functional nephrons. Therefore, apparently healthy dogs can have undetected progressive renal disease and a diagnosis is frequently not made until the dog presents with clinical signs of “end-stage” disease.

Plasma albumin is normally excluded from the glomerular filtrate primarily because of its size. The small amount of albumin that normally escapes into the glomerular lumen is reabsorbed or degraded by tubular epithelial cells.1 As a consequence, there are two potential mechanisms by which nephron damage can lead to microalbuminuria. First, glomerular damage can result in increased “leakage” of albumin into the glomerular filtrate, exceeding the capacity of the tubular albumin retrieval and degradation pathways. Second, tubular damage can result in decreased retrieval and/or degradation of albumin from the glomerular filtrate. Therefore, either glomerular or tubular damage can result in a continuous low level of albumin being excreted in the urine. The E.R.D.-HealthScreen test detects albumin levels >1.0 mg/dL in canine urine. In models of progressive renal disease in dogs, microalbuminuria is an early indicator of disease and increasing microalbuminuria correlates with disease progression.2-4

NOTE: The prevalence of microalbuminuria exceeds the reported occurrence of end-stage renal disease in dogs. Thus, the majority of microalbuminuric dogs will not progress to develop end-stage renal disease. Microalbuminuria, especially when increasing in magnitude over time, is a risk factor for the development of end-stage renal disease. While all persistently microalbuminuric dogs are “at risk” of developing end-stage renal disease, most will not due to tremendous renal reserve capacity. Increased monitoring of “at risk” dogs [See Suggestions for Managing Microalbuminuric, Non-azotemic Dogs] will allow for earlier identification of individual animals that progress to end-stage renal disease.

1 Russo LM, et. al. Renal handling of albumin: a critical review of basic concepts and perspective. Amer J Kidney Dis 2002;39:899-919.

2 Vaden SL, et. al. Longitudinal study of microalbuminuria in Soft-Coated Wheaten Terriers. J Vet Intern Med 2001;15:300.

3 Grauer GF, et. al. Development of microalbuminuria in dogs with heartworm disease. J Vet Intern Med 2002;16:352.

4 Lees GE, et. al. Persistent albuminuria precedes onset of overt proteinuria in male dogs with X-linked hereditary nephropathy. J Vet Intern Med 2002;16:353.

Suggestions For Managing Microalbuminuric, Non-azotemic Dogs

If an underlying disease condition is identified (counsel owners that an underlying disease is discovered in >50% of patients), treat, and re-test. If an underlying condition is not identified and the microalbuminuria trend is stable or decreasing, suggestions for patient management include the following: Monitor patient (e.g., physical examination, urinalysis + E.R.D.-HealthScreen Canine Urine Test, and serum creatinine every 6 - 12 months); Prevent inflammatory, infectious and/or metabolic diseases that could contribute to kidney damage (e.g., counsel owners on the importance of periodic health examinations, maintaining good oral health, heartworm testing and prevention, flea and tick prevention); Treat dehydration aggressively with intravenous fluids (e.g., counsel owners on the importance of seeking medical attention for treatment of persistent vomiting or diarrhea); Provide hemodynamic support with intravenous fluids during anesthesia; Use potentially nephrotoxic drugs judiciously and increase monitoring of animals that require therapy with these compounds

If an underlying condition is not identified and the magnitude of microalbuminuria increases over time, additional suggestions include the following: Monitor patient (e.g., physical examination, urinalysis + E.R.D.-HealthScreen Canine Urine Test, serum creatinine, blood pressure measurement every 3 - 6 months); Consider additional diagnostic procedures (e.g., thoracic and abdominal radiography, abdominal ultrasonography, serology for regionally prevalent infectious diseases, renal biopsy); Implement specific therapies reported to delay progression of renal disease such as prescription renal disease diet and ACE inhibitors; Counsel owners on the recognition of early clinical signs associated with decreases in renal function (e.g., polyuria, polydipsia)

Suggestions For Managing Azotemic Dogs

Dogs with end-stage renal disease may or may not have a positive result with the E.R.D.-HealthScreen Canine Urine Test. As the number of functional nephrons decline, microalbuminuria may decrease or become negative. In these dogs, a decreasing trend in the magnitude of microalbuminuria is associated with disease progression and is not an indication of improvement.

Management of azotemic dogs may include the Suggestions for Managing Microalbuminuric, Non-azotemic Dogs [See previous section] as well as medical management of chronic end-stage renal disease.

HESKA E.R.D.-HealthScreen Canine Urine Test Indications

The E.R.D.-HealthScreen Canine Urine Test is a tool developed specifically to assist veterinarians in the detection of microalbuminuria in dogs, to help monitor the progression of early renal damage, and to help monitor the success of treatment programs.

Required Materials

1. Canine urine sample (2 mL)

2. Refractometer

3. Distilled water

4. Test tube or container - if sample dilution is required (not provided)

5. E.R.D.-HealthScreen™ Urine Canine Test Sample Dilution Tube (provided)

6. E.R.D.-HealthScreen™ Urine Canine Test Device (provided)

7. Timing device

Sample Collection And Storage

Collect a urine sample (2 mL minimum volume) using either the E.R.D.-HealthScreen™ Urine Sample Kit (available separately from Heska) or standard procedures (e.g., free catch, catheterization, cystocentesis). Urine samples may be stored refrigerated at 2° - 7° C (36° - 45° F) for up to 24 hours. For longer storage, freeze at or below -20° C (-4° F) in vials with airtight seals. NOTE: Stored samples must be warmed to room temperature prior to testing.

Procedure

1. Using a refractometer, determine the specific gravity of the urine sample.

2. Prepare and dispense urine into the E.R.D.-HealthScreen Canine Urine Test Sample Dilution Tube according to the following instructions:

If the specific gravity is less than 1.020

Add the urine sample to the line marked 1.020

If the specific gravity is 1.020 or above (to the upper limit of the refractometer)

Add the urine sample (1 mL) to the line marked “Sample”; Add distilled water to the line that matches the specific gravity of the urine sample

If the specific gravity is greater than the upper limit of the refractometer

Dilute the urine sample 50:50 - use 1 mL of urine and 1 mL of distilled water - in a separate container (i.e., not the Sample Dilution Tube); Measure the specific gravity of the diluted sample - this is the specific gravity utilized for running the test; Add the diluted sample (1 mL) to the line marked “Sample”; Add distilled water to the line that matches the specific gravity of the diluted sample

NOTE: Following instructions in Step 2 allows each urine sample to be normalized (i.e., standardized) prior to performing the test. Therefore, specific gravity variations will not affect comparison of sequential urine samples from the same dog.

3. Cap the Sample Dilution Tube and mix the sample by inverting the tube 3 times.

4. Remove the E.R.D.-HealthScreen Canine Urine Test Device from the foil pouch and place it into the Sample Dilution Tube. Move the Test Device up and down twice to ensure proper sample flow.

5. Leave the Test Device in the urine sample for a minimum of 3 minutes (not to exceed 1 hour).

6. Remove the Test Device and read results by comparing relative intensities of the colored band(s) in the test window (Refer to “Interpretation of Results” Section).

Interpretation Of Test Results

Compare the band(s) in the test window with the “Interpretation of Results” card. The relative intensity of the band(s) is used to classify the sample into one of two categories: Negative or Positive. The sample is negative if the bottom band is darker than the top band. The sample is positive if the 2 bands are equal in intensity (low positive), if the top band is slightly darker than the bottom band (medium positive), if the top band is very dark and the bottom band is very faint (high positive), or if the top band is very dark and the bottom band is absent (very high positive).

If no bands are present, if only the bottom band is present, or if the bands appear broken or blotched, the test is invalid and should be repeated.

A negative result with the E.R.D.-HealthScreen Canine Urine Test indicates the dog does not have detectable microalbuminuria (i.e., urine albumin levels are <1.0 mg/dL).

A positive result with the E.R.D.-HealthScreen Canine Urine Test indicates the dog has readily detectable microalbuminuria (i.e., urine albumin levels are >1.0 mg/dL).

Changes in the level of microalbuminuria, as an indication of disease progression or response to treatment, can be monitored using the semiquantitative E.R.D.-HealthScreen Canine Urine Test or alternatively, using a quantitative laboratory test available through Heska.

Call 1-800-GO HESKA (800-464-3752) for more details.

Precautions

1. Do not use grossly hematuric samples. Urine samples that are visibly pink or red will be positive due to contamination with blood albumin.

2. Do not use the Test Device or Sample Dilution Tube more than once.

3. The Test Device must be used within 1 hour after opening the foil pouch. Discard any opened, unused test devices.

Storage And Stability

Store test kit at room temperature (15° - 30° C [59° - 86° F]).

See package for expiration date.

For technical assistance, call Heska at 1-800-GO HESKA.

Patents Pending.

©2003 Heska Corporation.

Presentation: Available in cartons of 10 tests.

NAC No.: 15550020

HESKA CORPORATION
Distributed by AVENTIX ANIMAL HEALTH CORP.
4350 MAINWAY, BURLINGTON, ON, L7L 5R7
Telephone:   905-332-4744
Toll-Free:   877-909-2242
Fax:   905-332-4844
Website:   www.aventix.ca
Email:   aventix@aventix.ca
Every effort has been made to ensure the accuracy of the HESKA E.R.D.-HealthScreen Canine Urine Test information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-09-05

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