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Canine Package Insert

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.

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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^® Canine Urine Test detects albumin levels greater than 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.

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Procedure

See “Running the Test.”

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)

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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.

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^® Canine Urine Test Sample Dilution Tube (provided)
6. E.R.D.-HealthScreen^® Canine Urine Test Device (provided)
7. Timing device

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Sample Collection and Storage

Collect a urine sample (2 mL minimum volume) using 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.

Interpretation of Test Results

See “Interpreting Test Results.”

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.

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