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Kidney Disease Test Instructions

Areas of application

The PreventID® Albumin is a highly sensitive and quick test to determine the presence of albumin in urine. The detection of raised levels of albumin in urine is important for the early detection and monitoring of nephropathy (kidney disease) in diabetics and patients with high blood pressure.

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Introduction

Nearly every second diabetic develops a diabetic nephropathy (DNP) during the course of his disease. This means a kidney function disturbance that is caused by a long-term increased blood sugar level within the scope of a diabetes mellitus. Only through the early detection of a diabetic nephropathy can a progression of the kidney damage be hindered with the help of selective therapeutical measures. If a diabetic nephropathy remains undetected it will, after a few years, lead to kidney failure which will make dialysis treatment or a kidney transplant necessary.

An early sign of a nephropathy is a slight increase in the albumin concentration in the urine (= Microalbuminuria). Very small amounts of albumin are also secreted by healthy kidneys; a level of over 18 mg/l urine indicates a microalbuminuria. A microalbuminuria can also occur in non-diabetics e.g. in the case of long-term, poorly controlled high blood pressure (hypertonia).

The older urine-stick tests to determine albumin levels do not measure in this low area and are therefore not suitable for use in the detection of microalbuminuria. The PreventID® Albumin classifies a sample as negative or as positive when the albumin level is under 18 mg/l (negative) or over 18 mg/l (positive).

To be certain that a positive test result really is indicative of the beginning of a nephropathy, the testing for microalbuminuria should be repeated again twice within a time-frame of 4 weeks. If two of the three urine samples are positive, then a microalbuminuria is confirmed.

Should this be the case, it is imperative to consult a doctor and both blood sugar levels and blood pressure should be examined.

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Test principle

The PreventID® Albumin is an immunochromatographical test and is based upon antigen-antibody reactions. Human albumin will be detected.

Precautions

Do not use the test unit after the expiry date. The PreventID® Albumin should be stored, and the test conducted, at room temperature (18 – 26 °C). The test unit is sensitive to humidity and high temperatures. Therefore, the test should be protected from heat and used no later than 4 hours after opening the foil packaging. Test components are to be disposed of in the conventional garbage.

Important Information

For in vitro diagnostic use only. Do not swallow!
Do not eat or smoke while handling specimen.
Dispose of all test components in conventional garbage.
Do not use test if the pouch is torn or if the test device is visibly damaged.
Do not use the kit after the expiration date.
Any queries should be directed to Preventis GmbH, Germany

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Materials provided

A PreventID® Albumin test is comprised of the following components:

Test unit in foil packaging (the pouch with anti-moisture chemicals is not required for the test)
Test instructions

Extra utensils required: clean specimen container to collect urine, a watch (to time 3 minutes), possibly an absorbent cloth

Urine sample

Collect a sample from the first urine of the morning (middle flow) in a clean specimen container. Bring the urine sample to room temperature before conducting the test.

Conducting the test

Fill the container with a sample of the first urine of the morning (middle flow), to a liquid-height of at least 3 cm. Allow the urine to cool to room temperature (approx. 10 minutes). Open the foil packaging and remove the test unit. The pouch with anti-moisture chemicals included in the packaging is not required for the test.
Place the test unit with the narrow end down in the container with the urine sample. Carefully tap the test unit on the bottom of the container a few times to dislodge any air bubbles that may form on the plastic housing. Place the test unit in the container so that the star on it is fully immersed in the urine.
Wait for at least 3 minutes but not more than 8 hours before removing test unit to read. After removing place test unit on an absorbent paper towel.
Please note: If, within the first 3 minutes, no colour band in the upper result window develops, an air bubble has possibly hindered the entry of fluid into the test unit housing. The air bubble can be removed by gently shaking the test unit and it can then be replaced in the urine sample. Check again for a colour band in the upper result window after 3 minutes.
Read the test results within 8 hours of conducting the test with the help of the test indications. Dispose of test components in the conventional garbage.

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Test evaluation

The PreventID® Albumin determines albumin levels in a concentration area of 1 to > 2500 mg/l. The albumin concentration in urine should not be above 18 mg/l in a healthy person. Results are to be interpreted as portrayed in the figure below.

kidney disease test results

Negative Test Result

In a urine albumin test that is to be interpreted as having a negative result, the lower colour band is more intensive in colour than the upper (fig.1a) or both colour bands have the same intensity (fig. 1b). n Albumin concentration < 18 mg/l
Please note: One individual, negative result does not exclude the presence of a kidney disease with 100% certainty. Diabetics with a negative result should repeat the test no later than a year after the first test.

Positive Test Result

In a urine albumin test that is to be interpreted as having a positive result, the upper, blue colour band is more intensive in colour than the lower colour band (fig. 1c). n Albumin concentration > 18 mg/l 4.

One individual positive result (> 18 mg/l) may be an indication of kidney disease and should, in this case, be followed up by further examinations. If only the upper colour band is visible, but not the lower, the presence of a very high albumin level (at least 160mg/l, fig.1d) is indicated.

Please note: With a positive result, two further tests should be carried out on different days. If two of the three tests are positive, it is imperative that you consult a doctor and inform him of the test results. Do not make any alterations to your medication without having first consulted your doctor.

No Result

If, after conducting the test, neither of the colour bands are visible or only the lower colour band is visible, the test is invalid (fig. 1e). The test is also invalid when an interrupted colour band is visible (fig. 1g) and should be repeated with a new test unit.

Should problems reoccur during the conduction of the test, or if the results are unclear, please contact Simplicity Health.

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Test Limitations

As with all diagnostic tests, a positive result and conclusive diagnosis should not be based on the test alone, but rather on a thorough clarification of the disease symptomology by a doctor. A negative result does not exclude nephropathy with a 100% certainty.

Factors that may influence the results of a urine albumin determination

The amount of albumin excreted by a healthy person may vary according to various reasons. Physical strain or effort, increased blood pressure, pregnancy or an acute infection may cause an increase in the albumin level in urine, without the presence of a nephropathy. In cases such as these, the test should be conducted after these factors have been eliminated.

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