Rapid self-test for the detection of albumin in urine (renal failure)

General Points

Albumin is normally present in the urine in very small quantities or is not detectable. A high albumin level reflects dysfunction of the filtering function of the kidneys. Glucose or triglyceride (fat) concentration and a history of diabetes or hypertension are factors that promote the urinary excretion of albumin.

The M-Albu-Check-1 Strip is a manual qualitative immunochromatographic screening test for the detection of abnormal albumin concentrations in urine. It can be used at home by lay users for self-testing.
In less than 10 minutes, it is possible to detect abnormal albumin concentrations in the urine.

Test Procedure

  1. – Collect a urine sample using the supplied plastic cup (urine sample height : between 1 cm and 1.5 cm in the cup).

  2. – Tear the aluminium pouch (from the notch) and remove the strip only, holding it by the grip end. Dispose of the desiccant bag.

  3. – Dip the strip vertically in the cup containing your urine sample, placing it in the notch provided for that purpose (Fig. 1) during 5 to 10 seconds.

    WARNING : THE URINE LEVEL MUST NOT EXCEED THE HORIZONTAL BLUE LINE PRINTED ON THE STRIP UNDER THE SMALL ARROWS.

  4. – Place the strip horizontally on a flat dry surface and allow the reaction to occur.

  5. – Read the result after 5 to 10 minutes. Do not interpret the result after 15 minutes.

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Results Interpretation

For the interpretation of the results, it is necessary to compare the intensity of the coloration of the test line and the control line (Fig. 2).

Urine level indicator
Test line
Control line
Grip end

Positive result

The intensity of the control line coloration is higher than the coloration of the test line. This result indicates that your urine contains more than 20 mg/L of albumin. Please repeat the assay with a new test. If again positive, you are advised to consult your physician.
Caution: in some cases, the test line may not develop at all.

Borderline result

The coloration intensity of the test line and the control line is similar. This result indicates that your urine contains between 10 and 20 mg/L of albumin. Please control your urinary albumin level from time to time.

Negative result

The intensity of the test line coloration is higher than the coloration of the control line. This result indicates that your urine contains less than 10 mg/L of albumin.

Inconclusive result

If there is no line appearing in the control zone, the test is invalid. In this case, it is not possible to interpret the test and it is recommended to repeat the test with a new M-Albu-Check-1 Strip and a fresh urine sample.

Questions and Answers

How does M-Albu-Check-1 Strip work?

The kidneys filter the blood to remove impurities. Thus, compounds of small size are eliminated in the urine while larger proteins are retained. Albumin is one of those proteins. If the kidneys are functioning normally, albumin is not present in the urine or is only present at very low concentrations. The M-Albu-Check-1 Strip test enables determination of abnormal albumin concentrations in the urine.
In case of positive result, it means that the Microalbumin concentration is higher than 20 mg/L (as determined against ERM* standard).
*European Reference Materials

The test should preferably be conducted with the first urine of the morning.

The concentration of compounds in the urine is generally higher in the first urine of the morning. For that reason, morning urine samples should preferably be used to obtain the best results. However, the M-Albu-Check-1 Strip test may be conducted on a urine sample obtained at any time of day.

If the result is positive, it means that the test has detected more than 20 mg/L of albumin in your urine. This result may be a temporary change in your physiological state. Repeat the test several days later. If the positive result is confirmed, consult your physician and show him/her the test and leaflet.

A borderline result means that the test has detected an albumin concentration greater than 10 mg/L and less than 20 mg/L. This result does not require particular surveillance other than regular control of your urinary albumin level.

Yes, intensive physical exertion induces an increase in urinary albumin level. You should avoid conducting a M-Albu-Check-1 Strip test in that context.

Yes, in the event of blood in urine, inflammation, immune disorders, urinary tract infection or HIV infection. All those states may be accompanied by an elevated urinary albumin concentration.

Excessive liquid intake the day before the test may induce a false-negative result. Conversely, inadequate fluids intake may induce a false positive result. You should therefore drink normally.

The M-Albu-Check-1 Strip test is accurate and has been used for more than 20 years by professionals (hospitals, laboratories) in the field. Evaluation reports show an overall agreement of 98.63% (CI 95% [94.87 – 100]) ** with reference method. Although this test is reliable, false positive or false negative results could be obtained.

** IC 95%: 95 % Confidence Interval.