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Intended use

Semi-quantitative test for the detection of microalbumin in urine. Elevated urinary microalbumin levels constitute an early sign of possible kidney or cardiovascular diseases, which are characterized by albuminuria. Detection of microalbuminuria can aid in the diagnosis and treatment of incipient nephropathy in diabetics and hypertensive patients.

LREFAmerican Diabetes Association. "Consensus development conference on the diagnosis and management of nephropathy in patients with diabetes mellitus." Diabetes Care. 1994;17:1357-1361.
LREFMaher J.F "Diabetic nephropathy: early detection, prevention and management." AM Fam Physician. 1992;45:1661-1668.
LREFBorch-Johnsen K., Wenzel H., Viberti G.C., et al. "Is screening and intervention for microalbuminuria worthwhile in patients with insulin dependent diabetes?" BMJ. 1993;306:1722-1725.
LREFDeckert T, Feldt-Rasmussen B, Borch-Johnsen K, et al. Albuminuria reflects widespread vascular damage. The Steno hypothesis. Diabetologia. 1989;32:219-226.
LREFJensen JS, Feldt-Rasmussen B; Strandgaard S, et al. Arterial hypertension, microalbuminuria, and risk of ischemic heart disease. Hypertension 2000;35:898-903.
LREFAgrawal B, Berger A, Wolf K, et al. Microalbuminuria screening by reagent strip predicts cardiovascular risk in hypertension. J Hypertens. 1996;14:223-228.
LREFGerstein HC, Mann JFE, Qilong Y, et al. Albuminuria and risk of cardiovascular events, death, and heart failure in diabetic and nondiabetic individuals. JAMA. 2001;286:421-426.
LREFBigazzi R, Baldari D, Campese VM: Microalbuminuria predicts cardiovascular events and renal insufficiency in patients with essential hypertension. J Hypertens 1998;16:1325-1333.
LREFHillege HL, Janssen WM, Bak AA, et al. Microalbuminuria is common, also in a nondiabetic, nonhypertensive population, and an independent indicator of cardiovascular risk factors and cardiovascular morbidity. J Intern Med. 2001;249:519-526.
LREFKnight EL, Kramer HM, Curhan GC: High normal blood pressure and micro-albuminuria. Am J of Kidney Diseases 2003;41:588-595.

For professional use only.

For in vitro diagnostic use only.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

The albumin present in the urine specifically binds with a soluble antibody-gold conjugate present on a zone on the test strip. Excess conjugate is retained in a separation zone containing immobilized human albumin. This allows only the conjugate-albumin immunocomplex from the sample to reach the detection zone. After one minute, the intensity of the color produced (white to red) is directly proportional to the albumin content in the urine.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

The albumin concentration of an average urine specimen should not exceed 15‑20 mg/L.

LREFCembrowski G, Testing for Microalbuminuria: Promises and Pitfalls, Laboratory Medicine. 1990;21:491-496.

Clinical diabetic nephropathy is indicated when microalbuminuria (> 20 mg/L) is present in at least 2 of the 3 morning urine samples.

LREFMogensen CE, Cohen JJ, Jarrington JT, et al. Microalbuminuria as a predictor of clinical diabetic nephropathy. Kidney Int. 1987;31:673-689.

A normal microalbuminuria value does not rule out renal disease.

LREFAmerican Diabetes Association. "Consensus development conference on the diagnosis and management of nephropathy in patients with diabetes mellitus." Diabetes Care. 1994;17:1357-1361.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "


The amount of albumin excreted in the urine can vary according to changes in posture, amount of hydration, physical activity, blood pressure in the individual, and during pregnancy. Because of this individual variation, it is recommended that at least 3 separate samples be collected and analyzed within a given week to obtain an accurate assessment of the patient.

LREFMogensen CE, Cohen JJ, Jarrington JT, et al. Microalbuminuria as a predictor of clinical diabetic nephropathy. Kidney Int. 1987;31:673-689.
Urine samples should not be obtained following strenuous physical activity.

A wet detection pad indicates that the reaction has come to an end. If the detection pad is still dry after 1 minute despite correct immersion depth and duration, check the color development after another 1 or 2 minutes.

Acute illnesses that present with fever are known to cause an increase in urinary albumin excretion, such as urinary tract infection or bleeding into the urinary tract. Urine from menstruating females will occasionally yield a false positive result. Therefore, a decision of the usefulness of the test must be made by the professional. It is recommended that testing of individuals be performed when there is no longer a condition. No cross reactivity exceeding 0.5 % has been found with IgA, IgG, human leukocytes and erythrocytes, α1‑antitrypsin, acidic α1‑glycoprotein, α‑amylase, hemoglobin, transferrin or Tamm‑Horsfall proteins. 

LREFSchlipfenbacher RL, U Traeger, W Werner. Micral-Test: the first immuno-metric dipstick for rapid and easy screening of microalbuminuria, Poster Presentation, American Association of Clinical Chemistry, July 1990.

The Bence‑Jones protein leads to false‑positive results and to elevated positive results. The Retinol‑binding protein leads to elevated positive results.

Common therapeutic drugs and endogenous substances were tested for a potential interference to the Chemstrip Micral test strips.
For therapeutic drugs testing within this range the following observations were made:

Therapeutic drugs

No interference up to

Effect above stated concentration

Ascorbic acid

400 mg/L



100 mg/L


Salicyluric acid

100 mg/L


Except for oxytetracycline which leads to a 15 % elevation of the test result

LREFEvaluation Report, Micral-Test II, Roche Diagnostics.
and ascorbic acid, ofloxacine and salicyluric acid which lead to false-negative results, no interference by drugs has been found. Knowledge of the effects of drugs upon the test may not be complete. In doubtful cases, it is therefore advisable, as far as it is medically justifiable, to repeat the test after discontinuation of the medication.

Endogenous substances were tested at abnormal high concentrations.

For endogenous substances testing within this range the following observations were made:

Endogenous substance

No interference up to

Effect above stated concentration


2500 mg/L

False positive and elevated albumin results


300 mg/L

False positive and elevated albumin results


150 mg/L


Uric acid

550 mg/L



40000 mg/L



120 mg/L

Elevated positive


11 mg/L

No valid test result due to color interference

Specimens should not be collected in containers that have been cleaned with strong oxidizing agents.

If specimen is colder than 10 °C (50 °F), the color reaction is diminished.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "




", "Language": "en" }, { "Name": "SystemInformation", "Value": "", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Test strips are ready‑for‑use.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Store at 2‑8 °C.


unopened at 2‑8 °C

up to the stated expiration date

after opening at 2‑30 °C

6 months provided it does not exceed the expiration date

Write the date the strips were opened on the container. Discard the container and strips 6 months after the date opened or after the expiration date on the container, whichever comes first.

Do not use the test strip after the specified expiration date.

Tightly re‑cap the container immediately after removing a test strip.

Do not freeze.

", "Language": "en" }, { "Name": "Calibration", "Value": "


Calibration of Chemstrip Micral test strips by the user is not required.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

The performance characteristics of the Chemstrip Micral product have been determined in both the laboratory and clinical tests. Parameters of importance to the user are sensitivity, specificity, accuracy, and precision. Generally, the tests have been developed to be specific for the constituent to be measured with the exception of interferences listed previously.

For visually read strips, accuracy is a function of the manner in which the color blocks on the vial label are determined and the discrimination of the human eye in reading the tests. Precision is difficult to assess in a test of this type because of the variability of the human eye. It is for this reason that each user is encouraged to develop his own standards for performance.

Studies in a sample population prone to renal pathology were conducted to compare Chemstrip Micral semi‑quantitative results with values obtained from a quantitative RIA method and a quantitative immunoprecipitin method.

", "Language": "en" }, { "Name": "Precision", "Value": "


Repeatability- 10 replicates of 4 urine specimens at different levels were assayed by 3 operators. The level of precision was determined based on the frequency with which each operator obtained replicate readings on the same specimen. The following percents of replicate readings were obtained:

Concentration Tested (mg/L)

Operator 1

Operator 2

Operator 3


100 %

100 %

100 %


100 %

100 %

90 %


100 %

100 %

100 %


100 %

80 %

100 %

Lot-to-Lot - 10 replicates of each level were assayed on 2 lots of Chemstrip Micral test strips by 3 operators. The following percents of replicate readings were obtained:

Concentration Tested (mg/L)

Operator 1

Operator 2

Operator 3


100 %

100 %

100 %


100 %

100 %

90 %


100 %

100 %

100 %


100 %

90 %

100 %

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "


Microalbuminuria refers to an albumin concentration in the urine which is greater than normal, but usually not detectable with routine protein dipstick assays which permit measurement of albumin at levels of 15 mg/dL or greater. There are multiple renal disease etiologies in which laboratory findings include proteinuria.

LREFThe Merck Manual, Volume 1, Clinical Evaluation of Genitourinary Disorders: Diagnostic Procedures, General Medicine, 15th Edition, 1987;1199.
Albumin is the prominent protein in most renal diseases.
LREFThe Merck Manual, Volume 1, Clinical Evaluation of Genitourinary Disorders: Diagnostic Procedures, General Medicine, 15th Edition, 1987;1199.
Monitoring low concentrations of albumin in the urine is helpful for early detection in patients at risk for renal disease.

Those at risk for renal disease in which albuminuria may be present include, but are not limited to, patients with type 1 and type 2 diabetes, hypertension,

LREFScherberich JE, Mösbauer A, Meissner A, et al. Kidney and serum derived proteins in urine of patients suffering from renal diseases or arterial hypertension. Klin Wochenschr. 1989;67 Suppl 17:44-47.
LREFMujais SK., Marked proteinuria in hypertensive nephrosclerosis. Am J Nephrol. 1985;5(3):190-195.
and renal disease in pregnancy.
LREFKincaid-Smith P; Fairley KF., Renal disease in pregnancy, Am J Kidney Dis. 1987;9(4):328-333.
LREFChakhashvili GI., The significance of immunochemical study of plasma albumins and uroproteins in pregnant women. Soobshch Akad Nauk Gruz. 1979;SSR 94(2):493-496.
Of all patients beginning therapy for end‑stage renal disease in the United States, diabetic nephropathy is the major cause of renal failure in 25 %.
LREFFriedman EA. Diabetic Nephropathy. Strategies in prevention and management. Kidney Int. 1982;21:780-791.
Recent studies of the natural history of patients with long-standing diabetes showed that microalbuminuria preceded clinical diabetic nephropathy.
LREFCembrowski G, Testing for Microalbuminuria: Promises and Pitfalls, Laboratory Medicine. 1990;21:491-496.
Further studies indicate that normalization of blood glucose and blood pressure can prolong the progression from microalbuminuria to clinical nephropathy.
LREFCembrowski G, Testing for Microalbuminuria: Promises and Pitfalls, Laboratory Medicine. 1990;21:491-496.

", "Language": "en" }, { "Name": "Reagents", "Value": "


Each test contains per 1 cm2 test patch area the following:

Monoclonal antibodies: Anti-human albumin (immunoglobulin G) labelled with colloidal gold (mouse): 6 µg, fixed albumin: 9.5 µg.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

Product safety labeling follows EU GHS guidance.

Do not touch test zone or remove white covering foil from test strip. Chemstrip Micral test strips contain albumin of human origin.

All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods used assays approved by the FDA or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.
However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.

LREFOccupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.
LREFDirective 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.

Dispose of used test strips according to the regulations for potentially infectious materials. The remaining packaging components can be disposed as ordinary packaging materials.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Quality control for this procedure consists of following good laboratory techniques, ensuring that reagents have been properly stored and specimens handled according to instructions. The analyst should be aware of the sources of error outlined under \"Limitations-interference.\" Each laboratory should establish its own goals for adequate standards of performance.

Commercially prepared control solutions should be used on a regular basis, as established by your institution’s quality control protocols. The value range of the controls should be within the Chemstrip Micral test strip reading range of 0‑100 mg/L.

If the expected results are not obtained and repetition of the assay excludes errors in technique, the following steps should be taken:

  1. Check the expiration date on the vial label.

  2. To verify that the Chemstrip Micral test strip has not been exposed to extreme heat or moisture, open a new vial of test strips and retest.

  3. For further information, contact US Customer Technical Support 1-800-440-3638.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

When performing a test using Chemstrip Micral test strips, the urine specimen should be collected in a clean, dry specimen container. When a urine culture is ordered, it is necessary to collect the specimen in a sterile container.

LREFGraff, Sister Laurine, A Handbook of Routine Urinalysis. 1983:7.
Perform the culture prior to testing for microalbuminuria as the test strip will contaminate the specimen. Due to the physiological variation of albumin, it is recommended that 3 separate morning (midstream) urine samples be collected and analyzed within a given week. If testing cannot be performed within 3 days of collection, the urine sample should be refrigerated. Urine that has been refrigerated (for a maximum of 2 weeks) must be brought to at least 50 °F (10 °C) before testing. Any turbidity of the urine does not affect the test results. The use of urine preservatives with this product has not been evaluated; therefore, the use of preservatives is not recommended. Urine samples that have been allowed to stand at room temperature for more than 3 days or refrigerated for more than 14 days are considered unacceptable for analysis.
LREFEvaluation Report, Micral-Test II, Roche Diagnostics.
The sample should not be frozen.

", "Language": "en" } ] } } ] }

Micral-Test® strip

Quick, early and reliable detection of albumin in urine1,2,3

IVD For in vitro diagnostic use.
Micral-Test® strip
Do you have any questions?

Reliable results to detect albumin in urine1,4


Normal urine contains very little protein: usually, less than 10 mg/dL or 100 mg per 24 hours is excreted.5 Persistent microalbuminuria indicateds a high probability of damage to the kidney glomerular filtration capacity.Albuminuria is the term used when albumin levels reach >200 mg/L in the urine.6 Microalbuminuria is the term used when albumin levels in the urine are 20-200 mg/L.6 Even though only a small amount of albumin is present in the urine in microalbuminuria, this can be an indicator that the patient has the beginnings of kidney damage.7 Patients with microalbuminuria have an elevated risk of developing progressive renal disease as well as increased risk of cardiovascular disease.8 Action taken by a healthcare practitioners (HCP) at this stage can halt or reverse the damage to the kidneys.12

Suitable for all patient groups, the Micral-Test strip is a cost efficient way to gain actionable health information.9,11

Specific for human albumin9

The Micral-Test® strip is based on an immuno­logical test principle using gold-labelled monoclonal antibodies with a chromogenic color indicator enabling confidence in results.


Sensitive across the diagnostic range9,10


The Micral-Test® is used as an aid in early diagnosis of microalbuminuria via detection of microalbumin in urine.1,2,3


Fast and easy


After 60 seconds, the result is ready for visual reading with a convenient color comparison on the strip box. The Micral-Test strip is easy to handle.2


Special design of the Micral-Test strip delivers accurate results4,9


  • The Immunological test principle with monoclonal antibodies is highly specific for human albumin
  • The urine sample is absorbed by the test strip and transferred through the following two zones before reaching the detection pad:
    Zone 1 – Conjugate Fleece contains free gold-labelled antibodies
    Zone 2 – Capture Matrix Fleece with fixed human serum albumin (HSA)
Micral-Test® strip illustration

Three simple testing steps

Step 1

Dip the test strip into the urine for 5 seconds 

Step 2

Place the strip on a nonabsorbent surface or across the top of the collection cup to allow excess urine to drain, wait for 1 minute

Step 3

Compare the color of the detection pad on the strip with the color scale on the test strip vial

The expected value for normal urine samples
  • The albumin concentration of an average urine specimen should not exceed 15 – 20 mg/L13
  • Clinical diabetic nephropathy is indicated when microalbuminuria (> 20 mg/L) is present in at least two of the three morning urine samples9
  • A normal microalbuminuria value does not necessarily rule out renal disease10


  1. Solarin, A. U. & Njokanma, F. O., 2015. The Micral-Test as a screening tool to detect microalbuminuria-albuminuria in children 5 - 15 years old with sickle cell anaemia, Lagos State University Teaching Hospital. SAJCH, 9(2), pp. 41-44.
  2. Afifa, K. & Asma, S. B., 2016. Screening for Nephropathy in Diabetes Mellitus: Is Micral-Test Valid among All Diabetics?. International Journal of Chronic Diseases, Volume 2016(Article ID 2910627), p. 7.
  3. Król, E. & Rutkowski, B., 2009. Early Detection of Chronic Kidney Disease: Results of the PolNef Study. Amercian Journal of Nephrology, Volume 29, p. 264–273.
  4. Amjad, A. & Muhammad, S., 2017. Role of Micral Test For the Detection of Microalbuminurea. Med. Forum, 28(8), pp. 36-38.
  5. Strasinger, S. K. & Di Lorenzo, M. S., 2007. Urinalysis and Body Fluids. 5th ed. Philadelphia(PA): F. A. Davies Company. p 57.
  6. Hasslacher. C. 1993. Clinical significance of microalbuminuria and evaluation of the micral-test. Clin Biochem. Volume 26 (4). pp. 283-287.
  7. Glassock, R. J., 2010. Is the presence of microalbuminuria a relevant marker of kidney disease?. Curr Hypertens Rep, 12(5), p. 365.
  8. Singh, A. & Satchell, S. C., 2011. Microalbuminuria: causes and implications. Pediatr Nephrol, 26(11), p. 1957.
  9. Micral-Test®, Method Sheet-package insert
  10. American Diabetes Association. “Consensus development conference on the diagnosis and management of nephropathy in patients with diabetes mellitus.” Diabetes Care. 1994;17:1357-1361.
  11. Srisubat A. & Sriratanaban J.. 2014. Cost-effectiveness of annual microalbuminuria screening in Thai diabetics. Asian Biomedicine 8(3). pp. 371-379
  12. Cembrowski G.. 1990. Testing for Microalbuminuria: Promises and Pitfalls. Laboratory Medicine. Volume 21. pp. 491-496.
  13. Chemstrip® Micral®, Method Sheet-package insert


Detailed Specifications

Ordering Information

Compatible Instruments

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