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.

For professional use only.

For in vitro diagnostic use only.

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.

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

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

A normal microalbuminuria value does not rule out renal disease.

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.

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. 

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:

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

Endogenous substances were tested at abnormal high concentrations.

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

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.

Test strips are ready‑for‑use.

Store at 2‑8 °C.

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.

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

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.

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:

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:

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.

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,

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.

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.

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

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.

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.