Urine Microalbumin (mALB) Assay Kit – Bulk Reagents

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US$299.00

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Selling unit: per 100ml

Product Name

  1. Common name: Urine microalbumin (mALB) determination kit (immunoturbidimetric method)
  2. English name: mALB Reagent Kit (Immunoturbidimetric Method)

Reagent Ratio

3:1, 4:1, 5:1, common ratio 3:1, other ratios need to be customized

Intended Use

This kit is used to determine the amount of microalbumin (MALB) in human urine.

Measurement of albumin in urine can better identify proteinuria caused by increased glomerular pathological permeability and is an indicator for the diagnosis of early kidney injury.

Test Principle

Trace amounts of albumin in the sample react with specific anti-human albumin antibodies in buffer, immediately forming insoluble antigen-antibody complexes and producing a certain turbidity. The turbidity level reflects the amount of MALB in the sample, and the amount of MALB in the sample can be calculated by comparing it with the standard curve prepared from the same treated calibrator.

Main Components

Reagent components included in the product.

Urine Microalbumin (mALB) Assay Kit & Bulk Reagents

*Components are not interchangeable in kits with different lot numbers.

*Reagent components not included in the product, but necessary for the test: outsourced normal and abnormal QCs and calibrators.

Storage Conditions And Expiration Date

The kit is stored at 2-8°C away from light and is valid for one year.

Reagents that have been opened are taken care not to be contaminated and the reagents are stabilized in the instrument compartment (2-8°C) for one month.

The reagents must not be frozen.

Applicable Instruments

Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 series automatic biochemical analyzers.

Sample Request

Collect mid-morning urine or 24h random urine, if the liquid is clear, please measure it immediately; if the liquid is turbid, please centrifuge (3000 r/min×10 min) to take the supernatant for analysis; if the test is not timely, please add sodium azide reagent (0.05%) to the sample to preserve it, store it at -20 ℃, thaw the specimen at room temperature before the test, mix and centrifuge as above, and take the supernatant for analysis.

MALB in the sample is stable for 7 days when stored at room temperature (15-25 °C), for 1 month at 2-8 °C and for 6 months at -20 °C.

Test Method

  1. Reagent preparation: liquid reagents are ready to use out of the bottle.
  2. test conditions: (different test instruments can be requested according to the different parameters on the machine)

Urine Microalbumin (mALB) Assay Kit & Bulk Reagents

Operation steps.

Urine Microalbumin (mALB) Assay Kit & Bulk Reagents

*Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers.

  1. Calibration procedure.

Use the matching calibrator.

  1. QC control procedures.

It is recommended that each laboratory establish its own quality control system and select appropriate quality control products for quality control. The measured values of QC products should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.

  1. Calculation.

5 points are calibrated and the corresponding values are entered. Plot the standard curve with △A as vertical coordinate and concentration as horizontal coordinate, and correct this standard curve with suitable mathematical model such as Logit-Log4P, Spline model, and save this standard curve for calculating the results. The reagents of different batches must be re-calibrated.

Positive Judgment Value Or Reference Interval

0~30 mg/L

It is recommended that each laboratory establish its own reference range of normal values.

Interpretation Of Test Results

The mALB measurement in urine is only one of the indicators used by the clinician to make a diagnosis of the patient. The clinician must also make a comprehensive judgment based on the patient’s physical symptoms, medical history, and other diagnostic items and diagnostic tools.

Limitations Of The Test Method

The following substances were dissolved into urine containing HSA at concentrations of 23.4 mg/L and 40.9 mg/L for measurement, and these substances did not cause interference with the albumin results of this experiment in the following concentration ranges: VC ≤ 4 g/L, bilirubin ≤ 250 mg/L, and

Cre ≤ 4g/L, Gentamicin ≤ 10g/L, Glu ≤ 40g/L, acetaminophen ≤ 5g/l, KCL ≤ 10g/L, NaCl ≤ 20g/L, UREA ≤ 40g/L.

Product Performance Index

Absorbance of reagent blank: wavelength 340 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≤ 0.25.

Analytical sensitivity: the absorbance change rate ΔA/min≥0.04 when the kit tests 2.0 mg/L of the analyte.

Linearity interval: for the test serum samples, the linear correlation coefficient|r| should be not less than 0.975 in the interval of 2~240 mg/L. In the interval of 2~30 mg/L, the absolute deviation of linearity should not exceed 3 mg/L; in the interval of (30~240 mg/L, the relative deviation of linearity should not exceed ± 10%.

Precision: repeatability CV ≤ 10%; relative extreme difference between batches ≤ 15%.

Accuracy: Relative deviation ≤ 10%.

Caution

  1. 1. This product is for in vitro diagnosis only.
  2. 2. Avoid contamination when using the reagent, the container used must be clean, and please take necessary precautions, do not swallow, and avoid contact with skin and mucous membrane.
  3. 3. Please dispose of the measured samples and waste liquids in accordance with the relevant national and local laws and regulations.
  4. 4. When changing the reagent lot number, please recalibrate.

Reference

  1. ERCNNA, THEIMMUNOTURBIDIMETRIC CEASUREMENT OF IMMUNOGLOBULING, CLIN, CHEM.(1990), 71 (3): 1410-1458
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