Microalbumin

• Latex-enhanced immunoturbidimetric assay
• Ready-to-use, liquid-stable reagents
• Only a 10pL sample quantity required
• A Wide assay range:
  • Sensitivity – 5 mg/L
  • Linearity – 300 mg/L
• Calibrators included in the kit

INTENDED USE:

This Kit is intended for Invitro quantitative determination of Microalbumin in human urine.

CLINICAL SIGNIFICANCE :

Microalbumin Kit (mALB), urinary albumin excretion of 30- 300 mg/24 hrs is used as the first marker of having diabetic nephropathy, which is common cause of renal glomerular damage. The course of disease may take several years to develop from Microalbumin to macroalbumin (urinary albumin >300 mg/24 hrs) and then transform to kidney failure, The testing result of microalbumin has been seen as a standard detection of diabetic complications.

PRINCIPLE:

The Kit utilizes latex-enhanced immunoturbidimetry to measure the mALB level in urine.During the test, mALB in the sample binds with the specific mALB antibody which is coated on latex particles to cause agglutination. The turbidity caused by agglutination is detected optically by chemistry analyzer.The change in absorbance is proportional to the level of mALB in the sample. The actual concentration is obtained by comparing with a calibration curve with known concentrations.

WORKING REAGENT:

Mix 4 parts of mALB R1 and 1 Part of mALB R2.

REAGENT COMPOSITION:

Reagent 1

Phosphate.        Buffer 100mm

NaCI.                       150mmol/L

PEG                              4%

Reagent 2

Latex particles with Goat anti-human mAlb antibody:-    4g/dL

NaCI:-    150mmol/L

STORAGE AND STABILITY:

The reagent is stable till the expiry date stated on the label when stored at 2-8°C . Protect from light and avoid contamination.

SAMPLE MATERIAL:

Follow standard laboratory procedures to collect urinesamples and store them at 2-4°C for up to 2 days or at -20°Cfor up to 1 months. Avoid repeated freezing and thawingUrine should be centrifuged before testing.

PROCEDURE OF MULTIPOINT CURVE:

Microalbumin is based on Non-Linear Reactions,henceit is strongly recommended to run Spline mode to plot the Multipoint curve to have better accuracy and precision result.

PROCEDURE:

Wavelength : 630nm (600 – 650nm)

Cuvette : 1cm light

Path Temperature: 37°C

Measure against distilled water blank

CALCULATION:

Microalbumin = Asample   /    ACalibrator    X     Conc.of Calibrator (mg/L).

LINEARITY :

The reagent is linear up to 300 mg/L. If the sample give higher Concentration should be diluted in saline Nacl 0.9% (1+4) 1 part of sample & 4 part of saline & then multiply with dilution factor by 5.

NORMAL REFERENCE RANGE:

Upto 25 mg/L or 30mg/day It is recommended that each laboratory should assign its own normal range.

QUALITY CONTROL:

To ensure adequate quality control, it is recommended that the laboratory should use a normal and abnormal commercial reference control serum.The quality control material is used to check the function of reagents and the machine together.

LIMITATIONS & PRECAUTIONS :

•  Storage conditions as mentioned on the kit to be adhered.
• Do not freeze or expose the reagents to higher temperature as it may affect the performance of the kit.
• Before the assay bring all the reagents to room temperature.
• Avoid contamination of all the reagent during assay process.
• Use clean glassware free from dust and debris.
• Reagent to sample ratio as mentioned above must be strictly observed as any change to it affects the result.
• In case reagent comes in contact with eyes,immediately rinse with plenty of water and seek medical advice.

REFERENCES:

•  Wild D(Ed.)., The Immunology Handbook 1994.
• Tietz, N.W., Textbook of Clinical Chemistry Second Edition,Burtis E.A. and Ashwood, E.R. eds. W.B. SaundersCompany, 1994
• CLSI/NCCLS, Interference Test in Clinical Chemistry, EP7-P,1986.