Albumin Reagents (BCG Method) – Clinical Chemistry

Intended Use: This reagent kit is used for in-vitro quantitative determination of Albumin in serum and plasma. 

Pack size: 2 × 50 ml 

Stability: 18 months 

Storage: 2° to 8° C 

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Product overview

VDx Albumin (BCG Method) is a liquid reagent for the quantitative determination of albumin in serum and plasma. Under acidic conditions, albumin binds to bromocresol green (BCG) to form a green-coloured albumin–BCG complex, which is measured photometrically at 628 nm. The intensity of the colour formed is directly proportional to albumin concentration in the sample. 

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Test specifications

• Method: BCG (end point) 

• Wavelength: 628 nm (600–650 nm) 

• Specimen: serum or heparinised plasma 

• Incubation (manual): 1 minute; read within 10 minutes 

• Linearity: 6 gm/dl 

• Units: gm/dl 

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Intended use

This reagent kit is used for in-vitro quantitative determination of Albumin in serum and plasma. 

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Test principle

Under acidic conditions, albumin present in the serum sample binds to bromocresol green to form a green-coloured albumin–BCG complex, which is photometrically measured at 628 nm. Intensity of the colour formed is directly proportional to albumin concentration in the sample. 

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Kit contents

• Reagent 1: BCG Reagent
• Reagent 2: Calibrator (concentration as indicated on the label)
• Insert: 01 No. 

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Preparation of the working reagent

VDx Albumin liquid reagent is ready to use. 

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Storage and stability

VDx Albumin liquid reagent is stable till the expiry date indicated on the labels when stored at 2–8°C. Bring reagents to room temperature prior to use and return reagents to the refrigerator after use. 

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Specimen collection and storage

Serum or heparinised plasma can be used. Samples should preferably be used on the same day. If necessary, samples may be preserved up to one week if stored at 2–8°C. Bring samples to room temperature prior to use. 

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Test procedure (manual)

Pipette into test tube: 

• Blank Standard Test
• BCG reagent 1.0 ml 1.0 ml 1.0 ml
• Calibrator – 10 µl –
• Sample – – 10 µl
• Distilled water 10 µl – –
  

Mix and read the absorbance of the Test (At), Calibrator (Ac) and Blank (Ab) after 1 minute and within 10 minutes at 628 nm (600–650 nm) against distilled water. 

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Calculations

Albumin (gm/dl) = (At − Ab) / (Ac − Ab) × Albumin concentration provided on calibrator label 

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Expected values

Albumin: 3.2 – 5.5 gm/dl

It is recommended that each laboratory should establish its own normal range. 

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Performance characteristics 

• Linearity: 6 gm/dl 
• Comparison: r = 0.97; y = 0.96x − 0.2 
• Precision: within-run and run-to-run CV% values are provided in the IFU table (Low/High). 
• Specificity / Interference notes: ampicillin is noted as a highly interfering substance in the BCG method; no interference up to 1 gm/L haemoglobin and bilirubin 30 mg/dl. 

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Automated applications

VDx Albumin liquid reagents can be used with (examples listed in IFU): Hitachi 700 series, 1000, 2000, XT, Express 550 plus, Syncron CX4, Lisa BTR 810/820/830, RA 50, Erbachem-5 plus, etc. Application sheets are available on request. 

Input parameters: end point reaction; wavelength 628 nm; incubation time 1 min; calibrator concentration as on label; units gm/dl; reagent volume 1 ml; serum/calibrator volume 10 µl; linearity 6 gm/dl. 

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Precautions (selected)

• For in-vitro diagnostics use only.
• Do not inhale the reagent or pipette by mouth.
• Do not freeze or expose reagents to higher temperature.
• Before the assay bring reagents to room temperature.
• Avoid contamination of reagent during assay process.
• Use clean glassware free from dust or debris.
• Do not use the reagent if it is hazy or cloudy. 

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Quality control

For accuracy, it is necessary to run known serum controls with each assay. 

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Frequently Answered Questions

What are albumin reagents used for?

They are used for in-vitro quantitative determination of albumin in serum and plasma. 

Which method does this albumin reagent use?

BCG method, measured photometrically at 628 nm (600–650 nm). 

What sample type is required?

Serum or heparinised plasma. 

What is the stated measuring range?

Linearity is stated as 6 gm/dl.